bcbsri4tier2013 v11 pacriteriamemberfile 20130224 · 2020. 10. 1. · guanfacine hcl reserpine tabs...

Prior Authorization Criteria BCBSRI 4-Tier 2013 Last Updated: 02/2013 Effective: March 1, 2013

Formulary ID: 13462 1

ABATACEPT

Products Affected Orencia

PA Criteria Criteria Details

Covered Uses All FDA-approved indications not otherwise excluded from Part D.

Exclusion Criteria

N/A

Required Medical Information

• Diagnosis of moderate to severe Rheumatoid Arthritis OR moderate to severe Juvenile Idiopathic Arthritis AND • Member has had an inadequate response to one or more nonbiologic disease modifying antirheumatic drugs OR • Member has had an inadequate response to one or more biologic disease modifying antirheumatic drugs.

Age Restrictions Patient is 18 years of age or older for RA. Patient is 6-17 years of age for juvenile idiopathic arthritis.

Prescriber Restrictions

N/A

Coverage Duration

12 months

Other Criteria N/A


ABIRATERONE

Products Affected Zytiga



Exclusion Criteria

N/A


• Patient is male AND • Patient has a diagnosis of metastatic castration-resistant prostate cancer AND • Patient has received prior chemotherapy containing docetaxel OR patient is medically unable to tolerate chemotherapy

Age Restrictions Patient is 18 years of age or older


N/A

Coverage Duration

12 months

Other Criteria Abiraterone acetate 1,000 mg will be used in combination with prednisone 5 mg twice daily


ADALIMUMAB

Products Affected Humira

Humira Pen-crohns Diseasestarter



Exclusion Criteria

N/A



• Patient has a diagnosis of moderate to severe rheumatoid arthritis (RA) AND • Patient has had inadequate response to, intolerance to, or contraindication to one or more non-biologic disease modifying anti-rheumatic drugs for at least 3 consecutive months OR • Patient has been diagnosed with RA for less than 6 months with high disease activity for 3—6 months or with high disease activity for less than 3 months but also with poor prognostic features AND • Adalimumab will be used in combination with methotrexate OR • Diagnosis of moderate to severe polyarticular juvenile idiopathic arthritis AND • Patient has had inadequate response to, intolerance to, or contraindication to one or more non-biologic disease modifying anti-rheumatic drugs for at least 3 consecutive months OR • Patient has a diagnosis of psoriatic arthritis or ankylosing spondylitis AND • Patient has had inadequate response to, intolerance to, or contraindication to: o One or more non-steroidal anti-inflammatory drugs (NSAIDs) OR o One or more non-biologic disease modifying anti-rheumatic drugs OR • Patient has a diagnosis of moderate to severe Crohn’s disease OR • Patient has a diagnosis of moderate to severe chronic plaque psoriasis (affecting more than 5% of body surface area (BSA) or affecting crucial body areas such as the hands, feet, face, or genitals) AND • Patient has had an inadequate response to, is intolerant to, or is contraindicated to conventional therapy with at least one of the following: o Phototherapy (including, but not limited to, Ultraviolet A with a psoralen [PUVA] and/or retinoids [RePUVA]) for at least one continuous month OR o One or more oral systemic treatments (i.e., methotrexate, cyclosporine, acitretin, sulfasalazine) for at least three consecutive months

Age Restrictions Patient is 4 years of age or older for polyarticular juvenile idiopathic arthritis, patient is 18 years of age or older for all other indications


N/A

Coverage Duration

12 months


Other Criteria N/A


AGALSIDASE

Products Affected Fabrazyme INJ 35MG



Exclusion Criteria

N/A


Diagnosis

Age Restrictions N/A


N/A

Coverage Duration

Lifetime

Other Criteria N/A


ALGLUCOSIDASE ALFA

Products Affected Lumizyme

Myozyme



Exclusion Criteria

N/A


Diagnosis



N/A

Coverage Duration

Lifetime

Other Criteria N/A


AMBRISENTAN

Products Affected Letairis



Exclusion Criteria

N/A


• Diagnosis of PAH (WHO Group I) in Class II through III patients AND • For female patients, pregnancy must be excluded prior to the start of therapy and will be prevented thereafter with reliable contraception



Prescription is written by or in consultation with a pulmonologist or cardiologist

Coverage Duration

12 months

Other Criteria N/A


ANABOLIC STEROIDS (OXANDROLONE)

Products Affected Oxandrin

Oxandrolone



Exclusion Criteria

N/A


• Patient is receiving treatment to counterbalance protein catabolism associated with chronic corticosteroid administration OR • Patient is receiving treatment for relief of osteoporosis-related bone pain



N/A

Coverage Duration

12 months

Other Criteria N/A


ANABOLIC STEROIDS (OXYMETHOLONE)

Products Affected Anadrol-50



Exclusion Criteria

N/A


• Patient has a diagnosis of refractory anemia caused by deficient red cell production AND • Treatment will not replace other measures such as transfusion, iron supplementation, immunosuppressive therapy, corticosteroids, or erythropoiesis-stimulating agents



N/A

Coverage Duration

12 months

Other Criteria N/A


ANAKINRA

Products Affected Kineret



Exclusion Criteria

N/A


• Diagnosis of moderate to severe RA AND • The patient must meet the following requirements: o Inadequate response to one or more non-biologic disease modifying antirheumatic drugs (DMARDS) [e.g., hydroxychloroquine, leflunomide, methotrexate, and sulfasalazine] OR o Inadequate response to one or more biologic DMARDS (e.g., adalimumab, infliximab, etanercept, etc.)

Age Restrictions Patient must be 18 years or older


N/A

Coverage Duration

12 months

Other Criteria N/A


ANALGESICS (HIGH RISK MEDICATIONS)

Products Affected Meperidine Hcl INJ 25MG/ML,

50MG/ML Meperidine Hcl ORAL SOLN Meperitab

Pentazocine/acetaminophen Pentazocine/naloxone Hcl Talwin



Exclusion Criteria

N/A


• Diagnosis AND • The prescribing physician has been made aware that the requested drug is considered a high risk medication for elderly patients (age 65 and older) and wishes to proceed with the originally prescribed medication OR • Patient has already tried and failed any ONE non-high risk formulary alternative OR • Prescriber has been made aware that the requested drug is a high risk medication and wishes to proceed with the originally prescribed medication.

Age Restrictions Applies to patients 65 years or older


N/A

Coverage Duration

12 months

Other Criteria N/A


ANDRODERM

Products Affected Androderm


Covered Uses All FDA-approved indications not otherwise excluded from Part D

Exclusion Criteria

carcioma of the breast, known or suspected carcinoma of the prostate


Patient is male, diagnosis of hypogonadism (primary or hypogonadotropic) AND serum testosterone level (free or total) value and laboratory reference value range reported by laboratory service has been provided AND diagnosis is confirmed by a low-for-age serum testosterone (total or free) level defined by the normal laboratory reference value



N/A

Coverage Duration

12 months

Other Criteria For renewal, patient has experienced an objective response to therapy and has not developed any contraindication to therapy


ANDROGENS (HIGH RISK MEDICATIONS)

Products Affected Android

Methitest Testred



Exclusion Criteria

N/A





N/A

Coverage Duration

12 months

Other Criteria N/A


ANTIDEPRESSANTS (HIGH RISK MEDICATIONS)

Products Affected Amitriptyline Hcl Chlordiazepoxide/amitriptyline Clomipramine Hcl Doxepin Hcl

Imipramine Hcl Imipramine Pamoate Perphenazine/amitriptyline Trimipramine Maleate



Exclusion Criteria

N/A


• Diagnosis AND • The prescribing physician has been made aware that the requested drug is considered a high risk medication for elderly patients (age 65 and older) and wishes to proceed with the originally prescribed medication



N/A

Coverage Duration

12 months

Other Criteria N/A


ANTI-EMETICS (HIGH RISK MEDICATIONS)

Products Affected Diphenhydramine Hcl CAPS 50MG Diphenhydramine Hcl INJ Hydroxyzine Hcl Hydroxyzine Pamoate Metoclopramide Hcl Phenadoz

Promethazine Hcl Promethegan RECTAL SUPP 25MG,

50MG Tigan Trimethobenzamide Hcl



Exclusion Criteria

N/A





N/A

Coverage Duration

12 months

Other Criteria N/A


ANTIHISTAMINES (HIGH RISK MEDICATIONS)

Products Affected Carbinoxamine Maleate Clemastine Fumarate SYRP Clemastine Fumarate TABS 2.68MG

Cyproheptadine Hcl Palgic LIQD Promethazine Vc



Exclusion Criteria

N/A





N/A

Coverage Duration

12 months

Other Criteria N/A


ANTIHYPERTENSIVE (HIGH RISK MEDICATIONS)

Products Affected Guanfacine Hcl

Reserpine TABS 0.25MG



Exclusion Criteria

N/A





N/A

Coverage Duration

12 months

Other Criteria N/A


ANTIPARKINSON (HIGH RISK MEDICATIONS)

Products Affected Benztropine Mesylate

Trihexyphenidyl Hcl



Exclusion Criteria

N/A





N/A

Coverage Duration

12 months

Other Criteria N/A


ANXIOLYTICS (HIGH RISK MEDICATIONS)

Products Affected Meprobamate



Exclusion Criteria

N/A





N/A

Coverage Duration

12 months

Other Criteria N/A


ATTENTION DEFICIT HYPERACTIVITY DISORDER

AGENTS (HIGH RISK MEDICATIONS)

Products Affected Adderall Adderall Xr Amphetamine/dextroamphetamine Concerta Daytrana Desoxyn Dexmethylphenidate Hcl Dextroamphetamine Sulfate Dextroamphetamine Sulfate Er Focalin Xr Metadate CD Metadate Er

Methamphetamine Hcl Methylin Methylphenidate Hcl Methylphenidate Hcl CD Methylphenidate Hcl Er ORAL CP24 Methylphenidate Hcl Er ORAL

TBCR 20MG, 27MG, 36MG, 54MG Methylphenidate Hydrochloride Ritalin Ritalin La Ritalin Sr Vyvanse ORAL CAPS 30MG,

50MG, 70MG



Exclusion Criteria

N/A





N/A

Coverage Duration

12 months

Other Criteria N/A


AUBAGIO

Products Affected Aubagio


Covered Uses All FDA-approved indications not otherwise excluded from Part D. First clinical episode.

Exclusion Criteria

Severe hepatic impairment, current treatment with leflunomide (Arava), pregnancy, or women of child-bearing potential who are not using reliable contraception


Diagnosis of relapsing form of multiple sclerosis (relapsing-remitting multiple sclerosis and progressive-relapsing multiple sclerosis) and patient has an inadequate response, intolerance, or contraindication to interferon beta and Copaxone OR patient has experienced a first clinical episode and has MRI features consistent with multiple sclerosis and patient has an inadequate response, intolerance, or contraindication to interferon beta and Copaxone

Age Restrictions 18 years of age or older


N/A

Coverage Duration

12 months

Other Criteria For renewal, confirm that the patient had an objective response to therapy (.ie. no or slowed progression of disease)


AXITINIB

Products Affected Inlyta



Exclusion Criteria

N/A


• Patient has a diagnosis of advanced renal cell carcinoma AND • Patient has failed one or more systemic therapy for renal cell carcinoma



N/A

Coverage Duration

12 months

Other Criteria Renewal criteria: patient has not had disease progression based on Response Evaluation Criteria in Solid Tumors (RECIST).


BARBITURATES

Products Affected Butisol Sodium



Exclusion Criteria

Coverage not provided for contraindications to oral phenobarbital therapy: marked impairment of liver function (e.g., severe hepatic disease) OR pulmonary disease in which dyspnea or obstruction is evident.


Diagnosis



N/A

Coverage Duration

12 months

Other Criteria A message will be sent to the pharmacy to verify the diagnosis. After the pharmacist verifies that it's being used for an FDA approved diagnosis, the pharmacy can then submit a clarification code to override the PA restriction and the claim will pay.


BECAPLERMIN

Products Affected Regranex



Exclusion Criteria

N/A


• Patient has lower extremity diabetic neuropathic ulcer(s) that extend into the subcutaneous tissue or beyond (Stages III and IV of the NPUAP/WOCN pressure ulcer staging) AND • Patient’s diabetic ulcer(s) has an adequate blood supply (defined as transcutaneous oxygen tension [TcpO2] of greater than 30 mm Hg on limb where ulcer is located) AND • Patient is receiving a program of good ulcer care (consisting of initial complete sharp debridement, a non-weight-bearing regimen, systemic treatment for wound-related infection if present, moist saline dressings changed twice a day, and additional debridement as necessary)



N/A

Coverage Duration

12 months

Other Criteria N/A


BENZODIAZEPINES

Products Affected Alprazolam Alprazolam Er TB24 0.5MG Alprazolam Intensol Alprazolam Odt Alprazolam Xr ORAL TB24 1MG,

2MG, 3MG Chlordiazepoxide Hcl Clonazepam Clonazepam Odt Clorazepate Dipotassium Diazepam ORAL TABS Diazepam RECTAL GEL Diazepam SOLN

Diazepam Intensol Estazolam Flurazepam Hcl Klonopin Lorazepam ORAL TABS Lorazepam Intensol Niravam Onfi Oxazepam Temazepam Triazolam Xanax Xanax Xr



Exclusion Criteria

Coverage not provided for contraindications to therapy: acute closed-angle glaucoma (with the exception of oxazepam) and for lorazepam injection only: sleep apnea syndrome or severe respiratory insufficiency except in those patients receiving lorazepam for amnestic effects while being mechanically ventilated.


Diagnosis



N/A

Coverage Duration

12 months

Other Criteria A message will be sent to the pharmacy to verify the diagnosis. After the pharmacist verifies that it's being used for an FDA approved diagnosis, the pharmacy can then submit a clarification code to override the PA restriction and the claim will pay.


BEXAROTENE

Products Affected Targretin



Exclusion Criteria

N/A


Diagnosis



N/A

Coverage Duration

12 months

Other Criteria N/A


BOCEPREVIR

Products Affected Victrelis



Exclusion Criteria

Coverage will not be provided if patient is pregnant or unwilling to comply with required contraception or coadministration with alfuzosin, carbamazepine, phenobarbital, phenytoin, rifampin, dihyroergotamine, ergonovine, ergotamine, methylergovovine, cisapride, St. John’s Wort, lovastatin, simvastatin, drosperinone, REVATIO (sildenafil) or ADCIRCA (tadalafil) (pulmonary arterial hypertension use), pimozide, triazolam, and midazolam (orally administered).


• Patient has a documented diagnosis of Chronic Hepatitis C Virus Genotype 1 with compensated liver disease AND • Patient is receiving concurrent therapy with ribavirin and PEG-INTRON (peginterferon alfa-2b) or PEGASYS (peginterferon alfa-2a) AND • Patient is treatment naïve to peginterferon alfa and ribavirin therapy OR • Patient has been previously treated with peginterferon and ribavirin and was considered a partial responder, defined as a greater than or equal to 2-log10 reduction in HCV-RNA at week 12, but with a detectable HCV-RNA level during the therapy period. OR • Patient has been previously treated with peginterferon and ribavirin and was a null responder, defined as less than a 2-log10 HCV-RNA decline by treatment week 12. OR • Patient has been previously treated with peginterferon and ribavirin and was considered a prior relapser, defined as HCV-RNA undetectable at end of treatment with a pegylated interferon-based regimen, but HCV-RNA detectable during the follow-up period AND • Patient has not previously failed a regimen with an HCV protease inhibitor (INCIVEK or VICTRELIS)



N/A

Coverage Duration

Initial approval is 12 weeks.


Other Criteria Additional approval of 12 to 32 weeks is dependent on genotype and HCV RNA response at specific timepoints based on FDA-approved labeling.


BOSENTAN

Products Affected Tracleer



Exclusion Criteria

Patient is not receiving concomitant cyclosporine-A or glyburide therapy.


• Diagnosis of PAH (WHO Group I) in Class II through IV patients AND • Patient does not have moderate-to-severe hepatic impairment or appropriate baseline liver function tests have or will be performed prior to the start of therapy for patients with mild hepatic impairment AND • For female patients, pregnancy must be excluded prior to the start of therapy and will be prevented thereafter with reliable contraception



Prescription is written by or in consultation with a pulmonologist or cardiologist

Coverage Duration

12 months

Other Criteria N/A


BOSULIF

Products Affected Bosulif



Exclusion Criteria

N/A


Diagnosis of Philadelphia chromosome-positive chronic myelogenous leukemia AND disease is resistant or intolerant to prior therapy (such as Gleevec, Sprycel, or Tasigna)



N/A

Coverage Duration

12 months

Other Criteria N/A


BUPRENORPHINE

Products Affected Buprenorphine Hcl SUBLINGUAL

SUBL Suboxone SUBLINGUAL FILM

8MG; 2MG

Suboxone SUBLINGUAL SUBL 8MG; 2MG



Exclusion Criteria

N/A


• Patient has a diagnosis of opioid dependence AND • Prescriber is certified through SAMHSA (Substance Abuse and Mental Health Services Administration) to prescribe Suboxone (buprenorphine) and provide registration number AND • Prescription is part of an overall treatment program (e.g., self-help groups, counseling, provide ongoing care, vocational training)



N/A

Coverage Duration

Up to 9 months

Other Criteria Renewal criteria also requires: • Patient is not receiving any other opioids AND • Prescriber is evaluating random urine drug screens and assessment of the patient’s progress (e.g., relapse, progress/accomplishment of treatment goals) Coverage duration is as follows: 1 month for Subutex in non-pregnant patients, 3 months for Suboxone initial therapy or Subutex initial therapy in pregnancy, 9 months for Suboxone renewals and Subutex renewals in pregnancy


BUPRENORPHINE PATCH

Products Affected Butrans Suboxone SUBLINGUAL FILM

2MG; 0.5MG

Suboxone SUBLINGUAL SUBL 2MG; 0.5MG



Exclusion Criteria

Coverage is not provided for patients with any contraindications to therapy including: significant respiratory depression or severe bronchial asthma, known or suspected paralytic ileu, management of acute pain or in patients who require opioid analgesia for a short period of time, the management of post-operative pain, including use after out-patient or day surgeries, the management of mild pain the management of intermittent pain.


• Patient has diagnosis of moderate to severe pain requiring continuous, around-the-clock opioid analgesic for an extended period of time AND • Patient has tried and failed, is unable to tolerate, or has contraindication(s) to at least one therapy from each of the following two drug categories: (1) non-steroidal antiinflammatory (NSAIDs) and (2) opioid (immediate and extended-release) and/or opioid combination products OR • Patient has documented swallowing difficulties.

Age Restrictions Patient must be 18 years of age or older


N/A

Coverage Duration

12 months

Other Criteria N/A


BUSULFAN

Products Affected Myleran



Exclusion Criteria

N/A


Diagnosis



N/A

Coverage Duration

12 months

Other Criteria N/A


CALCIPOTRIENE AND BETAMETHASONE

Products Affected Taclonex



Exclusion Criteria

Known or suspected disorders of calcium metabolism or erythrodermic, exfoliative and pustular psoriasis.


• Patient has a diagnosis of stable moderate to severe psoriasis vulgaris (plaque psoriasis) AND • Patient has less than or equal to 30% body surface area affected AND • Patient meets any of the following criteria: o Patient has tried adequate treatment (at least 2 weeks) with at least one medium to high potency topical steroid OR o Patient has contraindications to utilizing topical steroids in absence of calcipotriene OR o Patient has tried adequate treatment (at least 2 weeks) with vitamin D analogs (calcipotriene, calcitriol) OR o Patient has tried adequate treatment (at least 2 weeks) or is intolerant to tazarotene



N/A

Coverage Duration

12 months

Other Criteria N/A


CALCIUM CHANNEL BLOCKERS, DIHYDROPYRIDINE

(HIGH RISK MEDICATIONS)

Products Affected Nifedipine



Exclusion Criteria

N/A





N/A

Coverage Duration

12 months

Other Criteria N/A


CANNABINOIDS (DRONABINOL)

Products Affected Dronabinol

Marinol



Exclusion Criteria

N/A


• Patient has a diagnosis of cancer with chemotherapy-induced nausea/vomiting AND • Patient has failed to achieve desired outcome with at least two other antiemetic agents such as: aprepitant/fosaprepitant, dexamethasone, 5-hydroxytriptamine-3 (5-HT3) serotonin receptor antagonists (dolasetron, granisetron, ondansetron, palonosetron), butyrophenones (droperidol, haloperidol), phenothiazines (prochlorperazine, promethazine), metoclopramide OR • Patient has a diagnosis of acquired immunodeficiency syndrome (AIDS) with anorexia associated with weight loss



N/A

Coverage Duration

12 months

Other Criteria N/A


CANNABINOIDS (NABILONE)

Products Affected Cesamet



Exclusion Criteria

N/A


• Patient has cancer with chemotherapy-induced nausea/vomiting AND • Patient has failed to achieve desired outcome with at least two other antiemetic agents such as: aprepitant/fosaprepitant, dexamethasone, 5-hydroxytriptamine-3 (5-HT3) serotonin receptor antagonists (dolasetron, granisetron, ondansetron, palonosetron), butyrophenones (droperidol, haloperidol), phenothiazines (prochlorperazine, promethazine), metoclopramide, or dronabinol



N/A

Coverage Duration

12 months

Other Criteria N/A


CELECOXIB

Products Affected Celebrex



Exclusion Criteria

N/A


• Patient is 65 years of age or older OR • Patient has had a trial of one of the following therapies: NSAIDS or salicylates OR • Patient is currently receiving treatment with antiulcer agents (i.e. proton-pump inhibitors [PPIs], histamine-2-receptor antagonists [H2RAs], and misoprostol), anticoagulants, platelet aggregation inhibitors, glucocorticosteroids, or methotrexate. OR • Patient has a history of ulcer disease



N/A

Coverage Duration

12 months

Other Criteria Claim will pay at point-of-service if patient is 65 years or older and meets the required medical information field


CERTOLIZUMAB

Products Affected Cimzia



Exclusion Criteria

N/A


• Patient has a diagnosis of moderate to severe Crohn’s disease AND • Patient has failed to achieve symptom control after an adequate therapy with, is intolerant to, or is contraindicated to: adalimumab [HUMIRA®] OR infliximab [REMICADE®] OR • Patient has a diagnosis of moderate to severe rheumatoid arthritis AND • Patient has had inadequate response to, intolerance to, or contraindication to one or more non-biologic disease modifying anti-rheumatic drugs (DMARDs) for at least 3 consecutive months AND • Patient has failed to achieve symptom control after an adequate therapy with, is intolerant to, or is contraindicated to both adalimumab [HUMIRA®] or etanercept [ENBREL®]



N/A

Coverage Duration

12 months

Other Criteria N/A


CRIZOTINIB

Products Affected Xalkori



Exclusion Criteria

N/A


• Patient has diagnosis of locally advanced or metastatic non-small cell lung cancer (NSCLC) AND • Patient has documented anaplastic lymphoma kinase (ALK)-positive NSCLC disease as detected by FDA approved diagnostic test or Clinical Laboratory Improvement Amendments-approved facility AND • Patient will be using crizotinib as monotherapy



N/A

Coverage Duration

12 months

Other Criteria Renewal criteria: • Patient has experienced an objective response to therapy AND • Patient has not experienced any occurrence of pneumonitis, Grade 4 QTc prolongation, recurrent Grade 3 QTc prolongation, or Grade 2, 3 or 4 ALT or AST/bilirubin elevation with concurrent Grade 2, 3 or 4 total bilirubin elevations.


CYSTIC FIBROSIS RESPIRATORY AGENTS

Products Affected Cayston

Pulmozyme Tobi



Exclusion Criteria

N/A


Diagnosis



N/A

Coverage Duration

12 months

Other Criteria N/A


DALFAMPRIDINE

Products Affected Ampyra



Exclusion Criteria

Coverage is not provided for patients who have a history of seizures, moderate or severe renal impairment (CrCl less than 50 mL/min) or is currently using any other forms of 4-aminopyridine


• Patient has a documented diagnosis of one of the four types of multiple sclerosis (MS) (relapse-remitting, primary-progressive, secondary-progressive, and progressive-relapsing) AND • Patient is ambulatory (able to walk with or without an assistive device for at least 25 feet in 8 to 45 seconds)



N/A

Coverage Duration

3 months

Other Criteria Renewal review: patient has demonstrated documented improvement by maintaining a stable walking speed without worsening of ambulation AND at least a 20% improvement in the T25FW from baseline.


DASATINIB

Products Affected Sprycel



Exclusion Criteria

N/A


o Patient has newly diagnosed Philadelphia chromosome positive CML in the chronic phase OR o Patient has a diagnosis of chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib OR o Patient has a diagnosis of Ph+positive ALL with resistance or intolerance to prior therapy including imatinib



N/A

Coverage Duration

12 months

Other Criteria N/A


DEFERIPRONE

Products Affected Ferriprox



Exclusion Criteria

N/A


• Patient has a diagnosis of transfusional iron overload due to thalassemia syndromes AND • Patient has failed prior chelation therapy with DESFERAL (deferoxamine) or EXJADE (deferasirox) [failure defined as serum ferritin greater than 2,500 mcg/L] OR • Patient has a contraindication or intolerance to DESFERAL (deferoxamine) or EXJADE (deferasirox) AND • Absolute neutrophil count (ANC) greater than 1.5 x 109/L



N/A

Coverage Duration

12 months

Other Criteria Renewal criteria: • Patient has experienced an objective response to therapy defined as a greater than or equal to 20% decline in serum ferritin • Absolute neutrophil count (ANC) greater than 1.5 x 109/L


DEGARELIX

Products Affected Firmagon



Exclusion Criteria

N/A


• Patient is male AND • Patient has a diagnosis of advanced or metastatic prostate cancer

Age Restrictions Patient must be at least 18 years of age


N/A

Coverage Duration

12 months

Other Criteria N/A


DENOSUMAB (PROLIA)

Products Affected Prolia



Exclusion Criteria

N/A


• Patient is female and is receiving adjuvant aromatase inhibitor therapy for breast cancer and is at high risk for fracture OR • Patient is male and is receiving androgen deprivation therapy for non-metastatic prostate cancer and is at high risk for fracture OR • Patient is a postmenopausal female with a diagnosis of osteoporosis and at high risk of fracture defined as one of the following: history of osteoporotic fractures or multiple risk factors for fractures AND • Patient has a documented trial and therapeutic failure with a bisphosphonate. Therapeutic failure is defined as new fractures in compliant patients on therapy for at least six months or significant loss of bone mineral density on follow-up scans after 12 to 24 months of therapy OR Patient has a documented contraindication, is intolerant to bisphosphonate therapy, or is unable to comply with appropriate administration recommendations for oral or injectable bisphosphonate therapy AND • Patient is concomitantly taking calcium 1000 mg daily and at least 400 IU vitamin D daily AND • Patient will have pre-existing hypocalcemia and vitamin D deficiency corrected prior to administration of PROLIA, and calcium, mineral, and vitamin D levels will be monitored periodically during treatment



N/A

Coverage Duration

12 months

Other Criteria Approvable under Part D only if patient is in a long term care facility OR the medication is not being administered with an infusion pump.


DENOSUMAB (XGEVA)

Products Affected Xgeva



Exclusion Criteria

N/A


• Patient has bone metastasis(es) from a solid tumor (due to breast cancer, castrate-resistant prostate cancer, thyroid carcinoma, or non-small cell lung cancer) and is using XGEVA for the prevention of skeletal-related events



N/A

Coverage Duration

12 months



DICLOFENAC PATCH

Products Affected Flector



Exclusion Criteria

Coverage not provided for the following contraindications to therapy: patient previously experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs, use for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery, orapplication to non-intact or damaged skin resulting from any etiology (e.g. exudative dermatitis, eczema, infected lesion, burns or wounds).


• Patient is receiving treatment for acute pain due to minor strains, sprains and contusions AND • Patient has experienced treatment failure with at least 1 prescription strength oral NSAIDs OR • Patient has a documented swallowing disorder



N/A

Coverage Duration

1 month

Other Criteria N/A


EPOPROSTENOL

Products Affected Epoprostenol Sodium

Flolan Veletri INJ 1.5MG



Exclusion Criteria

N/A


• Patient has a diagnosis of PAH (WHO Group I) WHO/NYHA Class IV patients OR • Patient has a diagnosis of PAH (WHO Group I) WHO/NYHA Class II-III patients who do not respond adequately to, are unable to tolerate, or are not candidates for endothelin receptor antagonists (e.g. TRACLEER [bosentan] or LETAIRIS [ambrisentan]) and phosphodiesterase-5 (PDE-5) inhibitors (e.g. REVATIO [sildenafil], ADCIRCA [tadalafil]).



Prescription is written by a pulmonologist or cardiologist or documentation of consultation with pulmonologist or cardiologist

Coverage Duration

12 months

Other Criteria N/A


ERLOTINIB

Products Affected Tarceva



Exclusion Criteria

N/A


• Patient has diagnosis of locally advanced or metastatic non-small cell lung cancer (NSCLC) AND • Patient has failed at least one prior chemotherapy regimen OR • Erlotinib will be used as maintenance therapy in patients with no evidence of disease progression after 4 cycles of standard first-line platinum-based chemotherapy AND • The patient has documented known positive/activated EGFR mutation discovered prior to first-line therapy or during chemotherapy OR • Patient has a diagnosis of locally advanced, unresectable, or metastatic pancreatic cancer AND • Erlotinib will be used in combination with gemcitabine (Gemzar)



N/A

Coverage Duration

12 months

Other Criteria N/A


ERYTHROPOIESIS-STIMULATING AGENTS

(DARBEPOETIN)

Products Affected Aranesp Albumin Free INJ 100MCG/0.5ML, 100MCG/ML, 150MCG/0.3ML, 200MCG/0.4ML, 200MCG/ML, 25MCG/0.42ML, 25MCG/ML, 300MCG/0.6ML, 300MCG/ML, 40MCG/0.4ML, 40MCG/ML, 500MCG/ML, 60MCG/0.3ML, 60MCG/ML



Exclusion Criteria

Patient with uncontrolled hypertension or antibody-mediated pure red cell aplasia


• Patient has one of the following diagnoses: o Anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy AND two additional months of chemotherapy is anticipated OR o Anemia of chronic kidney disease (CKD) OR o Anemia due to myelodysplastic syndrome with endogenous serum erythropoietin level less than or equal to 500 mU/mL AND • Pretreatment hemoglobin level as follows: o Anemic patient at high risk for perioperative blood loss, Hgb: between 10 and 13 g/dL OR o All other indications, Hgb is less than 10 g/dL AND • Patient must have adequate iron stores prior to initiation of therapy defined as ferritin greater than 100 mcg/L and serum transferrin saturation greater than 20% AND • Other causes of anemia have been ruled out



Prescribed by a hematologist or an oncologist if patient with non-myeloid malignancies or myelodysplastic syndrome or hematolgist or nephrologist if anemia in patients with CKD


Coverage Duration

Initial authorization will be 3 months.

Other Criteria Continued use shall be reviewed at least every 6 months for all indications and 12 months for CKD. Renewal criteria: • Patient must have adequate iron stores defined as ferritin greater than 100 mcg/L and serum transferrin saturation greather than 20% AND • For CKD: o If patient has end stage renal disease and is on dialysis, covered under Part B, otherwise covered under Part D. O Measurable response after 12 weeks defined as an increase in Hgb greater than 1 g/dL or a reduction in RBC transfusion requirements AND o For dialysis patients: Hgb less than 11g/dL OR Hgb greater than 11 and physician will decrease or interrupt dose OR for non-dialysis patients: Hgb less than 10 g/dL OR Hgb greater than 10 and physician will decrease or interrupt dose OR • For Non-Myeloid Malignancies: o Measurable response after 8 weeks defined as an increase in Hgb of 1g/dL or a reduction of transfusion requirements AND concurrent myelosuppressive chemotherapy OR • For other indications Hgb is less than or equal to 12 g/dL AND o Myelodysplastic syndrome: measurable response after 8 weeks defined as a 1.5 g/dL rise in Hgb or a decrease in RBC transfusion requirements OR o Concomitant trial of NEUPOGEN® (G-CSF/filgrastrim) and a measurable response as defined above after 6-8 weeks of NEUPOGEN® therapy OR • For Hepatitis C: measurable response after 8 weeks defined as an increase in Hgb greater than 1g/dL or a reduction in RBC transfusion requirements AND concurrent interferon/ribavirin or pegylated interferon/ribavirin therapy OR • For Zidovudine-treated HIV: measurable response after 8 weeks defined as an increase in Hgb greater than 1g/dL or a reduction in RBC transfusion requirements OR documented dose escalation (up to max of 300 U/kg every 4-8 weeks) AND Zidovudine doses less than or equal to 4200 mg/week


ERYTHROPOIESIS-STIMULATING AGENTS (EPOETIN)

Products Affected Epogen

Procrit


Covered Uses All medically accepted indications not otherwise excluded from Part D

Exclusion Criteria

Patient with uncontrolled hypertension or antibody-mediated pure red cell aplasia


• Patient has one of the following diagnoses: o Anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy AND two additional months of chemotherapy is anticipated OR o Anemia of chronic kidney disease (CKD) OR o Anemia in zidovudine-treated HIV-infection with serum erythropoietin levels less than or equal to 500 mU/mL and zidovudine doses less than or equal to 4200 mg/week AND prescribed by an infectious disease specialist OR o Anemia secondary to treatment of hepatitis C infection with a combination of ribavirin and interferon/peginterferon AND prescribed by a hepatologist, infectious disease specialist, or gastroenterologist OR o Treatment of anemic patient at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery to reduce the need for allogeneic blood transfusion AND prescribed by a surgeon AND • Pretreatment hemoglobin level as follows: o Anemic patient at high risk for perioperative blood loss, Hgb between 10 and 13 g/dL OR o All other indications, Hgb less than 10 g/dL AND • Patient must have adequate iron stores prior to initiation of therapy defined as ferritin greater than 100 mcg/L and serum transferrin saturation greater than 20% AND • Other causes of anemia have been ruled out



Prescribed by a hematologist or an oncologist if patient with non-myeloid malignancies or myelodysplastic syndrome, hematolgist or nephrologist if anemia in patients with CKD, neonatologist if anemia due to prematurity, surgeon if surgery patient


Coverage Duration

Initial authorization will be 3 months.

Other Criteria Renewal criteria: • Patient must have adequate iron stores defined as ferritin greater than 100 mcg/L and serum transferrin saturation greater than 20% AND • For Chronic Kidney Disease: o If patient has end stage renal disease and is on dialysis, covered under Part B, otherwise covered under Part D. O Measurable response after 12 weeks defined as an increase in Hgb greater than 1 g/dL or a reduction in RBC transfusion requirements AND o For dialysis patients: Hgb less than 11g/dL OR Hgb greater than 11 and physician will decrease or interrupt dose OR for non-dialysis patients: Hgb less than 10 g/dL OR Hgb greater than 10 and physician will decrease or interrupt dose OR • For Non-Myeloid Malignancies: o Measurable response after 8 weeks defined as an increase in Hgb greater than 1g/dL or a reduction of transfusion requirements AND concurrent myelosuppressive chemotherapy OR • For other indications Hgb less than or equal to 12 g/dL OR • For Hepatitis C: measurable response after 8 weeks defined as an increase in Hgb greater than 1g/dL or a reduction in RBC transfusion requirements AND concurrent interferon/ribavirin or pegylated interferon/ribavirin therapy OR • For Zidovudine-treated HIV: measurable response after 8 weeks defined as an increase in Hgb greater than 1g/dL or a reduction in RBC transfusion requirements OR documented dose escalation (up to max of 300 U/kg every 4-8 weeks) AND Zidovudine doses less than or equal to 4200 mg/week


ETANERCEPT

Products Affected Enbrel

Enbrel Sureclick



Exclusion Criteria

N/A



• Patient has a diagnosis of moderate to severe rheumatoid arthritis (RA) AND • Patient has had inadequate response to, intolerance to, or contraindication to one or more non-biologic disease modifying anti-rheumatic drugs (DMARDs) for at least 3 consecutive months OR • Patient has a diagnosis of moderate to severe RA AND • Patient has had RA for less than 6 months with high disease activity for 3—6 months or with high disease activity for less than 3 months but also with poor prognostic features AND • Etanercept will be used in combination with methotrexate OR • Diagnosis of moderate to severe polyarticular juvenile idiopathic arthritis AND • Patient has had inadequate response to, intolerance to, or contraindication to one or more non-biologic DMARDs for at least 3 consecutive months OR • Patient has a diagnosis of psoriatic arthritis OR ankylosing spondylitis AND • Patient has had inadequate response to, intolerance to, or contraindication to: o One or more non-steroidal anti-inflammatory drugs (NSAIDs) OR o One or more non-biologic DMARDs OR • Patient has a diagnosis of moderate to severe chronic plaque psoriasis (affecting more than 5% of body surface area (BSA) or affecting crucial body areas such as the hands, feet, face, or genitals) AND • Patient has had an inadequate response to, is intolerant to, or is contraindicated to conventional therapy with at least one of the following: o Phototherapy (including, but not limited to, Ultraviolet A with a psoralen [PUVA] and/or retinoids [RePUVA]) for at least one continuous month OR o One or more oral systemic treatments (i.e., methotrexate, cyclosporine, acitretin, sulfasalazine) for at least three consecutive months.

Age Restrictions Patient must be at least 2 years of age for polyarticular juvenile idiopathic arthritis, patient must be at least 18 years of age for all other indications


N/A

Coverage Duration

12 months

Other Criteria N/A


EVEROLIMUS

Products Affected Afinitor



Exclusion Criteria

N/A


• Patient has a diagnosis of advanced/metastatic renal cell carcinoma (RCC) AND • Patient has failed therapy (disease progressed) with sunitinib [SUTENT] or sorafenib [NEXAVAR] OR •Patient has a diagnosis of progressive neuroendocrine tumors of pancreatic origin (PNET) that are unresectable, locally advanced, or metastatic OR • Patient has Subependymal Giant Cell Astrocytoma associated with tuberous sclerosis (TS) that requires therapeutic intervention but is not a candidate for curative surgical resection OR • Patient has a diagnosis of renal angiomyolipoma and tuberous sclerosis complex AND • Patient does not require immediate surgerycurative surgical resection OR • Patient is a postmenopausal woman AND • Patient has a diagnosis of advanced hormone receptor-positive, HER2-negative breast cancer AND • Patient has failed treatment with letrozole [Femara] or anastrozole [Arimidex] AND • Afinitor will be used in combination with exemestane [Aromasin]

Age Restrictions Patient is greater than or equal to 18 years of age for Renal Cell Carcinoma and Progressive Neuroendocrine Tumors. Patient is greater than or equal to 3 years of age for Subependymal Giant Cell Astrocytoma


N/A

Coverage Duration

12 months


Other Criteria N/A


FENTANYL, SHORT-ACTING

Products Affected Abstral Actiq Fentanyl Citrate Oral Transmucosal Fentora

Onsolis Subsys SUBLINGUAL LIQD

100MCG, 1200MCG, 1600MCG, 200MCG, 400MCG, 600MCG, 600MCG, 800MCG



Exclusion Criteria

Fentanyl is not being used for the management of acute or postoperative pain, including headache/migraine, dental pain, or use in the emergency room


• Patient has a diagnosis of cancer and use is for breakthrough cancer pain AND • Patient is opioid tolerant and taking at least 60 mg morphine/day, at least 25 mcg transdermal fentanyl/hour, at least 30 mg of oxycodone daily, at least 8 mg oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer AND • Other formulary short-acting strong narcotic analgesic alternatives (other than fentanyl) have been ineffective, not tolerated, or contraindicated. Examples of short-acting strong narcotics include, but are not limited to, concentrated morphine oral solution, oxycodone or hydromorphone

Age Restrictions Patient must be at least 18 years of age for ABSTRAL, FENTORA and ONSOLIS. Patient must be at least 16 years of age for ACTIQ.


N/A

Coverage Duration

12 months

Other Criteria N/A


FILGRASTIM

Products Affected Neupogen INJ 300MCG/0.5ML, 480MCG/0.8ML, 480MCG/1.6ML



Exclusion Criteria

N/A


• Patient has a diagnosis of cancer and is receiving myelosuppressive chemotherapy OR • Patient has a diagnosis of acute myeloid leukemia and is receiving induction or consolidation chemotherapy OR • Patient has a diagnosis of cancer and is receiving a bone marrow transplant OR • Patient is undergoing peripheral blood progenitor cell collection and therapy OR • Patient has a diagnosis of severe chronic neutropenia (congenital, cyclic, or idiopathic)



N/A

Coverage Duration

12 months

Other Criteria N/A


FINGOLIMOD

Products Affected Gilenya



Exclusion Criteria

N/A


• Patient is diagnosed with a relapsing form of MS AND • Patient will be observed in a controlled setting, for signs and symptoms of bradycardia for 6 hours after the first dose



N/A

Coverage Duration

12 months

Other Criteria N/A


GABAPENTIN (GRALISE)

Products Affected Gralise



Exclusion Criteria

N/A


• Patient has a diagnosis of post-herpetic neuralgia AND • Patient has tried and failed a dose of at least 1800 mg of generic gabapentin OR • Patient had experienced intolerance to generic gabapentin.



N/A

Coverage Duration

12 months

Other Criteria N/A


GABAPENTIN ENACARBIL

Products Affected Horizant



Exclusion Criteria

N/A


• Patient has a diagnosis of moderate to severe primary restless legs syndrome



N/A

Coverage Duration

12 months

Other Criteria N/A


GALSULFASE

Products Affected Naglazyme



Exclusion Criteria

N/A


Diagnosis



N/A

Coverage Duration

12 months

Other Criteria N/A


GASTROINTESTINAL AGENTS (HIGH RISK

MEDICATIONS)

Products Affected Dicyclomine Hcl Diphenoxylate/atropine

Lonox Motofen Propantheline Bromide



Exclusion Criteria

N/A





N/A

Coverage Duration

12 months

Other Criteria N/A


GLATIRAMER

Products Affected Copaxone



Exclusion Criteria

N/A


• Patient has a diagnosis of relapsing-remitting multiple sclerosis OR • Patient has experienced a first clinical episode and has MRI features consistent with multiple sclerosis



N/A

Coverage Duration

12 months

Other Criteria N/A


GOLIMUMAB

Products Affected Simponi



Exclusion Criteria

N/A


• Patient has a diagnosis of moderate to severe rheumatoid arthritis AND • Patient will be on concomitant methotrexate therapy AND • Patient has had inadequate response to, intolerance to, or contraindication to one or more non-biologic disease modifying anti-rheumatic drugs (DMARD) for at least 3 consecutive months OR • Patient has a diagnosis of psoriatic arthritis OR ankylosing spondylitis AND • Patient has had inadequate response to, intolerance to, or contraindication to: o One or more non-steroidal anti-inflammatory drugs (NSAIDs) OR o One or more non-biologic DMARDs



N/A

Coverage Duration

12 months

Other Criteria N/A


GROWTH HORMONE - GHD & GROWTH FAILURE

Products Affected Genotropin Genotropin Miniquick Humatrope INJ 12MG, 24MG, 6MG Humatrope Combo Pack Norditropin Flexpro Norditropin Nordiflex Pen

Nutropin Nutropin Aq Nutropin Aq Pen Omnitrope INJ 5MG/1.5ML Saizen INJ 5MG Saizen Click.easy Tev-tropin



Exclusion Criteria

N/A


Diagnosis



Prescription is written by an endocrinologist

Coverage Duration

12 months

Other Criteria N/A


GROWTH HORMONE (SEROSTIM)

Products Affected Serostim



Exclusion Criteria

N/A


• Diagnosis of AIDs-wasting syndrome or cachexia (define as unintentional weight loss greater than or equal to 10% of baseline weight) AND • Treatment failure with or intolerance to dronabinol or megestrol AND • Patient is currently receiving treatment with antiretrovirals



N/A

Coverage Duration

12 weeks

Other Criteria Renewal criteria: • Patient has experienced an increase in body weight and/or body cell mass AND • Wasting is still evident


GROWTH HORMONE (ZORBTIVE)

Products Affected Zorbtive



Exclusion Criteria

N/A


• Patient has a diagnosis of short bowel syndrome AND • Patient is receiving specialized nutritional support (i.e. parenteral nutrition)



N/A

Coverage Duration

Duration of approval is limited to 4 weeks. Additional authorizations not provided.

Other Criteria N/A


H.P. ACTHAR GEL

Products Affected Acthar Hp



Exclusion Criteria

Scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of peptic ulcer, congestive heart failure, uncontrolled hypertension, primary adrenocortical insufficiency, adrenocortical hyperfunction, sensitivity to proteins or porcine origin, or where congenital infections are suspected in infants, administration of live or live attenuated vaccines in patients receiving immunosuppressive doses of H.P. Acthar Gel


Diagnosis of infantile spasms (IS) OR use after failure of corticosteroid therapy for the following conditions: multiple sclerosis (MS), adjunctive therapy in psoriatic arthritis, rheumatoid arthritis, including juvenile idiopathic arthritis, ankylosing spondylitis, for exacerbations or as maintenance therapy of systemic lupus erythematous, systemic dermatomyositis (polymyositis), severe erythema multiforme, Stevens-Johnson Syndrome, serum sickness, severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation, symptomatic sarcoidosis, to induce a diuresis or a remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus

Age Restrictions 2 years of age or younger for diagnosis of IS, 18 years of age or older in MS


N/A

Coverage Duration

IS - plan year. Collagen diseases - 6 months. Others - 1 month

Other Criteria N/A


HEPATITIS B AGENTS

Products Affected Baraclude

Hepsera Tyzeka



Exclusion Criteria

N/A


Diagonsis



N/A

Coverage Duration

12 months

Other Criteria N/A


HYDROMORPHONE

Products Affected Exalgo ORAL TB24 12MG, 16MG, 8MG



Exclusion Criteria

Coverage is not provided for patients with any contraindications to therapy including: significant respiratory depression and acute or severe bronchial asthma or hypercarbia, known or suspected paralytic ileus, patients who have had surgical procedures or known allergy to sulfite-containing medications


• Patient has diagnosis of moderate to severe pain requiring continuous, around-the-clock opioid analgesia for an extended period of time AND • Patient is opioid tolerant. Opioid tolerant patients are those who are taking around-the-clock medicine consisting of at least 60 mg of oral morphine daily, at least 25 mcg of transdermal fentanyl/hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid daily for a week or longer AND • Documentation of a trial of at least one generic extended-release opioid product



N/A

Coverage Duration

12 months

Other Criteria N/A


IBANDRONATE

Products Affected Boniva INJ



Exclusion Criteria

N/A


• Patient has any of the following diagnoses: o Osteoporosis in a postmenopausal female o Primary or hypogonadal osteoporosis in a male AND • Documented trial and therapeutic failure of an oral bisphosphonate for six months. Therapeutic failure is defined as new fractures in compliant patients on therapy for at least six months or significant loss of bone mineral density on follow-up scans after 12 to 24 months of therapy OR • Patient has a documented contraindication, is intolerant to oral bisphosphonate therapy or is unable to comply with appropriate administration recommendations for oral bisphosphonate therapy



N/A

Coverage Duration

12 months



ILOPROST

Products Affected Ventavis SOLN 10MCG/ML



Exclusion Criteria

N/A





Pulmonologist or cardiologist or documentation of consultation with pulmonologist or cardiologist

Coverage Duration

12 months

Other Criteria N/A


IMATINIB

Products Affected Gleevec



Exclusion Criteria

N/A



• Patient has a diagnosis of Philadelphia chromosome positive chronic myelogenous leukemia that is newly diagnosed in the chronic phase (CP), accelerated phase (AP) or blast crisis (BC), or in chronic phase after failure of interferon alpha therapy OR • Patient has a diagnosis of Philadelphia chromosome positive acute lymphoblastic leukemia that is relapsed or refractory OR • Patient has documented c-KIT (CD117) positive unresectable or metastatic malignant gastrointestinal stromal tumor (GIST) OR • Patient had resection of c-KIT (CD117) positive GIST and imatinib will be used as an adjuvant therapy OR • Patient has a diagnosis of dermatofibrosarcoma protuberans that is unresectable, recurrent, or metastatic OR • Patient has a diagnosis of hypereosinophilic syndrome (HES) or chronic eosinophilic leukemia (CEL) with documentation of FIP1L1-PDGFR-a fusion kinase [mutational analysis or FISH demonstration of CHIC2 allele deletion] OR • Patient has a diagnosis of HES or CEL and is FIP1L1-PDGFR-a fusion kinase negative or unknown OR • Patient has a diagnosis of myelodysplastic syndrome or myeloproliferative disease associated with PDGFR gene rearrangements OR • Patient has a diagnosis of systemic mastocytosis without the D816V c-KIT mutation or with c-KIT mutational status unknown OR • Patient has a diagnosis of Ph+ CML that is newly diagnosed in the CP

Age Restrictions Patients at least 18 years of age for FDA approved indications in adults. Patients at least 2 years of age and older for Philadelphia chromosome positive chronic myelogenous leukemia


N/A

Coverage Duration

12 months

Other Criteria N/A


IMIGLUCERASE

Products Affected Cerezyme INJ 200UNIT



Exclusion Criteria

N/A


Diagnosis



N/A

Coverage Duration

12 months

Other Criteria N/A


IMMUNE GLOBULIN

Products Affected Carimune Nanofiltered INJ 3GM Gammagard Liquid

Gamunex-c INJ 1GM/10ML Privigen INJ 20GM/200ML



Exclusion Criteria

Coverage is not provided in patients with selective IgA deficiency, history of anaphylactic reaction or hypersensitivity to immune globulin preparations. For the IM formulation only, coverage not provided for patients with severe thrombocytopenia or coagulation disorders where IM injections are contraindicated.


Diagnosis



N/A

Coverage Duration

12 months

Other Criteria N/A


INCOBOTULINUMTOXINA

Products Affected Xeomin INJ 50UNIT



Exclusion Criteria

Coverage not provided for contraindications to therapy: hypersensitivity to human albumin or sucrose OR presence of infection at the proposed injection site(s)


Coverage provided for the following diagnoses: • Blepharospasm OR • Cervical dystonia (including spasmodic torticollis)



N/A

Coverage Duration

12 months

Other Criteria N/A


INFLIXIMAB

Products Affected Remicade



Exclusion Criteria

N/A


• Patient has a diagnosis of moderate to severe Crohn’s disease or ulcerative colitis OR • Patient has a diagnosis of moderate to severe rheumatoid arthritis (RA) AND • Patient has had inadequate response to, intolerance to, or contraindication to one or more non-biologic disease modifying anti-rheumatic drugs (DMARDs) for at least 3 consecutive months AND • Patient will be on concomitant methotrexate therapy OR • Patient has been diagnosed with RA for less than 6 months with high disease activity for 3—6 months or with high disease activity for less than 3 months but also with poor prognostic features AND • Infliximab will be used in combination with methotrexate OR • Patient has a diagnosis of ankylosing spondylitis OR psoriatic arthritis AND • Patient has had inadequate response to, intolerance to, or contraindication to: o One or more non-steroidal anti-inflammatory drugs (NSAIDs) OR o One or more non-biologic DMARDs OR • Patient has a diagnosis of chronic severe plaque psoriasis (affecting more than 10% of body surface area (BSA) or affecting crucial body areas such as the hands, feet, face, or genitals) AND • Patient has had an inadequate response to, is intolerant to, or is contraindicated to conventional therapy with at least one of the following: o Phototherapy (including, but not limited to, Ultraviolet A with a psoralen [PUVA] and/or retinoids [RePUVA]) for at least one continuous month OR o One or more oral systemic treatments (i.e., methotrexate, cyclosporine, acitretin, sulfasalazine) for at least three consecutive months.


Age Restrictions Patients at least 18 years of age and older for FDA approved indications in adults. Patients at least 6 years of age and older for Crohn's disease or ulcerative colitis.


N/A

Coverage Duration

12 months



INTERFERON ALFACON

Products Affected Infergen INJ 15MCG/0.5ML



Exclusion Criteria

Coverage is not provided for patients with the following: autoimmune hepatitis, hepatic decompensation (Child Pugh Score greater than 6[Class B or C]), or known hypersensitivity to interferons


• Patient is receiving treatment for hepatitis C infection AND • Patient is considered a relapser/non-responder to combination treatment with peg-interferon and ribavirin AND • Patient is receiving combination therapy with ribavirin, unless contraindicated

Age Restrictions Patients at least 18 years of age and older


N/A

Coverage Duration

12 months

Other Criteria N/A


INTERFERONS (MULTIPLE SCLEROSIS)

Products Affected Avonex Betaseron

Rebif Rebif Titration Pack



Exclusion Criteria

N/A


• Patient has a diagnosis of a relapsing form of multiple sclerosis OR • Patient has experienced a first clinical episode and MRI features are consistent with multiple sclerosis



N/A

Coverage Duration

12 months

Other Criteria N/A


INTERLEUKIN BLOCKERS (CANAKINUMAB)

Products Affected Ilaris



Exclusion Criteria

N/A


•Patient has diagnosis of Cryopyrin-Associated Periodic Syndromes (CAPS), including (1) Familial Cold Auto-inflammatory Syndrome (FCAS) and/or (2) Muckle-Wells Syndrome (MWS)

Age Restrictions Patient must be at least 4 year of age


Diagnosed by or upon consultation with an immunologist, allergist, dermatologist, rheumatologist, neurologist or other medical specialist.

Coverage Duration

12 months

Other Criteria N/A


INTERLEUKIN BLOCKERS (RILONACEPT)

Products Affected Arcalyst



Exclusion Criteria

N/A


•Patient has diagnosis of Cryopyrin-Associated Periodic Syndromes (CAPS), including (1) Familial Cold Auto-inflammatory Syndrome (FCAS) and/or (2) Muckle-Wells Syndrome (MWS)

Age Restrictions Patient must be at least 12 year of age


Diagnosed by or upon consultation with an immunologist, allergist, dermatologist, rheumatologist, neurologist or other medical specialist.

Coverage Duration

12 months

Other Criteria N/A


IVACAFTOR

Products Affected Kalydeco



Exclusion Criteria

N/A


• Patient has a diagnosis of cystic fibrosis AND • Patient has a known G551D mutation on at least one allele in the cystic fibrosis transmembrane conductance regulator (CFTR) gene documented by an FDA-cleared CF-mutation test that includes measurement of the G551D mutation



N/A

Coverage Duration

12 months

Other Criteria Renewal criteria: patient has had an objective response to therapy such as an improvement over baseline for any of the following parameters: • Forced expiratory volume at 1 second (FEV1) • Sweat chloride concentration • Decreased number of pulmonary exacerbations • Weight gain • Improvement in CF symptoms including respiratory symptoms such as cough, sputum production, or difficulty breathing


LAPATINIB

Products Affected Tykerb



Exclusion Criteria

N/A


• Patient has advanced or metastatic breast cancer whose tumor overexpresses HER2 AND • Patient received prior therapy including an anthracycline, a taxane, and trastuzumab [HERCEPTIN] AND • Lapatinib will be used in combination with capecitabine [XELODA] OR • Patient is a postmenopausal woman with hormone receptor positive metastatic breast cancer that overexpresses HER2 receptor for whom hormonal therapy is indicated AND • Lapatinib will be used in combination with letrozole [FEMARA]



N/A

Coverage Duration

12 months

Other Criteria N/A


LARONIDASE

Products Affected Aldurazyme



Exclusion Criteria

N/A


Diagnosis



N/A

Coverage Duration

12 months

Other Criteria N/A


LENALIDOMIDE

Products Affected Revlimid ORAL CAPS 10MG, 15MG, 25MG, 5MG



Exclusion Criteria

N/A


Diagnosis



N/A

Coverage Duration

12 months

Other Criteria N/A


LEUPROLIDE (ELIGARD)

Products Affected Eligard



Exclusion Criteria

N/A





N/A

Coverage Duration

12 months

Other Criteria N/A


LEUPROLIDE (LUPRON)

Products Affected Leuprolide Acetate Lupron Depot INJ 22.5MG, 3.75MG,

30MG, 45MG, 7.5MG

Lupron Depot-ped INJ 11.25MG, 11.25MG, 15MG



Exclusion Criteria

Coverage is not provided for patients who are pregnant


• Patient is male and has a diagnosis of advanced or metastatic prostate cancer OR • Patient is female and has a diagnosis of endometriosis AND • In patients with child-bearing potential, patient will be using nonhormonal contraception during and for 12 weeks after therapy AND • Patient has had an inadequate pain control response or patient has an intolerance or contraindication to one of the following: danazol (six month trial), combination [estrogen/progesterone] oral contraceptives (six month trial), or progestins (six month trial) OR • Patient has a diagnosis of anemia due to uterine leiomyomata (fibroids) AND • Patient has been informed that pregnancy must be avoided by the use of nonhormonal methods of contraception AND • Patient is preoperative AND • Patient has failed 1 month of monotherapy with iron AND • Patient will be receiving concomitant iron therapy while on leuprolide OR • Patient has a diagnosis of idiopathic or neurogenic central precocious puberty (CPP) with onset of secondary sexual characteristics earlier than 8 years in females and 9 years in males

Age Restrictions Patient must be 18 years or older for all FDA approved indications except CPP, where patient must be less than 11 years if female and less than 12 years if male


N/A


Coverage Duration

12 months

Other Criteria Renewal criteria for endometriosis only: • Patient is females and has a diagnosis of endometriosis AND • Patient has been informed that pregnancy must be avoided by the use of nonhormonal methods of contraception AND • Patient is experiencing recurrence of symptoms after an initial course of therapy (6 months) with leuprolide acetate AND • Norethindrone acetate 5 mg daily will be coadministered


LINZESS

Products Affected Linzess


Covered Uses All FDA-approved indications not otherwise excluded from Part D

Exclusion Criteria

mechanical gastrointestinal obstruction


Diagnosis of irritable bowel syndrome with constipation (IBS-C) subtype for at least 12 non-consecutive weeks or diagnosis of chronic idiopathic constipation (CIC) for at least 3 months AND patient has tried and failed increasing fluid and fiber intake AND patient has tried and failed or has an intolerance or contraindicaiton to osmotic laxatives, stimulant laxatives, or stool softeners (if CIC) or probiotics (if IBS-C)



N/A

Coverage Duration

Initial: 4 months Renewal: Plan years

Other Criteria For renewal, patient has experienced an objective response to therapy (i.e. increase in the number of bowel movements).


LOW MOLECULAR WEIGHT HEPARIN AND RELATED

PRODUCTS

Products Affected Enoxaparin Sodium

Fragmin Lovenox INJ 300MG/3ML



Exclusion Criteria

N/A


Quantities above quantity limits approved for the following: • Pregnancy when anticoagulation is required OR • Cancer patient requiring treatment of DVT or PE OR • Failure, contraindication or intolerance to warfarin for any of the following indications: o Treatment of acute DVT with or without PE o Treatment of pulmonary embolism (PE) o Prophylaxis and/or treatment of thromboembolic complications associated with atrial fibrillation and/or mechanical cardiac valve replacement o Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction (MI) o Treatment of ST-segment elevation myocardial infarction (STEMI) managed medically or with subsequent percutaneous coronary intervention (PCI). o Children with Cerebral Sinovenous Thrombosis (CVST)



N/A

Coverage Duration

12 months

Other Criteria Prior authorization is only needed for claims that exceed the QL


MECASERMIN

Products Affected Increlex



Exclusion Criteria

N/A


• Bone epiphyses are not closed AND • Patient has a diagnosis of growth failure due to severe primary IGF-1 deficiency (Primary IGFD) defined as: o Height standard deviation score less than -3.0 AND o Basal IGF-1 standard deviation score less than -3.0 AND o Normal or elevated growth hormone OR • Patient has a diagnosis of growth failure due to growth hormone deletion with neutralizing antibodies to growth hormone

Age Restrictions Patient must be between 2 to 18 years of age


Prescription is written by or with documented consultation by a pediatric endocrinologist

Coverage Duration

12 months

Other Criteria Renewal criteria: • Patient’s epiphyses are open OR • Final adult height has not been reached as determined by the fifth percentile of adult height OR • GV is greater than 2 cm/year


METHYLNALTREXONE

Products Affected Relistor INJ 12MG/0.6ML



Exclusion Criteria

Coverage is not provided for use in patients with known or suspected mechanical gastrointestinal obstruction or severe or persistent diarrhea (therapy should be discontinued in cases of severe or persistent diarrhea


• Patient is diagnosed with an advanced illness (e.g., incurable cancer, end-stage chronic obstructive pulmonary disease (COPD)/emphysema, cardiovascular disease/heart failure, Alzheimer’s disease/dementia, HIV/AIDS, etc.) AND • Patient is receiving palliative care AND • Patient is being treated for opioid-induced constipation (OIC) AND • Patient has a documented trial and an insufficient response to, other laxative therapy



N/A

Coverage Duration

4 months

Other Criteria Use of methylnaltrexone in this diagnosis has not been studied beyond four months.


MIGLUSTAT

Products Affected Zavesca



Exclusion Criteria

N/A


Diagnosis



N/A

Coverage Duration

12 months

Other Criteria N/A


MILNACIPRAN

Products Affected Savella

Savella Titration Pack



Exclusion Criteria

Coverage is not provided for the following contraindications to milnacipran therapy: use of monoamine oxidase inhibitors (MAOI) concomitantly, or uncontrolled narrow-angle glaucoma


• Patient has a diagnosis of fibromyalgia



N/A

Coverage Duration

12 months

Other Criteria N/A


NATALIZUMAB

Products Affected Tysabri



Exclusion Criteria

Do not use in combination with immunosuppressants or inhibitors of TNF-alfa


• Patient has a diagnosis of a relapsing form of multiple sclerosis AND • Patient had an inadequate response to, or were unable to tolerate, an alternate multiple sclerosis therapy AND • Tysabri will be used as monotherapy OR • Patient has a diagnosis of moderate to severe Crohn's disease with evidence of inflammation AND • Patient had an inadequate response to, or were unable to tolerate, conventional Crohn's disease therapies and inhibitors of TNF-alfa



N/A

Coverage Duration

12 months

Other Criteria N/A


NILOTINIB

Products Affected Tasigna



Exclusion Criteria

Coverage is not provided for patients with long QT syndrome, hypokalemia, or hypomagnesemia


• Patient has newly diagnosed Philadelphia chromosome positive chronic myelogenous leukemia in the chronic phase OR • Patient is in the chronic phase or accelerated phase of Philadelphia chromosome positive chronic myelogenous leukemia and has resistance to or intolerance to prior therapy with imatinib



N/A

Coverage Duration

12 months

Other Criteria N/A


OMALIZUMAB

Products Affected Xolair



Exclusion Criteria

N/A


• Patient has diagnosis of moderate to severe persistent allergic asthma AND • Patient has evidence of specific allergic sensitivity confirmed by positive skin test (i.e. prick/puncture test) or blood test (i.e. RAST) for a specific IgE or in vitro reactivity to a perennial allergen AND • Patient has pretreatment serum IgE levels =30 IU/mL and =700 IU/mL AND • Patient’s symptoms are not adequately controlled with a high dose of inhaled corticosteroid plus long-acting beta agonist AND • Patient has two or more acute exacerbations while on controller medications within a 12 month period, including treatment with high dose injectable or oral corticosteroids, ER visits, or hospitalizations



N/A

Coverage Duration

12 months

Other Criteria Renewal requires the that the patient has experienced an objective response to therapy, defined as one or more of the following: o Reduction in number of asthma exacerbations from baseline o Improvement in FEV1 o Improvement in QoL as demonstrated by an improvement in the QoL score from baseline using a validated QoL questionnaire (e.g. Juniper Asthma Quality of Life Questionnaire)


ONABOTULINUMTOXINA

Products Affected Botox INJ 100UNIT



Exclusion Criteria

Coverage not provided for cosmetic indications (e.g. wrinkles, frown lines, aging neck, blepharoplasty (eyelid lift) or for patients with acute urinary tract infection or acute urinary retention (for intradetrusor administration).


• Patient has a diagnosis of cervical dystonia and onabotulinumtoxinA is being used to decrease the severity of abnormal head position and neck pain associated with cervical dystonia OR • Patient has a diagnosis of severe primary axillary hyperhidrosis inadequately managed with topical agents (defined as refractory to greater than 6 months treatment with topical aluminum chloride) OR • Patient has a diganosis of strabismus or blepharospasm associated with dystonia OR • Patient has a diagnosis of upper limb spasticity OR • Patient has a diagnosis of chronic migraine (greater than or equal to 15 days per month with headache lasting 4 hours a day or longer) and onabotulinumtoxinA is being used for prophylaxis OR • Patient has a diagnosis of urinary incontinence due to detrusor overactivity associated with a neurologic condition [e.g., spinal cord injury (SCI), multiple sclerosis (MS)] and • Patient has had an inadequate response to or are intolerant of an anticholinergic medication

Age Restrictions Patient is 12 years of age or older for strabismus and blepharospasm, patient is 16 years of age or older for cervical distonia, patient is 18 years of age or older for all other indications


N/A


Coverage Duration

12 months

Other Criteria N/A


ONCOLOGY (HIGH RISK MEDICATIONS)

Products Affected Megace Es

Megestrol Acetate



Exclusion Criteria

N/A





N/A

Coverage Duration

12 months

Other Criteria N/A


ORAL ESTROGENS AND PROGESTINS (HIGH RISK

MEDICATIONS)

Products Affected Activella TABS 0.5MG; 0.1MG Alora Cenestin Climara Pro Combipatch Delestrogen INJ 10MG/ML Divigel GEL 1MG/GM Enjuvia Estradiol Estradiol Valerate Estradiol/norethindrone Acetate

Estropipate Femhrt 1/5 Femhrt Low Dose Jinteli Menest Menostar Prefest Premarin ORAL TABS Premphase Prempro Vivelle-dot



Exclusion Criteria

N/A





N/A

Coverage Duration

12 months


Other Criteria N/A


ORLISTAT

Products Affected Xenical



Exclusion Criteria

Coverage is not provided for obesity, cholestasis, chronic malabsorption syndrome, and hypersensitivity to orlistat or any other component of the product


Patient has a diagnosis of one of the following: prophylaxis of coronary arteriosclerosis, type 2 diabetes mellitus prophylaxis, type 2 diabetes mellitus, hyperlipidemia



N/A

Coverage Duration

12 months

Other Criteria N/A


PALIVIZUMAB

Products Affected Synagis INJ 50MG/0.5ML



Exclusion Criteria

N/A


• Patient will use palivizumab for immunoprophylaxis of RSV during the peak months of infection in the patient’s geographic region AND • Patient meets one of the following criteria: o Infants born at 28 weeks, 6 days gestation or earlier and who are younger than 12 months of age at the start of the RSV season OR o Infants born at 29-31 weeks, 6 days gestation and who are younger than 6 months of age at the start of the RSV season OR o Infants born at 32-34 weeks, 6 days gestation and who are younger than 3 months of age at the start of RSV season if they have at least one of the following risk factors: child care attendance or sibling younger than 5 years of age OR o Infants born before 35 weeks, 0 days gestation who have either congenital abnormalities of the airway or neuromuscular disease that compromises handling of respiratory secretions during the first year of life OR o Infants and children younger than 2 years of age with hemodynamically significant congenital heart disease and who have at least one of the following criteria: receiving medication to control congestive heart failure, has moderate to severe pulmonary hypertension, or has cyanotic heart disease OR o Infants and children younger than 2 years of age who have received medical therapy (O2, bronchodilator, diuretic, or corticosteroid therapy) for chronic lung disease (CLD) within 6 months of the start of the RSV season

Age Restrictions Patient is under 2 years of age at the start of an RSV season


N/A


Coverage Duration

5 mths during RSV season OR until 3 months of age (max 3 monthly doses) for certain infants

Other Criteria N/A


PAZOPANIB

Products Affected Votrient



Exclusion Criteria

N/A


• Patient has a diagnosis of advanced/metastatic renal cell carcinoma



N/A

Coverage Duration

12 months

Other Criteria N/A


PDE-5 INHIBITORS FOR PAH

Products Affected Adcirca

Revatio Sildenafil Citrate



Exclusion Criteria

Coverage not provided for patients currently receiving nitrate therapy


• Patient has a diagnosis of Pulmonary Arterial Hypertension (PAH) (WHO Group I) WHO/NYHA functional class II or III OR • Patient has a diagnosis of Pulmonary Arterial Hypertension (PAH) (WHO Group I) WHO/NYHA functional class IV and documentation that the patient refuses IV therapy, is not capable of managing the complex delivery system, or is intolerant to or has contraindications to IV prostanoid therapy (i.e. epoprostenol, treprostinil).




Coverage Duration

12 months

Other Criteria N/A


PEGADEMASE

Products Affected Adagen



Exclusion Criteria

N/A


Diagnosis



N/A

Coverage Duration

12 months

Other Criteria N/A


PEGFILGRASTIM

Products Affected Neulasta



Exclusion Criteria

N/A


• Patient has a non-myeloid malignancy and is receiving myelosuppressive therapy associated with a clinically significant incidence of febrile neutropenia



N/A

Coverage Duration

12 months

Other Criteria N/A


PEGINTERFERON ALFA-2A

Products Affected Pegasys

Pegasys Proclick INJ 135MCG/0.5ML



Exclusion Criteria

Coverage not provided for the following contraindication to therapy: Pregnancy


• Patient is receiving treatment for chronic hepatitis B AND • Patient is treatment naïve to pegylated interferon therapy OR • Patient is receiving treatment for chronic hepatitis C AND •Patient will be receiving combination therapy with ribavirin, unless ribavirin is contraindicated AND • HCV genotype and patient type (for patients with concurrent HCV protease inhibitor therapy) are documented AND • Patient is treatment naïve to pegylated interferon therapy OR • Patient has previously been treated with pegylated interferon monotherapy and had bridging fibrosis or cirrhosis OR • Patient has previously received treatment with non-pegylated interferon with or without ribavirin and was considered a non-responder or relapser OR • Patient has HCV genotype 1 and will be receiving concurrent therapy with an HCV protease inhibitor



N/A

Coverage Duration

48 weeks for hep B, 16 to 72 weeks for hep C

Other Criteria Coverage duration is dependent on genotype and HCV RNA response at specific timepoints based on FDA-approved labeling.


PEGINTERFERON ALFA-2B (PEG-INTRON)

Products Affected Peg-intron INJ 50MCG/0.5ML Peg-intron Redipen

Peg-intron Redipen Pak 4 INJ 120MCG/0.5ML, 150MCG/0.5ML, 80MCG/0.5ML



Exclusion Criteria

Coverage not provided for the following contraindication to therapy: Pregnancy


• Patient is receiving treatment for chronic hepatitis C AND • HCV genotype and patient type (for patients with concurrent HCV protease inhibitor therapy) are documented. AND • Patient is treatment naïve to pegylated interferon therapy OR • Patient has previously been treated with pegylated interferon monotherapy and had bridging fibrosis or cirrhosis OR • Patient has previously received treatment with non-pegylated interferon with or without ribavirin and was considered a non-responder or relapser OR • Patient has HCV genotype 1 and will be receiving concurrent therapy with an HCV protease inhibitor AND •Patient will be receiving combination therapy with ribavirin, unless ribavirin is contraindicated



N/A

Coverage Duration

Duration of approval 16 to 72 weeks

Other Criteria Coverage duration is dependent on genotype and HCV RNA response at specific timepoints based on FDA-approved labeling.


PEGINTERFERON ALFA-2B (SYLATRON)

Products Affected Sylatron



Exclusion Criteria

Coverage not provided for patients with autoimmune hepatitis or hepatic decompensation (Child-Pugh score greater than 6 [class B and C])


Patient is being treated adjuvantly for melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection including complete lymphadenectomy



N/A

Coverage Duration

12 months

Other Criteria N/A


PEGVISOMANT

Products Affected Somavert



Exclusion Criteria

N/A


• Patient has a diagnosis of acromegaly AND • Patient has had inadequate response to surgery and/or radiation therapy and/or other medical therapies (such as dopamine agonists [bromocriptine, cabergoline] and/or somatostatin analogues [octreotide, lanreotide]) or, for whom these therapies are not appropriate.



N/A

Coverage Duration

12 months

Other Criteria Renewal requires that patient has experienced an objective response to therapy (biochemical control, decrease or normalization of IGF-1 levels)


PLATELET INHIBITORS (HIGH RISK MEDICATIONS)

Products Affected Ticlopidine Hcl



Exclusion Criteria

N/A





N/A

Coverage Duration

12 months

Other Criteria N/A


PLERIXAFOR

Products Affected Mozobil



Exclusion Criteria

Coverage is not provided for patients who are pregnant or breastfeeding


• Patient is to undergo autologous stem cell transplantation for the treatment of non-Hodgkin’s lymphoma (NHL) or multiple myeloma (MM ) AND • Patient will concomitantly receive a daily dose of G-CSF (filgrastim) for 4 days prior to the first evening dose of plerixafor and on each day prior to apheresis



N/A

Coverage Duration

30 days

Other Criteria N/A


QUININE

Products Affected Qualaquin

Quinine Sulfate



Exclusion Criteria

Coverage is not provided for patients with any of the following contraindications to therapy: prolongation of QT interval, glucose-6-phosphate dehydrogenase (G6PD) deficiency, myasthenia gravis, Known hypersensitivity to quinine, mefloquine, or quinidine, or optic neuritis


• Patient is being treated for uncomplicated Plasmodium falciparum malaria OR • Patient is being treated for uncomplicated Plasmodium vivax malaria OR • Patient is being treated for babesiosis



N/A

Coverage Duration

1 month

Other Criteria N/A


ROFLUMILAST

Products Affected Daliresp



Exclusion Criteria

Coverage is not provided for the following contraindication to therapy: moderate to severe liver impairment (Child-Pugh B or C)


• Patient has a diagnosis of severe COPD (defined as FEV1 less than or equalt to 50% of predicted and FEV1/FVC less than 0.7) associated with chronic bronchitis AND • Patient has a history of COPD exacerbations which required the use of systemic corticosteroids AND • Roflumilast is being used as adjunctive therapy to bronchodilator treatment (i.e. anticholinergics in combination with long-acting beta2 agonists or inhaled corticosteroids, or inhaled corticosteroid long-acting beta2 agonist combinations) to reduce the risk of COPD exacerbations



N/A

Coverage Duration

12 months

Other Criteria N/A


RUXOLITINIB

Products Affected Jakafi



Exclusion Criteria

N/A


• Patient has a diagnosis of intermediate or high-risk primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis defined by two or more of the IWG-MRT IPSS or DIPSS-Plus Criteria (age greater than 65 years, hemoglobin less than 10 g/dL, white blood cell count greater than 25 x 109/L, peripheral blasts greater than or equal to 1%, constitutional symptoms, platelet count less than 100 x 109/L, red cell transfusion need, and unfavorable karyotype)



N/A

Coverage Duration

6 months intially, 12 months thereafter

Other Criteria Renewal after initial 6- months requires that the patient has experienced an objective response to therapy defined as: • 35% reduction in spleen volume from baseline as measured by CT or MRI or a 50% reduction in spleen size from baseline based on palpation OR • Greater than or equal to 50% reduction in Total Symptom Score from baseline as measured by the modified Myelofibrosis Symptom Assessment Form (MFSAF) Annual review thereafter requires that the patient maintain the above criteria.


SAPROPTERIN

Products Affected Kuvan



Exclusion Criteria

N/A


Therapeutic Trial (up to 2 months): • Patient has diagnosis of Phenylketonuria (PKU) AND • Patient is, and will be maintained during sapropterin therapy, on a phenylalanine-restricted diet AND • Patient will have blood PHE levels measured after 1 week of therapy and periodically for up to 2 months of therapy to determine response Continuation Therapy for Responders (after 2 months): • Patient has diagnosis of PKU AND • Patient has been determined to be a sapropterin responder (i.e., baseline PHE blood levels have decreased by greater than 30% from baseline level AND • Patient is, and will be maintained during sapropterin therapy, on a PHE-restricted diet AND • Patient will have blood PHE levels measured periodically during therapy



N/A

Coverage Duration

Initially approve new patient 2 mths. If responder, then approve 12 months.

Other Criteria N/A


SARGRAMOSTIM

Products Affected Leukine



Exclusion Criteria

N/A


• Patient has a diagnosis of acute myelogenous leukemia and has undergone induction chemotherapy OR • Leukine will be used for mobilization and following transplantation of autologous peripheral blood progenitor cells OR • Leukine will be used for myeloid reconstruction following autologous bone marrow transplantation OR • Leukine will be used for myeloid reconstruction following allogeneic bone marrow transplantation OR • Patient has undergone allogeneic or autologous bone marrow transplantation and engraftment is delayed or has failed



N/A

Coverage Duration

12 months

Other Criteria N/A


SEDATIVE HYPNOTICS (HIGH RISK MEDICATIONS)

Products Affected Zaleplon

Zolpidem Tartrate Zolpidem Tartrate Er



Exclusion Criteria

N/A





N/A

Coverage Duration

12 months

Other Criteria N/A


SELEGILINE TRANSDERMAL

Products Affected Emsam



Exclusion Criteria

Coverage not provided for patients using Emsam in conjunction with SSRIs, SNRIs, TCAs, bupropion, buspirone, meperidine, tramadol, methadone, pentazocine, dextromethorphan, St. John's Wort, mirtazaprine, cyclobenzaprine, oral selegiline, other MAOIs, oxcarbazepine, carbamazepine, and/or sympathomimetic amines.


• Patient has a diagnosis of major depressive disorder (MDD) AND • Patient has tried adequate treatment with at least TWO oral antidepressants from differing classes OR • Patient is unable to take any formulation of oral medication



N/A

Coverage Duration

12 months

Other Criteria N/A


SIMVASTATIN 80 MG

Products Affected Simvastatin TABS 80MG

Vytorin TABS 10MG; 80MG



Exclusion Criteria

N/A


• Patient has to have a history of use (of simvastatin 80 mg)



N/A

Coverage Duration

12 months

Other Criteria N/A


SKELETAL MUSCLE RELAXANTS (HIGH RISK

MEDICATIONS)

Products Affected Amrix Carisoprodol TABS 350MG Carisoprodol/aspirin Carisoprodol/aspirin/codeine Chlorzoxazone

Cyclobenzaprine Hcl ORAL TABS Methocarbamol Orphenadrine Citrate Orphenadrine Citrate Er Orphenadrine Compound Ds Orphenadrine/asa/caffeine



Exclusion Criteria

N/A





N/A

Coverage Duration

12 months

Other Criteria N/A


SODIUM OXYBATE

Products Affected Xyrem



Exclusion Criteria

Coverage is not provided for patients with succinic semialdehyde dehydrogenase deficiency or patients using concomitant treatment with sedative hypnotic agents


• Patient has a documented (i.e., multiple sleep latency test) diagnosis of narcolepsy with excessive daytime sleepiness, cataplexy, or both AND • For patients with a diagnosis of narcolepsy with excessive daytime sleepiness, patient has had a previous trial with or has a contraindication, intolerance, or allergy to modafinil (PROVIGIL) or armodafinil (NUVIGIL)

Age Restrictions Patients must be 16 years of age or older


N/A

Coverage Duration

12 months

Other Criteria N/A


SOMATOSTATINS

Products Affected Octreotide Acetate Sandostatin INJ 100MCG/ML,

500MCG/ML, 50MCG/ML

Sandostatin Lar Depot Somatuline Depot



Exclusion Criteria

N/A


Diagonsis



N/A

Coverage Duration

12 months

Other Criteria N/A


SORAFENIB

Products Affected Nexavar



Exclusion Criteria

Coverage not provided for patient with squamous cell lung cancer being treated with carboplatin and paclitaxel


• Patient has a diagnosis of advanced renal cell carcinoma OR • Patient has a diagnosis of unresectable hepatocellular carcinoma



N/A

Coverage Duration

12 months

Other Criteria N/A


STIVARGA

Products Affected Stivarga



Exclusion Criteria

N/A


Diagnosis of metastatic colorectal cancer AND patient was previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based therapy, an anti-vascular endothelial growth factor (VEGF) therapy, and if KRAS wild type, an anti-epidermal growth factor receptor (EGFR) therapy



N/A

Coverage Duration

12 months

Other Criteria hepatic function will be monitored and if patient develops elevated liver function tests or hepatocellular necrosis, Stivarga will be interrupted and the reduced or discontinued


SULFONYLUREAS (HIGH RISK MEDICATIONS)

Products Affected Chlorpropamide Glyburide

Glyburide Micronized Glyburide/metformin Hcl



Exclusion Criteria

N/A





N/A

Coverage Duration

12 months

Other Criteria N/A


SUNITINIB

Products Affected Sutent



Exclusion Criteria

N/A


• Patient has a diagnosis of advanced/metastatic renal cell carcinoma (RCC) OR • Treatment is for gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib (GLEEVEC) OR • Treatment is for progressive, well-differentiated pancreatic neuroendocrine tumor (pNET) in patients with unresectable locally advanced or metastatic disease



N/A

Coverage Duration

12 months

Other Criteria N/A


TADALAFIL (CIALIS)

Products Affected Cialis ORAL TABS 2.5MG, 5MG



Exclusion Criteria

Coverage is not provided for erectile dysfunction without signs and symptoms of BPH or concurrent use with nitrates.


• Tadalafil 2.5 mg or 5 mg is being requested AND • Patient has a diagnosis of benign prostatic hyperplasia (BPH) AND • Patient has experienced intolerance to or treatment failure with an alpha-blocker (e.g. doxazosin, prazosin, tamsulosin) or 5-alpha reductase inhibitors (e.g. dutasteride, finasteride)



N/A

Coverage Duration

12 months

Other Criteria N/A


TAZAROTENE

Products Affected Tazorac



Exclusion Criteria

N/A


• Patient has a diagnosis of acne vulgaris of mild to moderate severity AND • Patient has tried adequate treatment (at least 2 weeks) with at least one other topical acne product (e.g., benzoyl peroxide, salicylic acid, clindamycin, erythromycin, adapalene, azelaic acid, and/or tretinoin) OR • Patient has a diagnosis of stable moderate to severe plaque psoriasis (psoriasis vulgaris) and all of the following criteria are met: o Less than 20% body surface area involvement AND o Patient has a contraindication to or has tried adequate treatment (at least 2 weeks) with at least one other topical psoriasis product (e.g., medium to high potency corticosteroids and/or vitamin D analogs) AND • Female patients of child-bearing potential are utilizing adequate birth-control measures (pharmacological and/or barrier) during therapy OR • Female patients of child-bearing potential not utilizing adequate birth-control measures have a documented negative pregnancy test 2 weeks prior to initiation of tazarotene therapy

Age Restrictions Patient is 12 years of age or older for acne


N/A

Coverage Duration

12 months

Other Criteria N/A


TELAPREVIR

Products Affected Incivek



Exclusion Criteria

Coverage will not be provided if patient is pregnant or unwilling to comply with required contraception or coadministration with alfuzosin, carbamazepine, phenobarbital, phenytoin, rifampin, dihyroergotamine, ergonovine, ergotamine, methylergovovine, cisapride, St. John’s Wort, lovastatin, simvastatin, drosperinone, REVATIO (sildenafil) or ADCIRCA (tadalafil) (pulmonary arterial hypertension use), pimozide, triazolam, and midazolam (orally administered).


• Patient has a documented diagnosis of Chronic Hepatitis C Virus Genotype 1 with compensated liver disease AND • Patient is receiving concurrent therapy with ribavirin and PEG-INTRON (peginterferon alfa-2b) or PEGASYS (peginterferon alfa-2a) AND • Patient is treatment naïve to peginterferon alfa and ribavirin therapy OR • Patient has been previously treated with interferon based treatment and was considered a null responder, defined as less than 2-log10 reduction in HCV-RNA at week 12 of prior treatment with peginterferon alfa and ribavirin OR • Patient has been previously treated with interferon based treatment and was considered a partial responder, defined as a greather than or equal to 2-log10 reduction in HCV-RNA at week 12, but not achieving HCV RNA undetectable at end of treatment with peginterferon alfa and ribavirin OR •Patient has been previously treated with interferon based treatment and was considered a prior relapser, defined as HCV-RNA undetectable at end of treatment with a pegylated interferon-based regimen, but HCV-RNA detectable within 24 weeks of treatment follow up AND • Patient has not previously failed a regimen with an HCV protease inhibitor (INCIVEK or VICTRELIS)



N/A


Coverage Duration

Up to 12 weeks

Other Criteria Renewal criteria (for an additional 4 weeks of therapy, 12 weeks total): • HCV-RNA levels at week 4 are less than 1000 IU/mL • Patient is continuing on the same dose of INCIVEK • Patient is receiving concurrent therapy with peginterferon alfa and ribavirin


TELITHROMYCIN

Products Affected Ketek



Exclusion Criteria

Coverage not provided for contraindications to therapy: myasthenia gravis, previous history of hepatitis and/or jaundice associated with the use of telithromycin or any macrolide antibiotic, history of hypersensitivity to telithromycin and/or any components of KETEK tablets, or any macrolide antibiotic, concomitant administration with cisapride or pimozide, or concomitant administration with colchicine in patients with renal or hepatic impairment


• Patient is being treated for mild to moderate community-acquired pneumonia due to one of the following microorganisms: o Streptococcus pneumoniae (including multidrug resistant isolates [MDRSP†]) o Haemophilus influenza o Moraxella catarrhalis o Chlamydophila pneumoniae o Mycoplasma pneumoniae



N/A

Coverage Duration

14 days

Other Criteria N/A


TERIPARATIDE

Products Affected Forteo



Exclusion Criteria

N/A


• Patient has any of the following diagnoses: o Osteoporosis in a postmenopausal female OR o Primary or hypogonadal osteoporosis in a male OR o Osteoporosis associated with sustained systemic glucocorticoid therapy AND • Patient is considered at high-risk for fracture by meeting one or more of the following criteria: o History of osteoporotic fracture OR o Multiple risk factors for fracture OR o Documented trial and therapeutic failure of oral bisphosphonate, where therapeutic failure is defined as new fractures in compliant patients on therapy for at least 6 months, failure to produce a clinically significant change in a biochemical marker(s) of bone turnover, or significant loss of bone mineral density (BMD) on follow-up scans after 12-24 months of therapy OR o Documented contraindication, or is intolerant to oral bisphosphonate therapy.



N/A

Coverage Duration

12 months

Other Criteria N/A


TESAMORELIN

Products Affected Egrifta INJ 1MG



Exclusion Criteria

Coverage not provided for pregnant patients and patients with active malignancy (newly diagnosed or recurrent)


• Patient has a diagnosis of lipodystrophy secondary to HIV-infection AND • Patient has been receiving therapy with an antiretroviral agent AND • Patient meets the following gender-specific measurements: o Males: waist circumference greater than 37.4 inches AND waist-to-hip ratio is greater than 0.94 o Females: waist circumference greater than 37 inches AND waist-to-hip ratio is greater than 0.88



N/A

Coverage Duration

12 months

Other Criteria Renewal review: requires documentation that the patient has experienced a reduction from baseline in visceral adipose tissue as measured by waist circumference after treatment with tesamorelin therapy


TETRABENAZINE

Products Affected Xenazine



Exclusion Criteria

Coverage not provided for contraindications to therapy: actively suicidal, untreated or inadequately treated depression, impaired hepatic function, concomitant use of monoamine oxidase inhibitors, concomitant use of reserpine or within 20 days of discontinuing reserpine


• Patient is being treated for chorea associated with Huntington’s disease OR • Patient is being treated for tardive dyskinesia OR • Patient is being treated for Gilles de la Tourette’s syndrome AND • Any medication possibly contributing to the underlying symptoms of chorea and/or tardive dyskinesia has been discontinued (e.g. antipsychotics, metoclopramide, amphetamines, methylphenidate, dopamine agonists, etc.) unless cessation would be detrimental to the underlying condition AND • Patient will be routinely monitored for signs/symptoms of depression and suicidality during therapy and subsequent treatment initiated if/when necessary AND • For patients requiring doses greater than 50 mg per day, patient will be genotyped for CYP2D6 to determine whether they are poor metabolizers (PMs) [do not express CYP2D6] or extensive or intermediate metabolizers (Ems or Ims) [express CYP2D6]



N/A

Coverage Duration

12 months

Other Criteria N/A


THROMBOPOIETIN RECEPTOR AGONISTS

(ELTROMBOPAG)

Products Affected Promacta



Exclusion Criteria

N/A


• Patient has a diagnosis of relapsed/refractory chronic immune (idiopathic) thrombocytopenic purpura (ITP) for greater than 6 months AND • Patient’s baseline platelet count is less than 50,000/mcL AND • Patient’s degree of thrombocytopenia and clinical condition increase the risk of bleeding AND • Patient had an insufficient response, intolerance, or contraindication to corticosteroids, immune globulin OR • Patient had an inadequate response or contraindication to a splenectomy

Age Restrictions Patient is 18 years of age or older.


N/A

Coverage Duration

12 months

Other Criteria Renewal criteria: patient’s platelet count has increased to a level sufficient to avoid clinically important bleeding after at least 4 weeks of therapy at the maximum weekly dose (75 mg for eltrombopag)


THROMBOPOIETIN RECEPTOR AGONISTS

(ROMIPLOSTIM)

Products Affected Nplate



Exclusion Criteria

N/A


• Patient has a diagnosis of relapsed/refractory chronic immune (idiopathic) thrombocytopenic purpura (ITP) for greater than 6 months AND • Patient’s baseline platelet count is less than 50,000/mcL AND • Patient’s degree of thrombocytopenia and clinical condition increase the risk of bleeding AND • Patient had an insufficient response, intolerance, or contraindication to corticosteroids, immune globulin OR • Patient had an inadequate response or contraindication to a splenectomy

Age Restrictions Patient is 18 years of age or older.


N/A

Coverage Duration

12 months

Other Criteria Renewal criteria: patient’s platelet count has increased to a level sufficient to avoid clinically important bleeding after at least 4 weeks of therapy at the maximum weekly dose (10 mcg/kg)


TOCILIZUMAB

Products Affected Actemra INJ 200MG/10ML



Exclusion Criteria

N/A


• Patient has a diagnosis of moderate to severe rheumatoid arthritis AND • Patient has had inadequate response to, intolerance to, or contraindication to one or more non-biologic disease modifying anti-rheumatic drugs (DMARDs) for at least 3 consecutive months AND • Documented inadequate response to one or more TNF antagonist therapies (certolizumab [CIMZIA®], etanercept [ENBREL®], adalimumab [HUMIRA®], infliximab [REMICADE®], or golimumab [SIMPONI®]) OR • Diagnosis of systemic juvenile idiopathic arthritis AND • Patient has a documented inadequate response or intolerance to at least one oral systemic agent (i.e., NSAID, corticosteroid).

Age Restrictions Patient must be 18 years of age or older for RA or 2 years of age or older for JIA


N/A

Coverage Duration

12 months



TOPICAL RETINOID-TYPE PRODUCTS

Products Affected Adapalene Avita Differin Epiduo Retin-a

Retin-a Micro Tretinoin EXTERNAL CREA Tretinoin EXTERNAL GEL Tretin-x Ziana



Exclusion Criteria

N/A


• Patient has a diagnosis of mild to moderate acne vulgaris (including comedonal, cystic, and nodular) OR • Patient has a diagnosis of acne rosacea AND • atient has experienced treatment failure of or intolerance to sulfacetamide, metronidazole OR azelaic acid OR • Patient is receiving treatment for actinic keratoses (or solar keratoses) with multiple lesions on the face OR • Patient is receiving treatment for flat warts (verucca plana/juveniles) OR • Patient is receiving treatment for a hyperkeratosis disorder (i.e. epidermolytic hyperkeratosis, lenticularis perstans [Flegel’s disease], palmoplantar hyperatosis, keratosis follicularis [Darier’s disease]) OR • Patient has a diagnosis of ichthyosis (i.e. congenital, lamellar, vulgaris, or X-linked)

Age Restrictions Patients greater than 40 years of age to screen this age group for cosmetic use.


N/A

Coverage Duration

12 months


Other Criteria N/A


TREPROSTINIL

Products Affected Remodulin Tyvaso

Tyvaso Refill Tyvaso Starter



Exclusion Criteria

N/A






Coverage Duration

12 months

Other Criteria N/A


TRIPTORELIN

Products Affected Trelstar Depot Mixject

Trelstar La Mixject Trelstar Mixject



Exclusion Criteria

N/A





N/A

Coverage Duration

12 months

Other Criteria N/A


USTEKINUMAB

Products Affected Stelara



Exclusion Criteria

N/A


• Patient has a diagnosis of moderate to severe chronic plaque psoriasis (affecting more than 5% of body surface area (BSA) or affecting crucial body areas such as the hands, feet, face, or genitals) AND • Patient has had an inadequate response to, is intolerant to, or is contraindicated to conventional therapy with at least one of the following: o Phototherapy (including, but not limited to, Ultraviolet A with a psoralen [PUVA] and/or retinoids [RePUVA]) for at least one continuous month OR o One or more oral systemic treatments (i.e., methotrexate, cyclosporine, acitretin, sulfasalazine) for at least three consecutive months. AND • Patient has had an inadequate response to, is intolerant to, or is contraindicated to at least one of the following biologic agents: adalimumab [HUMIRA®], etanercept [ENBREL®], or infliximab [REMICADE®].



N/A

Coverage Duration

12 months

Other Criteria N/A


UTI ANTIBACTERIALS (HIGH RISK MEDICATIONS)

Products Affected Furadantin Macrodantin CAPS 25MG Nitrofurantoin

Nitrofurantoin Macrocrystalline CAPS 50MG

Nitrofurantoin Monohydrate



Exclusion Criteria

N/A





N/A

Coverage Duration

12 months

Other Criteria N/A


VANDETANIB

Products Affected Caprelsa



Exclusion Criteria

Coverage not provided for patients with congenital long QT syndrome


Patient has a diagnosis of symptomatic or progressive medullary thyroid cancer with unresectable locally advanced or metastatic disease.



N/A

Coverage Duration

12 months

Other Criteria N/A


VASODILATORS (HIGH RISK MEDICATIONS)

Products Affected Dipyridamole ORAL TABS



Exclusion Criteria

N/A





N/A

Coverage Duration

12 months

Other Criteria N/A


VELAGLUCERASE ALFA

Products Affected Vpriv



Exclusion Criteria

N/A


Diagnosis



N/A

Coverage Duration

12 months

Other Criteria N/A


VEMURAFENIB

Products Affected Zelboraf



Exclusion Criteria

N/A


• Patient has a diagnosis of unresectable or metastatic melanoma. AND • Patient has positive BRAF-V600E mutation documented by an FDA-approved test or Clinical Laboratory Improvement Amendments-approved facility.



N/A

Coverage Duration

12 months

Other Criteria N/A


VISMODEGIB

Products Affected Erivedge



Exclusion Criteria

N/A


• Patient has a diagnosis of metastatic basal cell carcinoma OR • Patient has locally advanced basal cell carcinoma AND • The following applies: o Patient experienced recurrence following surgery OR o Patient is not a candidate for surgery and radiation



N/A

Coverage Duration

12 months

Other Criteria Renewal criteria: • Patient has not had disease progression as defined by any of the following: o Greater than or equal to 20% increase in lesion size (sum of the longest diameter{SLD}) o New ulceration of target lesions persisting without evidence of healing for at least 2 weeks o New lesions by radiographic assessment or physical examination o Progression of non-target lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 • Patient is not experiencing unacceptable toxicity


VORINOSTAT

Products Affected Zolinza



Exclusion Criteria

N/A


Diagnosis



N/A

Coverage Duration

12 months

Other Criteria N/A


WAKE PROMOTING AGENTS

Products Affected Modafinil

Nuvigil Provigil



Exclusion Criteria

N/A


•Diagnosis of excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS) AND • There is documentation of the following: o Residual excessive daytime sleepiness associated with OSAHS despite optimal treatment with continuous positive airway pressure (CPAP) therapy AND oCompliance with CPAP or bilevel positive airway pressure (BiPAP) for at least 2 months. OR • Diagnosis of excessive sleepiness associated with narcolepsy AND • Patients had experienced treatment failure, intolerance, or contraindication to at least one other CNS stimulant, such as methylphenidate, mixed amphetamine salts, or dextroamphetamine OR • Diagnosis of excessive sleepiness associated with shift-work sleep disorder (SWSD) AND • Patient must meet all of the following criteria: o Sleep disturbance causes specific measurable functional impairment in social, occupational, or other important areas of functioning that has persisted at least 3 months AND o Non-pharmacologic therapies (e.g. planned sleep schedules and timed light exposure) have been inadequate in improving functional impairments.



N/A

Coverage Duration

12 months


Other Criteria N/A


XTANDI

Products Affected Xtandi



Exclusion Criteria

N/A


Diagnosis of metastatic prostate cancer AND patient is male AND patient received prior chemotherapy that containing docetaxel



N/A

Coverage Duration

12 months

Other Criteria N/A


ZOLEDRONIC ACID (RECLAST)

Products Affected Reclast



Exclusion Criteria

Coverage is not allowed if the patient has any of the followingt: creatinine clearance is less than 35 mL/min, hypocalcemia, hypersensitivity to zoledronic acid or any component of the product, currently receiving ZOMETA


• Patient is a postmenopausal female receiving RECLAST for the treatment or prevention of osteoporosis OR • Patient is male with a diagnosis of osteoporosis and is receiving treatment to increase bone mass OR • Patient is receiving RECLAST for the treatment and prevention of glucocorticoid-induced osteoporosis OR • Patient has a diagnosis of Paget’s disease of bone with any of the following: elevations in serum alkaline phosphatase of two times or higher than the upper limit of the age-specific normal reference range, symptomatic disease, or risk for complications from the disease AND • Patient has experienced treatment failure to oral bisphosphonates (treatment failure is defined as new fractures in compliant patients on therapy for at least 6 months, failure to produce a clinically significant change in a biochemical marker(s) of bone turnover, or significant loss of bone mineral density (BMD) on follow-up scans after 12 to 24 months of therapy) unless intolerant to or has a contraindication to an oral bisphosphonate.



N/A

Coverage Duration

12 months


ZOLEDRONIC ACID (ZOMETA)

Products Affected Zometa



Exclusion Criteria

Coverage is not allowed if the patient has any of the followingt: creatinine clearance is less than 35 mL/min, hypocalcemia, hypersensitivity to zoledronic acid or any component of the product, currently receiving RECLAST


• Diagnosis of one of the following: o Hypercalcemia of malignancy (HCM) OR o Bone metastases of solid tumors (i.e., breast cancer, prostate cancer) in conjunction with standard antineoplastic therapy. In patients with bone metastases associated with prostate cancer, zoledronic acid should be reserved for those with disease progression following at least one hormonal therapy (i.e., antiandrogen [bicalutamide, flutamide, nilutamide], LHRH agonist [leuprolide, goserelin], LHRH antagonists [degarelix]) OR o Multiple myeloma (MM) with associated bone disease [defined as bone metastases, osteolytic lesions, osteopenia, etc] AND • Zoledronic acid one-time dose does not exceed 4 mg AND • Patient is not being treated with RECLAST (zoledronic acid)



N/A

Coverage Duration

One-time dose for HCM, 12 months for other indications.

Other Criteria Retreatment of HCM may be considered upon request, at a minimum of 7 days after initial treatment, if serum calcium does not return to normal or remain at normal after initial treatment.

167

PART B VERSUS PART D

Products Affected Abraxane Acetylcysteine INHALATION SOLN Acyclovir Sodium INJ 500MG Adriamycin INJ 2MG/ML Albuterol Sulfate INHALATION

NEBU Alimta INJ 500MG Alkeran INJ Aloxi Amifostine Aminophylline Aminosyn Aminosyn II Aminosyn II 4.25/dextrose25% Aminosyn II 8.5%/electrolytes Aminosyn-hbc Aminosyn-hf Aminosyn-pf Aminosyn-pf 7% Amiodarone Hcl INJ 50MG/ML Amphotericin B Ampicillin Sodium INJ 10GM,

125MG, 1GM Ampicillin-sulbactam Anzemet ORAL TABS Aralast Np INJ 400MG Arranon Arzerra INJ 100MG/5ML Atgam Avastin INJ 100MG/4ML Avelox INJ Azactam In Iso-osmotic Dextrose Azasan Azathioprine Azathioprine Sodium Azithromycin INJ 500MG Bicnu Bleomycin Sulfate INJ 30UNIT Brovana

Budesonide INHALATION SUSP Busulfex Calcitriol INJ Calcitriol ORAL CAPS Calcitriol ORAL SOLN Campath Carboplatin INJ 150MG/15ML Carnitor INJ Carnitor ORAL SOLN Cefazolin Sodium INJ 10GM, 1GM,

1GM; 5%, 500MG Cefotaxime Sodium Cefoxitin Sodium INJ 10GM, 1GM,

2GM Ceftazidime INJ 1GM, 2GM, 6GM Ceftriaxone Sodium Cefuroxime Sodium INJ 1.5GM,

7.5GM, 750MG Cefuroxime/dextrose Cellcept Cellcept Intravenous Chlorothiazide Sodium Cipro I.v.-in D5w INJ

200MG/100ML; 5% Ciprofloxacin INJ 400MG/40ML Ciprofloxacin I.v.-in D5w Cisplatin INJ 100MG/100ML Cladribine Cleocin In D5w Clindamycin Phosphate Add-vantage Clinimix 2.75%/dextrose 5% Clinimix 4.25%/dextrose 10% Clinimix 4.25%/dextrose 20% Clinimix 4.25%/dextrose 25% Clinimix 4.25%/dextrose 5% Clinimix 5%/dextrose 15% Clinimix 5%/dextrose 20% Clinimix 5%/dextrose 25% Clinisol Sf 15% Clolar

168

Colistimethate Sodium Cosmegen Coumadin INJ Cromolyn Sodium NEBU Cubicin Cyclophosphamide ORAL TABS Cyclosporine Cyclosporine Modified Cytarabine INJ 500MG Cytarabine Aqueous Dacarbazine INJ 200MG Dacogen Dactinomycin Daunorubicin Hcl INJ 5MG/ML Daunoxome Dexrazoxane INJ 500MG Dextrose 10% Flex Container Dextrose 10%/nacl 0.2% Dextrose 10%/nacl 0.45% Dextrose 2.5%/sodium Chloride

0.45% Dextrose 5% Dextrose 5% /electrolyte #48 Viaflex Dextrose 5%/nacl 0.2% Dextrose 5%/nacl 0.225% Dextrose 5%/nacl 0.33% Dextrose 5%/nacl 0.45% Dextrose 5%/nacl 0.9% Dextrose 5%/potassium Chloride

0.15% Diltiazem Hcl INJ 100MG,

50MG/10ML Docefrez Docetaxel INJ 80MG/4ML,

80MG/8ML Doxil Doxorubicin Hcl INJ 2MG/ML Doxycycline Hyclate INJ Duramorph Elitek INJ 1.5MG Ellence INJ 200MG/100ML Eloxatin INJ 100MG/20ML Elspar Emend ORAL CAPS

Engerix-b INJ 10MCG/0.5ML, 10MCG/0.5ML, 20MCG/ML

Epirubicin Hcl INJ 50MG/25ML Eraxis INJ 100MG Erbitux INJ 100MG/50ML Erythrocin Lactobionate INJ 500MG Etopophos Etoposide INJ Famotidine INJ Famotidine Premixed Fluconazole In Dextrose INJ

56MG/ML; 400MG/200ML Fludarabine Phosphate INJ 50MG Fluorouracil INJ 2.5GM/50ML Fortaz INJ 1GM, 1GM/50ML; 5%,

2GM, 2GM/50ML; 5%, 6GM Foscarnet Sodium Freamine Hbc 6.9% Freamine III INJ 72MEQ/L;

600MG/100ML; 810MG/100ML; 3MEQ/L; 14MG/100ML; 1190MG/100ML; 240MG/100ML; 590MG/100ML; 770MG/100ML; 620MG/100ML; 450MG/100ML; 480MG/100ML; 10MMOLE/L; 115MG/100ML; 950MG/100ML; 500MG/100ML; 10MEQ/L; 340MG/100ML; 130MG/100ML; 560MG/100ML

Ganciclovir Gemcitabine Hcl INJ 1GM Gemzar INJ 1GM Gengraf Gentamicin Sulfate INJ Gentamicin Sulfate/0.9% Sodium

Chloride INJ 0.9MG/ML; 0.9%, 1.4MG/ML; 0.9%, 1.6MG/ML; 0.9%, 1MG/ML; 0.9%

Gentamicin Sulfate/sodium Chloride INJ 1.2MG/ML; 0.9%

Granisetron Hcl INJ 0.1MG/ML, 1MG/ML

Granisetron Hcl TABS Halaven Hecoria

169

Hectorol Heparin Sodium Heparin Sodium/d5w Hepatamine Hepatasol Herceptin Hycamtin INJ Idarubicin Hcl INJ 10MG/10ML Ifex INJ 3GM Ifosfamide INJ 1GM Ifosfamide/mesna Imipenem/cilastatin Imovax Rabies (h.d.c.v.) Intralipid Ionosol-b/dextrose 5% Ionosol-mb/dextrose 5% Ipratropium Bromide INHALATION

SOLN 0.02% Ipratropium Bromide/albuterol

Sulfate Irinotecan INJ 100MG/5ML Isolyte-h/dextrose 5% Isolyte-p/dextrose 5% Isolyte-s Isolyte-s/dextrose 5% Isotonic Gentamicin INJ 0.8MG/ML;

0.9% Istodax Ixempra Kit INJ 45MG Jevtana Kcl 0.075%/d5w/nacl 0.45% Kcl 0.15%/d5w/lr Kcl 0.15%/d5w/nacl 0.2% Kcl 0.15%/d5w/nacl 0.225% Kcl 0.15%/d5w/nacl 0.9% Kcl 0.3%/d5w/nacl 0.45% Kcl 0.3%/d5w/nacl 0.9% Kepivance Keppra INJ Labetalol Hcl INJ Lactated Ringers Viaflex Levalbuterol Levalbuterol Hcl Levaquin INJ 5%; 750MG/150ML

Levetiracetam INJ 500MG/5ML Levocarnitine Levofloxacin INJ Levofloxacin In D5w INJ 5%;

500MG/100ML Liothyronine Sodium INJ Lipodox Liposyn III INJ 1.2%; 2.5%; 10%,

1.8%; 2.5%; 30% Magnesium Sulfate In D5w INJ 5%;

10MG/ML Melphalan Hydrochloride Meropenem INJ 500MG Mesna Methotrexate Metoprolol Tartrate INJ Metronidazole In Nacl 0.79% Mitomycin INJ 20MG Mitoxantrone Hcl INJ 2MG/ML,

2MG/ML, 2MG/ML, 2MG/ML Morphine Sulfate INJ 0.5MG/ML,

1MG/ML Mustargen Mycophenolate Mofetil Myfortic Nafcillin Sodium INJ 10GM, 1GM Nallpen/dextrose Nebupent Neoral Nephramine Neutrexin Nexium I.v. Nipent Nitroglycerin INJ Normosol-r Normosol-r In D5w Nulojix Ondansetron Hcl INJ 4MG/2ML Ondansetron Hcl ORAL SOLN Ondansetron Hcl ORAL TABS Ondansetron Odt Ontak Oxaliplatin INJ 100MG/20ML Paclitaxel INJ 300MG/50ML

170

Pantoprazole Sodium INJ Penicillin G Potassium In Iso-osmotic

Dextrose INJ 0; 40000UNIT/ML, 0; 60000UNIT/ML

Pentostatin Perforomist Piperacillin Sodium/tazobactam

Sodium INJ 3GM; 0.375GM, 4GM; 0.5GM

Plasma-lyte A Plasma-lyte-148 Plasma-lyte-56/d5w Potassium Chloride INJ

0.4MEQ/ML, 10MEQ/100ML, 10MEQ/50ML, 2MEQ/ML, 30MEQ/100ML

Potassium Chloride 0.15% /nacl 0.45% Viaflex

Potassium Chloride 0.15% D5w/nacl 0.33%

Potassium Chloride 0.15% D5w/nacl 0.45% Viaflex

Potassium Chloride 0.15% Nacl 0.9% Potassium Chloride 0.22% D5w/nacl

0.45% Potassium Chloride 0.224%/dextrose

5% Viaflex Potassium Chloride 0.3%/ Nacl 0.9% Potassium Chloride 0.3%/d5w Premasol Prograf Prolastin INJ 500MG Prolastin-c Proleukin Propranolol Hcl INJ Protonix INJ Pulmicort SUSP 1MG/2ML Rabavert Rapamune Recombivax Hb INJ 10MCG/ML,

40MCG/ML Rifampin INJ Ringers Injection Rituxan

Sandimmune Simulect INJ 20MG Sodium Chloride INJ 0.9%,

2.5MEQ/ML, 3%, 5% Sodium Chloride 0.45% Viaflex Sodium Edecrin Sulfamethoxazole/trimethoprim INJ Tacrolimus Taxotere INJ 80MG/2ML,

80MG/4ML Tazicef INJ 1GM, 2GM, 6GM Teflaro Tetanus Toxoid Adsorbed Thiotepa Thymoglobulin Tobramycin Sulfate INJ 10MG/ML,

80MG/2ML Tobramycin Sulfate/sodium Chloride Toposar Topotecan Hcl INJ 4MG Torisel Torsemide INJ 20MG/2ML Tranexamic Acid INJ Travasol Treanda INJ 100MG Trexall Trisenox Trophamine Twinrix Tygacil Unasyn INJ 2GM; 1GM Valproate Sodium Vancomycin Hcl INJ 1000MG,

10GM, 500MG Vectibix INJ 100MG/5ML Velcade Verapamil Hcl INJ Vfend IV Vibativ INJ 250MG Vidaza Vimpat INJ Vinblastine Sulfate INJ 10MG Vincasar Pfs Vincristine Sulfate

171

Vinorelbine Tartrate INJ 50MG/5ML Virazole Voriconazole INJ Xopenex Zanosar Zantac INJ 50MG/50ML; 0.45% Zemplar Zinacef INJ 1.5GM, 750MG Zinacef In Iso-osmotic Dextrose

Zinacef In Iso-osmotic Diluent Zinecard INJ 250MG Zortress Zosyn INJ 3GM; 0.375GM, 5%;

2GM/50ML; 0.25GM/50ML, 5%; 3GM/50ML; 0.375GM/50ML

Zyvox INJ

Details This drug may be covered under Medicare Part B or D depending upon the circumstances. Information may need to be submitted describing the use and setting of the drug to make the determination.

172

INDEX

A

Abatacept ............................................................... 1 Abiraterone ............................................................ 2 Abraxane ........................................................... 167 Abstral ................................................................. 61 Acetylcysteine ................................................... 167 Actemra ............................................................. 148 Acthar Hp ............................................................ 73 Actiq .................................................................... 61 Activella ............................................................ 108 Acyclovir Sodium ............................................. 167 Adagen .............................................................. 115 Adalimumab .......................................................... 3 Adapalene .......................................................... 149 Adcirca .............................................................. 114 Adderall ............................................................... 21 Adderall Xr .......................................................... 21 Adriamycin ........................................................ 167 Afinitor ................................................................ 59 Agalsidase ............................................................. 6 Albuterol Sulfate ............................................... 167 Aldurazyme ......................................................... 91 Alglucosidase Alfa ................................................ 7 Alimta ................................................................ 167 Alkeran .............................................................. 167 Alora .................................................................. 108 Aloxi .................................................................. 167 Alprazolam .......................................................... 26 Alprazolam Er ..................................................... 26 Alprazolam Intensol ............................................ 26 Alprazolam Odt ................................................... 26 Alprazolam Xr ..................................................... 26 Ambrisentan .......................................................... 8 Amifostine ......................................................... 167 Aminophylline ................................................... 167 Aminosyn .......................................................... 167 Aminosyn II ...................................................... 167

Aminosyn II 4.25/dextrose25% ......................... 167 Aminosyn II 8.5%/electrolytes .......................... 167 Aminosyn-hbc .................................................... 167 Aminosyn-hf ...................................................... 167 Aminosyn-pf ...................................................... 167 Aminosyn-pf 7% ................................................ 167 Amiodarone Hcl ................................................. 167 Amitriptyline Hcl ................................................. 15 Amphetamine/dextroamphetamine ...................... 21 Amphotericin B .................................................. 167 Ampicillin Sodium ............................................. 167 Ampicillin-sulbactam ......................................... 167 Ampyra ................................................................ 43 Amrix ................................................................. 131 Anabolic Steroids (oxandrolone) ........................... 9 Anabolic Steroids (oxymetholone) ...................... 10 Anadrol-50 ........................................................... 10 Anakinra ............................................................... 11 Analgesics (high Risk Medications) .................... 12 Androderm ........................................................... 13 Androgens (high Risk Medications) .................... 14 Android ................................................................ 14 Antidepressants (high Risk Medications) ............ 15 Anti-emetics (high Risk Medications) ................. 16 Antihistamines (high Risk Medications) ............. 17 Antihypertensive (high Risk Medications) .......... 18 Antiparkinson (high Risk Medications) ............... 19 Anxiolytics (high Risk Medications) ................... 20 Anzemet ............................................................. 167 Aralast Np .......................................................... 167 Aranesp Albumin Free ......................................... 53 Arcalyst ................................................................ 88 Arranon .............................................................. 167 Arzerra ............................................................... 167 Atgam ................................................................. 167 Attention Deficit Hyperactivity Disorder Agents

(high Risk Medications) ................................... 21 Aubagio ................................................................ 22

173

Avastin .............................................................. 167 Avelox ............................................................... 167 Avita .................................................................. 149 Avonex ................................................................ 86 Axitinib ............................................................... 23 Azactam In Iso-osmotic Dextrose ..................... 167 Azasan ............................................................... 167 Azathioprine ...................................................... 167 Azathioprine Sodium......................................... 167 Azithromycin ..................................................... 167

B

Baraclude ............................................................. 74 Barbiturates ......................................................... 24 Becaplermin ........................................................ 25 Benzodiazepines .................................................. 26 Benztropine Mesylate .......................................... 19 Betaseron ............................................................. 86 Bexarotene ........................................................... 27 Bicnu ................................................................. 167 Bleomycin Sulfate ............................................. 167 Boceprevir ........................................................... 28 Boniva ................................................................. 76 Bosentan .............................................................. 30 Bosulif ................................................................. 31 Botox ................................................................. 105 Brovana ............................................................. 167 Budesonide ........................................................ 167 Buprenorphine ..................................................... 32 Buprenorphine Hcl .............................................. 32 Buprenorphine Patch ........................................... 33 Busulfan .............................................................. 34 Busulfex ............................................................ 167 Butisol Sodium .................................................... 24 Butrans ................................................................ 33

C

Calcipotriene And Betamethasone ...................... 35 Calcitriol ............................................................ 167 Calcium Channel Blockers, Dihydropyridine (high

Risk Medications) ........................................... 36

Campath ............................................................. 167 Cannabinoids (dronabinol) ................................... 37 Cannabinoids (nabilone) ...................................... 38 Caprelsa.............................................................. 155 Carbinoxamine Maleate ....................................... 17 Carboplatin ......................................................... 167 Carimune Nanofiltered ......................................... 81 Carisoprodol ....................................................... 131 Carisoprodol/aspirin ........................................... 131 Carisoprodol/aspirin/codeine ............................. 131 Carnitor .............................................................. 167 Cayston ................................................................ 42 Cefazolin Sodium............................................... 167 Cefotaxime Sodium ........................................... 167 Cefoxitin Sodium ............................................... 167 Ceftazidime ........................................................ 167 Ceftriaxone Sodium ........................................... 167 Cefuroxime Sodium ........................................... 167 Cefuroxime/dextrose .......................................... 167 Celebrex ............................................................... 39 Celecoxib ............................................................. 39 Cellcept .............................................................. 167 Cellcept Intravenous .......................................... 167 Cenestin.............................................................. 108 Cerezyme ............................................................. 80 Certolizumab ........................................................ 40 Cesamet ................................................................ 38 Chlordiazepoxide Hcl .......................................... 26 Chlordiazepoxide/amitriptyline ........................... 15 Chlorothiazide Sodium ...................................... 167 Chlorpropamide ................................................. 136 Chlorzoxazone ................................................... 131 Cialis .................................................................. 138 Cimzia .................................................................. 40 Cipro I.v.-in D5w ............................................... 167 Ciprofloxacin ..................................................... 167 Ciprofloxacin I.v.-in D5w .................................. 167 Cisplatin ............................................................. 167 Cladribine ........................................................... 167 Clemastine Fumarate ........................................... 17 Cleocin In D5w .................................................. 167

174

Climara Pro ....................................................... 108 Clindamycin Phosphate Add-vantage ............... 167 Clinimix 2.75%/dextrose 5% ............................ 167 Clinimix 4.25%/dextrose 10% .......................... 167 Clinimix 4.25%/dextrose 20% .......................... 167 Clinimix 4.25%/dextrose 25% .......................... 167 Clinimix 4.25%/dextrose 5% ............................ 167 Clinimix 5%/dextrose 15% ............................... 167 Clinimix 5%/dextrose 20% ............................... 167 Clinimix 5%/dextrose 25% ............................... 167 Clinisol Sf 15% ................................................. 167 Clolar ................................................................. 168 Clomipramine Hcl ............................................... 15 Clonazepam ......................................................... 26 Clonazepam Odt .................................................. 26 Clorazepate Dipotassium..................................... 26 Colistimethate Sodium ...................................... 168 Combipatch ....................................................... 108 Concerta .............................................................. 21 Copaxone ............................................................. 68 Cosmegen .......................................................... 168 Coumadin .......................................................... 168 Crizotinib ............................................................. 41 Cromolyn Sodium ............................................. 168 Cubicin .............................................................. 168 Cyclobenzaprine Hcl ......................................... 131 Cyclophosphamide ............................................ 168 Cyclosporine ..................................................... 168 Cyclosporine Modified ...................................... 168 Cyproheptadine Hcl............................................. 17 Cystic Fibrosis Respiratory Agents ..................... 42 Cytarabine ......................................................... 168 Cytarabine Aqueous .......................................... 168

D

Dacarbazine ....................................................... 168 Dacogen ............................................................. 168 Dactinomycin .................................................... 168 Dalfampridine...................................................... 43 Daliresp ............................................................. 124 Dasatinib.............................................................. 44

Daunorubicin Hcl ............................................... 168 Daunoxome ........................................................ 168 Daytrana ............................................................... 21 Deferiprone .......................................................... 45 Degarelix .............................................................. 46 Delestrogen ........................................................ 108 Denosumab (prolia) ............................................. 47 Denosumab (xgeva) ............................................. 49 Desoxyn ............................................................... 21 Dexmethylphenidate Hcl ..................................... 21 Dexrazoxane ...................................................... 168 Dextroamphetamine Sulfate ................................. 21 Dextroamphetamine Sulfate Er ............................ 21 Dextrose 10% Flex Container ............................ 168 Dextrose 10%/nacl 0.2% .................................... 168 Dextrose 10%/nacl 0.45% .................................. 168 Dextrose 2.5%/sodium Chloride 0.45% ............. 168 Dextrose 5% ....................................................... 168 Dextrose 5% /electrolyte #48 Viaflex ................ 168 Dextrose 5%/nacl 0.2% ...................................... 168 Dextrose 5%/nacl 0.225% .................................. 168 Dextrose 5%/nacl 0.33% .................................... 168 Dextrose 5%/nacl 0.45% .................................... 168 Dextrose 5%/nacl 0.9% ...................................... 168 Dextrose 5%/potassium Chloride 0.15% ........... 168 Diazepam ............................................................. 26 Diazepam Intensol ............................................... 26 Diclofenac Patch .................................................. 50 Dicyclomine Hcl .................................................. 67 Differin ............................................................... 149 Diltiazem Hcl ..................................................... 168 Diphenhydramine Hcl .......................................... 16 Diphenoxylate/atropine ........................................ 67 Dipyridamole ..................................................... 156 Divigel................................................................ 108 Docefrez ............................................................. 168 Docetaxel ........................................................... 168 Doxepin Hcl ......................................................... 15 Doxil .................................................................. 168 Doxorubicin Hcl................................................. 168 Doxycycline Hyclate .......................................... 168

175

Dronabinol ........................................................... 37 Duramorph ........................................................ 168

E

Egrifta ................................................................ 144 Eligard ................................................................. 93 Elitek ................................................................. 168 Ellence ............................................................... 168 Eloxatin ............................................................. 168 Elspar ................................................................. 168 Emend................................................................ 168 Emsam ............................................................... 129 Enbrel .................................................................. 57 Enbrel Sureclick .................................................. 57 Engerix-b ........................................................... 168 Enjuvia .............................................................. 108 Enoxaparin Sodium ............................................. 97 Epiduo ............................................................... 149 Epirubicin Hcl ................................................... 168 Epogen ................................................................. 55 Epoprostenol ....................................................... 51 Epoprostenol Sodium .......................................... 51 Eraxis ................................................................. 168 Erbitux ............................................................... 168 Erivedge ............................................................ 159 Erlotinib ............................................................... 52 Erythrocin Lactobionate .................................... 168 Erythropoiesis-stimulating Agents (darbepoetin) 53 Erythropoiesis-stimulating Agents (epoetin) ...... 55 Estazolam ............................................................ 26 Estradiol ............................................................ 108 Estradiol Valerate .............................................. 108 Estradiol/norethindrone Acetate ........................ 108 Estropipate ......................................................... 108 Etanercept ............................................................ 57 Etopophos .......................................................... 168 Etoposide ........................................................... 168 Everolimus .......................................................... 59 Exalgo.................................................................. 75

F

Fabrazyme .............................................................. 6 Famotidine ......................................................... 168 Famotidine Premixed ......................................... 168 Femhrt 1/5 .......................................................... 108 Femhrt Low Dose .............................................. 108 Fentanyl Citrate Oral Transmucosal .................... 61 Fentanyl, Short-acting .......................................... 61 Fentora ................................................................. 61 Ferriprox .............................................................. 45 Filgrastim ............................................................. 62 Fingolimod ........................................................... 63 Firmagon .............................................................. 46 Flector .................................................................. 50 Flolan ................................................................... 51 Fluconazole In Dextrose .................................... 168 Fludarabine Phosphate ....................................... 168 Fluorouracil ........................................................ 168 Flurazepam Hcl .................................................... 26 Focalin Xr ............................................................ 21 Fortaz ................................................................. 168 Forteo ................................................................. 143 Foscarnet Sodium............................................... 168 Fragmin ................................................................ 97 Freamine Hbc 6.9% ........................................... 168 Freamine III ....................................................... 168 Furadantin .......................................................... 154

G

Gabapentin (gralise) ............................................. 64 Gabapentin Enacarbil ........................................... 65 Galsulfase ............................................................. 66 Gammagard Liquid .............................................. 81 Gamunex-c ........................................................... 81 Ganciclovir ......................................................... 168 Gastrointestinal Agents (high Risk Medications) 67 Gemcitabine Hcl ................................................ 168 Gemzar ............................................................... 168 Gengraf .............................................................. 168 Genotropin ........................................................... 70 Genotropin Miniquick .......................................... 70

176

Gentamicin Sulfate ............................................ 168 Gentamicin Sulfate/0.9% Sodium Chloride ...... 168 Gentamicin Sulfate/sodium Chloride ................ 168 Gilenya ................................................................ 63 Glatiramer............................................................ 68 Gleevec ................................................................ 78 Glyburide ........................................................... 136 Glyburide Micronized ....................................... 136 Glyburide/metformin Hcl .................................. 136 Golimumab .......................................................... 69 Gralise ................................................................. 64 Granisetron Hcl ................................................. 168 Growth Hormone - Ghd & Growth Failure ......... 70 Growth Hormone (serostim) ............................... 71 Growth Hormone (zorbtive) ................................ 72 Guanfacine Hcl .................................................... 18

H

H.p. Acthar Gel ................................................... 73 Halaven.............................................................. 168 Hecoria .............................................................. 169 Hectorol ............................................................. 169 Heparin Sodium................................................. 169 Heparin Sodium/d5w......................................... 169 Hepatamine........................................................ 169 Hepatasol ........................................................... 169 Hepatitis B Agents .............................................. 74 Hepsera ................................................................ 74 Herceptin ........................................................... 169 Horizant ............................................................... 65 Humatrope ........................................................... 70 Humatrope Combo Pack ..................................... 70 Humira ................................................................... 3 Humira Pen-crohns Diseasestarter ........................ 3 Hycamtin ........................................................... 169 Hydromorphone .................................................. 75 Hydroxyzine Hcl ................................................. 16 Hydroxyzine Pamoate ......................................... 16

I

Ibandronate .......................................................... 76

Idarubicin Hcl .................................................... 169 Ifex ..................................................................... 169 Ifosfamide .......................................................... 169 Ifosfamide/mesna ............................................... 169 Ilaris ..................................................................... 87 Iloprost ................................................................. 77 Imatinib ................................................................ 78 Imiglucerase ......................................................... 80 Imipenem/cilastatin ............................................ 169 Imipramine Hcl .................................................... 15 Imipramine Pamoate ............................................ 15 Immune Globulin ................................................. 81 Imovax Rabies (h.d.c.v.) .................................... 169 Incivek................................................................ 140 Incobotulinumtoxina ............................................ 82 Increlex ................................................................ 98 Infergen ................................................................ 85 Infliximab ............................................................. 83 Inlyta .................................................................... 23 Interferon Alfacon ................................................ 85 Interferons (multiple Sclerosis) ............................ 86 Interleukin Blockers (canakinumab) .................... 87 Interleukin Blockers (rilonacept) ......................... 88 Intralipid ............................................................. 169 Ionosol-b/dextrose 5% ....................................... 169 Ionosol-mb/dextrose 5% .................................... 169 Ipratropium Bromide ......................................... 169 Ipratropium Bromide/albuterol Sulfate .............. 169 Irinotecan ........................................................... 169 Isolyte-h/dextrose 5% ........................................ 169 Isolyte-p/dextrose 5% ........................................ 169 Isolyte-s .............................................................. 169 Isolyte-s/dextrose 5% ......................................... 169 Isotonic Gentamicin ........................................... 169 Istodax ................................................................ 169 Ivacaftor ............................................................... 89 Ixempra Kit ........................................................ 169

J

Jakafi .................................................................. 125 Jevtana................................................................ 169

177

Jinteli ................................................................. 108

K

Kalydeco.............................................................. 89 Kcl 0.075%/d5w/nacl 0.45% ............................. 169 Kcl 0.15%/d5w/lr .............................................. 169 Kcl 0.15%/d5w/nacl 0.2% ................................. 169 Kcl 0.15%/d5w/nacl 0.225% ............................. 169 Kcl 0.15%/d5w/nacl 0.9% ................................. 169 Kcl 0.3%/d5w/nacl 0.45% ................................. 169 Kcl 0.3%/d5w/nacl 0.9% ................................... 169 Kepivance .......................................................... 169 Keppra ............................................................... 169 Ketek ................................................................. 142 Kineret ................................................................. 11 Klonopin .............................................................. 26 Kuvan ................................................................ 126

L

Labetalol Hcl ..................................................... 169 Lactated Ringers Viaflex ................................... 169 Lapatinib.............................................................. 90 Laronidase ........................................................... 91 Lenalidomide ....................................................... 92 Letairis ................................................................... 8 Leukine .............................................................. 127 Leuprolide (eligard)............................................. 93 Leuprolide (lupron) ............................................. 94 Leuprolide Acetate .............................................. 94 Levalbuterol ...................................................... 169 Levalbuterol Hcl ................................................ 169 Levaquin ............................................................ 169 Levetiracetam .................................................... 169 Levocarnitine ..................................................... 169 Levofloxacin...................................................... 169 Levofloxacin In D5w ........................................ 169 Linzess ................................................................. 96 Liothyronine Sodium......................................... 169 Lipodox ............................................................. 169 Liposyn III ......................................................... 169 Lonox .................................................................. 67

Lorazepam ............................................................ 26 Lorazepam Intensol .............................................. 26 Lovenox ............................................................... 97 Low Molecular Weight Heparin And Related

Products............................................................ 97 Lumizyme .............................................................. 7 Lupron Depot ....................................................... 94 Lupron Depot-ped ................................................ 94

M

Macrodantin ....................................................... 154 Magnesium Sulfate In D5w ............................... 169 Marinol ................................................................. 37 Mecasermin .......................................................... 98 Megace Es .......................................................... 107 Megestrol Acetate .............................................. 107 Melphalan Hydrochloride .................................. 169 Menest ................................................................ 108 Menostar ............................................................ 108 Meperidine Hcl .................................................... 12 Meperitab ............................................................. 12 Meprobamate ....................................................... 20 Meropenem ........................................................ 169 Mesna ................................................................. 169 Metadate CD ........................................................ 21 Metadate Er .......................................................... 21 Methamphetamine Hcl ......................................... 21 Methitest .............................................................. 14 Methocarbamol .................................................. 131 Methotrexate ...................................................... 169 Methylin ............................................................... 21 Methylnaltrexone ................................................. 99 Methylphenidate Hcl ............................................ 21 Methylphenidate Hcl CD ..................................... 21 Methylphenidate Hcl Er ....................................... 21 Methylphenidate Hydrochloride .......................... 21 Metoclopramide Hcl ............................................ 16 Metoprolol Tartrate ............................................ 169 Metronidazole In Nacl 0.79% ............................ 169 Miglustat ............................................................ 100 Milnacipran ........................................................ 101

178

Mitomycin ......................................................... 169 Mitoxantrone Hcl .............................................. 169 Modafinil ........................................................... 161 Morphine Sulfate ............................................... 169 Motofen ............................................................... 67 Mozobil ............................................................. 122 Mustargen .......................................................... 169 Mycophenolate Mofetil ..................................... 169 Myfortic ............................................................. 169 Myleran ............................................................... 34 Myozyme ............................................................... 7

N

Nafcillin Sodium ............................................... 169 Naglazyme ........................................................... 66 Nallpen/dextrose................................................ 169 Natalizumab ...................................................... 102 Nebupent ........................................................... 169 Neoral ................................................................ 169 Nephramine ....................................................... 169 Neulasta ............................................................. 116 Neupogen ............................................................ 62 Neutrexin ........................................................... 169 Nexavar ............................................................. 134 Nexium I.v. ........................................................ 169 Nifedipine ............................................................ 36 Nilotinib ............................................................ 103 Nipent ................................................................ 169 Niravam ............................................................... 26 Nitrofurantoin .................................................... 154 Nitrofurantoin Macrocrystalline ........................ 154 Nitrofurantoin Monohydrate ............................. 154 Nitroglycerin ..................................................... 169 Norditropin Flexpro............................................. 70 Norditropin Nordiflex Pen .................................. 70 Normosol-r ........................................................ 169 Normosol-r In D5w ........................................... 169 Nplate ................................................................ 147 Nulojix ............................................................... 169 Nutropin .............................................................. 70 Nutropin Aq ........................................................ 70

Nutropin Aq Pen .................................................. 70 Nuvigil ............................................................... 161

O

Octreotide Acetate ............................................. 133 Omalizumab ....................................................... 104 Omnitrope ............................................................ 70 Onabotulinumtoxina .......................................... 105 Oncology (high Risk Medications) .................... 107 Ondansetron Hcl ................................................ 169 Ondansetron Odt ................................................ 169 Onfi ...................................................................... 26 Onsolis ................................................................. 61 Ontak .................................................................. 169 Oral Estrogens And Progestins (high Risk

Medications) .................................................. 108 Orencia ................................................................... 1 Orlistat................................................................ 110 Orphenadrine Citrate .......................................... 131 Orphenadrine Citrate Er ..................................... 131 Orphenadrine Compound Ds ............................. 131 Orphenadrine/asa/caffeine ................................. 131 Oxaliplatin.......................................................... 169 Oxandrin ................................................................ 9 Oxandrolone ........................................................... 9 Oxazepam ............................................................ 26

P

Paclitaxel ............................................................ 170 Palgic.................................................................... 17 Palivizumab........................................................ 111 Pantoprazole Sodium ......................................... 170 Part B Versus Part D .......................................... 167 Pazopanib ........................................................... 113 Pde-5 Inhibitors For Pah .................................... 114 Pegademase ........................................................ 115 Pegasys ............................................................... 117 Pegasys Proclick ................................................ 117 Pegfilgrastim ...................................................... 116 Peginterferon Alfa-2a ......................................... 117 Peginterferon Alfa-2b (peg-intron) .................... 118

179

Peginterferon Alfa-2b (sylatron) ....................... 119 Peg-intron .......................................................... 118 Peg-intron Redipen ............................................ 118 Peg-intron Redipen Pak 4 .................................. 118 Pegvisomant ...................................................... 120 Penicillin G Potassium In Iso-osmotic Dextrose

....................................................................... 170 Pentazocine/acetaminophen ................................ 12 Pentazocine/naloxone Hcl ................................... 12 Pentostatin ......................................................... 170 Perforomist ........................................................ 170 Perphenazine/amitriptyline.................................. 15 Phenadoz ............................................................. 16 Piperacillin Sodium/tazobactam Sodium .......... 170 Plasma-lyte A .................................................... 170 Plasma-lyte-148 ................................................. 170 Plasma-lyte-56/d5w ........................................... 170 Platelet Inhibitors (high Risk Medications) ...... 121 Plerixafor ........................................................... 122 Potassium Chloride ........................................... 170 Potassium Chloride 0.15% /nacl 0.45% Viaflex 170 Potassium Chloride 0.15% D5w/nacl 0.33% .... 170 Potassium Chloride 0.15% D5w/nacl 0.45%

Viaflex ........................................................... 170 Potassium Chloride 0.15% Nacl 0.9% .............. 170 Potassium Chloride 0.22% D5w/nacl 0.45% .... 170 Potassium Chloride 0.224%/dextrose 5% Viaflex

....................................................................... 170 Potassium Chloride 0.3%/ Nacl 0.9% ............... 170 Potassium Chloride 0.3%/d5w .......................... 170 Prefest ................................................................ 108 Premarin ............................................................ 108 Premasol ............................................................ 170 Premphase ......................................................... 108 Prempro ............................................................. 108 Privigen ............................................................... 81 Procrit .................................................................. 55 Prograf ............................................................... 170 Prolastin ............................................................. 170 Prolastin-c.......................................................... 170 Proleukin ........................................................... 170

Prolia .................................................................... 47 Promacta ............................................................ 146 Promethazine Hcl ................................................. 16 Promethazine Vc .................................................. 17 Promethegan ........................................................ 16 Propantheline Bromide ........................................ 67 Propranolol Hcl .................................................. 170 Protonix .............................................................. 170 Provigil ............................................................... 161 Pulmicort ............................................................ 170 Pulmozyme .......................................................... 42

Q

Qualaquin ........................................................... 123 Quinine ............................................................... 123 Quinine Sulfate .................................................. 123

R

Rabavert ............................................................. 170 Rapamune .......................................................... 170 Rebif ..................................................................... 86 Rebif Titration Pack ............................................. 86 Reclast ................................................................ 164 Recombivax Hb ................................................. 170 Regranex .............................................................. 25 Relistor ................................................................. 99 Remicade.............................................................. 83 Remodulin .......................................................... 151 Reserpine.............................................................. 18 Retin-a ................................................................ 149 Retin-a Micro ..................................................... 149 Revatio ............................................................... 114 Revlimid ............................................................... 92 Rifampin ............................................................ 170 Ringers Injection ................................................ 170 Ritalin ................................................................... 21 Ritalin La ............................................................. 21 Ritalin Sr .............................................................. 21 Rituxan ............................................................... 170 Roflumilast ......................................................... 124 Ruxolitinib ......................................................... 125

180

S

Saizen .................................................................. 70 Saizen Click.easy ................................................ 70 Sandimmune ...................................................... 170 Sandostatin ........................................................ 133 Sandostatin Lar Depot ....................................... 133 Sapropterin ........................................................ 126 Sargramostim .................................................... 127 Savella ............................................................... 101 Savella Titration Pack ....................................... 101 Sedative Hypnotics (high Risk Medications) .... 128 Selegiline Transdermal ...................................... 129 Serostim ............................................................... 71 Sildenafil Citrate ............................................... 114 Simponi ............................................................... 69 Simulect ............................................................. 170 Simvastatin ........................................................ 130 Simvastatin 80 Mg ............................................ 130 Skeletal Muscle Relaxants (high Risk

Medications) .................................................. 131 Sodium Chloride ............................................... 170 Sodium Chloride 0.45% Viaflex ....................... 170 Sodium Edecrin ................................................. 170 Sodium Oxybate ................................................ 132 Somatostatins .................................................... 133 Somatuline Depot .............................................. 133 Somavert............................................................ 120 Sorafenib ........................................................... 134 Sprycel ................................................................. 44 Stelara ................................................................ 153 Stivarga.............................................................. 135 Suboxone ....................................................... 32, 33 Subsys ................................................................. 61 Sulfamethoxazole/trimethoprim ........................ 170 Sulfonylureas (high Risk Medications) ............. 136 Sunitinib ............................................................ 137 Sutent ................................................................. 137 Sylatron ............................................................. 119 Synagis .............................................................. 111

T

Taclonex ............................................................... 35 Tacrolimus ......................................................... 170 Tadalafil (cialis) ................................................. 138 Talwin .................................................................. 12 Tarceva ................................................................. 52 Targretin ............................................................... 27 Tasigna ............................................................... 103 Taxotere ............................................................. 170 Tazarotene .......................................................... 139 Tazicef ................................................................ 170 Tazorac ............................................................... 139 Teflaro ................................................................ 170 Telaprevir ........................................................... 140 Telithromycin ..................................................... 142 Temazepam .......................................................... 26 Teriparatide ........................................................ 143 Tesamorelin........................................................ 144 Testred.................................................................. 14 Tetanus Toxoid Adsorbed .................................. 170 Tetrabenazine ..................................................... 145 Tev-tropin ............................................................ 70 Thiotepa ............................................................. 170 Thrombopoietin Receptor Agonists (eltrombopag)

........................................................................ 146 Thrombopoietin Receptor Agonists (romiplostim)

........................................................................ 147 Thymoglobulin ................................................... 170 Ticlopidine Hcl .................................................. 121 Tigan .................................................................... 16 Tobi ...................................................................... 42 Tobramycin Sulfate ............................................ 170 Tobramycin Sulfate/sodium Chloride ................ 170 Tocilizumab ....................................................... 148 Topical Retinoid-type Products ......................... 149 Toposar .............................................................. 170 Topotecan Hcl .................................................... 170 Torisel ................................................................ 170 Torsemide .......................................................... 170 Tracleer ................................................................ 30

181

Tranexamic Acid ............................................... 170 Travasol ............................................................. 170 Treanda .............................................................. 170 Trelstar Depot Mixject ...................................... 152 Trelstar La Mixject ............................................ 152 Trelstar Mixject ................................................. 152 Treprostinil ........................................................ 151 Tretinoin ............................................................ 149 Tretin-x .............................................................. 149 Trexall ............................................................... 170 Triazolam ............................................................ 26 Trihexyphenidyl Hcl ........................................... 19 Trimethobenzamide Hcl ...................................... 16 Trimipramine Maleate ......................................... 15 Triptorelin.......................................................... 152 Trisenox ............................................................. 170 Trophamine ....................................................... 170 Twinrix .............................................................. 170 Tygacil ............................................................... 170 Tykerb ................................................................. 90 Tysabri ............................................................... 102 Tyvaso ............................................................... 151 Tyvaso Refill ..................................................... 151 Tyvaso Starter ................................................... 151 Tyzeka ................................................................. 74

U

Unasyn ............................................................... 170 Ustekinumab...................................................... 153 Uti Antibacterials (high Risk Medications) ...... 154

V

Valproate Sodium .............................................. 170 Vancomycin Hcl ................................................ 170 Vandetanib ........................................................ 155 Vasodilators (high Risk Medications) ............... 156 Vectibix ............................................................. 170 Velaglucerase Alfa ............................................ 157 Velcade .............................................................. 170 Veletri .................................................................. 51 Vemurafenib ...................................................... 158

Ventavis ............................................................... 77 Verapamil Hcl .................................................... 170 Vfend IV ............................................................ 170 Vibativ................................................................ 170 Victrelis ................................................................ 28 Vidaza ................................................................ 170 Vimpat................................................................ 170 Vinblastine Sulfate ............................................. 170 Vincasar Pfs ....................................................... 170 Vincristine Sulfate ............................................. 171 Vinorelbine Tartrate ........................................... 171 Virazole .............................................................. 171 Vismodegib ........................................................ 159 Vivelle-dot ......................................................... 108 Voriconazole ...................................................... 171 Vorinostat ........................................................... 160 Votrient .............................................................. 113 Vpriv .................................................................. 157 Vytorin ............................................................... 130 Vyvanse................................................................ 21

W

Wake Promoting Agents .................................... 161

X

Xalkori ................................................................. 41 Xanax ................................................................... 26 Xanax Xr .............................................................. 26 Xenazine ............................................................ 145 Xenical ............................................................... 110 Xeomin ................................................................. 82 Xgeva ................................................................... 49 Xolair ................................................................. 104 Xopenex ............................................................. 171 Xtandi ................................................................. 163 Xyrem ................................................................ 132

Z

Zaleplon ............................................................. 128 Zanosar ............................................................... 171 Zantac ................................................................. 171 Zavesca .............................................................. 100

182

Zelboraf ............................................................. 158 Zemplar ............................................................. 171 Ziana .................................................................. 149 Zinacef ............................................................... 171 Zinacef In Iso-osmotic Dextrose ....................... 171 Zinacef In Iso-osmotic Diluent ......................... 171 Zinecard ............................................................. 171 Zoledronic Acid (reclast) .................................. 164 Zoledronic Acid (zometa) ................................. 166

Zolinza ............................................................... 160 Zolpidem Tartrate .............................................. 128 Zolpidem Tartrate Er .......................................... 128 Zometa ............................................................... 166 Zorbtive ................................................................ 72 Zortress .............................................................. 171 Zosyn.................................................................. 171 Zytiga ..................................................................... 2 Zyvox ................................................................. 171

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