prior authorization medications requiring review...

Prior Authorization Medications Requiring Review – Criteria for Use The Medicare Part D formulary does not allow prior authorization or criteria restrictions on medications; this document applies to the

Commercial, Triple Tier, Multi-Choice, and Qualified Health Plans formularies. * The Pharmacy Consult Service reviews criteria restrictions for Diabetes, Hepatitis C, and Multiple Sclerosis Medications

Last Revised: February 3, 2017 CONFIDENTIAL: FOR INTERNAL KAISER PERMANENTE USE ONLY

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Brand Name and/or Therapeutic Class

Generic Name J-Code Medicare Status Notes

Acthar® Corticotropin gel J0800 Medicare Part D Reviewed by the Pharmacy Consult Service for Mutiple Sclerosis indication only

Ampyra™ Dalfampridine Medicare Part D Reviewed by the Pharmacy Consult

Service Arcalyst™ Rilonacept powder for

solution J3490 Medicare Part D

Aubagio® Teriflunomide Medicare Part D Reviewed by the Pharmacy Consult

Service Berinert® Human C1 Inhibitor Medicare Part D Botulinum Toxin: Botox® (P) Dysport™ (N) Myobloc® (N) Xeomin® (N)

Botulinum Toxins Type A Botulinum Toxins Type B

J0585 (type A) J0587 (type B)

Medicare Part D

Cerdelga™ Eliglustat Medicare Part D Cholbam® cholic acid Medicare Part D Cinqair® Reslizumab Medicare Part B or D Cinryze® Human C1 Inhibitor Medicare Part B or D Daklinza® Daclatasvir Medicare Part D Reviewed by the

Pharmacy Consult Service


of 76



Dipeptidyl peptidase 4 (DPP-IV) inhibitors*: Tradjenta™ (P) Jentadueto™ (P) Januvia™ (N) Janumet™ (N) Juvisync™ (N) Nesina™ (N) Onglyza™ (N) Kazano™ (N) Kombiglyze™ XR (N) Oseni™ (N) Glyxambi™(N)

Linagliptin Sitagliptin Sitagliptin and metformin Linagliptin and metformin Sitagliptin and simvastatin Alogliptin Saxagliptin Alogliptin and metformin Saxagliptin and metformin ER Alogliptin and pioglitazone Linagliptin and empagliflozin

Medicare Part D Reviewed by the Pharmacy Consult

Service

Eloctate Antihemophilic Factor (Recombinant)

Medicare Part B

Entyvio® Vedolizumab Medicare Part B or D Enzyme replacement therapy: Vpriv® (P) Cerezyme® (N) Elelyso® (N)

Velaglucerase Alfa Imiglucerase Taliglucerase Alfa

Epclusa® sofosbuvir and velpatasvir Medicare Part D Reviewed by the Pharmacy Consult

Service Fabrazyme Agalsidase Beta Firazyr® (N) Icatibant Medicare Part D Gattex® (N) Teduglutide

Medicare Part D

Gilenya™ (N) Fingolimod Medicare Part D Reviewed by the Pharmacy Consult

Service Glatiramer acetate Glatopa (P) Copaxone® (N)

Glatiramer acetate


Service

GLP-1 Receptor Agonists*: Bydureon™ (P) Byetta™ (N) Victoza® (N) Tanzeum (N) Trulicity (N)

Exenatide Extended-Release Exenatide SQ solution Liraglutide injection Albiglutide Dulaglutide


Service

Growth Hormones: Omnitrope® (P) Genotropin® (N) Humatrope® (N)

Somatropin (Growth hormone) injectable

J2940-J2941

Medicare Part D


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Norditropin® (N) Nutropin AQ (N) Saizen® (N) Serostim® (N) Zorbtive® (N) Harvoni® Ledipasvir and sofosbuvir Medicare Part D Reviewed by the


Hetlioz® Tasimelteon Medicare Part D Hyaluronic Acid Derivatives (viscosupplements): Supartz® (P) Synvisc® (2) Euflexxa® (N) Hyalgan® (N) Orthovisc® (N) Synvisc-One® (N)

Hyaluronic Acid Injections J7321-J7322 Medicare Part B

Ilaris® Canakinumab Medicare Part D Interferons: Avonex® (P) Plegridy® (N)

Interferon beta-1a Peginterferon beta-1a

Medicare Part D

Reviewed by the Pharmacy Consult

Service


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Jetrea® Ocriplasmin Juxtapid™ Lomitapide Medicare Part D Kalbitor® Ecallantide Medicare Part D Kalydeco™ Ivacaftor Medicare Part D Korlym™ Mifepristone Medicare Part D Kuvan™ Sapropterin tablets J3490 Medicare Part D Kynamro™ Mipomersen sodium Medicare Part D Lemtrada® Alemtuzumab Medicare Part B Reviewed by the


Natpara® Parathyroid hormone Medicare Part D Nucala® Mepolizumab Medicare Part B or D Olysio® Simeprevir Medicare Part D Reviewed by the


Orkambi® lumacaftor and ivacaftor Medicare Part D Procysbi™ Cysteamine delayed-release Medicare Part D Prolia® Denosumab Medicare Part B or D Provenge® Sipuleucel-T Q2043 Medicare Part B Ravicti® Glycerol phenylbutyrate Medicare Part D Ruconest® C1 inhibitor (recombinant) Medicare Part B or D Sabril® Vigabatrin Medicare Part D Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitors*: Jardiance™ (P) Invokana™ (N) Farxiga™ (N) Glyxambi™(N) Invokamet™(N) Xigduo XR™(N)

Empagliflozin Canagliflozin Dapagliflozin Empagliflozin and linagliptin Canagliflozin and metformin Dapagliflozin and metformin

Medicare Part D

Reviewed by the Pharmacy Consult

Service


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Somavert® Pegvisomant Medicare Part D Sovaldi® Sofosbuvir Medicare Part D Reviewed by the


Supprelin® LA Histrelin implant J9226 Medicare Part D Symlin*® Pramlintide SQ solution J3490 Medicare Part D Reviewed by the


Tecfidera™ Dimethyl fumarate Medicare Part D Reviewed by the Pharmacy Consult

Service Technivie® Ombitasvir/paritaprevir/

ritonavir Medicare Part D Reviewed by the


Tysabri® Natalizumab IV solution J2323 Medicare Part B Reviewed by the Pharmacy Consult

Service for Mutiple Sclerosis indication only

Viekira Pak® Viekira XR®

Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir


Service Xenazine® Tetrabenazine Medicare Part D Xgeva® Denosumab Medicare Part B Xiaflex™ Collagenase clostridium

histolyticum injection J0775 Medicare Part B

Xolair® Omalizumab injectable J2357 Medicare Part D Zavesca® Miglustat Zepatier® Elbasvir and Grazoprevir Medicare Part D Reviewed by the


Zinbryta™ Daclizumab Medicare Part D Reviewed by the Pharmacy Consult

Service P- Preferred when criteria met 2-2nd line (if preferred failed) NP- Non-preferred

*Because the Medicare Part D formulary does not allow prior authorization or criteria restrictions on medications, this document applies to the Commercial, Triple Tier, and Multi-Choice formularies.

CONFIDENTIAL: FOR INTERNAL KAISER PERMANENTE USE ONLY

Last Revised: February 3, 2017 of 76

Medications Requiring Review – Criteria for Use Drug Prior Authorization Criteria

Acthar® (Corticotropin (gel))

Candidates for treatment with Acthar® should meet the following pertinent criteria: Acthar® gel will not be covered in patients with any of the following diagnoses:

• Congestive heart failure • Uncontrolled Hypertension • Osteoporosis • History of or presence of peptic ulcer • Primary adrenocortical insufficiency or adrenocortical hyperactivity • Scleroderma • Hypersensitivity to porcine protein • Pancreatitis • Thromboembolic disorder • Ocular herpes simplex • Systemic fungal infections

Criteria for use for diagnosis of infantile spasms:

1. Diagnosis of infantile spasms 2. Less than 2 years of age 3. Prescribed by pediatric neurologist or neurologist

Criteria for use for Nephritic Syndrome:

1. A diagnosis of idiopathic nephritic syndrome 2. Prescriber must be a nephrologist 3. Patient failed to achieve a sustained partial or complete remission of nephritic syndrome

after 6 months of therapy with first line therapy (i.e., corticosteroids) AND after 6 months of therapy with second line therapies with demonstrated efficacy (i.e., cyclosporine, tacrolimus, rituximab, and mycophenolate mofetil). Patient is expected to continue therapy for at least 3 months and is able to afford the cost of therapy in order to prevent abrupt discontinuation of therapy.

Criteria for use for FDA-approved corticosteroid responsive conditions:

1. A documented diagnosis of any of the following conditions: a. Rheumatic disorder (psoriatic arthritis, rheumatoid arthritis, ankylosis spondylitis) b. Collagen diseases (SLE, polymyositis) c. Treatment of serum sickness d. Treatment of systematic sarcoidosis e. Ophthalmic-disease (keratitis, iritis, optic neuritis, anterior segment inflammation) f. Dermatological diseases (severe erythema multiforme or Stevens Johnson

syndrome) 2. Patient experienced a limited or unsatisfactory response or experienced intolerance to IV or

high dose oral steroids

Criteria for use for acute exacerbation of MS: 1. Documented diagnosis of acute exacerbation of multiple sclerosis 2. Prescribed by a neurologist 3. Patient experienced a limited or unsatisfactory response or experienced intolerance to IV or

high dose oral steroids




Drug Prior Authorization Criteria 4. Patient is currently on an immunomodulator agent for the treatment of multiple sclerosis 5. Patient demonstrates severe exacerbation symptoms (i.e severe weakness, severe loss of

vision, severe coordination problems, or severe walking impairment) Approval period: 6 months for nephritic syndrome and 3 months all other indications Monitoring: Laboratory monitoring for BMP, blood pressure, pulse, A1C, weight, and TSH, cholesterol (i.e., TC, LDL, HDL and triglycerides) should be completed at baseline and every 3 months for the duration of treatment with Acthar® gel

Ampyra™ (Dalfampridine)

Ampyra™ extended release tablets should be reserved for treatment intended to improve walking capacity in ambulatory patients with multiple sclerosis (MS). Ampyra™ is symptomatic treatment only and is not disease-modifying.

Candidates for treatment with Ampyra™ should meet the following criteria: 1. Must be prescribed by a neurologist 2. Patient has a confirmed diagnosis of MS. 3. Patient is ambulatory with a baseline 25 foot walk between 8 to 45 seconds

a. Documentation of baseline timed 25 foot walk must be submitted by the prescribing physician.

4. Should be used for improvement of speed of ambulation. 5. Physical therapy should be considered and appropriately used before exposing patients to

Ampyra™ 6. Patient must have normal renal function (CrCl > 50 ml/min). 7. Patient does not have a history of seizures

Reasons for non-coverage Ampyra™ should NOT be used in patients with any of the following:

1. History of seizures 2. Moderate or severe renal impairment

o Moderate renal impairment is defined as creatinine clearance (CrCl) of 30 to 50 mL/min; severe impairment is defined as CrCl of less than 30 mL/min.

3. Non-Ambulatory patients o Ampyra™ clinical trials included only ambulatory patients. Therefore, efficacy and

safety have not been tested in non-ambulatory patients. 4. Patients taking any other form of fampridine, such as compounded fampridine (4-

aminopyridine or 4-AP) products.

Initial approval period: 2 months • Patient should be evaluated for response 30-60 days after starting the medication • Patient should be instructed that continuation on the drug depends upon being evaluated for

response. • Patients should be advised that the reason for this evaluation is to avoid any unnecessary

exposure to the drug and its possible risk. Continued approval: If a response is obtained during the first 2 months that the patient is on the medication, medical records documenting this response, including the walking time for the 25 foot walking test after taking Ampyra™ along with a new prior authorization request should be submitted prior to continued approval being granted. Continued approval period is 12 months.




Drug Prior Authorization Criteria Response Assessment: A response should become evident within two weeks. Patients should be given a trial of Ampyra™ lasting from 30 to 60 days and then evaluated for response to determine whether to continue the drug. One objective indicator should be used, along with any subjective indicators, to assess response.

a. A useful objective assessment is the Timed 25-Foot Walk (T25FW) test. This was the test used in clinical trials qualifying Ampyra™ for approval.

i. A baseline should be established at one or more visit after any possible physical therapy and before initiation of Ampyra™.

ii. Response to Ampyra™ can then be evaluated with repeat T25FW tests (or equivalent) after 30 to 60 days of drug.

b. A subjective assessment should include meaningful improvements in functional parameters or activities of daily living.

c. Response to Ampyra™ should be evident within two months. i. Continuation of Ampyra™ in patients who do not have a significant response – a

majority of patients in clinical trials – may expose these patients to the risk of seizures without sufficient benefit to justify the risk.

ii. Modest improvements in walking speed or function must be considered against the risk of seizures.

Dosing: • The maximum dose of Ampyra™ is one 10 mg tablet twice daily, approximately 12 hours

apart. Patients should NOT take more than 10 mg every 12 hours. o Patient education must include emphasis on spacing doses approximately 12 hours

apart. Irregular dosing intervals will result in uneven blood levels since the drug itself has a relatively short half-life. Uneven drug levels could raise the risk for seizures.

o Patients must be cautioned not to “double-up” if they miss a dose and not to take a possible “extra” dose if they have forgotten whether they took a dose.

o Patients must be advised to always swallow tablets whole and to never split, crush, chew, or otherwise disrupt the extended-release formulation, since this could lead to uneven blood levels.

Notes:

• Ampyra™ results were modest in published studies. o Only about 30% of clinical trial patients had an improvement in average walking

speed of 20% or more (while about 10% of placebo-treated patients had the same level of improvement). To put this in perspective, an average 20% improvement in a timed walk over a 25-foot distance means on average the patient walked 25 feet 8 seconds if baseline was 10 seconds, or in 10 seconds if baseline was 12.5 seconds.

o In clinical trials, a response was defined as having an improvement in walking speed in more than half of the timed 25-foot walk tests. In two trials, 35% and 43% of patients met this standard for improvement (versus 8% and 9% of placebo-treated patients. In the minority of patients who achieved this response criterion, the improvements amounted to just under 2 seconds improvement over 25 feet, versus a 0.5 second improvement with placebo.

These average improvements should be weighed against the risks of treatment – primarily the risk for seizures. Ordering information:




Drug Prior Authorization Criteria Ampyra™ is available through the KP Specialty Pharmacy. Prescribers must complete the KP Specialty Pharmacy Ampyra™ Drug Order Form at http://pharmacy.kp.org/Kp-CMS/California/DrugInformation/ViewMedSafetyDNMgmtCA.aspx?I32Object=1084&nodeValue=113 and fax it to KP-SP (1-650-301-5790).

Arcalyst™ (Rilonacept)

Candidates for treatment with Arcalyst™ should meet ALL the following criteria:

1. Diagnosis of cryopyrin-associated periodic syndromes (CAPS) 2. Patient has documented laboratory evidence of a genetic mutation in the Cold-Induced Auto-

inflammatory Syndrome 1 (CIAS1- sometimes referred to as the NLRP3). 3. There is clinical documentation that the patient is experiencing classic symptoms of CAPS in

either criteria below: a. Familial Cold Auto-Inflammatory Syndrome (FCAS) - recurrent episodes of rash,

fever/chills, and joint pain following exposure to mild cold environment (e.g. cool breeze, air conditioning). Symptoms generally last for up to 24 hours.

b. Muckle-Wells Syndrome (MWS) - chronic fever and rash sometimes exacerbated by generalized cold exposure. Episodes can last up to 2-3 days.

4. There is clinical documentation of significant functional impairment leading to limitations of activities of daily living (ADLs).

5. Failed, intolerant, or allergic to at least one of the following: a. Anakinra (Kineret®) injection b. Canakinumab (Ilaris®) injection

Reasons for non-coverage:

• Concurrent use of live vaccines or tumor necrosis factor • Chronic or active infections • Untreated latent tuberculosis • 11 years or younger

Initial approval period: 1 month Continued approval: 12 months based on physician documentation of disease stability and improvement. Caution:

• Increased risk of malignancies may occur Monitoring:

• Improvement in signs and symptoms of cryopyrin-associated periodic syndromes (ie, fever, urticaria-like rash, arthralgia, myalgia, fatigue, and conjunctivitis)

• Lipid profiles; 2 to 3 months after initiation of therapy and periodically Dosing:

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Drug Prior Authorization Criteria • Adult dose: The recommended loading dose is 320 milligrams (mg) subcutaneously (SubQ) as

2 doses of 160 mg at 2 different sites. Followed by 160 mg SubQ once-weekly. Do not administer more than once weekly.

• Pediatric dose: The recommended loading dose is 4.4 milligrams/kilogram (mg/kg) subcutaneously (SubQ) (up to a maximum dose of 320 mg) as 1 or 2 injections with a maximum volume of 2 mL. If administered as 2 injections, then administer at 2 different sites. Followed by 2.2 mg/kg (up to a maximum dose of 160 mg) SubQ once weekly. Do not administer more than once weekly

Aubagio® (Teriflunomide)

Aubagio (teriflunomide) tablets should be reserved for treatment of relapsing forms of multiple sclerosis in patients with moderate disease activity who have contraindications or severe intolerance to preferred therapies or have severe injection site reactions not responsive to conservative measures. Candidates for treatment with Aubagio® should meet ALL the following criteria:

1. Documented diagnosis of relapsing-remitting multiple sclerosis (RRMS) 2. Prescribed by a Neurologist 3. Females of child bearing age (12-50 years of age) should have a baseline negative pregnancy

test (within 1 month) AND agreement to be on two forms of reliable birth control ( confirm order for IUD or other contraceptive)

4. Documented negative PPD (tuberculin) test 5. Aubagio is being used as monotherapy 6. Documented severe intolerance or relative contraindication to glatiramer acetate (Glatopa or

Copaxone®)* AND one interferon therapy (ie. Avonex®, Betaseron®, Extavia® or Rebif®)* OR 7. Patient is unable to master self-injection technique and lacks a caregiver who can perform

injections OR 8. Patient has a history of severe injection site reactions not responsive to conservative

measures while on injectable agents for MS (eg: lipoatrophy or skin necrosis) *NOTE: Injection fatigue or fear of needles is not a reason for intolerance or inadequate response. Reasons for non-coverage: Aubagio should NOT be used in patients with ANY of the following:

• Secondary progressive MS with no clinical or MRI evidence of relapses • Good disease control and tolerance of another disease-modifying drug for MS • Pre-existing hepatic disease or total bilirubin, ALT or AST greater than 2 times the upper limit

of normal • Clinical conditions or medications which could potentially affect or worsen hepatic function • Current leflunomide treatment • Pregnancy or lactation • High-risk features for early progression to secondary-progressive MS (see Table 1)




Drug Prior Authorization Criteria For patients with ANY high-risk features listed in Table 1, escalation therapy with Gilenya (preferred), Tysabri or Rituxan (off-label) may be more appropriate and should be recommended instead.

Table 1: High-risk features for early progression History of MS attack/relapse with

Lesion load Duration Symptom type Timing / frequency

≥ 30 days and significant functional

limitations, except for ongoing sensory

symptoms

Sphincter OR Motor OR

Cerebellar (ataxia or tremor)

≥ 3 relapses in the first 2 years after

diagnosis OR Average of ≥ 1

relapse/ year over 2 to 3 years OR

After 6 months of therapy, relapse in the next 6 months

After 1 yr of therapy, ≥ 3 new or enlarging T2 lesions, continued gad+ lesions, or diffusion-restricted imaging lesions over a 1 yr period OR

≥ 5 lesions over 2 years OR

≥ 1 cord lesion Initial approval period: 1 year Continued approval for treatment with Aubagio® should meet ALL the following criteria:

1. Adherence to Aubagio (≥ 80%) 2. Documented beneficial effect from therapy 3. Documented ALT measured monthly for first 6 months of therapy

Note: Consider discontinuation if ALT ≥ 3 x ULN 4. Documented bilirubin and CBC measured within 6 months of therapy

Continued approval: 1 year Dosage and Administration

• The recommended dose of Aubagio® is 7 mg or 14 mg daily. • Due to the possibility of increased risk of infections, Aubagio should be used as monotherapy

and not in combination with other disease-modifying therapies for MS. • Aubagio should be used with caution in patients who are receiving chronic

immunosuppressant therapy, other immunomodulatory drugs, or are significantly immunocompromised for any reason.

Monitoring

• All patients should have the following laboratory values completed within 6 months prior to and post initiation of therapy: complete blood count (CBC), liver transaminase, and serum bilirubin.

• All patients should be monitored for signs and symptoms of infection • All patients should have a baseline and periodic monitoring of blood pressure • Renal function and potassium levels should be monitored in patients with symptoms of renal




Drug Prior Authorization Criteria failure or elevated potassium levels

• All patients should be screened for latent tuberculosis infection with a tuberculin skin test before starting the drug

• For women of childbearing potential, patient agrees to use a form of contraception to prevent pregnancy during Aubagio treatment and for two months after discontinuation of Aubagio

Ordering information: Aubagio® is available through the KP Specialty Pharmacy. If approved for coverage, prescribers must complete the KP-SP Aubagio Order Form and fax it to the KP-Specialty Pharmacy (1-650-301-5790).

Berinert® (Human C1 Inhibitor)

Candidates for treatment with Berinert® should meet ALL the following criteria:

1. A diagnosis of Type I or Type II hereditary angioedema. 2. Prescriber must be an allergist. 3. Treatment of acute facial or abdominal facial attacks of HAE in adult or adolescent patients 4. Contraindications or inability to tolerate 17α-alkylated androgens (ex. danazol, oxandrolone

and stanozolol) (especially in females of child-bearing age, 12-50 years of age), including hirsutism, menstrual irregularities, hepatic dysfunction, undiagnosed vaginal bleeding, porphyria, cardiac or renal disease, depression, muscle cramps and thrombosis. Patients with significant lipid abnormalities might also be considered.

5. Lack of response to currently available therapies such as 17α-alkylated androgens as evidenced by lack of symptom control.


• Routine prophylaxis against angioedema attacks in adolescent and adult patients with HAE • Treatment for laryngeal attacks • 12 years of age or younger

Initial Approval: 3 months

Subsequent approval will be based on clinical documentation of functional improvement, a decrease in frequency of HAE attack, and an improvement in severity and duration of attacks.

Monitoring: • Symptomatic improvement • Symptoms of hypersensitivity reaction during or after infusion • Signs of thrombosis

Consider long-term prophylaxis for patients with HAE who experience ≥one severe event per month or who are disabled more than five days per month OR if the patient has a history of previous airway compromise. Options include:

1. 17α-alkylated androgens (danazol, stanozolol if available, and oxandrolone): Generally treatment of choice for long-term preventative treatment. Contraindications include

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Drug Prior Authorization Criteria pregnancy, breastfeeding, significantly impaired renal/ hepatic function, etc (refer to package insert for complete list). See Milan or Budapest Protocols for dosing recommendations. Use in children should be undertaken only with great caution.

2. Antifibrinolytics (epsilon aminocaproic acid [Amicar]): Less effective than androgens. Often reserved for patients who do not tolerate or in whom anabolic androgens are contraindicated.

3. Human C1 inhibitor (Cinryze®) replacement: May be necessary in patients in whom androgens are not effective (frequent angioedema attacks), not tolerated or contraindicated.

o Human C1 inhibitor prophylaxis is the safest prophylactic agent to use during pregnancy.

Botulinum Toxins: Preferred: Botox® Type A Injections Non-preferred: Dysport® Type A Injection Myobloc® Type B Injections Xeomin® Type A Injection

Candidates for treatment with Botulinum products should meet ALL the following pertinent criteria: Botulinum products are not interchangeable; potency differences may exist between the products. Use of Botulinum Toxin for Hyperhidrosis* Patient must meet ALL criteria for coverage:

1. Receive recommendation from Dermatology after failed medical treatment with Drysol® and Robinul®.

2. Medical complications from hyperhidrosis including skin maceration or dermatitis. 3. No history of neuromuscular disease. 4. No recent infection or malignancy in affected area. 5. No history of hyperthyroidism.

Use of Botulinum Toxin for Blepharospasm** Patient must meet ALL criteria for coverage

1. Diagnosis of bilateral blepharospasm 2. No neuroleptic-induce blepharospasm 3. No known hypersensitivity to botulinum toxins, human serum albumin, or sucrose 4. No treatment with botulinum toxins for any other indications within the past 16 weeks

Use of Botulinum Toxin for Cervical Dystonia Patient must meet ALL criteria for coverage

1. Diagnosis of primary cervical dystonia (CD) 2. Negative impact on quality of life (pain, motor function impairment, abnormal appearance

leading to isolation) 3. Muscles involved can be adequately localized to treat with botulinum toxins 4. No history of neuromuscular disease 5. No known hypersensitivity to botulinum toxins, serum albumin, or sucrose 6. No treatment with botulinum toxins for any other indications within the past 16 weeks

Use of Botulinum Toxin for Overactive Bladder




Drug Prior Authorization Criteria 1. Diagnosis of overactive bladder 2. Symptoms of urge urinary incontinence, urgency, and frequency 3. Documented inadequate response to or are intolerant to at least 2 of the following:

a. Oxybutynin b. Trospium c. Oxytrol d. Tolterodine

Use of Botulinum Toxin for Urinary Incontinence due to Detrusor Overactivity Associated with a Neurologic Condition

1. Diagnosis of a neurologic condition [e.g., spinal cord injury (SCI), multiple sclerosis (MS)] 2. Symptoms of urge urinary incontinence, urgency, and frequency 3. Documented inadequate response to or are intolerant to at least 2 of the following:

a. Oxybutynin b. Trospium c. Oxytrol d. Tolterodine

Use of Botulinum Toxin for Upper Limb Spasticity* Patient must meet ALL criteria for coverage:

1. Complete neurological evaluation 2. Failure to improve with standard therapy which includes dopaminergic medications

(Sinemet®, Artane®), muscle relaxants (Lioresal), and benodiazepines (Valium®). 3. Spasticity in biceps, wrist, or fingers 4. No weakness, atrophy, or infection in the target muscle 5. No hypersensitivity to botulinum toxin or other component of the product 6. No evidence of pre-existing cardiovascular disease or dysphagia

Use of Botulinum Toxin for Cerebral Palsy* Patient must meet ALL criteria for coverage:

1. Complete neurological evaluation 2. Failure to improve with standard therapy which includes dopaminergic medications

(Sinemet®, Artane®), muscle relaxants (Lioresal), and benodiazepines (Valium®). 3. Use limited to the muscles of the arms and legs. 4. No weakness, atrophy, or infection in the target muscle 5. No hypersensitivity to botulinum toxin or other component of the product 6. No evidence of pre-existing cardiovascular disease or dysphagia

Initial approval : 6 months Continued Approval: Up to 4 treatments per 12 months if there is documented evidence of response to therapy




Drug Prior Authorization Criteria NOTES:

• Botulinum Toxin is Pregnancy Category C and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

• The FDA has received reports of systemic adverse reactions including respiratory compromise and death following the use of Botulinum toxins types A (Botox®, Botox® Cosmetic) and B (Myobloc®) for both FDA-approved and unapproved uses. The reactions reported are suggestive of botulism, which occurs when Botulinum toxin spreads in the body beyond the site where it was injected. The most serious cases had outcomes that included hospitalization and death, and occurred mostly in children treated for cerebral palsy-associated limb spasticity. Consider these adverse events when reviewing requests.

* Consider Botulinum Toxin A (Botox®) before Botulinum Toxin B (Myobloc®) and Botulinum Toxin A (Dysport®). ** Xeomin® is FDA approved for the treatment of blepharospasm in patients previously treated with Botox® and cervical dystonia and should only be covered for FDA-approved indications. †The Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) is the most commonly used. It consists of three subscales: severity (range 0-35), disability (range 0-23), and pain (range 0-20), which together add up to the TWSTRS Total score of 0-87

Cerdelga (Eliglustat)

Candidates for treatment with Cerdelga should meet ALL the following criteria:

1. Documented diagnosis of Type 1 Gaucher’s Disease 2. Patient is symptomatic (i.e. radiologic evidence of skeletal disease, platelet count

<60,000 microL, liver >2.5 times normal size, spleen > 15 times normal size). 3. 18 years of age or older 4. Patient has been evaluated by a Geneticist 5. Patient has been tested using an FDA cleared test to determine the patient’s

CYP2D6 genotype 6. Patient’s CYP2D6 genotype has been classified as an extensive metabolizers

(EMs), intermediate metabolizers (IMs), or poor metabolizers (PMs) 7. Tried and failed or unable to tolerate enzyme replacement therapy (Cerezyme,

Vpriv, Elelyso) enzyme replacement therapy for at least 6 months

Initial approval period: 6 months Continued approval: 12 months if patient is responding to treatment (improving platelet count, decreased hepatomegaly and splenomegaly) Dosing and Administration:

• CYP2D6 EMs or IMs: 84 mg orally twice daily • CYP2D6 PMs: 84 mg orally once daily • Swallow capsules whole, do not crush, dissolve or open capsules • Avoid eating grapefruit or drinking grapefruit juice




Drug Prior Authorization Criteria Ordering information: Cerdelga is available through the KP Specialty Pharmacy. If approved for coverage, prescribers must complete the KP-SP Cerdelga Order Form and fax it to the KP-Specialty Pharmacy (1-650-301-5790).

Cholbam (cholic acid)

Candidates for treatment with Cholbam should meet ALL of the following criteria:

1. Ordering providers are restricted to: pediatric gastroenterology and adult hepatology/gastroenterology

2. Must have a diagnosis of bile acid synthesis disorder A) Bile acid disorders due to single enzyme defects (SEDs) OR B) Adjunctive treatment of peroxisomal disorders (PDs) including Zellweger spectrum disorders in patients who exhibit manifestations of liver disease, steatorrhea, or complications from decreased fat-soluble vitamin absorption

3. Must provide baseline liver function tests

Reasons for non-coverage: 1. Patients with extrahepatic manifestations of bile acid synthesis disorders due to SEDs or PDs

including Zellweger spectrum disorders

Initial approval period: 3 months

Continued approval: Every 3 months for the first year, then every 6 months thereafter based on: 1. Adherence to Cholbam (>80%) and 2. Documented beneficial effect from therapy including all of the following:

a. Body weight increased by 10% or is stable at >50th percentile b. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) <50U/L or

baseline levels reduced by 80% c. Total bilirubin level reduced to <1mg/dL d. Must not have evidence of cholestasis on liver biopsy

Monitoring:

• Every month for the first 3 months, every 3 months for the next 9 months, and every 6 months during the next three years, and annually thereafter:

o Bilirubin o ALT/AST/GGT Liver function tests o INR

Reasons for Discontinuation:

• Liver function does not improve within 3 months of starting treatment • Complete biliary obstruction develops • Persistent clinical or laboratory indicators of worsening liver function or cholestasis

Ordering information: Cholbam is available through the Cholbam Total Care Hub. If approved for coverage, prescribers must complete the Patient Enrollment Form for Cholbam Total Care Hub and fax it to 877-473-3171.

http://pharmacy.kp.org/kp-cms/California/DrugInformation/ViewMedSafetyDNMgmtCA.aspx?I32Object=1484&nodeValue=113

http://www.cholbam.com/wp-content/uploads/2015/03/Cholbam-Physician-Order-Rx_Med-Necessity-Form-081814-v2-2.pdf




Drug Prior Authorization Criteria Cinqair® (Reslizumab)

Candidates for Cinqair® should meet ALL of the following criteria:

1. Documented trial of or intolerance to mepolizumab (Nucala) [KPGA’s preferred interleukin-5 antagonist]

2. Prescribed by a pulmonologist or allergy specialist 3. 18 years of age or older 4. Has a diagnosis of severe asthma with an eosinophilic phenotype:

a. Documented blood eosinophil count of > 400 cells/µl. 5. Uncontrolled asthma* despite an aggressive drug therapy regimen including: High-dose

inhaled corticosteroid (ICS), plus a long-acting beta-agonist (LABA), [i.e. Mometasone 200 mcg/formoterol 5 mcg (Dulera) two puffs twice a day], with or without oral corticosteroids.

a. Patients who are not on daily oral corticosteroids but who otherwise meet the above criteria and who have had frequent and/or severe exacerbations in the past 12 months requiring systemic corticosteroids for > 3 days can be considered for reslizumab (Cinqair).

6. NOT being used for the treatment of other eosinophilic conditions such as hypereosinophilic syndromes, neoplastic disease, or parasitic disease.

7. NOT being treated for relief of acute bronchospasm or status asthmaticus. 8. NOT currently on omalizumab (Xolair), mepolizumab (Nucala), or other monoclonal antibody

for the treatment of asthma 9. Only administered by a healthcare professional with appropriate medical support to manage

anaphylaxis and monitored for hypersensitivity reactions during infusion and for approximately 60 minutes after each infusion.

*Indicators of uncontrolled asthma: Two or more exacerbations in the past 12 months requiring systemic corticosteroids for > 3 days, serious exacerbations, at least one hospitalization, ICU stay or mechanical ventilation in the past 12 months, or Asthma control test (ACT) is consistently < 20. Initial Approval: 3 months Continued Approval: 12 months if the patient has experienced any of the following:

• Member has experienced a reduction in asthma signs and symptoms including wheezing, chest tightness, coughing, shortness of breath

• Member has experienced a decrease in administration of rescue medication, albuterol (salbutamol)

• Member has experienced a decrease in exacerbation frequency (no increase in ICS dose or CS dose)

• Member has experienced an increase in predicted FEV1 from the pretreatment baseline • Member has an objective improvement in quality of life: Asthma Control Test (ACT)

Dosage and administration: • The recommended dose is 3 mg/kg every 4 weeks as an intravenous infusion over 20-50

minutes • Should be prepared and administered by a healthcare professional

Monitoring: • Patients should be observed for hypersensitivity reactions during the infusion and for

approximately 60 minutes after administration for signs/symptoms of anaphylaxis




Drug Prior Authorization Criteria • Signs of infection • FEV1, peak flow, and/or other pulmonary function tests • Frequency of administration of rescue medication (short-acting beta2-agonist, albuterol) • Asthma signs and symptoms including wheezing, chest tightness, coughing, shortness of

breath • Frequency of exacerbation

Cinryze® (Human C1 Inhibitor solution)

Candidates for treatment with Cinryze® should meet ALL the following criteria:

1. A diagnosis of Type I or Type II hereditary angioedema. 2. Prescriber must be an allergist. 3. Contraindications or inability to tolerate 17α-alkylated androgens (ex.danazol, oxandrolone

and stanozolol) (especially in females of child-bearing age), including hirsutism, menstrual irregularities, hepatic dysfunction, undiagnosed vaginal bleeding, porphyria, cardiac or renal disease, depression, muscle cramps and thrombosis. Patients with significant lipid abnormalities might also be considered.


5. Special circumstances may include use in pregnant females with hereditary angioedema (HAE). [Note: Studies in pregnant women have not been conducted and the effects on the fetus or on reproductive capacity are not definitively known. At this time, Cinryze® should be given to a pregnant woman only if clearly needed.]


• Treatment of angioedema acute attacks in adult and adolescent patients with HAE • Under 9 years of age

Initial Approval: 3 months Subsequent approval will be based on clinical documentation of functional improvement, a decrease in frequency of HAE attack, and an improvement in severity and duration of attacks. Monitoring:

• Reduction in number, severity, and duration of swelling attacks • Symptoms of hypersensitivity during or after infusion • Signs of thrombosis

Short-term Prophylaxis: 1. Minor Procedures: Use of human C1 inhibitor is not required before minor manipulations if

human C1 inhibitor is immediately available. As an alternative, danazol can be used in appropriate patients (starting at least 7days before the procedure).

2. Major Procedures or Intubation: Consider the use of human C1 inhibitor for short-term prophylaxis to prevent attacks of angioedema when a patient with HAE has a planned




Drug Prior Authorization Criteria exposure to a situation likely to trigger an attack, such as substantial dental work, invasive medical procedures, and surgical procedures.

a. Doses of 500-1,500 units intravenously given one hour before the provoking event have been studied.

b. Two doses of human C1 inhibitor should be available. c. Although there is limited data in the United States regarding the use of human C1

inhibitor in pregnancy, a set of international consensus guidelines state that human C1 inhibitor is the safest prophylactic agent to use during pregnancy.

Long-term Prophylaxis: For patients with HAE who experience ≥one severe event per month or who

are disabled more than five days per month OR if the patient has a history of previous airway compromise, consider long-term prophylaxis. Options include: 1. 17α-alkylated androgens (danazol, stanozolol if available, and oxandrolone): Generally

treatment of choice for long-term preventative treatment. Contraindications include pregnancy, breastfeeding, significantly impaired renal/ hepatic function, etc (refer to package insert for complete list). See Milan or Budapest Protocols for dosing recommendations. Use in children should be undertaken only with great caution.

2. Antifibrinolytics (epsilon aminocaproic acid [Amicar®]): Less effective than androgens. Often reserved for patients who do not tolerate or in whom anabolic androgens are contraindicated.

3. Human C1 inhibitor replacement: May be necessary in patients in whom androgens are not effective (frequent angioedema attacks), not tolerated or contraindicated.


Daklinza® (Daclatasvir)

Daklinza is a non-preferred treatment agent at Kaiser Permanente. Please refer all requests to internal KP Hepatology or Infectious Disease for discussion.

DPP-4 inhibitors: Preferred: Tradjenta™ (Linagliptin) Jentadueto™ (Linagliptin and metformin)

Non-Preferred: 1. Nesina™

(Alogliptin)

Non-preferred DPP-4 inhibitors: Only to be used when the preferred DPP-4 inhibitor (Tradjenta™) has failed. For non-preferred combination product:

1. Patient must meet criteria for DPP-4 inhibitor (below) AND 2. Separate prescriptions are required for ingredients in non-preferred combination products

** DPP-4 inhibitors are not substitutes for insulin in patients whose diabetes control may benefit from insulin therapy. The preferred DPP-4 inhibitor (Tradjenta) will be covered for current KP new start members who meet ALL of the following criteria:

3. Documented diagnosis of type 2 diabetes mellitus 4. HbgA1c level 7% - 8.5%

a. A1c goal < 7% unless greater than 65 years of age and significant comorbidities 5. Failed to obtain adequate glycemic control on combination therapy with:

a. Continuous adherence with refilling maximum tolerated doses (i.e at least 1000mg per day) of metformin (unless patient is not a candidate for metformin therapy) AND




Drug Prior Authorization Criteria 2. Januvia™

(Sitagliptin) 3. Onglyza™

(Saxagliptin) Non-Covered combination products (separate prescriptions required for ingredients in combination products):

Kazano™ (Alogliptin and metformin) Oseni™ (Alogliptin and pioglitazone)

Kombiglyze™ XR (Saxagliptin and metformin extended-release)

Janumet™ (Sitagliptin and metformin)

Glyxambi (empagliflozin and linagliptan)

b. Continuous adherence with refilling maximum tolerated doses of a sulfonylurea (unless the patient is not a candidate for sulfonylurea therapy or the patient is already on multiple daily insulin injections (i.e prandial insulin) AND

c. Titration of insulin: For non-obese patients (BMI ≤29) an insulin dose of 0.4-0.6 units/kg/day and for obese patients (BMI ≥30) an insulin dose of 0.8 – 1.2 units/kg/day) OR

i. The DPP-4 inhibitor may be initiated prior to insulin trial if patient meets ONE of the following criteria:

1. Prescriber/PCP documents hypoglycemia is uniquely undesirable, so unable to use insulin (e.g., in patients who have hazardous jobs, or DOT Licenses) OR

2. The patient has incurred significant weight gain (≥ 5% increase in body weight after 6 months of starting an antidiabetic agent) secondary to oral antidiabetic medications or insulin therapy which is considered to be hazardous to the patient.

6. Patient is not currently on an anti-diabetic agent in any of the following classes: GLP-1 receptor agonists, SGLT2 inhibitor, and DPP-4 inhibitors

7. Documented trial or unable to tolerate Tradjenta, if request is for non-preferred DPP-4 inhibitor

Initial approval period: 5 months Patient must obtain HbgA1c after 3 months of initiating therapy

(this lab should be ordered when initiating therapy). Continued approval: 1 year, based on:

1. Adherence to maximum tolerated doses of metformin and sulfonylurea (unless patient is not a candidate or cannot tolerate metformin or sulfonylurea therapy) and

2. Documented HgbA1c lowering of 0.5 % from initial A1c to result in an A1c of <8 (must be performed within the past 3-6 months.

Members new to KP already taking Tradjenta™ (preferred DPP-4 inhibitor or a non-preferred DPP-4 inhibitor initiated prior to enrollment: Will be covered for those who meet ALL the following criteria:

1. Documented diagnosis of type 2 diabetes mellitus and 2. Adherence to maximum tolerated doses of metformin and sulfonylurea (unless patient is not

a candidate or cannot tolerate metformin or sulfonylurea therapy) and 3. A1c < 8 within 30 days and 4. Documented intolerance to or inadequate control with Tradjenta if request for a non-

preferred DPP-4 Inhibitor

Continued Approval: 1 year based on: 1. Adherence to maximum tolerated doses of metformin and sulfonylurea (unless patient is not

a candidate or cannot tolerate metformin or sulfonylurea therapy) and 2. Documented HgbA1c lowering of 0.5 % from initial A1c to result in an A1c of <8 (must be

performed within the past 3-6 months).




Drug Prior Authorization Criteria ***New KP members already taking a DPP-4 inhibitor whose diabetes is not controlled (i.e., HgbA1c> 8%) must meet the criteria for current KP new start members.

Note: For new KP members the prescriber does not have to be an internal provider for initial approval. Reasons for non-coverage:

• Type 1 diabetes mellitus • Treatment of diabetic ketoacidosis • Pediatric patients (<18 years old) • Prior history of a serious allergic reaction to DPP-4 inhibitors (i.e., anaphylaxis, angioedema,

Stevens-Johnson syndrome, etc.) • Severe hepatic insufficiency (Child-Pugh score >9)

Use caution in the following patients:

• ESRD requiring hemodialysis or peritoneal dialysis • Pregnant/nursing women • Concomitant use with a sulfonylurea due to increased risk of hypoglycemia • History of pancreatitis

Monitoring:

• Renal function prior to initiation of the DPP-4 inhibitor and periodically afterwards • A1c level • Serum glucose level • Development of pancreatitis after initiation or dose increases

Eloctate (Antihemophilic Factor (Recombinant), Fc Fusion Protein)

Candidates for treatment with Eloctate should meet ALL the following criteria:

1. Documented diagnosis of Hemophilia A (<1% endogenous Factor VIII activity) 2. Being use for one of the following:

a) Control and prevention of bleeding episodes b) Perioperative management c) Routine prophylaxis to prevent or reduce the frequency of bleeding episodes

3. Tried and failed or unable to tolerate TWO of the following: a) Advate b) Kogenate FS c) Xyntha d) Helixate FS

Initial approval period: 12 months Dosing and Administration:

• One unit per kilogram body weight will raise the Factor VIII level by 2% international units per deciliter [IU/dL]. Each vial of Eloctate is labeled with the amount of recombinant factor VIII in IU.

• Dosing formula for bleeding episodes and perioperative management: o Estimated Increment of Factor VIII (IU/dL or % of normal) = [Total Dose (IU)/body

weight (kg)] x 2 (IU/dL per IU/kg) OR




Drug Prior Authorization Criteria o Required Dose (IU) = Body Weight (kg) x Desired Factor VIII Rise (IU/dL or % of

normal) x 0.5 (IU/kg per IU/dL) • Dosing for routine prophylaxis is: 50 IU/kg every 4 days; it may be adjusted based on patient

response with dosing in the range of 25-65 IU/kg at 3-5 day Entyvio® (Vedolizumab)

Candidates for treatment with Entyvio® should meet ALL the following criteria:

1. Prescribed by a gastroenterologist 2. Documented diagnosis of moderate to severe active ulcerative colitis or Crohn’s disease 3. Inadequate response or an inability to tolerate ONE conventional therapy (i.e. sulfasalazine,

mesalamine, azathioprine, or 6-mercaptopurine) 4. Inadequate response or an inability to tolerate corticosteroids (i.e. prednisone,

methylprednisolone, budesonide) 5. Inadequate response or an inability to tolerate ONE TNF-α inhibitor (i.e. infliximab

(Remicade), adalimumab (Humira)) 6. Entyvio® should not be used concomitantly with a TNF- α inhibitor 7. Patient has documented negative test for tuberculosis within the past 12 months

Reasons for non-coverage: Entyvio® should NOT be used in patients with any of the following:

• Patients under 18 years old • Presence of active severe infection or history of recurrent severe infections • Signs and symptoms of liver injury such as jaundice, dark urine, elevated liver transaminases,

right upper abdominal discomfort, fatigue and anorexia. • Diagnosis or signs or symptoms of progressive multifocal leukoencephalopathy (PML)

Initial approval period: 14 weeks (Infusions at 0, 2, 6, and 14 weeks) Continued approval for treatment with Entyvio® should meet ALL the following criteria:

1. Review of compliance to Entyvio® 2. Documented beneficial effect from therapy such as reduction in signs or symptoms of disease


• The recommended dose of Entyvio® for ulcerative colitis and Crohn’s disease is 300 mg infused intravenously (IV) over 30 minutes at 0, 2, and 6 weeks, then 300 mg IV every 8 weeks thereafter.

Monitoring 1. All patients should be monitored for hypersensitivity reactions during infusion until it is

complete. o Stop the infusion and consult the physician immediately if signs or symptoms related to a

hypersensitivity reaction are seen. These may include anaphylaxis, dyspnea, bronchospasm, urticarial, flushing, rash, or increased blood pressure and heart rate. Symptom onset could occur during the infusion, immediately after the infusion or up to several hours after the infusion.




Drug Prior Authorization Criteria 2. Patients should be monitored for signs and symptoms of severe infections like tuberculosis,

sepsis and anal abscess. 3. Monitor patients for signs and symptoms of liver injury such as elevated liver transaminases

and bilirubin, jaundice, right upper abdominal discomfort, dark urine, anorexia or fatigue. 4. Patients should be monitored for signs and symptoms of PML including progressive unilateral

weakness, vision disturbance, changes in thinking and memory, confusion and personality changes.

Enzyme replacement therapy Preferred: Vpriv (Velaglucerase alfa) Non-Preferred: Cerezyme (Imiglucerase) Elelyso (Taliglucerase alfa)

Candidates for treatment should meet ALL the following criteria:


<60,000 microL, liver >2.5 times normal size, spleen > 15 times normal size) 3. Patient has been evaluated by a Geneticist

Initial approval period: 6 months Continued approval: 12 months if patient is responding to treatment (improving platelet count, decreased hepatomegaly and splenomegaly) Monitoring:

• Disease monitoring: CBC, liver enzymes, IgG antibodies; MRI, CT, or US of liver and spleen; bone density studies; monitor antibodies in those patients who developed antibodies to other enzyme replacement therapies

Dosing and Administration: Cerezyme

• Administered by intravenous infusion over 1-2 hours. • Dosage should be individualized to each patient. Initial dosages range from 2.5 U/kg of body

weight 3 times a week to 60 U/kg once every 2 weeks. Vpriv

• Patients Naïve to Enzyme Replacement Therapy: 60 Units/kg • Patients being treated with stable imiglucerase dosages for Gaucher disease: Can switch to

VPRIV at previous imiglucerase dose two weeks after last imiglucerase dose Elelyso

• Treatment-naïve adult and pediatric patients 4 years of age and older: 60 units/kg administered every other week as a 60 to 120 minute intravenous infusion

• Patients switching from imiglucerase: Begin treatment with Elelyso at the same unit/kg dose as the patient's previous imiglucerase dose. Physicians can make dosage adjustments based on achievement and maintenance of each patient's therapeutic goals

Epclusa® (Sofosbuvir/velpatasvir)

Candidates for Epclusa should meet ALL the following criteria:

1. Is the medication prescribed by a Gastroenterologist or Infectious Disease specialist? If yes, go to #2 If No, patient does NOT meet criteria for Epclusa; go to # 5

2. Does the patient have a documented Hepatitis C Virus RNA PCR quantitative in previous 90

days?




Drug Prior Authorization Criteria If yes, go to # 3 If No, patient does NOT meet criteria for Epclusa: patient needs updated viral load, go to #5

3. Does patient have Genotype 2 or 3? If Yes, go to #4 If No, go to #5

4. Does the patient have an eGFR > 30 ml/min/1.73 m2 If yes, Patient meets criteria for Epclusa for 12 weeks If No, Go to # 5

5. Has patient been reviewed by the KP Hepatology Clinic OR KP Infectious Disease service? If yes, continue with approval If No, please contact Lisa Woolard, PharmD at 770-677-5869

Initial Approval: 14 days

Continued Approval/Established duration of treatment: GI or ID specialist will call after start of therapy if patient needs to stop or change therapy:

• 12 week total duration

Dosage and Administration: • One tablet (400 mg of sofosbuvir and 100 mg of velpatasvir) taken orally once daily with or

without food.

Fabrazyme (Agalsidase beta)

Candidates for treatment with Fabrazyme should meet ALL the following criteria: 1. Patient age >8 years old 2. Documented diagnosis of Fabry disease confirmed by one of the following:

a) α-galactosidase activity level < 1.5 nmol/hr/ml in plasma; OR b) β-galactosidase activity level < 4 nmol/hr/mg in leukocytes

3. Additional labs (prior to starting Fabrazyme): a) Globotriaosylceramide (GL-3) concentrations in plasma > 5ng/mcL b) SCr < 2.5 mg/dL and no history of renal dialysis or transplantation

Initial approval period: 6 months Continued approval: 12 months Dosing and Administration:

• 1 mg/kg body weight given every two weeks as an IV infusion o Initial IV infusion rate should be no more than 0.25mg/min (15 mg/hr) and may be

slowed if an infusion-associated reaction occurs o After patient tolerance to the infusion is well established, the infusion rate may be

increased in increments of 0.05-0.08 mg/min (3-5mg/hr) each subsequent infusion • Patients should receive antipyretics prior to infusion




Drug Prior Authorization Criteria Firazyr® (Icatibant)

Candidates for treatment with Firazyr® should meet ALL the following criteria:

1. A diagnosis of Type I or Type II hereditary angioedema. 2. Prescriber must be an allergist. 3. Treatment of acute facial or abdominal facial attacks of HAE in adult or adolescent patients 4. Contraindications or inability to tolerate 17α-alkylated androgens (especially in females of

child-bearing age), including hirsutism, menstrual irregularities, hepatic dysfunction, undiagnosed vaginal bleeding, porphyria, cardiac or renal disease, depression, muscle cramps and thrombosis. Patients with significant lipid abnormalities might also be considered.



• Routine prophylaxis against angioedema attacks in adolescent and adult patients with HAE • 18 years of age or younger



Monitoring: • Symptomatic improvement • Patients with laryngeal attacks should seek medical attention to assure that airway

obstruction in resolved. Consider long-term prophylaxis for patients with HAE who experience ≥one severe event per month or who are disabled more than five days per month OR if the patient has a history of previous airway compromise. Options include:

1. 17α-alkylated androgens (danazol, stanozolol if available, and oxandrolone): Generally treatment of choice for long-term preventative treatment. Contraindications include pregnancy, breastfeeding, significantly impaired renal/ hepatic function, etc (refer to package insert for complete list). See Milan or Budapest Protocols for dosing recommendations. Use in children should be undertaken only with great caution.




Gattex® (Teduglutide)

Candidates for treatment with Gattex® should meet ALL the following criteria:

1. Diagnosis of short bowel syndrome (SBS)




Drug Prior Authorization Criteria 2. Dependent on parenteral nutrition (PN) and/or intravenous (IV) fluids continuously for at least

12 months 3. Prescribed by a gastroenterologist who is a certified REMS provider

*NOTE: For more information and to enroll, please go to the following site: http://www.gattexrems.com/

4. 18 years or age or older 5. Colonoscopy performed within the last 6 months 6. Serum bilirubin, alkaline phosphatase, lipase and amylase levels drawn within the last 6

months

Initial approval period: 1 year Continued approval: 1 year, based on review of compliance to therapy and documented beneficial effect from therapy. Patient must also have documented colonoscopy 1 year after therapy with Gattex®. Dosing and Administration:

• SubQ: 0.05 mg/kg once daily Monitoring:

• Serum bilirubin, alkaline phosphatase, lipase and amylase (baseline [within 6 months prior to initiation] and every 6 months thereafter)

• Colonoscopy of entire colon and removal of polyps (baseline [within 6 months prior to initiation], 1 year, and ≤5 years thereafter)

• Monitor fluid status in patients with cardiovascular disease; signs/symptoms of intestinal obstruction; signs/symptoms suggestive of gall bladder disease or pancreatitis

Ordering information Gattex® is only available from certified pharmacies that are enrolled in the Gattex® REMS program. At this time, Gattex® is not available through our KP pharmacies or the KP Specialty Pharmacy. Prescriber’s should review the education materials which are part of the REMS and complete post-training knowledge assessment questions at http://www.gattexrems.com.

Gilenya™ (Fingolimod)

Gilenya should be reserved for treatment of patients with relapsing forms of multiple sclerosis exhibiting high-disease activity or prognostic factors for early progression to secondary progressive multiple sclerosis. Candidates for treatment with Gilenya™ should meet ALL the following criteria:

1. Documented diagnosis of relapsing-remitting multiple sclerosis (RRMS) or progressive-relapsing multiple sclerosis (PRMS)

2. Prescribed by a Neurologist 3. Gilenya is prescribed for use as monotherapy for treatment of MS 4. Documented baseline CBC with differential, ophthalmologic exam, LFT, serum bilirubin and

EKG

http://www.gattexrems.com/

http://www.gattexrems.com/




Drug Prior Authorization Criteria 5. For females of child bearing age (12-50 years of age), a baseline negative pregnancy test

within the past month AND either a prescription for birth control (IUD or other contraceptive) or documentation of the patient declining contraception and being counseled of the potential risk of pregnancy.

6. Documented inadequate response, intolerance or contraindication to Copaxone®* AND ONE interferon therapy (ie. Avonex®, Betaseron®, Extavia® or Rebif®)* OR

7. Documented evidence of high-risk features for early progression to secondary-progressive MS (see Table 1)

*NOTE: Injection fatigue or fear of needles are not reasons for intolerance or inadequate response.





symptoms







After 1 yr of therapy, ≥ 3 new or enlarging T2 lesions, continued gad+ lesions, or diffusion-restrictedimaging lesions over a 1 yr period OR


≥ 1 cord lesion Reasons for non-coverage: Gilenya should NOT be used in patients with ANY of the following:

• Unstable angina within the last 6 months • Concomitant Class Ia or Class III anti-arrhythmic drugs (beta-blockers, diltiazem, verapamil,

quinidine, disopyramide, procainamide, amiodarone, dofetilide, ibutilide, dronedarone, sotalol)

• Heart failure, class III/IV within the last 6 months • Decompensated heart failure requiring hospitalization within the last 6 months • Mobitz type II second-degree or third-degree atrioventricular block (history or current),

unless the patient has a functional pacemaker • Myocardial infarction within the last 6 months • QTc interval at baseline 500 milliseconds or greater • Sick-sinus syndrome (history or current), unless the patient has a functional pacemaker • Heart rate less than 55 bpm • Irregular heartbeat • Stroke within the last 6 months • TIA within the last 6 months




Drug Prior Authorization Criteria • Opportunistic infection • Macular edema or significant risk factors for macular edema (diabetes or uveitis), unless

documentation that benefit of Gilenya outweighs risk • Pregnancy or lactation

Initial approval period: 1 year Continued approval for treatment with Gilenya should meet ALL the following criteria:

1. Adherence to Gilenya (≥ 80%) 2. Documented beneficial effect from therapy 3. Documentation of recent ophthalmologic examination (3-4 months after therapy initiation)


• Gilenya is dosed at 0.5 mg orally once daily, with or without food. Doses higher than 0.5 mg daily are associated with minimal benefit and a higher risk of adverse events.

• Gilenya should be used with caution in patients who are receiving chronic immunosuppressant therapy, other immunomodulatory drugs, or are significantly immunocompromised for any reason.

Monitoring

• All patients should be observed for six hours after the first dose is given, monitoring for signs and symptoms of bradycardia.

• For women of childbearing potential, patient should agree to use a form of contraception to prevent pregnancy during Gilenya treatment and for two months after discontinuation of Gilenya.

• All Patients should have documented immunity to varicella zoster virus (chicken pox) prior to initiating therapy. o If needed, Varivax series must be completed at least 1 month prior to initiating therapy

• Monitor CD4 counts and adjust dose accordingly • Patients should be monitored for any new signs or symptoms which might suggest PML. At

the first such sign or symptom of PML, Gilenya treatment should be withheld immediately and diagnostic measures should be undertaken.

• Monitor for signs and symptoms of posterior reversible encephalopathy syndrome (PRES). Discontinue use if PRES is suspected.

Glatiramer acetate: Preferred: Glatopa 20 mg/ml Non-preferred: Copaxone 20 mg/ml

Non-preferred glatiramer acetate (Copaxone 40 mg/mL): Only to be used when preferred glatiramer acetate (Glatopa 20 mg/mL) has failed.

The preferred glatiramer acetate (Glatopa 20 mg/mL) will be covered for members who meet ALL of the following criteria:

1. Documented diagnosis of relapsing multiple sclerosis AND 2. Glatiramer acetate is prescribed by a neurologist AND 3. Glatiramer acetate is to be used as monotherapy disease-modifying treatment of MS AND




Drug Prior Authorization Criteria Copaxone 40 mg/ml

4. Presence of a relative contraindication to interferon beta (eg: treatment-resistant psychosis or depression, suicidal ideation/behavior, cardiomyopathy, hepatic impairment) OR

5. Documented inadequate response or intolerance to at least one interferon therapy (Avonex, Betaseron®, Extavia® or Rebif®)

a. Note: Extavia is the preferred first-line interferon therapy at KP. Recommend Extavia if the patient has no contraindications and no history of interferon therapy use. .

6. If the physician's request for coverage of a non-preferred glatiramer acetate is based upon the physician's and/or member's unwillingness to change to a preferred alternative, the request will be denied unless the member meets the criteria.


• Secondary progressive MS with no clinical or MRI evidence of relapses • Presence of high-risk features for early progression to secondary-progressive MS (see Table

1) For patients with ANY high-risk feature listed in Table 1, escalation therapy with Gilenya (preferred), Tysabri or Rituxan (off-label) may be more appropriate and should be recommended instead.

Table 1: High-risk features for early progression

History of MS attack/relapse with Lesion load Duration Symptom type Timing / frequency

≥ 30 days and significant functional limitations, except for ongoing sensory symptoms

• Sphincter OR • Motor OR • Cerebellar

(ataxia or tremor)

• ≥ 3 relapses in the first 2 years after diagnosis OR

• Average of ≥ 1 relapse/ year over 2 to 3 years OR after 6 months of therapy, relapse in the next 6 months

• After 1 yr of therapy, ≥ 3 new or enlarging T2 lesions, continued gad+ lesions, or diffusion-restricted imaging lesions over a 1 yr period OR

• ≥ 5 lesions over 2 years OR

• ≥ 1 cord lesion Initial approval period: 1 year Continued approval for treatment with glatiramer should meet ALL the following criteria:

• Adherence to glatiramer acetate therapy (>=80%) • Documented beneficial effect from therapy




Drug Prior Authorization Criteria Continued approval: 1 year Dosage and Administration

• Glatopa 20 mg injected subcutaneously one time daily GLP-1 Receptor Agonists Preferred: Bydureon™ Pen (Exenatide Extended-Release) Non-Preferred: 1. Byetta™ (Exenatide)

2. Tanzeum® (albiglutide)

Victoza® (Liraglutide)

Trulicity® (Dulaglutide)

**NOTE**: Non-preferred GLP-1 receptor agonists are only to be used when a preferred GLP-1 receptor agonist (Bydureon™ or Byetta™) has failed Byetta™) has failed

Non-preferred GLP-1 receptor agonists: Only to be used when a preferred GLP-1 receptor agonist (Bydureon™) has failed. ** GLP-1 receptor agonists are not substitutes for insulin in patients whose diabetes may benefit from insulin treatment The preferred GLP-1 Receptor Agonists will be covered for current KP new start members who meet ALL of the following criteria:

1. Documented diagnosis of type 2 diabetes mellitus 2. Patient has continuous adherence with refilling maximum tolerated doses (i.e at least 1000

mg per day) of metformin (unless patient is not a candidate for metformin therapy) 3. HbgA1c level 7% - 8.5%

a. A1c goal < 7% unless greater than 65 years of age and significant comorbidities 4. Failed to obtain adequate glycemic control on combination therapy with:

a. Continuous adherence with refilling maximum tolerated doses (i.e at least 1000mg per day) of metformin (unless patient is not a candidate for metformin therapy) and

b. Continuous adherence with refilling maximum tolerated doses of a sulfonylurea (unless the patient is not a candidate for sulfonylurea therapy or the patient is already on multiple daily insulin injections (i.e prandial insulin) and


i. The GLP-1 agonist may be initiated prior to insulin trial if patient meets ONE of the following criteria:


2. The patient has incurred significant weight gain (≥ 5% increase in body weight after 6 months of starting an antidiabetic agent)) secondary to oral antidiabetic medications or insulin therapy which is considered to be hazardous to the patient OR

3. Prescriber indicates promotion of weight loss is a major consideration and this patients HgbA1c is close to target HbgA1c level is close to target (<8.0%) (For patients with BMI 35 and above).

5. Patient is not currently on an anti-diabetic agent in any of the following classes: GLP-1 receptor agonists, SGLT2 inhibitor, and DPP-4 inhibitors.




Drug Prior Authorization Criteria 6. Documented trial or unable to tolerate Bydureon, if request is for non-preferred GLP-1

receptor agonists. Initial approval period: 5 months. Patient must obtain A1c after 3 months of initiating therapy (this

lab should be ordered when initiating therapy). Continued approval: 1 year, based on:

7. Adherence to maximum tolerated doses of metformin and sulfonylurea (unless patient is not a candidate or cannot tolerate metformin or sulfonylurea therapy) and


Members new to KP taking Bydureon™ (preferred GLP-1 receptor agonists) or a non-preferred GLP-1 -receptor agonist initiated prior to enrollment: Will be covered for those who meet ALL of the following criteria:


a candidate or cannot tolerate metformin or sulfonylurea therapy) and 11. A1c < 8 within 30 days and 12. Documented intolerance to or inadequate control with Bydureon if request for a non-

preferred GLP-1 receptor agonist.

Continued Approval: 1 year Based on: 13. Adherence to maximum tolerated doses of metformin and sulfonylurea (unless patient is not



***New KP members already taking a DPP-4 inhibitor whose diabetes is not controlled (i.e., HgbA1c> 8%) must meet the criteria for current KP new start members. Note: For new KP members the prescriber does not have to be an internal provider for initial approval. Reasons for non-coverage:

15. Type 1 diabetes mellitus 16. Treatment of diabetic ketoacidosis 17. Concurrent use with meglitinides (i.e., repaglinide, nateglinide), or alpha-glucosidase

inhibitors (i.e., acarbose, miglitol) 18. Pediatric patients (<18 years old) 19. ESRD or severe renal impairment (CrCl <30 mL/min) 20. Patients with severe gastrointestinal disease (including gastroparesis) 21. Diagnosis of pancreatitis, including hemorrhagic and necrotizing, prior to or after initiation of

GLP-1 receptor agonists (postmarketing cases, including fatalities, have been reported, therapy should be discontinued immediately).

22. Prior history of a serious allergic reaction to a GLP-1 receptor agonist (i.e., anaphylaxis, angioedema, Stevens-Johnson syndrome, etc.)




Drug Prior Authorization Criteria 23. Personal or family history of medullary thyroid cancer (MTC) or in patients with Multiple

Endocrine Neoplasia syndrome type 2 (MEN 2) Use caution in the following patients:

24. Pregnant/nursing women (Pregnancy Category C) 25. Concomitant use with pharmacologic agents known to affect renal function/hydration status/

and or patients experiencing nausea/vomiting/diarrhea with or without dehydration (i.e., ace-inhibitors, NSAIDS, diuretics)

26. Concomitant use with a sulfonylurea (hypoglycemia) 27. Concomitant use with warfarin (increased INR, sometimes with bleeding) 28. Concomitant use with oral medications that require rapid gastric gastrointestinal absorption

(GLP-1 receptor agonists slow gastric emptying) 29. Concomitant use with oral medications dependent on threshold concentrations for efficacy

(i.e., contraceptives, antibiotics) – Patients should take drugs 1 hour prior to GLP-1 receptor agonist injection

Monitoring:

30. Renal function prior to initiation of a GLP-1 receptor agonist and periodically afterwards 31. A1c level 32. Fasting and postprandial glucose 33. Signs/symptoms of acute pancreatitis including unexplained, persistent, severe abdominal

pain with or without vomiting Growth hormones: Preferred: Omnitrope® cartridges for use in pen Non-preferred: Gentropin® Humatrope® Norditropin® Nutropin AQ® Saizen® Serostim® Zorbtive® **NOTE**: Non-preferred growth hormone is only to be used when preferred (Omnitrope®)

Candidates for treatment with Growth hormones should meet ALL the following criteria: ** Note: For all first time approvals, Omnitrope® is the first-line agent when growth hormone is indicated for growth hormone deficiency. Omnitrope® should be tried before approval is granted for other growth hormone agents. Criteria for use of growth hormones in children (<18 years of age):

1. A diagnosis of Turner’s Syndrome that is confirmed by abnormal karyotype in female children greater than five years of age with appropriate timing and use of hormone replacement therapy; OR

2. Patients who have a diagnosis of classical growth hormone deficiency and who meet all the criteria below:

a. Height is consistently two standards deviation below mean for like age, pubertal maturation and gender over at least one year of serial measurements; and

b. Growth velocity that is less than the tenth percentile of normal for like age, pubertal maturation and gender over at least one year of serial measurements; and

c. Two provocative tests for growth hormones secretion with neither having a Peak > 10 ng/ ml; OR

**Bone age determination within six months of the request, reflecting more than two standards deviations below that for like age and gender; with (c.) AND either (a.) or (b.), OR

3. Children with Prader-Willi Syndrome confirmed by appropriate genetic testing WITHOUT therapeutic contraindications: severe obesity or respiratory impairment; OR

4. Pre-pubertal children with chronic renal insufficiency, before renal transplant, providing: nutritional status optimized; metabolic abnormalities optimized; and steroid therapy minimized; OR

5. Patients who are small for gestational age and meet all the criteria below: a. Patient is 2 years of age or older




Drug Prior Authorization Criteria growth hormone has failed

b. Child was born small for gestational age, defined as birth weight and/or length at least two standard deviations below the mean for gestational age.

c. Child fails to manifest catch-up growth by two years of age, defined as height at least two standard deviations below the mean for age and sex.

**Note: Bone age reflects the potential for the response to GH. Height standard deviation score for chronologic age increase throughout all treatment years, but for bone age (BA) did not change significantly. Human GH treatment cannot make up a deficit in height prognosis already present at diagnosis, but prevents further loss of stature, which is why early diagnosis is important so that GH therapy can be instituted before significant height for BA deficit has occurred. (J Pediatr 1988;112:875-9). Discontinuation of treatment: Treatment with growth hormone will be discontinued if one or more of the following occurs:

1. Height velocity is not at or above the tenth percentile for like age, pubertal maturation and gender after one year of treatment (i.e. the treatment is not effective in achieving a significant increase in stature after one year of treatment).

a. Height velocity must be obtained by at least two measurements over a one-year period on stable HGH dosage;

2. Bone age is greater than or equal to 14 years of age for females and 16 years of age for males; OR

3. The patient achieves a height that is within the 3rd percentile for normal adult height for the same sex

Criteria for use of growth hormones in adults (>18 years of age): Initial Evaluation

1. The patient has one of the following: a. The patient has growth hormone deficiency syndrome, either alone or with multiple

hormone deficiencies, as a result of pituitary disease, hypothalamic disease, surgery, radiation or trauma OR

b. Patients who were growth hormone-deficient during childhood who have growth hormone deficiency syndrome confirmed as an adult before replacement therapy is started

AND 2. The patient has failed at least one growth hormone (GH) stimulation test as an adult

a. Failure of GH stimulation test is defined as: i. A peak GH value of <5 mcg/L after stimulation when measure by RIA

(polyclonal antibody) OR ii. A peak GH value of <2.5 mg/L after stimulation when measured by IRMA

(monoclonal antibody) Reasons for Non-Coverage:

• Growth hormone should not be administered or covered in patients with any of the following:

o Acute critical illness (e.g., with complications after cardiac or abdominal surgery, with multiple accidental trauma, or with acute respiratory failure)




Drug Prior Authorization Criteria o Evidence of active malignancy [One possible approach would be to consider growth

hormone therapy if the patient has been free of active malignancy for one year after therapy for pituitary tumor or five years after other malignancies.]

o Proliferative retinopathy o Uncontrolled hypertension o Benign intracranial hypertension o Pregnancy (relative contraindication due to lack of study evidence and the fact that

placental GH is secreted in the second and third trimester.) • Growth hormones will not be covered when being used for any of the following:

o Performance enhancement in athletes o Treatment of obesity o Prevention or delay of the aging process o Treatment of partial growth hormone deficiency

Initial Approval Period: 12 months Continued Evaluation

1. The patient has been approved for GH previously through QRM AND 2. The patient is being monitored for adverse effects of GH AND 3. The patient’s IGF-1 level has been evaluated to confirm the appropriateness of the current

dose AND 4. The patient has had benefits from GH therapy in any of the following response parameters;

body composition, hip-to-waist ratio, cardiovascular health, bone mineral density, serum cholesterol, physical strength, or quality of life.

Continued Approval Period: 12 months

Harvoni (ledipasvir/sofosbuvir)

Candidates for treatment with Harvoni should meet ALL the following criteria:

1. Is the medication prescribed by a Gastroenterologist or Infectious Disease specialist? If yes, go to #2 If no, patient does NOT meet criteria for Harvoni; go to #17

2. Has patient previously been treated with Harvoni? If yes, patient does NOT meet criteria for Harvoni; go to #17 If no, go to #3

3. Does the patient understand the medical and financial requirements and agree to complete the treatment course?

If yes, go to #4 If no, patient does NOT meet criteria for Harvoni; go to #17

4. Does the patient have a documented Hepatitis C Virus RNA PCR quantitative in the previous 90 days?

If yes, go to #5 If no, patient does NOT meet criteria for Harvoni; patient needs updated viral load, go to #17

5. Does the patient have decompensated cirrhosis (moderate or severe hepatic impairment, Child-Turcotte-Pugh (CTP) Class B or C)?




Drug Prior Authorization Criteria If yes, go to #14 If no, go to #6

6. Has the patient undergone liver transplantation? If yes, go to #15 If no, go to #7

7. Does the patient have genotype 1, 3, 4 or 6? If yes, go to #8 If no, patient does NOT meet criteria for Harvoni; go to #17

8. Is the patient co-infected with HIV?

If yes, patient QUALIFIES for Harvoni for 12 weeks; go to #16 If no, go to #9

9. Does the patient have a documented genotype 3, 4 or 6?

If yes, patient QUALIFIES for Harvoni for 12 weeks; go to #17 If no, go to #10

10. Does the genotype 1 patient have advanced fibrosis/cirrhosis as evidenced by one of the

following: a) Liver biopsy confirming a stage 3 or stage 4 disease OR b) Fibroscan score greater than or equal to 12.5 kPa OR c) Radiological imaging consistent with cirrhosis OR d) Physical findings or clinical evidence consistent with cirrhosis as attested by prescribing

physician If yes, patient QUALIFIES for Harvoni for 12 weeks; go to #17 If no, go to #11

11. Is the genotype 1, non-cirrhotic patient treatment naïve? If yes, go to #12 If no, go to #13

12. Is patient’s viral load less than 6 million?

If yes, patient QUALIFIES for Harvoni for 8 weeks; go to #17 If no, patient QUALIFIES for Harvoni for 12 weeks; go to #17

13. Was the genotype 1, non-cirrhotic, treatment-experienced patient previously treated with sofosbuvir (Sovaldi)?

If yes, patient does NOT meet criteria for Harvoni because treatment is deferred due to insufficient evidence; go to #17 If no, patient QUALIFIES for Harvoni for 12 weeks; go to #17

14. Does the patient have genotype 1, 3, 4, 5 or 6? If yes, patient QUALIFIES for Harvoni for 12 weeks; go to #17 If no, patient does NOT meet criteria for Harvoni; go to #17

15. Is the patient genotype 1, 3, or 4?




Drug Prior Authorization Criteria If yes, patient QUALIFIES for Harvoni for 12 weeks; go to #17 If no, patient does NOT meet criteria for Harvoni; go to #17

16. Has the regimen been approved reviewed by KP Infectious Disease? If yes, continue with approval; go to #17 If no, please contact Adanna Igboko, PharmD at 770-431-4486

17. If prescribed by an external provider, has PCS contacted the internal KP Hepatology clinic for

internal KP physician review? If yes, continue with approval If no, please contact Lisa Woolard, PharmD at 770-667-5869

Initial Approval: 14 days.

Continued Approval/Established Duration of Treatment: GI or ID specialist will call after start of therapy if patient needs to stop or change therapy duration.

• For Genotype 1, non-cirrhotic, treatment naïve, baseline RNA < 6 million: 8 weeks total duration

• For patient who have failed or intolerant to ribavirin despite dose adjustment: 24 weeks total duration.

• For all others: 12 weeks total duration

Dosage and Administration • Recommended dosage: One tablet (90 mg of ledipasvir and 400 mg of sofosbuvir) taken

orally once daily with or without food.

Monitoring: • Serum HCV-RNA at baseline, during treatment, at the end of treatment, during treatment

follow-up, and when clinically indicated.

Dispensing information: Must be dispensed at Glenlake Pharmacy with an applicable quantity limit.

Hetlioz® (tasimelteon)

Candidates for treatment with Hetlioz® should meet ALL the following criteria:

1. Prescribed by a specialist trained in sleep disorders 2. Patient has documented diagnosis of Non-24-Hour Sleep-Wake Disorder 3. Must have a log of when the patient sleeps and is awake that supports the diagnosis of Non-

24-Hour Sleep-Wake Disorder 4. Patient must be totally blind and have no light perception 5. Patient must have no other concomitant sleep disorder (i.e. sleep apnea, insomnia) 6. The patient has received at least 6 months of continuous therapy (i.e., 6 consecutive months

of daily treatment) with melatonin under the guidance of a physician who specializes in the treatment of sleep disorders

7. The patient did not achieve adequate results with melatonin therapy according to the prescribing physician (e.g., entrainment, clinically meaningful or significant increases in nighttime sleep, clinically meaningful or significant decreases in daytime sleep)

8. Documented inadequate response or unable to tolerate Rozerem




Drug Prior Authorization Criteria Reasons for non-coverage:

• Patient has severe hepatic impairment Initial Approval: 2 months Continued Approval:

• Hetlioz should be discontinued if after 2 months of initiated treatment the patient has not significantly improved from response received during melatonin 6 month trial.

• If after 2 months of initiated treatment, the patient has documented positive clinical response to Hetlioz therapy (e.g., entrainment, clinically meaningful or significant increases in nighttime sleep, clinically meaningful or significant decreases in daytime sleep), then 12 months of continued approval.

Dosage and Administration

• One 20-mg capsule prior to bedtime, at the same time every night. Hyaluronic Acid Injection: Preferred: Supartz® (P) Non-preferred: Synvisc® (2nd Line) Euflexxa® (N) Hyalgan® (N) Synvisc-One® (N) **Note**: Supartz® is the preferred medication. Synvisc® may be approved if Supartz® is deemed ineffective or the patient has intolerance to Supartz®.

Candidates for treatment with Hyaluronic Acid Injection should meet ALL the following criteria:

1. Patient has clinically documented osteoarthritis of the knees (American College of Rheumatology criteria) confirmed by history, exam, x-ray, and synovial fluid analysis, and requested for use in knee

2. Failed or intolerant to nonpharmacological therapies (physical therapy, ice, weight loss, etc.) 3. Documented inadequate control of pain or intolerance to an adequate trial (at least 3 months)

of ONE of the following: acetaminophen (4 grams/day), NSAIDs, and other non-narcotic or narcotic analgesics

4. Documented inadequate trial with intra-articular corticosteroid injection (i.e efficacy lasting less than 6-8 weeks)

Initial Approval: 1 to 5 weeks depending on the product Criteria for Continuation of Therapy: There are no data on repeated courses of therapy for Euflexxa® and Supartz®; there is no evidence of increased adverse drug events in repeated courses of therapy for Hyalgan®, Synvisc®, and Orthovisc® when separated by at least six months. **Note: Supartz® is the preferred medication. Synvisc® may be approved if Supartz® is deemed ineffective or the patient has intolerance to Supartz®.

Ilaris® (Canakinumab)

Candidates for treatment with Ilaris® should meet ALL the following criteria: Criteria for cryopyrin-associated periodic syndromes (CAPS):

1. Documented diagnosis of cryopyrin-associated periodic syndromes (CAPS)




Drug Prior Authorization Criteria 2. Documented laboratory evidence of a genetic mutation in the Cold-Induced Auto-inflammatory

Syndrome 1 (CIAS1- sometimes referred to as the NLRP3). 3. Clinical documentation that the patient is experiencing classic symptoms of CAPS in either

criteria below: a. Familial Cold Auto-Inflammatory Syndrome (FCAS): recurrent episodes of rash,

fever/chills, and joint pain following exposure to mild cold environment. (e.g. cool breeze, air conditioning) Symptoms generally last for up to 24 hours.

b. Muckle-Wells Syndrome (MWS): chronic fever and rash sometimes exacerbated by generalized cold exposure. Episodes can last up to 2-3 days.

4. Clinical documentation of significant functional impairment leading to limitations of activities of daily living (ADLs).

5. Documented inadequate response or inability to tolerate either of the following: a. Prednisone b. Anakinra (Kineret®) injection

Criteria for systemic juvenile idiopathic arthritis (SJIA)

1. Documented diagnosis of systemic juvenile idiopathic arthritis (SJIA) 2. Prescribed by a rheumatologist 3. Documented inadequate response or inability to tolerate at least ONE of the following

a. Methotrexate b. NSAIDs c. Intraarticular glucocorticoid injections

4. Documented inadequate response or inability to tolerate to a tumor necrosis factor–α (TNF-α) inhibitor (i.e., Enbrel (etanercept), Humira (adalimumab), Remicade (infliximab))

5. Documented inadequate response or inability to tolerate to TWO of the following: a. Actemra (tocilizumab) b. Kineret (anakinra) c. Orencia (abatacept)

Reasons for non-coverage: • Concurrent use of immunosuppressive therapy • Chronic, active, or recurrent infections • Untreated latent tuberculosis • Under 2 years of age (systemic juvenile idiopathic arthritis (SJIA)) or under 4 years of age

(cryopyrin-associated periodic syndromes (CAPS))

Initial approval period: 1 month Continued approval: Up to 1 year based on physician documentation of disease stability and improvement. Caution:

• Concurrent use with live vaccines not recommended • Increased risk of malignancies may occur

https://www.clinicalkey.com/#section

https://www.clinicalkey.com/#section




Drug Prior Authorization Criteria • Infections, serious (mostly upper respiratory tract) have been reported; discontinue if

serious infection develops Monitoring:

• Serum C reactive protein and serum amyloid A levels periodically • Improvement in signs and symptoms of cryopyrin-associated periodic syndromes (ie, fever,

urticaria-like rash, arthralgia, myalgia, fatigue, and conjunctivitis) or systemic juvenile idiopathic arthritis (SJIA)

• Latent tuberculosis test prior to initiating therapy Dosing: Cryopyrin-associated periodic syndromes (CAPS)

• The recommended dose of Ilaris® is 150 mg for CAPS patients with body weight greater than 40kg.

• For CAPS patients with body weight between 15 kg and 40 kg, the recommended dose is 2mg/kg.

• For children 15 to 40 kg with an inadequate response, the dose can be increased to 3mg/kg. • Ilaris is administered every 8 weeks as a single dose via subcutaneous injection.

Systemic juvenile idiopathic arthritis (SJIA)

• The recommended dose for patients with body weight ≥ 7.5 kg is 4 mg/kg • Administered every 4 weeks via subcutaneous injection • Maximum: 300 mg/dose

Interferon beta-1a: Preferred: Avonex Non-preferred: Plegridy

Non-preferred Interferon beta-1a (Plegridy): Only to be used when a preferred Interferon beta-1a (Avonex) has failed.

Candidates for treatment with Avonex should meet the following criteria:

1. Diagnosis of relapsing multiple sclerosis AND 2. Prescribed by a neurologist AND 3. Medication is to be used as monotherapy disease-modifying treatment of MS AND 4. At least one of the following

a. A documented history of severe injection site reactions not responsive to conservative measures (eg: lipoatrophy or skin necrosis) while taking an injectable MS medication (Extavia, Betaseron, Rebif, Glatopa, Copaxone) OR

b. Presence of significant non-modifiable barriers prohibiting use of preferred disease-modifying therapies requiring reconstitution and/or administration of multiple injections a week eg: clinically confirmed cognitive impairment, pediatric patient OR

c. Documented inadequate response or severe intolerance to glatiramer acetate (Glatopa, Copaxone®)

d. *NOTE: Injection fatigue or fear of needles are not reasons for intolerance or inadequate response.

Note: Extavia is the preferred first-line interferon therapy. Recommend Extavia if appropriate.




Drug Prior Authorization Criteria Candidates for treatment with Plegridy should meet the criteria for Avonex and have tried and failed Avonex.

Reasons for non-coverage: Avonex or Plegridy should NOT be used in patients with ANY of the following:

• Secondary progressive MS with no clinical or MRI evidence of relapses • History of treatment-resistant psychosis, depression or suicidal ideation/behavior • Severe hepatic impairment • High-risk features for early progression to secondary-progressive MS (see Table 1)

For patients with ANY high-risk feature listed in Table 1, escalation therapy with Gilenya (preferred), Tysabri or Rituxan (off-label) may be more appropriate and should be recommended instead.

Table 1: High-risk features for early progression

History of MS attack/relapse with Lesion load Duration Symptom type Timing / frequency

≥ 30 days and significant functional limitations, except for ongoing sensory symptoms

• Sphincter OR • Motor OR • Cerebellar

(ataxia or tremor)

• ≥ 3 relapses in the first 2 years after diagnosis OR

• Average of ≥ 1 relapse/ year over 2 to 3 years ORAfter 6 months of therapy, relapse in the next 6 months

• After 1 yr of therapy, ≥ 3 new or enlarging T2 lesions, continued gad+ lesions, or diffusion-restricted imaging lesions over a 1 yr period OR

• ≥ 5 lesions over 2 years OR

• ≥ 1 cord lesion

Initial approval period: 1 year

Continued approval for treatment with Avonex should meet ALL the following criteria: • Adherence to therapy (>=80%) • Documented beneficial effect from therapy

Continued approval: 1 year

Dosage and Administration • The recommended dose of Avonex is 30 mcg injected intramuscularly weekly. • The recommended dose of Plegridy is 125 mcg injected subcutaneously every 14 days




Drug Prior Authorization Criteria Jetrea® (Ocriplasmin)

Candidates for treatment with Jetrea® should meet ALL the following criteria:

1. Patient is at least 18 years of age 2. Prescribed by a retinal specialist 3. Patient has a documented diagnosis of symptomatic vitreomacular adhesion to the macula

within a 6-mm central retinal field surrounded by elevation of the posterior vitreous cortex, as seen on optical coherence tomography (OCT) (these symptoms may include, but are not limited to visual distortion, black spots, or floaters).

4. The vitreo-macular adhesion has been observed over a period of 6 or more weeks for spontaneous resolution

5. Patient has best-corrected visual acuity of 20/25 or less in the affected eye Reasons for non-coverage: Jetrea should NOT be used in patients with ANY of the following:

• Proliferative diabetic retinopathy • Neovascular age-related macular degeneration, • Retinal vascular occlusion, • Aphakia, • High myopia (more than −8 diopters), • Uncontrolled glaucoma, • Macular hole greater than 400 μm in diameter, • Vitreous opacification, • Lenticular or zonular instability, • History of retinal detachment in either eye • Prior vitrectomy • Prior laser photocoagulation of the macula, • Prior treatment with ocriplasmin; or • Treatment with ocular surgery, intravitreal injection, or retinal laser photocoagulation in the

previous 3 months.

Initial approval: One time only for each eye Dosage and Administration The recommended dose is 0.125 mg (0.1 mL of the diluted solution) administered by intravitreal injection to the affected eye once as a single dose.

Juxtapid™ (Lomitapide)

Candidates for treatment with Juxtapid™ should meet ALL the following criteria:

1. Documented clinical and laboratory determined diagnosis of homozygous familial hypercholesterolemia (HoFH)

2. 18 years of age or older 3. Prescribed by a certified REMS provider demonstrated with supporting documentation (signed

attestation) *NOTE: For more information and to enroll, please go to the following site: http://www.juxtapidremsprogram.com/

http://www.juxtapidremsprogram.com/




Drug Prior Authorization Criteria 4. Tried and failed or intolerant to at least THREE of the following:

• Simvastatin 40 mg daily • Pravastatin 80 mg daily • Atorvastatin 80 mg daily • Crestor 40 mg daily

5. Documented in the medical record that prior to the initiation of therapy, the patient has been and will continue to follow a low-fat diet supplying <20% of energy from fat

6. Documented Baseline laboratory measures of ALT, AST, alkaline phosphatase, and total bilirubin prior to starting Juxtapid™

7. If patient is a female of child bearing age, must have a baseline negative pregnancy test (within 1 month) AND must be on at least one form of effective contraception

Reason for non-coverage:

• Moderate or severe hepatic impairment or active liver disease including unexplained persistent abnormal liver function tests

Initial approval: 6 months Continued approval for treatment with Juxtapid™ should meet ALL the following criteria:

1. Review of compliance to Juxtapid™ 2. Review of compliance to recommend liver enzyme laboratory testing 3. Documented cholesterol control as evidence by significant LDL lowering from pre-treatment

levels

Continued approval: 1 year

Limitations of use: • The safety and effectiveness of Juxtapid™ have not been established in patients with

hypercholesterolemia who do not have HoFH • The effect of Juxtapid™ on cardiovascular morbidity and mortality has not been determined

Monitoring • Before treatment, measure ALT, AST, alkaline phosphatase, and total bilirubin and then ALT

and AST regularly as recommended; obtain a negative pregnancy test in females of reproductive potential

• During treatment, adjust the dose of Juxtapid if the ALT or AST are ≥ 3 x ULN

Dosing and Administration • Initiate treatment at 5 mg once daily. Initiate a low-fat diet supplying <20% of energy from fat. • Titrate dose based on acceptable safety/tolerability: increase to 10 mg daily after at least 2

weeks; and then, at a minimum of 4-week intervals, to 20 mg, 40 mg, and up to the maximum recommended dose of 60 mg daily

Ordering Information Juxtapid™ is only available from certified pharmacies that are enrolled in the Juxtapid™ REMS program. At this time, Juxtapid™ is not available through our KP Pharmacies or the KP Specialty Pharmacy. Prescriber’s should complete the Juxtapid™ Prescriber Enrollment Form and fax to Juxtapid™ REMS Program at 855-898-2498 or scan form and email to [email protected]. The Juxtapid™ Prescriber Enrollment form is available at:




Drug Prior Authorization Criteria http://www.juxtapidremsprogram.com/_pdf/JUXTAPID_REMS_Program_Prescriber_Enrollment_Form_editable.pdf

Kalbitor® (Ecallantide)

Candidates for Kalbitor® should meet ALL of the following criteria:

1. A diagnosis of Type I or Type II hereditary angioedema. 2. Prescriber must be an allergist. 3. Contraindications or inability to tolerate 17α-alkylated androgens (danazol, stanozolol, and

oxandrolone) (especially in females of child-bearing age), including hirsutism, menstrual irregularities, hepatic dysfunction, undiagnosed vaginal bleeding, porphyria, cardiac or renal disease, depression, muscle cramps and thrombosis. Patients with significant lipid abnormalities might also be considered.


5. Lack of response to Berinert® Reasons for non-coverage:

• Routine prophylaxis against angioedema attacks in adolescent and adult patients with HAE • Under 16 years of age

Initial Approval: 3 months Subsequent approval will be based on clinical documentation of functional improvement, a decrease in frequency of HAE attack, and an improvement in severity and duration of attacks. Monitoring:

• Symptomatic improvement • Symptoms of hypersensitivity reaction during or after infusion

Consider long-term prophylaxis for patients with HAE who experience ≥ one severe event per month

or who are disabled more than five days per month OR if the patient has a history of previous airway compromise.

Options include: 1. 17α-alkylated androgens (danazol, stanozolol if available, and oxandrolone): Generally

treatment of choice for long-term preventative treatment. Contraindications include pregnancy, breastfeeding, significantly impaired renal/ hepatic function, etc (refer to package insert for complete list). See Milan or Budapest Protocols for dosing recommendations. Use in children should be undertaken only with great caution.

2. Antifibrinolytics (epsilon aminocaproic acid [Amicar]): Less effective than androgens. Often reserved for patients who do not tolerate or in whom anabolic androgens are contraindicated.


• Human C1 inhibitor prophylaxis is the safest prophylactic agent to use during pregnancy.

http://www.juxtapidremsprogram.com/_pdf/JUXTAPID_REMS_Program_Prescriber_Enrollment_Form_editable.pdf

http://www.juxtapidremsprogram.com/_pdf/JUXTAPID_REMS_Program_Prescriber_Enrollment_Form_editable.pdf




Drug Prior Authorization Criteria Kalydeco™ (Ivacaftor)

Candidates for Kalydeco™ should meet ALL of the following criteria:

1. Confirmed diagnosis of cystic fibrosis (CF) 2. Prescribed by a pulmonologist 3. Age 2 years or older 4. At least one of the following mutations in the cystic fibrosis transmembrane conductance

regulator (CFTR) gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, or S549R OR Patients with R117H mutation in the CFTR gene who have clinically significant disease.

Use caution in the following patients:

• Patient with abnormal liver function defined as elevation in three or more of the following levels of >3 times the upper limit of normal: ALT, AST, AP, GGT or total bilirubin

• Patient with CrCl <30 ml/min • Concomitant use of ivacaftor with strong CYP3A4 inducers (e.g., rifampin, St. John’s wort)

substantially decreases available ivacaftor which may decrease effectiveness. Therefore, co-administration is not recommended.

Dosing and Administation:

• Adults and pediatric patients age 6 years and older: one 150 mg tablet taken orally every 12 hours with fat-containing food. (2.2, 12.3)

• Pediatric patients 2 to less than 6 years of age and less than 14 kg: one 50 mg packet mixed with 1 teaspoon (5 mL) of soft food or liquid and administered orally every 12 hours with fat-containing food.

• Pediatric patients 2 to less than 6 years of age and 14 kg or greater: one 75 mg packet mixed with 1 teaspoon (5 mL) of soft food or liquid and administered orally every 12 hours with fat-containing food.

• Pediatric patients less than 2 years of age: not recommended. • Reduce dose in patients with moderate and severe hepatic impairment. • Reduce dose when co-administered with drugs that are moderate or strong

CYP3A inhibitors. Monitoring:

• Monitor ALT/AST at baseline, every three months for one year, then once yearly thereafter • Monitor efficacy via forced expiratory volume in on second (FEV1), patient weight and sweat

chloride concentration (optional) • Monitor for adherence to drug regimen and for adverse events which could be related to

treatment Initial Approval: 6 months Continued Approval: 12 months if patient has documented evidence of response to therapy and ALT/AST levels have been checked within the last 3 months.

Ordering information: Kalydeco™ is available through the KP Specialty Pharmacy. Prescribers must complete the KP Specialty Pharmacy Kalydeco™ Drug Order Form at http://pharmacy.kp.org/kp-cms/California/DrugInformation/ViewMedSafetyDNMgmtCA.aspx?I32Object=1198&nodeValue=113 and fax it to KP-Specialty Pharmacy (1-650-301-5790).






Drug Prior Authorization Criteria Korlym™ (Mifepristone)

Candidates for treatment with Korlym™ should meet ALL the following criteria:

1. Documented diagnosis of Cushing’s syndrome 2. Documented diagnosis of type 2 diabetes mellitus or glucose intolerant secondary to

Cushing’s syndrome 3. Prescribed by an endocrinologist 4. Patient has failed surgery or is not a candidate for surgery for Cushing’s syndrome 5. Failed to obtain adequate glycemic control on combination therapy with:

a. Maximum tolerated doses of metformin monotherapy (unless patient is not a candidate for metformin therapy) and

b. Maximum tolerated doses of a sulfonylurea (unless the patient is not a candidate for sulfonylurea therapy) and

c. Maximum tolerated titration of insulin OR meets the following criteria: i. Korlym™ may be initiated prior to insulin trial, if the Endocrinologist

indicates hypoglycemia is uniquely undesirable, so unable to use insulin (e.g., in patients who have hazardous jobs)

6. Documented inadequate response to ONE of the following cortisol-blocking medications: ketoconazole, metyrapone (Metopirone), or mitotane (Lysodren)

7. If patient is a female of child bearing age (12-50 years of age), must have a baseline negative pregnancy test (within 1 month)


• Pregnant women (Pregnancy Category X) • Concomitant use simvastatin or lovastatin and CYP3A substrates with narrow therapeutic

range • Concurrent long-term corticosteroid use • Women with history of unexplained vaginal bleeding • Women with endometrial hyperplasia with atypia or endometrial carcinoma

Initial Approval: 6 months Continued Approval: 12 months if patient has documented clinical benefit from medication and no reported adverse events to Korlym™ Dosage and Administration

• The recommended starting dose for Korlym™ is 300 mg once daily

Monitoring: • Patients should be closely monitored for signs and symptoms of adrenal insufficiency • Hypokalemia should be corrected prior to treatment and monitored for during treatment

Ordering information: Korlym™ is only dispensed by CuraScript specialty pharmacy. For more information, visit




Drug Prior Authorization Criteria http://pharmacy.kp.org/KpCMS/California/DrugInformation/ViewMedSafetyDNMgmtCA.aspx?I32

Object=1226&nodeValue=113 Kuvan™ (Sapropterin)

Candidates for Kuvan™ should meet ALL of the following criteria: 1. Diagnosis of Phenylketonuria 2. Absence of the following medications:

a. Medications known to inhibit folate metabolism (eg, methotrexate) b. Nitric oxide-mediated vasorelaxation medications (eg sildenafil, vardenafil, tadalafil) c. Levodopa

3. Currently following a phenylalanine restricted diet Initial Coverage: 2 months Continued Coverage: 6 months if patient’s phenylalanine levels have decreased 30% from baseline level Monitoring:

• Monitor blood phenylalanine levels at baseline, after 1 week of treatment, periodically for first month, and regularly thereafter

Kynamro™ (Mipomersen sodium)

Candidates for treatment with Kynamro™ should meet ALL the following criteria:

1. Documented clinical and laboratory determined diagnosis of homozygous familial hypercholesterolemia (HoFH)

2. 18 years of age or older 3. Prescribed by a certified REMS provider demonstrated with supporting documentation (signed

attestation) *NOTE: For more information and to enroll, please go to the following site: http://www.kynamrorems.com/

4. Tried and failed or intolerant to at least THREE of the following: • Simvastatin 40 mg daily • Pravastatin 80 mg daily • Atorvastatin 80 mg daily • Crestor 40 mg daily

5. Documented in the medical record that prior to the initiation of therapy, the patient has been and will continue to follow a low-fat diet supplying <20% of energy from fat

6. Used as adjunct to lipid lowering medications 7. If patient is a female of child bearing age (18-50 years of age), must have a baseline negative

pregnancy test (within 1 month) AND must be on at least one form of effective contraception Reason for Non-coverage:

• Moderate or severe hepatic impairment or active liver disease including unexplained persistent abnormal liver function tests

• Patients receiving LDL apheresis with the use of Kynamro™

Initial approval: 6 months

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http://pharmacy.kp.org/KpCMS/California/DrugInformation/ViewMedSafetyDNMgmtCA.aspx?I32Object=1226&nodeValue=113

http://www.kynamrorems.com/




Drug Prior Authorization Criteria Continued approval for treatment with Kynamro™ should meet ALL the following criteria:

1. Review of compliance to Kynamro™ 2. Review of compliance to recommend liver enzyme laboratory testing 3. Documented cholesterol control as evidence by significant LDL lowering from pre-treatment

levels Continued approval: 1 year Limitations of Use

• The safety and effectiveness of Kynamro™ have not been established in patients with hypercholesterolemia who do not have HoFH

• The effect of Kynamro™ on cardiovascular morbidity and mortality has not been determined • The use of Kynamro™ as an adjunct to LDL apheresis is not recommended

Monitoring

• Before treatment, measure ALT, AST, alkaline phosphatase, and total bilirubin and then ALT and AST regularly as recommended

• During treatment, withhold the dose of Kynamro™ if the ALT or AST is ≥3 times the upper limit of normal

• Discontinue Kynamro™ for clinically significant liver toxicity Dosing and Administration

• The recommended dose is 200 mg once weekly as a subcutaneous injection • The vial or pre-filled syringe should be removed from 2-8°C (36-46°F) refrigerated storage and

allowed to reach room temperature for at least 30 minutes prior to administration Ordering information: Kynamro™ is only available from certified pharmacies that are enrolled in the program. At this time, Kynamro™ is not available through our KP Pharmacies or the KP Specialty Pharmacy. Prescriber’s should complete and the Kynarmo™ Prescription Authorization and fax to Kynamro™ REMS Program at 877-596-2676. The prescription authorization form is available at: http://www.kynamrorems.com/~/media/Kynamro/Files/Prescription-Authorization-Form.pdf

Lemtrada® (Alemtuzumab)

Candidates for treatment with Lemtrada should meet ALL of the following criteria:

1. Diagnosis of relapsing multiple sclerosis (MS) 2. Prescribed by or in consultation with a multiple sclerosis specialist certified by the LEMTRADA

REMS program (1-855-676-6326) 3. Patient enrolled in the LEMTRADA REMS program and Lemtrada to be administered at a

certified healthcare facility with on-site access to equipment and personnel trained to manage infusion reactions

4. Lemtrada to be administered as monotherapy and not in combination with other disease-modifying therapies for MS

5. Evidence of continued inflammatory disease (new MRI lesions and/or relapses) on natalizumab (Tysabri) or rituximab (Rituxan)

6. CBC and thyroid function test within normal range, negative serum HIV antibody test, and negative TB test

7. Females of child bearing age (12-50 years of age) have documentation of a baseline negative

http://www.kynamrorems.com/%7E/media/Kynamro/Files/Prescription-Authorization-Form.pdf




Drug Prior Authorization Criteria pregnancy test within the past month AND either a prescription for birth control (IUD or other contraceptive) or documentation of patient declining contraception and being counseled of the potential risk in pregnancy


• Secondary progressive MS and no clinical or MRI evidence of relapses • Infection with Human Immunodeficiency Virus • History of thyroid cancer, melanoma and lymphoproliferative disorders • Concomitant use of antineoplastic or immunosuppressant therapies (eg: adalimumab,

alefacept, anakinra, azathioprine, cladribine, cyclophosphamide, cyclosporine, daclizumab, efalizumab, etanercept, fludarabine phosphate, infliximab, intravenous immunoglobulin, leflunomide, mercaptopurine, methotrexate, mitoxantrone, mycophenolate mofetil, mycophenolic acid, pemetrexed, rituximab, trastuzumab)

Approval period: 18 months Dosage and Administration

• 12 mg IV infusion over 4 hours on 5 consecutive days then 12 mg IV infusion over 4 hours on 3 consecutive days 12 months later

• Premedicate with corticosteroids prior to Lemtrada infusion for the first 3 days of each treatment course

• Administer antiviral agents for herpetic prophylaxis starting on the first day of Lemtrada dosing and continue for a minimum of 2 months after completion of Lemtrada dosing or until CD4+ lymphocyte count is more than 200 cells/µL

• Must be diluted prior to administration Monitoring

• Infusion reactions (may be delayed and may be life-threatening) • Recommended at baseline and monthly until 48 months after last treatment course:

o CBC w/ differential o Serum creatinine o Urinalysis with urine cell counts

• Thyroid function tests at baseline and every 3 months until 48 months after last treatment course

• Skin exam at baseline and yearly to monitor for melanoma • For females, human papillomavirus screening yearly • Autoimmune conditions including thyroid disorders and immune thrombocytopenia • Signs or symptoms of infection • Signs or symptoms of PML • ECG prior to each treatment course

Ordering information: Prescriber, patient, pharmacy and infusion center must be enrolled in the LEMTRADA REMS program.




Drug Prior Authorization Criteria For information on how to enroll in the program, please visit https://www.lemtradarems.com/ or call 1-855-676-6326. Lemtrada is distributed by the manufacturer to certified pharmacies and infusion centers only.

Natpara® (parathyroid hormone)

Candidates for treatment with Natpara® should meet ALL the following criteria: 1. Prescribed by an Endocrinologist 2. Documented diagnosis of chronic hypoparathyroidism 3. Documented inadequate response or an inability to tolerate maximum titrated doses of

conventional therapy (i.e. oral calcium requirement ≥ 2000 mg per day AND calcitriol requirement ≥ 0.25 µg per day)

4. Documented laboratory evidence of sufficient 25-hydroxyvitamin D stores and serum calcium > 7.5 mg/dL

5. No documentation of calcium-sensing receptor mutations Reasons for non-coverage: Natpara® should NOT be used in patients with any of the following:

• Diagnosis of acute post-surgical hypoparathyroidism • Diagnosis of hypoparathyroidism caused by calcium-sensing receptor mutations • History or current diagnosis of osteosarcoma • Paget’s disease of bone or unexplained elevations of alkaline phosphatase • Pediatric and young adult patients with open epiphyses • Hereditary disorders predisposing to osteosarcoma • History of external beam or implant radiation therapy involving the skeleton

Initial approval period: 6 months Continued approval for treatment with Natpara® should meet ALL the following criteria:

1. Review of compliance to Natpara® 2. Documented beneficial effect from therapy such as reduction in signs or symptoms of disease


• The initial dose of Natpara® for hypoparathyroidism is 50 mcg once daily as a subcutaneous injection in the thigh (alternate thigh every day).

• The dose of Natpara® may be increased in increments of 25 mcg every 4 weeks up to a maximum daily dose of 100 mcg if serum calcium cannot be maintained above 8 mg/dL without an active form of vitamin D and/or oral calcium supplementation.

• The dose of Natpara® may be decreased to as low as 25 mcg per day if total serum calcium is repeatedly above 9 mg/dL after the active form of vitamin D has been discontinued and calcium supplement has been decreased to a dose sufficient to meet daily requirements.

Monitoring • Serum calcium concentration should be measured within 3 to 7 days of Natpara® initiation

and weekly during titration. Doses of calcium and vitamin D should be adjusted based on

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Drug Prior Authorization Criteria serum calcium value and clinical assessment.

• After dose has been stabilized, monitor serum calcium, albumin and phosphate every 3 to 6 months, and serum creatinine and 24-hr urinary calcium excretion every 6 to 12 months

• Monitor for signs and symptoms of hypocalcemia (tingling in fingers and toes, perioral numbness, muscle cramps, laryngospasm, seizures) or hypercalcemia (nausea, vomiting, constipation, low energy, muscle weakness).

*Prescribers and pharmacies will have to participate in the Natpara® REMS program for Natpara® to be made available to the patient. As of February 2015, NPS Pharmaceuticals has not allowed purchasing of Natpara by KP Pharmacy. Prescribers should contact NPS Advantage at 1-855-NATPARA (1-855-628-7872).

Nucala® (Mepolizumab) injection

Candidates for Nucala® should meet ALL of the following criteria:

10. Prescribed by a pulmonologist or allergy specialist 11. 12 years of age or older 12. Has a diagnosis of severe asthma with an eosinophilic phenotype:

a. Documented blood eosinophil count of: i. ≥ 150 cells/mm3 at therapy initiation OR

ii. ≥ 300 cells/mm3 in the previous 12 months 13. Uncontrolled asthma* despite an aggressive drug therapy regimen including: high-dose

inhaled corticosteroid (ICS), plus a long-acting beta-agonist (LABA) with or without daily use of oral corticosteroids (i.e. Mometasone 200 mcg/formoterol 5 mcg (Dulera) 2 puffs twice daily)

a. Patients who are not on daily oral corticosteroids but who otherwise meet the above criteria and who have had frequent and/or severe exacerbations in the past 12 months requiring systemic corticosteroids for > 3 days can be considered for mepolizumab.

14. NOT for the treatment of other causes of eosinophilia such as hypereosinophilic syndromes, neoplastic disease, or parasitic disease.

15. NOT used for the relief of acute bronchospasm or status asthmaticus 16. NOT currently receiving omalizumab (Xolair), reslizumab (Cinqair), or other monoclonal

antibody for the treatment of asthma.

*Indicators of uncontrolled asthma include: two or more exacerbations in the past 12 months requiring systemic corticosteroids for > 3 days, serious exacerbation: at least one hospitalization, ICU stay or mechanical ventilation in the past 12 months, or Asthma Control Test (ACT) is consistently < 20.

Initial Approval: 3 months Continued Approval: 12 months if the patient has experienced any of the following:

• Member has experienced a reduction in asthma signs and symptoms including wheezing, chest tightness, coughing, shortness of breath

• Member has experienced a decrease in administration of rescue medication, albuterol (salbutamol)

• Member has experienced a decrease in exacerbation frequency (no increase in ICS dose or CS dose)

• Member has experienced an increase in predicted FEV1 from the pretreatment baseline




Drug Prior Authorization Criteria • Member has an objective improvement in quality of life: Asthma Control Test (ACT)

Dosage and administration: • The recommended dose is 100 mg administered once every 4 weeks by subcutaneous

injection into the upper arm, thigh, or abdomen. • Should be reconstituted and administered by a healthcare professional

Monitoring: • Monitor the patient for hypersensitivity reactions approximately 60 minutes after the

administration of each dose. • FEV1, peak flow, and/or other pulmonary function tests • Frequency of administration of rescue medication (short-acting beta2-agonist, albuterol) • Asthma signs and symptoms including wheezing, chest tightness, coughing, shortness of

breath • Frequency of exacerbation

Olysio (simeprevir)

Olysio is a non-preferred treatment agent at Kaiser Permanente. Please refer all requests to internal KP Hepatology or Infectious Disease

Orkambi® (lumacaftor and ivacaftor)

Candidates for treatment with Orkambi® should meet ALL the following criteria:

1. Patient is at least 12 years of age 2. Prescribed by a Pulmonologist 3. Patient has a documented diagnosis of cystic fibrosis 4. Patient has documented homozygous for the F508del mutation in the cystic fibrosis

transmembrane conductance regulator (CFTR) gene 5. Patient’s baseline percent predicted FEV1 is 30 to 90%

Initial approval: 6 months Continued approval: 6 months if the following criteria are met:

1. Adherence as evidenced by refill history and quarterly clinic visits 2. The prescribing physician determines that the patient is tolerating lumacaftor/ivacaftor

therapy and has achieved a clinically meaningful indicator of response in at least one of the following parameters: a) Improvement of ppFEV1 from baseline b) Pulmonary exacerbation c) BMI

3. AST, ALT, bilirubin and ophthalmic changes (if appropriate) are adequately monitored

Monitoring:

• CF mutation test (prior to therapy if genotype is unknown) • ophthalmological examinations (baseline and follow-up in pediatric patients) • ALT, AST, and bilirubin (baseline, every 3 months for the first year of therapy, and annually

thereafter




Drug Prior Authorization Criteria • Increased monitoring may be necessary in patients with a history of elevated hepatic

transaminases or bilirubin); signs and symptoms of respiratory effects (in patients with a percent predicted FEV1 <40)

Dosage and Administration

• Adults and pediatric patients age 12 years and older: two tablets (each containing lumacaftor 200 mg/ivacaftor 125 mg) taken orally every 12 hours.

• Reduce dose in patients with moderate or severe hepatic impairment • When initiating Orkambi in patients taking strong CYP3A inhibitors, reduce Orkambi dose for

the first week of treatment.

Ordering information: Orkambi is available through the KP Specialty Pharmacy. If approved for coverage, prescribers must complete the KP-SP Orkambi Order Form and fax it to the KP-Specialty Pharmacy (1-650-301-5790).

Procysbi™ (delayed-release Cysteamine)

Candidates for treatment with Procysbi™ should meet ALL the following criteria:

1. Document diagnosis of nephropathic cystinosis 2. 6 years of age or older 3. Documented inadequate response or unable to tolerate Cystagon®(immediate-release

cysteamine) Reasons for non-coverage:

• Hypersensitivity to penicillamine

Initial Approval: 6 months. Maximum dosage approved should be restricted to 1.95 grams/ m2/day. Continued Approval: 12 months based on review of compliance to therapy and documentation of evidence of response to therapy Dosage and Administration

• Total daily dose is 1.3 gram/m2/day in two divided doses, every 12 hours. • Take Procysbi™ at least 2 hours after and at least 30 minutes before eating

Switching from Cystagon® to Procysbi™

• Total daily dose of Procysbi™ equal to their previous total daily dose of Cystagon® Initial Dosage in cysteamine-naïve patients

• Starting Dose: 1⁄6 to 1⁄4 of the maintenance dose of Procysbi™ • Maintenance Dose: 1.3 gram/m2/day, in two divided doses every 12 hours

Monitoring:

• WBC cystine levels (or plasma cysteamine concentration if adequate WBC cystine testing is not available) should be measured as follows:

o Monthly for 3 months, then quarterly for 1 year, then twice yearly at a minimum for patients never treated with Cystagon® before.

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Drug Prior Authorization Criteria o Two weeks, then quarterly for 6 months, then twice yearly at a minimum for

patients switching from Cystagon® to Procysbi™. • WBC cystine and/or plasma cysteamine measurements must be obtained 12.5 hours after the

evening dose the day before, and therefore 30 minutes after the following morning dose is given.

Prolia® (Denosumab)

Candidates for treatment with Prolia® should meet ALL the following criteria:

1. Prior osteoporotic fracture OR 2. High risk for fracture: WHO Fracture Risk Assessment (FRAX) 10-year risk of hip fracture of

≥3% OR a 10-year risk of a major osteoporotic fracture of ≥20% Web Link to WHO Fracture Risk Assessment Tool (FRAX): http://www.shef.ac.uk/FRAX/tool.jsp

3. Prescribed by an endocrinologist or a rheumatologist 4. Screened for secondary causes of osteoporosis 5. Documented inadequate response or unable to tolerate to an oral bisphosphonate (i.e.

alendronate, ibandronate, risendronate) 6. Documented inadequate response or unable to tolerate an IV bisphosphonate (i.e. Zoledronic

Acid) Reasons for non-coverage:

• Pediatric patients (<18 years old) • Pregnant/nursing women • Non-FDA approved indications

Initial Approval: 6 months (1 dose) Continued Approval: 12 months (2 doses) if patient has documented clinical benefit from medication and no reported adverse events to Prolia® Use Caution in the following patient population:

• Renal impairment (CrCl of 30 ml/min or less) or end-stage renal disease requiring hemodialysis

• Hypocalcemia Dosage and Administration

• Prolia® should be administered by a healthcare professional • 60 mg every 6 months as a subcutaneous injection in the upper arm, upper thigh, or

abdomen • All patients should receive calcium 1000 mg daily and at least 400 IU vitamin D daily

Monitoring:

• Serum calcium prior to therapy initiation and periodically. Adequately supplement all patients with calcium and vitamin D

• Symptoms of osteonecrosis of the jaw Provenge® (Sipuleucel-T)

Candidates for Provenge® should meet ALL of the following criteria:

http://www.shef.ac.uk/FRAX/tool.jsp




Drug Prior Authorization Criteria Prescriber should be enrolled in the Dendreon ON Call Program: (877) 556-3737. Representatives can be reached at (877) 336-3736 to answer general questions, Monday-Friday from 8:00a-8:00pm (ET) and 24 hours per day in the event of a product related health emergency

1. Histological documentation of adenocarcinoma of the prostate without evidence of neuroendocrine or small cell features

2. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 3. Patient must be asymptomatic or minimally symptomatic, without cancer-related bone pain

or use of opiod analgesics for cancer pain 4. Must have Progressive androgen independent prostate cancer.

a. Current (i.e., within past 6 months) and continuing evidence of disease progression while on medical castration or after surgical castration demonstrated by: i. PSA progressiona OR ii. progression of measurable diseaseb OR iii. progression of non-measurable diseasec

5. Must have metastatic disease as evidenced by: a. soft tissue metastases on CT of abdomen/pelvis within 6 months OR bony metastases on

bone scan within 6 months AND b. no known lung, liver, or brain metastases, malignant pleural effusions, or malignant

ascites 6. Life expectancy of at least 6 months 7. Testosterone < 50 ng/dL achieved via medical or surgical castration

a. Medical Castration (Lupron or Zoladex) has occurred and has been continued for at least 3 months OR

b. Surgical (orchiectomy) castration must have occurred at least 3 months prior 8. No known pathologic long-bone fractures, imminent pathologic long-bone fracture (cortical

erosion on radiography > 50%) or spinal cord compression. 9. No requirement for systemic immunosuppressive therapy (e.g. corticosteroids) for any

reason 10. None of the following may occur within 28 days prior to Provenge®:

a. Surgery b. External beam radiation therapy c. Treatment with chemotherapy d. Treatment with other investigational products e. Treatment with other systemic therapy for prostate cancer (except for medication

castration with Lupron® or Zoladex®) f. Treatment with 5-α-reductase inhibitors (e.g., finasteride [Proscar®], dutasteride

[Avodart®]) g. Treatment with high dose calcitriol [1,25(OH)2VitD] (i.e., > 0.5 µg/day) h. Treatment with ketoconazole i. Treatment with PC-SPES (or PC-SPEC) or Saw Palmetto j. Treatment with megestrol acetate (Megace®), diethylstilbesterol (DES), or cyproterone

acetate k. Treatment with non-steroidal antiandrogens (e.g., flutamide, nilutamide or bicalutamide)




Drug Prior Authorization Criteria l. No change (initiation or discontinuation) in bisphosphonate therapy m. No systemic corticosteroids

i. Use of inhaled, intranasal, intra-articular, and topical steroids is acceptable, as is a short course (i.e., < 1 day) of corticosteroids to prevent a reaction to the IV contrast used for CT scans

n. No use of narcotics for cancer related pain o. Average weekly pain score of > 4 (measured by the Visual Analogue Scale (VAS))14 days

prior to treatment initiation 11. The following lab values must be demonstrated prior to therapy initiation:

a. White blood cell (WBC) > 2,500 cells/µL b. Neutrophils > 1,000 cells/µL c. Platelets > 100,000 cells/µL d. Hemoglobin (HgB) > 9.0 g/dL e. Creatinine < 2.0 mg/dL f. Total Bilirubin < 2 x upper limit of normal (ULN) g. Aspartate transferase (AST) < 2.5 x ULN h. Alanine transferase (ALT) < 2.5 x ULN i. Serum PSA > 5.0 ng/mL

Notes:

a. PSA Progression: Two consecutive PSA values, at least 14 days apart, each > 5.0 ng/mL and > 50% above the minimum PSA observed during castration therapy or above the pre-treatment value if there was no response.

b. Measurable disease: > 50% increase in the sum of the cross products of all measurable lesions or the development of any new lesions. The change will be measured against the best response to castration therapy or against the pre-castration measurements if there was no response.

c. Non-measurable disease: o Soft tissue disease: The appearance of 1 or more new lesions, and/or unequivocal

worsening of non measurable disease when compared to imaging studies acquired during castration therapy or against the pre-castration studies if there was no response.

o Bone disease: Appearance of 2 or more new areas of abnormal uptake on bone scan when compared to imaging studies acquired during castration therapy or against the pre-castration studies if there was no response. Increased uptake of pre-existing lesions on bone scan does not constitute progression.

Approval Duration: Up to 3 doses (one course of treatment) Ordering information: Provenge® is provided only through specified KP treatment sites with training and coordination handled by Dendreon. For more information and to fill out the Kaiser Provenge® Enrollment Form, visit http://kpnet.kp.org/kphealthconnect/deploy/prod/ac/provenge.htm.

http://kpnet.kp.org/kphealthconnect/deploy/prod/ac/provenge.htm.




Drug Prior Authorization Criteria Ravicti™ (glycerol phenylbutyrate)

Candidates for treatment with Ravicti™ should meet ALL the following criteria:

1. Documented diagnosis of urea cycle disorder 2. Must be 2 years of age or older 3. Inadequate response to ONE of the following: dietary protein restriction or amino acid

supplementation 4. Must be used with dietary protein restriction 5. Documented inadequate response or unable to tolerate Buphenyl® (sodium phenylbutyrate)


• Known hypersensitivity to phenylbutyrate • Being used for treatment of acute hyperammonemia in patients with urea cycle disorders


Continued Approval: 12 months if there is documented evidence of response to therapy and patient is actively on dietary protein restriction

Dosage and Administration • Recommended initial dosing range is 4.5 to 11.2 mL/m2/day (5 to 12.4 g/m2/day) • Total daily dosage is given in 3 equally divided dosages, rounded up to nearest 0.5 mL • Instruct patients to take with food and to administer directly into mouth via oral syringe or

dosing cup • Must be used with dietary protein restriction

Monitoring: • Signs and symptoms of neurotoxicity (eg, confusion, headache, nausea, sleepiness,

somnolence, or vomiting) without increased ammonia levels or other illnesses • Plasma ammonia

Ordering information: Ravicti™ is available through the KP Specialty Pharmacy. Prescribers must complete the Ravicti Drug Order Form and fax it to KP-Specialty Pharmacy (1-650-301-5790).

Ruconest (C1 inhibitor (recombinant))

Candidates for treatment with Ruconest® should meet ALL the following criteria:

1. A diagnosis of Type I or Type II hereditary angioedema (HAE). 2. Prescribed by an allergist. 3. Treatment of acute attacks of HAE in adult or adolescent patients 4. Documented trial and lack of response to 17α-alkylated androgens or

contraindications/inability to tolerate 17α-alkylated androgens (especially in females of child-bearing age), including hirsutism, menstrual irregularities, hepatic dysfunction, undiagnosed vaginal bleeding, porphyria, cardiac or renal disease, depression, muscle cramps and thrombosis. Patients with significant lipid abnormalities might also be considered.

5. Documented trial or intolerance to ONE human C1-Inhibitor (Cinryze or Berinert) Reasons for non-coverage:

• Routine prophylaxis against angioedema attacks in adolescent and adult patients with HAE

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Drug Prior Authorization Criteria • 18 years of age or younger • Being used in the treatment of HAE patients with laryngeal attacks



Dosing and Administration: • The recommended dose of Ruconest is 50 IU per kg with a maximum of 4200 IU to be

administered as a slow intravenous injection over approximately 5 minutes. • If the attack symptoms persist, an additional (second) dose can be administered at the

recommended dose level. Do not exceed 4200 IU per dose. • No more than two doses should be administered within a 24 hour period.

Monitoring:

• Symptomatic improvement • Monitor for signs/symptoms of hypersensitivity reactions and thrombotic events.

Consider long-term prophylaxis for patients with HAE who experience ≥ one severe event per month or who are disabled more than five days per month OR if the patient has a history of previous airway compromise. Options include:

1. 17α-alkylated androgens (danazol, stanozolol if available, and oxandrolone): Generally treatment of choice for long-term preventative treatment. Contraindications include pregnancy, breastfeeding, significantly impaired renal/ hepatic function, etc (refer to package insert for complete list). See Milan or Budapest Protocols for dosing recommendations. Use in children should be undertaken only with great caution.



Human C1 inhibitor prophylaxis is the safest prophylactic agent to use during pregnancy.




Drug Prior Authorization Criteria Sabril® (Vigabatrin)

Candidates for Sabril® should meet ALL of the following criteria: Infantile Spasms

1. Prescribed by a neurologist 2. Between the ages of 1 month to 2 years old. 3. Potential benefit must outweigh the potential risk of vision loss. 4. Must have vision tested to the extent possible depending on the age of the child at baseline

before beginning treatment and at least every 3 months. Refractory Complex Partial Seizures

1. Prescribed by a neurologist. 2. 18 years of age or older. 3. Tried and failed at least 2 other anticonvulsant agents. 4. Vigabatrin used as adjunct therapy. 5. Potential benefit must outweigh the potential risk of vision loss. 6. Must have vision tested at baseline before beginning treatment and at least every 3 months.

Initial Approval period: 3 months Continued approval:

• Approval renewed every 3 months for Refractory Complex Partial Seizures o Must provide updates on eye exams upon renewal. o Must show a substantial clinical benefit within 3 months of starting treatment in order to

continue therapy. o Must show a substantial clinical benefit within 2-4 weeks of starting treatment in order

to continue therapy. Caution:

• Peripheral visual field defect, the risk increases with higher doses and longer duration. • Should not be used with other drugs associated with serious adverse ophthalmic effects such

as retinopathy or glaucoma unless the benefit outweighs the risk. • Renal impairment: CrCl greater than 50 to 80 mL/min, decrease dose by 25%; CrCl greater

than 30 to 50 mL/min, decrease dose by 50%; CrCl greater than 10 to 30 mL/min, decrease dose by 75%

Monitoring:

• Vision must be tested at baseline and every 3 months • Worsening of depression, suicidal ideation, and abnormal changes in behavior

Special considerations:

• FDA mandated Risk Evaluation and Mitigation Strategies (REMS) associated with Sabril®. • The medication is shipped directly to the patient.




Drug Prior Authorization Criteria • Available only through a special restricted distribution program called SHARE, by calling 1-

888-45-SHARE. • Only prescribers and pharmacies registered with SHARE may prescribe and distribute Sabril®. • For infants the medication is usually taken for 6-9 months. Dosage is often reduced at this

point to see if symptoms re-emerge. If so, the dosage is increased to previous levels. • Upon discontinuation, tapering of dose recommended

Dosing:

• Infantile Spasms: Initial, 50 mg/kg/day ORALLY in 2 divided doses; titrate by 25 to 50 mg/kg/day increments every 3 days up to a MAX of 150 mg/kg/day

• Refractory Complex Partial Seizures : Adjunct therapy: initial, 500 mg ORALLY twice daily; titrate total daily dose in 500-mg increments at weekly intervals to a MAX dose of 1500 mg twice daily

Ordering information: Sabril® is only available only through a special restricted distribution program called SHARE, by calling 1-888-45-SHARE. Only prescribers and pharmacies registered with SHARE may prescribe and distribute Sabril®. Important forms for the Sabril® Prescribing Process can be found at http://lundbeckshare.com/pg512_important_steps.aspx?utm_medium=Links&utm_source=www.sabril.net&utm_content=/hcp/.

SGLT2 inhibitors:

Preferred: Jardiance® (empagliflozin)

Synjardy® (empagliflozin and metformin)

Non-Preferred: Invokana™ (Canagliflozin) Farxiga™ (Dapagliflozin Non-Covered combination products (separate prescriptions required for ingredients in

For non-preferred combination product:

1. Patient must meet criteria for DPP-4 inhibitor and SGLT2 inhibitor AND/OR 2. Separate prescriptions are required for ingredients in non-preferred combination products:

The preferred SGLT2 Inhibitor will be covered for current KP new start members who meet ALL of the following criteria:

1. Documented diagnosis of type 2 diabetes mellitus 2. Patient has continuous adherence with refilling maximum tolerated doses (i.e at least 1000

mg per day) of metformin (unless patient is not a candidate for metformin therapy) 3. HbgA1c level 7% - 8.5%

a. A1C goal < 7% unless greater than 65 years of age and significant comorbidities 4. Failed to obtain adequate glycemic control on combination therapy with:

a. Continuous adherence with refilling maximum tolerated doses (i.e at least 1000mg per day) of metformin (unless patient is not a candidate for metformin therapy) and

b. Continuous adherence with refilling maximum tolerated doses of a sulfonylurea (unless the patient is not a candidate for sulfonylurea therapy or the patient is already on multiple daily insulin injections (i.e prandial insulin)


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Drug Prior Authorization Criteria combination products):

Glyxambi (empagliflozin and linagliptan)

Invokamet, XR (Canagliflozin and metformin)

Xigduo XR (Dapagliflozin and metformin)

i. The SGLT-2 Inhibitor may be initiated prior to insulin trial if patient meets ONE of the following criteria:


2. The patient has incurred significant weight gain (≥ 5% increase in body weight after 6 months of starting an antidiabetic agent)) secondary to oral antidiabetic medications or insulin therapy which is considered to be hazardous to the patient OR

3. Prescriber indicates promotion of weight loss is a major consideration and this patients HgbA1c is close to target HbgA1c level is close to target (<8.0%) (For patients with BMI 35 and above).

5. Patient is not currently on an anti-diabetic agent in any of the following classes: GLP-1 receptor agonists, SGLT2 inhibitor, and DPP-4 inhibitors.

6. Documented trial or unable to tolerate Jardiance, if request is for non-preferred SGLT2 inhibitor.

Initial approval period: 5 months. Patient must obtain HbgA1c after 3 months of initiating therapy (this lab should be ordered when initiating therapy).

Note: In patients requiring doses of less than 25 mg of Jardiance or 300 mg of Invokana, please request that the prescriber prescribe half-tablet dosing

1. Continued approval: 1 year, based on adherence to maximum tolerated doses of metformin

and sulfonylurea (unless patient is not a candidate or cannot tolerate metformin or sulfonylurea therapy) and


Members new to KP taking Jardiance™ (preferred SGLT2 inhibitor) or a non-preferred SGLT2 Inhibitor prior to enrollment: Will be covered for those who meet ALL of the following criteria:


a candidate or cannot tolerate metformin or sulfonylurea therapy) and 3. A1c < 8 within 30 days. Documented intolerance to or inadequate control with Jardiance if

request for a non-preferred SGLT2 Inhibitor

Continued Approval: 1 year based on: 1. Adherence to maximum tolerated doses of metformin and sulfonylurea (unless patient is not



***New KP members already taking a DPP-4 inhibitor whose diabetes is not controlled (i.e., HgbA1c> 8%) must meet the criteria for current KP new start members.




Drug Prior Authorization Criteria Note: For new KP members the prescriber does not have to be an internal provider for initial approval. Reasons for non-coverage:

1. Type 1 diabetes mellitus 2. Treatment of diabetic ketoacidosis 3. Pediatric patients (<18 years old) 4. Prior history of a serious allergic reaction to SGLT2 Inhibitors (i.e., anaphylaxis, angioedema,

Stevens-Johnson syndrome, etc.) 5. Severe renal impairment, end-stage renal disease, or dialysis (not recommended to initiate

Invokana™ in patients with an eGFR < 45 mL/min for or initiate Farxiga™ in patients with an eGFR < 60 mL/min)

6. Active bladder cancer for Farxiga™

Use caution in the following patients: 1. History of mycotic infections 2. History of bladder cancer for Farxiga™

Monitoring:

1. Renal function (baseline and during therapy) 2. Magnesium, potassium and phosphate for Invokana™ 3. LDL-C 4. Genital mycotic infections

Blood pressure Somavert® (Pegvisomant)

Candidates for treatment with Somavert® should meet ALL the following criteria:

1. Documented diagnosis of acromegaly 2. Prescribed by an endocrinologist 3. Documented inadequate response or not a candidate for surgery or radiation for the

management for acromegaly 4. Documented inadequate response or unable to tolerate Sandostatin® (octreotide) OR

Somatuline® (lanreotide) Initial Approval: 6 months Continued Approval: 12 months if there is documented evidence of improvement in disease symptoms or stabilization of disease state and liver enzymes have been assessed and recommendation to continue treatment aligns with prescribing information for continuation of treatment based on results of liver tests Dosage and Administration

• A loading dose of 40 mg of Somavert® should be administered subcutaneously under physician supervision

• Maintenance dose: 10 mg subcutaneously once daily • Doses may be adjusted by 5 mg increments in 4- to 6-week intervals based on IGF-I

concentrations (maximum maintenance dose: 30 mg/day)

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Drug Prior Authorization Criteria • Somavert® may be given in the thigh, buttocks, upper arm, or abdomen; the site of SC

injections should be rotated daily to help prevent lipohypertrophy Monitoring:

• GH-secreting tumor size • Serum glucose • Signs and symptoms of growth hormone deficiency • Serum IGF-I (every 4-6 weeks after initial dose and dosage change, every 6 months when

normalized • Liver function tests at monthly intervals during the first 6 months of treatment, quarterly for

the next 6 months, and then semi-annually for the next year Ordering information: Somavert® is furnished by the KP Speicalty Pharmacy (KP SP) in Daly City, California. Fax the Somavert® Order Form to KP SP (650-301-5790). The Somavert® Order Form can be found on the KP SP Website.

Sovaldi (sofosbuvir)

Sovaldi is a non-preferred treatment agent at Kaiser Permanente. Please refer all requests to internal KP Hepatology or Infectious Disease.

Supprelin® LA (Histrelin) implant

Candidates for Supprelin® LA should meet ALL of the following criteria: 1. Diagnosis of central precocious puberty confirmed by ALL of the following:

a. measurement of blood concentrations of total sex steroids (estrogens/testosterone) b. measurement of LH and FSH after stimulation with a GnRH analog c. assessment of bone age vs. chronological age

2. Failed (failure defined as the inability to suppress physical signs of puberty), intolerant, or allergic to Lupron Depot®

3. 2 years or older

Approval Duration: 1 year Dosing:

• Children ≥2 years: 50 mg implant surgically inserted every 12 months. Discontinue at the appropriate time for the onset of puberty.

Monitoring:

• LH, FSH, estradiol, or testosterone (after 1 month then every 6 months); height, bone age (every 6-12 months); tanner staging

Symlin® (Pramlintide)

Candidates for Symlin® should meet ALL of the following criteria: 1. Prescriber must be an Endocrinologist AND

Type 1 diabetics 2. Using both basal insulin and short-acting insulin AND 3. Requires three or more insulin injections daily, OR using an insulin pump

Type 2 diabetics

2. Receiving maximum tolerated doses of metformin, unless the patient is not a candidate for metformin therapy, AND






Drug Prior Authorization Criteria 3. Using both basal insulin and short-acting insulin, AND 4. Requires three or more insulin injections daily OR using an insulin pump AND 5. Failure to achieve adequate glycemic control despite individualized insulin management,

defined as: i. A1C level is greater than 7% and less than 9%, OR ii. Marked day-to-day variability in glucose levels (based on review of self-monitoring

blood glucose levels) Reasons for Non-Coverage: Symlin® is not covered for patients meeting any of the following criteria:

• Poor compliance with current insulin regimen • Poor compliance with prescribed self-blood glucose monitoring • An A1C greater than 9% • Recurrent severe hypoglycemia requiring assistance during the previous 6 months • Presence of hypoglycemia unawareness • Confirmed diagnosis of gastroparesis • Need for medications that stimulate GI motility • Pediatric patients (less than 18 years of age) • Concurrent use with other oral antidiabetic medications (except metformin and

sulfonylureas) or drugs that alter gastrointestinal motility Initial approval period: 6 months Continued approval: 1 year, based on review of compliance to therapy and documented improved glycemic control as evidenced by A1C lowering from pretreatment level

Tecfidera™ (Dimethyl fumarate)

Tecfidera should be reserved for treatment of relapsing forms of multiple sclerosis in patients with moderate disease activity who have contraindications or severe intolerance to preferred therapies or have severe injection site reactions not responsive to conservative measures. Candidates for treatment with Tecfidera™ should meet ALL the following criteria:

1. 18 years of age or older 2. Documented diagnosis of relapsing-remitting multiple sclerosis (MS) 3. Prescribed by a Neurologist 4. Tecfidera is prescribed for use as monotherapy 5. CBC within the past 6 months shows normal WBC and lymphocyte counts 6. For females of child bearing age (12-50 years of age), a baseline negative pregnancy test


7. Patient is unable to master self-injection technique and lacks a caregiver who can perform injections OR

8. Patient has a history of severe injection site reactions not responsive to conservative measures while on injectable agents for MS (eg: lipoatrophy or skin necrosis) OR




Drug Prior Authorization Criteria 9. Documented inadequate response,severe intolerance or relative contraindication to one

interferon therapy (i.e., Avonex®, Betaseron®, Extavia® or Rebif®)* AND glatiramer acetate (Glatopa or Copaxone®)*

*NOTE: Injection fatigue or fear of needles is not a reason for intolerance or inadequate response. Reasons for non-coverage: Tecfidera should NOT be used in patients with any of the following:

10. Secondary progressive MS with no clinical or MRI evidence of relapses 11. Good disease control and tolerance of another disease-modifying drug for MS 12. Lymphocyte count < 0.5 x 109/L 13. Signs and symptoms of serious infection 14. JCV antibody positive and previously treated with Tysabri 15. Pregnancy or lactation 16. High-risk features for early progression to secondary-progressive MS (see Table 1)

For patients with ANY high-risk features listed in Table 1, escalation therapy with Gilenya (preferred), Tysabri or Rituxan (off-label) may be more appropriate and should be recommended instead.





symptoms









≥ 1 cord lesion Initial approval period: 1 year Continued approval for treatment with Tecfidera should meet ALL the following criteria:

17. Adherence to Tecfidera (> 80%) 18. Documented beneficial effect from therapy 19. CBC with differential including lymphocyte count obtained 6 months after initiation of

treatment then at least once every 12 months 20. Lymphocyte count > 0.5 x 109/L 21. No signs and symptoms of serious infection

Continued approval period: 1 year




Drug Prior Authorization Criteria Dosage and Administration

22. Starting dose, for days 1-7: 120 mg orally twice a day 23. Maintenance dose, after 7 days: 240 mg orally twice a day

Monitoring

24. Obtain a CBC including lymphocyte count at baseline, 6 months after initiation and every 6 to 12 months thereafter

25. Monitor for signs or symptoms suggestive of progressive multifocal leukoencephalopathy (PML) including progressive weakness on one side of the body or clumsiness of limbs, vision disturbances and mental status changes – withhold therapy immediately and perform appropriate diagnostic evaluation.

Ordering information: Tecfidera™ is available through the KP specialty pharmacy. If approved for coverage, prescribers must complete the KP Specialty Pharmacy form Tecfidera™ Prescription Order Form at http://pharmacy.kp.org/KPCMS/California/DrugInformation/ViewMedSafetyDNMgmtCA.aspx?I32Object=1320&nodeValue=113 and fax it to KP-Specialty Pharmacy (1-650-301-5790).

Technivie® (Ombitasvir/paritaprevir/ ritonavir)

Technivie is a non-preferred treatment agent at Kaiser Permanente. Please refer all requests to internal KP Hepatology or Infectious Disease.

Tysabri® (Natalizumab)

Candidates for Tysabri® should meet ALL of the following criteria:

Testing for anti-JC virus (JCV) antibodies is recommended in patients considering or receiving Tysabri®

For Multiple Sclerosis: Tysabri should be reserved for treatment of patients with relapsing forms of multiple sclerosis exhibiting high-disease activity or prognostic factors for early progression to secondary progressive multiple sclerosis.

1. Patient and Physician are enrolled in the Tysabri TOUCH program *NOTE: For information on how to enroll in the TOUCH program please visit https://www.touchprogram.com/TTP/tolTOUCHEnroll.jsp

2. Diagnosis of relapsing-remitting multiple sclerosis (RRMS) or progressive-relapsing MS (PRMS)

3. Prescriber is a Neurologist 4. Tysabri is prescribed for use as monotherapy for treatment of MS 5. Documentation confirming that the potential benefits of Tysabri outweigh the risks from

therapy, including the risk of progressive multifocal leukoencephalopathy (PML) 6. Documented JC virus antibody test within 3 months 7. For females of child bearing age (12-50 years of age), a baseline negative pregnancy test


8. Documented inadequate response, contraindication, or unable to tolerate Copaxone,

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Drug Prior Authorization Criteria Gilenya, Aubagio (if moderate disease), Tecfidera (if moderate disease), and at least ONE interferon therapy (ie. Avonex®, Betaseron®, Extavia® or Rebif®)* OR

9. Documented evidence of high-risk features for early progression to secondary-progressive MS (see Table 1) and failure, intolerance or contraindication to Gilenya

*NOTE: Injection fatigue or fear of needles is not a reason for intolerance or inadequate response.





symptoms









≥ 1 cord lesion Reasons for non-coverage: Tysabri should not be used in patients with any of the following:

10. Diagnosis of primary progressive MS is or secondary progressive MS with no clinical or MRI evidence of relapses

11. Current diagnosis or history of PML 12. Patient is receiving concurrent disease-modifying treatments for MS 13. Patient is stable and well-controlled on current disease-modifying MS therapy 14. JCV antibody positive and immunosuppression (due to HIV, AIDS, leukemia, lymphoma or

organ transplantation) 15. JCV antibody positive and history of antineoplastics or immunosuppressants (eg:

adalimumab, alefacept alemtuzumab, anakinra, azathioprine, cladribine, cyclophosphamide, cyclosporine, daclizumab, efalizumab, etanercept, fludarabine phosphate, infliximab, intravenous immunoglobulin, leflunomide, mercaptopurine, methotrexate, mitoxantrone, mycophenolate mofetil, mycophenolic acid, pemetrexed, rituximab, trastuzumab)

Initial Approval: 3 months. Continued approval: 1 year based on the following:

16. Documented efficacy from the prescribing physician and compliance with the TOUCH program




Drug Prior Authorization Criteria 17. Patients with a previous negative assay for anti-JCV antibodies must be retested annually to

be considered for continued approval. For Crohn’s Disease:

18. Patient and Physician are enrolled in the Tysabri TOUCH program *NOTE: For information on how to enroll in the TOUCH program please visit https://www.touchprogram.com/TTP/tolTOUCHEnroll.jsp

19. Diagnosis of moderate to severe active Crohn’s disease 20. The potential benefits of Tysabri outweigh the risks from therapy, including the risk of

progressive multifocal leukoencephalopathy (PML) 21. Documented evidence of inflammation 22. Inadequate response or an inability to tolerate ONE conventional therapy (i.e sulfasalazine,

mesalamine, azathioprine, or 6-mercaptopurine 23. Inadequate response or an inability to tolerate corticosteroids 24. Inadequate response or an inability to tolerate ONE TNF-α inhibitor (infliximab (Remicade),

adalimumab (Humira), or Certolizumab (Cimzia)) 25. Tysabri not to be used concomitantly with immunosuppressants (e.g., 6-mercaptopurine,

azathioprine, cyclosporine, or methotrexate) or inhibitors of TNF-α Crohn’s Disease: Initial Approval: 3 months. Tysabri should be discontinued if clinical benefit has not been shown after 12 weeks. Continued approval:

26. For patients receiving a therapeutic benefit but still receiving oral corticosteroids reauthorization will only be granted for 3 additional months. If at the end of this time the patient cannot be tapered off oral corticosteroids Tysabri will not be reauthorized.

27. For patients receiving therapeutic benefit and able to be tapered from oral corticosteroids within 6 months reauthorization may be granted for up to one year with documented efficacy from the prescribing physician and compliance with the TOUCH program.

28. Patients with a previous negative assay for anti-JCV antibodies must be retested annually to be considered for continued approval.

29. Treatment duration greater than 2 years increases the risk of PML. Consider alternative therapies in such patients.

30. Due to the possibility of increased risk for PML or other infections: a. Tysabri should be used as monotherapy and not in combination with Avonex®

(interferon beta-1a), other beta-interferons (Betaseron® or Rebif®), or glatiramer acetate (Copaxone®).

Dosage and Administration: Multiple sclerosis

31. Tysabri should be administered to multiple sclerosis patients once every 4 weeks in a dose of 300 mg diluted in 100 ml Normal Saline given intravenously over about one hour. Tysabri should NOT be given as a bolus or push.

Crohn’s Disease

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Drug Prior Authorization Criteria 32. Tysabri should be given 300 mg infused over 1 hour every 4 weeks; discontinue if therapeutic

benefit is not observed within initial 12 weeks of therapy Multiple sclerosis and Crohn’s Disease:

33. Tysabri should only be administered in an infusion center with adequate facilities for treating a hypersensitivity or infusion-related reaction.

34. Tysabri should be used with caution in patients who are receiving chronic immunosuppressant therapy, other immunomodulatory drugs, or are significantly immunocompromised for any reason.

Monitoring: 35. During the infusion and for at least one hour after completion of the infusion of Tysabri,

patients should be observed for signs and symptoms of hypersensitivity or infusion-related reactions.

a. The Tysabri infusion must be stopped immediately, and the physician should be consulted immediately, if signs or symptoms related to a hypersensitivity reaction are seen. These may include urticaria, dizziness, fever, rash, rigors, pruritis, nausea, flushing, hypotension, dyspnea, or chest pain.

36. Patients should have a recent MRI brain scan prior to initiation of Tysabri treatment. This MRI may be helpful in differentiating MS symptoms from PML, should PML be suspected.

a. Patients should be monitored for any new signs or symptoms which might suggest PML. At the first such sign or symptom of PML, Tysabri treatment should be withheld immediately and diagnostic measures should be undertaken.

Ordering information: Prescribers must be enrolled TOUCH Prescribing Program. For information on how to enroll in the program, please visit https://www.touchprogram.com/TTP/tolTOUCHEnroll.jsp#Prescribers. If approved for coverage, Tysabri® is available through the KP Specialty Pharmacy. Prescribers must complete the KP Specialty Pharmacy Tysabri® Order Form at http://pharmacy.kp.org/Kp-CMS/California/DrugInformation/ViewMedSafetyDNMgmtCA.aspx?I32Object=1119&nodeValue=113 and fax it to KP-SP (1-650-301-5790).

Viekira Pak® Viekira XR® (Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir)

Viekira Pak and Viekira XR are non-preferred treatment agents at Kaiser Permanente. Please refer all requests to internal KP Hepatology or Infectious Disease.

Xenazine® (Tetrabenazine)

Candidates for treatment with Xenazine® should meet the following criteria:

1. Documented diagnosis of chorea associated with Huntington’s disease or tardive dyskinesia 2. Prescribed by a neurologist 3. Documented inadequate response or unable to tolerate any TWO antipsychotics (ex.

haloperidol, risperidone, ziprasidone, quetiapine , olanzapine, aripiprazole) 4. Documented inadequate response or unable to tolerate a benzodiazepine (ex. clonazepam)

https://www.touchprogram.com/TTP/tolTOUCHEnroll.jsp#Prescribers

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Drug Prior Authorization Criteria 5. Documented inadequate response or unable to tolerate amantadine (Symmetrel®) 6. Documented inadequate response or unable to tolerate riluzole (Rilutek®)


• Patients who are actively suicidal, or who have depression which is untreated or undertreated

• Patients with impaired hepatic function • Patients taking MAOIs or reserpine

Initial Approval: 3 months Continued Approval: 6 months if there is documented evidence of improvement in disease symptoms or stabilization of disease state Dosage and Administration Chorea associated with Huntington’s disease

• Initial: 12.5 mg once daily, may increase to 12.5 mg twice daily after 1 week • Maintenance: May be increased by 12.5 mg/day at weekly intervals; doses >37.5 mg/day

should be divided into 3 doses (maximum single dose: 25 mg) Monitoring:

• Improvement in movement disorder • Signs and/or symptoms of depression or suicide ideation

Xgeva® (Denosumab)

Candidates for Xgeva™ should meet ALL of the following criteria:

1. Diagnosis of bone metastases from prostate cancer 2. Diagnosis of bone metastases from solid tumors OTHER THAN Prostate

a. A therapeutic trial and clinical failure with zoledronic acid (Zometa®) a. Clinical failure defined as development of new skeletal related event

(SRE) while receiving treatment with zolendronic acid for at least 3 months

3. Must be prescribed by a hematologist or oncologist 4. Calcium levels have been checked and any pre-existing hypocalcemia has been corrected 5. Patient has had a baseline dental exam prior to initiating denosumab therapy


• Treatment of skeletal-related events in patients with multiple myleoma • Renal impairment (CrCl of 30 ml/min or less) or end-stage renal disease requiring

hemodialysis • Hypocalcemia • Pediatric patients (<18 years old) • Non-FDA approved indications





Drug Prior Authorization Criteria Continued Approval: 12 months if patient has documented clinical benefit from medication and no reported adverse events to Xgeva Use caution in the following patients:

• Pregnant/nursing women (Pregnancy Category D) Dosing:

• Inject 120 mg subcutaneously every four weeks • Medication MUST be given by a health care professional

Monitoring:

• Serum calcium prior to therapy initiation and periodically. Adequately supplement all patients with calcium and vitamin D

• Symptoms of osteonecrosis of the jaw Xiaflex™ (Collagenase Clostridium Histolticum)

Candidates for Xiaflex™ should meet ALL of the following criteria:

Xiaflex™ is only available through the Xiaflex™ Experience Program

Use of Xiaflex in patient with Dupuytren’s contracture: 1. Documented diagnosis of Dupuytren’s contracture with a palpable cord 2. Must be prescribed and administered by a hand surgeon, plastic surgeon, orthopedic surgeon

or rheumatologist 3. Documentation of training in Xialfex™ injections must be provided by the prescriber 4. A positive “table top test” – defined as the inability to simultaneously place the affected

finger and palm flat against a table top 5. Documented contracture of at least 20 degrees flexion for a metacarpophalangeal joint

contracture or at least 20 degrees flexion for a proximal interphalangeal joint contracture 6. Documentation that the flexion deformity results in functional limitations 7. Must be 18 years of age or older 8. Must not have had surgery on the primary joint within the past 90 days

Xiaflex™ will only be used on one cord at a time

• Treatment of each cord should be undertaken in sequential order with only one cord receiving Xiaflex™ at a time

Use of Xiaflex in patient with Peyronie’s disease:

1. Documented diagnosis of Peyronie’s disease with a palpable plaque 2. Patient has curvature deformity for at least 30 degrees at the start of therapy 3. Must be prescribed by a Urologist 4. Documented Peyronie’s symptoms (penile pain, erectile dysfunction, etc)

Reason for non-coverage:

• For the treatment of Peyronie’s plaques that involve the penile urethra




Drug Prior Authorization Criteria Initial approval: Dupuytren’s contracture: 3 months Peyronie’s disease: one treatment cycle (2 injections) Continued approval: Dupuytren’s contracture:

6. Injection may be repeated up to a maximum of 3 sessions for cord at 4 week intervals if reduction in primary joint contracture is not 0-5 degrees of full extension

7. Patient must follow-up within 24 hours following an injection for finger extension procedure if a contracture persists in order to qualify for more injections

Peyronie’s disease: • Re-authorization for another treatment cycle may be given if the curvature deformity is more

than 15 degrees after previous treatment cycle or if prescribing physician indicates another treatment cycle is clinically indicated (maximum of 4 treatment cycles)

• Patient must wait six weeks between treatment cycles

Dosage and Administration: Dupuytren’s contracture:

• The dose for Xiaflex™ is 0.58 mg per injection into a palpable cord with a contracture of a metacarpophalangeal (MP) joint or a proximal interphalangeal (PIP) joint, according to the injection procedure

• Finger extension procedures may be performed approximately 24 hours after the injection in the event the cord has not spontaneously ruptured

Peyronie’s disease: • A treatment cycle consists of two Xiaflex injection procedures and a penile modeling

procedure. • Induce a penile erection and identify and mark the target area in the Peyronie’s plaque to be

injected. • The penis should be in a flaccid state before injecting Xiaflex. Inject 0.58 mg Xiaflex into the

target plaque once on each of two days, 1 to 3 days apart, according to the injection procedure. Perform a penile modeling procedure 1 to 3 days after the second injection of each treatment cycle.

Use caution in the following patientsCaution is advised in those receiving anticoagulation therapy, with the exception of low-dose aspirin (maximum 150 mg/day). Monitoring:

• Patient must follow-up with provider within 24 hours following an injection for finger extension procedure

Xolair® (Omalizumab) injection

Candidates for Xolair® should meet ALL of the following criteria: Patients with Xolair® requests made by non-TSPMG pulmonary practitioners are required to be evaluated by a TSPMG pulmonary specialist prior to QRM approval for the medication for patients with moderate to severe persistent asthma.




Drug Prior Authorization Criteria Use of Xolair® in patients with moderate to severe persistent asthma:

1. Moderate to severe persistent asthma [based on criteria of the National Heart, Lung, and Blood Institute (NHLBIs) National Asthma Education and Prevention Program (NAEPP)]

2. Allergic asthma confirmed by positive skin testing or in vitro reactivity to a perennial aeroallergen

3. Prescribed by a pulmonologist or allergy specialist 4. Baseline total IgE serum level from 30-700 int. units/mL 5. Currently using a high dose inhaled corticosteroid (or combination product) OR has a

documented intolerance to inhaled corticosteroids 6. Currently on a long-acting β2 agonist (or combination product) OR has a documented

intolerance to long-acting β2 agonists 7. Tried and failed or has a documented intolerance to a leukotriene modifier 8. Experiencing exacerbations of asthma symptoms requiring increased inhaled corticosteroid

dosing, increased daily use of β2-agonist rescue medication or systemic steroids 9. Tried and failed or has a documented intolerance to mepolizumab (Nucala) if they have an

eosinophilic phenotype 10. 6 years of age and older

Use of Xolair® in patients with chronic idiopathic urticaria:

1. Documented diagnosis of chronic idiopathic urticaria 2. 12 years of age or older 3. Prescribed by an allergy specialist or dermatologist 4. Tried and failed therapy for a minimum of 4 weeks on ALL of the following unless

contraindicated: a. At least two different high-dose H1-antihistamines (e.g. loratadine, cetirizine) 2 – 4

times normal dose daily dose b. Montelukast in combination with a high-dose H1-antihistamine c. H2- antihistamines (e.g. famotidine, ranitidine) in combination with a high-dose H1-

antihistamine d. Anti-inflammatory agent (e.g. dapsone, hydroxychloroquine, or sulfasalazine) OR an

immunosuppressant agent (e.g. cyclosporine, mycophenolate) in combination with a high-dose antihistamine

Reasons for non-coverage: • History of or high risk for cancer • Patients with major autoimmune diseases (eg, lupus erythematosus, rheumatoid arthritis, et

al) • Patients with significant systemic diseases • Concomitant use of allergen immunotherapy with omalizumab, a combination which has not

been evaluated in clinical trials.

Initial Approval: Moderate to severe persistent asthma: 3 months Chronic idiopathic urticaria: 3 months Continued Approval:




Drug Prior Authorization Criteria Moderate to severe persistent asthma:

• 12 months if the patient has experienced a reduction in the frequency of asthma exacerbations and has had reduction in the use of rescue medications or inhaled corticosteroids while treated with Xolair.

• Omalizumab therapy should be discontinued after one year. • Reevaluate asthma control at one, three, and six month intervals or as necessary. • If asthma control deteriorates during reevaluation, consider restarting omalizumab therapy. • Serum total IgE levels measured less than one year following discontinuation of omalizumab

may not reflect steady state free IgE levels and should not be used to reassess the dosing regimen. Use serum IgE levels from pretreatment prior to initial dosing of omalizumab.

Chronic idiopathic urticaria: • 12 months if the patient has experienced a reduction in the frequency of symptoms (wheals,

pruritus). Dosage and administration: Moderate to severe persistent asthma:

• Subcutaneously: 75 to 375 mg every 2 or 4 weeks. Dose and frequency based on body weight and pretreatment total IgE serum levels. Dosing should be adjusted during therapy for significant changes in body weight.

Chronic idiopathic urticaria: • Subcutaneously: 150 or 300 mg every 4 weeks. Dosing is not dependent on serum IgE (free or

total) level or body weight. Monitoring: Moderate to severe persistent asthma:

• FEV1, peak flow, and/or other pulmonary function tests • Signs of infection • Significant changes in body weight (dose may need to be adjusted)

Chronic idiopathic urticaria: o Signs of infection

Zavesca (Miglustat)

Candidates for treatment with Zavesca should meet ALL the following criteria:


<60,000 microL, liver >2.5 times normal size, spleen > 15 times normal size) 3. 18 years of age or older 4. Patient has been evaluated by a Geneticist 5. Tried and failed or unable to tolerate enzyme replacement therapy (Cerezyme,

Vpriv, Elelyso) enzyme replacement therapy for at least 6 months. 6. Tried and failed or unable to tolerate eliglustat (Cerdelga)

Initial approval period: 6 months Continued approval: 12 months if patient is responding to treatment (improving platelet count, decreased hepatomegaly and splenomegaly)




Drug Prior Authorization Criteria Monitoring:

• Neurologic evaluations baseline and repeated every 6 months Dosing and Administration:

• Recommended dosage is 100 mg administered orally three times a day at regular intervals • May reduce dosage to 100 mg once or twice a day in some patients due to tremor or diarrhea

Ordering information: Zavesca is only dispensed by CuraScript specialty pharmacy (Fax: 888-773-7386). For more information, visit http://pharmacy.kp.org/Kp-CMS/California/DrugInformation/ViewMedSafetyDNMgmtCA.aspx?I32Object=1128&nodeValue=113

Zepatier® (Elbasvir and Grazoprevir)

Candidates for Zepatier® should meet ALL of the following criteria: 1. Is the medication prescribed by a Gastroenterologist or Infectious Disease specialist?

If yes, go to #2 If no, patient does NOT meet criteria for Zepatier; go to #7

2. Has the patient previously been treated with Zepatier? If yes, patient does NOT meet criteria for Zepatier; go to #7 If no, go to #3

3. Does the patient have a documented Hepatitis C Virus RNA PCR quantitative in the previous 90 days?

If yes, go to #4 If no, patient does NOT meet criteria for Zepatier; go to #7

4. Does the patient have a eGFR<30 ml/min/1.73 m2 or is on hemodialysis? If yes, go to #5 If no, patient does NOT meet criteria for Zepatier; go to #7

5. Does the patient have decompensated cirrhosis (moderate or severe hepatic impairment, Child-Turcotte-Pugh (CTP) Class B or C)?

If yes, patient does NOT meet criteria for Zepatier; go to #7 If no, go to #6

6. Does the patient have genotype 1 or 4? If yes, the patient QUALIFIES for 12 weeks of Zepatier If no, patient does NOT qualify for Zepatier

7. If prescribed by an external provider, has PCS contacted the KP Hepatology clinic for internal KP physician review?

If yes, continue with approval If no, please contact Lisa Woolard, PharmD at 770-677-5869






Drug Prior Authorization Criteria Initial Approval: 14 days

Continued Approval/Established Duration of Treatment: GI or ID specialist will call after start of therapy if patient needs to stop or change therapy duration.

• For Genotype 1 and genotype 4: 12 weeks total duration

Dosage and Administration: • Recommended dose: one tablet (100 mg of grazoprevir and 50mg of elbasvir) taken orally

once daily with or without food

Monitoring: • Serum HCV-RNA at baseline, weeks 4, 8, 12, during treatment follow up, and when clinically

indicated

Dispensing information: Must be dispensed at Glenlake Pharmacy with an applicable quantity limit.

ZinbrytaTM (daclizumab)

Candidates for treatment with Zinbryta™ should meet the following criteria: 8. Must be prescribed by a neurologist 9. Diagnosis of a relapsing form of multiple sclerosis (MS) 10. Evidence of continued inflammatory disease (new MRI lesions and/or relapses) on , two or

more drugs indicated for the treatment of MS including a trial of Gilenya® (fingolimod) unless contraindicated.

11. Documented baseline serum transaminase (ALT and AST) less than 2 times the upper limit of normal and total bilirubin less than or equal to upper limit of normal

12. Documented screening for Hepatitis B and C. Reasons for non-coverage: Zinbryta should NOT be used in patients with any of the following:

5. Pre-existing hepatic disease or hepatic impairment 6. History of autoimmune hepatitis or other autoimmune condition involving the liver 7. Tuberculosis or other severe active infection

Initial approval period: 12 months Continued approval: 12 months:

8. Transaminase levels (ALT, AST) and total bilirubin assessed within the last 1 month Monitoring:

• Transaminase levels (AST, ALT) and total bilirubin monthly and up to 6 months after the last dose.

Dosing: 150 mg subcutaneously once monthly Ordering information: Zinbryta is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Zinbryta REMS program (1-800-456-2255).




Drug Prior Authorization Criteria Zinbryta™ is available through the KP Specialty Pharmacy. Prescribers must complete the KP Specialty Pharmacy Zinbryta™ Drug order form at http://pharmacy.kp.org/KP-CMS/California/DrugInformation/ViewMedSafetyDNMgmtCA.aspx?I32Object=1673&nodeValue=113 and fax it to KP-SP (650) 301-5790.



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