idaho medicaid drug utilization review program
DESCRIPTION
Idaho Medicaid Drug Utilization Review Program . 17 January 2013. Follow-up to Previous Reviews. Immune Globulin (IV and SC) Atopic Dermatitis. Immune Globulin (IV and SC). Additional Responses to DUR letters sent in August 2012 - PowerPoint PPT PresentationTRANSCRIPT
Idaho Medicaid Drug Utilization Review Program
17 January 2013
1
Follow-up to Previous ReviewsImmune Globulin (IV and SC)Atopic Dermatitis
2
Immune Globulin (IV and SC)Additional Responses to DUR letters sent in
August 2012One doctor’s office had charged Idaho Medicaid for
immune globulin (brand name Privigen) 500mg as a single dose for four separate patients.
Patients had actually received promethazine 50mg injectable.
Doctor’s office has been asked to correct billing error
3
Immune Globulin (IV and SC)Additional Responses to DUR letters sent in
August 2012Adult male patient receiving immune globulin
1000mg/kg monthly for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). This patient is also a poorly controlled diabetic patient who has gained more than 100 pounds over the past year, resulting in significantly higher dosages. Standard of care is to use either ideal body weight or adjusted body weight (defined as ideal body weight plus 50% of the difference between actual and ideal body weight) in obese patients. Dose for December 2012 was reduced from 128gm ($14,930) to 100gm ($11,664). In addition, early refill request for patient convenience was denied for December 2012.
4
Immune Globulin (IV and SC)Additional Responses to DUR letters sent in
August 2012Pregnant woman whose first child died secondary
to congenital hemochromatosis (2008). Second child survived (2010) – mother had been treated with IVIG weekly from Weeks 14-37. Third pregnancy (due date February 2013) – mother is being treated with IVIG weekly starting at week 14 (September 2012). Have approved IVIG to continue throughout this third pregnancy.
5
Immune Globulin (IV and SC)Recommendations from October 2012 DUR
meeting1. Require prior authorization for this expensive
therapy both on the Medical side and the Pharmacy side.
2. Check for a FDA approved diagnosis and verify clinical benefits as well as monitor periodic IgG levels (if applicable to diagnosis, such as hypogammaglobulinemia).
3. Initially approve for 3-6 months with additional documentation required after that time period to renew the authorization.
4. Implementation date of 01/01/2013 6
Immune Globulin (IV and SC) Medical Claims
Claims paid on medical side between 8/01/2011 and 7/31/2012$288,410116 claims24 patientsAverage cost per prescription: $2486
7
Immune Globulin (IV and SC) Medical Claims
Requiring prior authorization for applicable J-codes effective 01/01/2013.
Notification of new prior authorization requirements published in Medic Aide
Pharmacy Unit will be processing these prior authorization requests.
8
Immune Globulin (IV and SC)Pharmacy Claims
Reviewing outpatient prescription claims between 8/01/2011 and 7/31/2012$279,52779 claims14 patientsAverage cost per prescription: $3538
9
Immune Globulin (IV and SC)Pharmacy Claims
Requiring prior authorization effective 01/01/2013 .
Notification letter sent out to current prescribers and pharmacies of patients receiving immune globulin between September – November 2012(letters sent second week of December) and to new patients receiving immune globulin in December 2012 (letters sent early January 2013).
10
Immune Globulin (IV and SC)Reference:
Intravenous Immune Globulin in Autoimmune and Inflammatory Disease. NEJM 2012;367:2015-25.
Review article in NEJM published in November 2012.
Medicare or a commercial insurer has approved reimbursement for such therapy [autoimmune conditions], often conditionally, requiring documentation of contraindications to or a lack of response to conventional therapies. 11
Atopic DermatitisThe P&T Committee requested a DUR on this drug
class to include patterns of use, presence or absence of step up therapy from steroids, specialty of prescribers and geographic region differences of prescribing patterns. The DUR should include an educational piece on risks of these agents compared to risks from steroids since many practitioners seem to be using these agents to spare patients from steroid exposure.
DUR completed April 2012 and it was felt that the medications were being used appropriately based on the data presented and these findings were presented to the P&T Committee.
12
Atopic DermatitisTreatment
Emollients are considered mainstay of maintenance therapy
Topical corticosteroids are the standard of care to which other treatments are compared and are considered first-line treatments for flare-ups. Local side effects include striae, atrophy, and telangiectasia. Systemic side effects including hypothalamic-pituitary-
adrenal axis suppression, reduced linear growth in children, and bone density changes in adults are the most worrisome. There is no conclusive evidence that appropriately used topical steroids cause significant systemic adverse effects.
Topical corticosteroids should be used for the shortest duration possible to control the flare-up.
13
Atopic DermatitisTreatment
Sedating antihistamines are useful when patients have sleep disturbances and concomitant allergic conditions.
Antibiotics should be reserved for patients with acutely infected lesions.
Topical calcineurin inhibitors should be second-line treatment for flare-ups and maintenance. Local side effects include skin burning and irritation.
Patients should also be counseled on proper sun protection. Black Box Warning – discussed on next slide
14
Atopic Dermatitis
15
Atopic DermatitisIn March 2010, the FDA issued a public health
advisory about the potential cancer risk associated with the use of Elidel (pimecrolimus) and Protopic (tacrolimus) products applied to the skin.This was based off of information from animal studies,
case reports in a small amount of patients, and how the drugs work. The FDA recommends that healthcare providers, patients,
and caregivers consider the following: Use these products only as second-line agents as short
term and intermittent treatment. Avoid the use in children under the age of 2. Use for a short period of time, not continuously. Children and adults with a weakened or compromised
immune system should not use these products. Use the minimum amount of the products needed to
control the patient’s symptoms. 16
Atopic DermatitisReferences
Hanifin, J.M., Cooper, K.D., Ho, V.C., Kang, S., et al. Guidelines of care for atopic dermatitis. Journal of the American Academy of Dermatology. 2004;50:391-404.
Peterson, J.D., Chan, L.S., A Comprehensive Management Guide for Atopic Dermatitis. Dermatology Nursing. 2006;18(6):531-542.
Buys, L.M., Treatment Options for Atopic Dermatitis. Am Fam Physician. 2007;Feb 15;75(4):523-528.
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm153525.htm. Retrieved March 16, 2012.
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm153941.htm. Retrieved March 16, 2012.
Elidel [package insert]. East Hanover, NJ; Novartis Pharmaceuticals Corp.; July 2010.
Protopic [package insert]. Deerfield, IL; Astellas Pharma US, Inc.; November 2011.
17
Atopic Dermatitis
18
The P&T Committee asked at their October 2012 meeting for the DUR Board to look at how frequently these medications were being filled.
A review of paid claims between 10/01/2011 and 10/01/2012 was done.
Atopic Dermatitis
19
Series10
100
200
300 293
8123 12 7 7 2 3 4 1 3
Paid claims between 10/01/2011 and 10/01/2012
1 2 3 4 5 6 7 8 9 10 11
# of claims
# o
f pat
ient
s –
both
Pr
otop
ic a
nd E
lidel
Atopic Dermatitis
20
Protopic Elidel0
50100150200250
87
216
30 506 162 103 33 40 22 12 21 00 3
Paid claims between 10/01/2011 and 10/01/2012
1 2 3 4 5 6 7 8 9 10 11
# of claims
# o
f pat
ient
s
Atopic Dermatitis
21
# of claims Age-both Age-Protopic Age-Elidel1 11.58 ± 10.62 11.97 ± 12.23 11.09 ± 9.792 13.20 ± 15.56 19.79 ± 20.96 10.51 ± 11.773 10.65 ± 7.91 14.50 ± 13.70 13.06 ± 11.914 15.33 ± 15.09 4.00 ± 2.83 17.60 ± 15.595 to 11 20.48 ± 20.31 18.36 ± 19.07 19.87 ± 20.66
Atopic Dermatitis
22
1 2 3 4 5 to 110
5
10
15
20
25
Both Protopic Elidel
# of claims
Ave
rage
Age
of P
atie
nt
Atopic Dermatitis
23
Patie
nt 6
4
Patie
nt 2
69
Patie
nt 2
01
Patie
nt 5
Patie
nt 2
Patie
nt 1
96
Patie
nt 8
Patie
nt 1
27
Patie
nt 7
3
Patie
nt 1
56
Patie
nt 7
5
Patie
nt 2
03
Patie
nt 3
99
0
5
10
15
20
25
30
Patients with more than 6 claims for Elidel/Protopic
# claims for Elidel/Protopic # claims for steroid
Atopic Dermatitis
24
More than 6 claims for Elidel or Protopic in one yearPatient Number
Patient Age (years) Drug
# Claims for Elidel/Protopic
# Claims for Topical Steroid Prescriber
Diagnosis in Electronic Profile
64 15 Elidel 11 24 Dermatologist atopic dermatitis
269 14 Elidel 11 11 P.A.atopic dermatitis, eczema
201 9 Elidel 11 3 Family Medicine No derm diagnosis
5 38 Protopic 10 0 Family Medicine No derm diagnosis
2 65 Elidel 9 15 N.P. eczema
196 9 Protopic 9 9 Dermatologistatopic dermatitis, eczema
8 61 Protopic 9 0 Family Medicine eczema, psoriasis
127 12 Elidel 9 0 Pediatrics No derm diagnosis
73 13 Elidel 8 8 Family Medicine eczema
156 10 Protopic 8 8 Allergistatopic dermatitis, eczema
75 41 Protopic 8 1 Family Medicineatopic dermatitis, eczema
203 10 Elidel 7 11 Dermatologist eczema
399 4 Elidel 7 0 Pediatricsatopic dermatitis, eczema
Atopic Dermatitis
25
0
2
4
66
0 013 3
Patients with more than 6 claims for Elidel/Protopic
Steroid Claims
0 - 3 claims more than 3 claims
# o
f pat
ient
s
Atopic Dermatitis
26
Dermatologist P.A. Family Medicine N.P. Pediatrics Allergist0
1
2
Patients with more than 6 claims for Elidel/Protopic
AD AD & eczema eczema & psoriasiseczema No Derm Dx
# o
f pat
ient
s
Atopic Dermatitis
27
30gm 60gm 100gm 120gm 300gm0
100
200
300317
13067
271 59
15 161
27 12 2
Paid claims between 10/01/2011 and 10/01/2012
Elidel Protopic 0.03% Protopic 0.1%Quantity Dispensed
# o
f cla
ims
Atopic Dermatitis
28
Conclusions:Overall only 13 of the 436 patients (3%) filled
their Elidel/Protopic more than once every other month.
Of those 13 patients, 7/13 were filling prescriptions for topical steroids at least as often as prescriptions for Elidel/Protopic.
For the 6 patients with no or infrequent topical steroid fills over the same time period, should any action be taken (e.g. send a DUR letter asking for chart notes)?
Should limits be placed on how often Elidel/Protopic is dispensed?
Atopic Dermatitis
29
Recommendations of DUR Board
Current Interventions/Outcomes StudiesP&T Committee Narcotic Analgesic
StudiesNational Summit on Opioid Safety
Psychotropic Medications in Foster ChildrenTwo (2) or more concomitant antipsychotics
Synagis UpdateRevatio
30
National Summit on Opioid Safety
October 31- November 1, 2012Seattle, Washington
31
Principles for more selective and cautious opioid prescribing*Principles for All Chronic Non-Cancer Pain
Patients1. Self-care is the foundation for effective
chronic non-cancer pain care2. Your relationship with the patient supports
effective self-care3. Guide care by progress toward resuming
activities4. Prioritize long-term effectiveness over short-
term pain relief
32* These principles are not intended for palliative care of chronic pain at end of life.
Principles for more selective and cautious opioid prescribing*Principles When Considering Long-term Use of
Opioids1. Put patient safety first2. Think twice before prescribing long-term
opioids for axial low back pain, headache and fibromyalgia
3. Systematically evaluate risks4. Consider intermittent opioid use5. Do not sustain opioid use long-term without
decisive benefits6. Keep opioid doses as low as possible
33* These principles are not intended for palliative care of chronic pain at end of life.
Principles for more selective and cautious opioid prescribing*Principles for Patients Using Opioids Long-term
1. Clearly communicate standardized expectations to reduce risks
2. Adhere to recommended precautions3. Avoid prescribing opioids and sedatives
concurrently4. Revisit discontinuing opioids or lowering dose5. Identify and treat prescription opioid misuse
disorders
34* These principles are not intended for palliative care of chronic pain at end of life.
Principles for more selective and cautious opioid prescribing*Prepared by the faculty of the National
Summit for Opioid SafetyThe National Summit had support from the
Group Health Foundation. It was co-sponsored by Group Health Research Institute; Project ROAM (Dept. of Family Medicine, University of Washington); and Physicians for Responsible Opioid Prescribing (PROP).
35* These principles are not intended for palliative care of chronic pain at end of life.
Foster Children Psychotropic Drugs Red Flags
1/17/2013
36
Red FlagsFive (5) or more psychotropic medications prescribed
concomitantly (reviewed August 2012)Two (2) or more concomitant antidepressants
(reviewed October 2013)Two (2) or more concomitant antipsychotic
medications (current)Two(2) or more concomitant stimulant medications
long-acting plus short-acting okThree (3) or more concomitant mood stabilizer
medicationsPsychotropic polypharmacy (2 or more agents) for a
given mental disorder prescribed before utilizing psychotropic monotherapy 37
38
Implementation of Red Flags
Retroactive
EvaluationIdentify outliers
Profile Review
DUR Board Intervention•Targeted education
Re-evaluation•individuals•overall
Further Action
Point of service edits•Informational (soft) – pharmacist override
•Hard Stop
ADHD Drugs Anti-depressants Mood Stabilizers Atypical Antipsychotics0%
5%
10%
15%
20%
25%
30%
35%
40%
36%
23%
13%
21%
9%
6%
0%
4%
Percent of Foster and Non-Foster Children Psychotropics by Drug Class
Calendar Year 2011
% Foster Children% Non-foster Children
Total foster =2785Total Non-Foster = 106,024
39
Foster Children Receiving Two or More Concurrent
Antipsychotics
40
Study Parameters and ResultsChildren in Foster Care ages 0-17Time Period 4/1/2012 through 9/30/201249 patients were identified with fills for two
or more different antipsychotics during time period26 patients received > or = 60 days
concurrentlyOther patients received for limited time period
(1-2 fills) or sequentially
41
Number of Participants by Age and Sex Meeting Criteria
4M 4F 5M 5F 6M 6F 7M 7F 8M 8F 9M 9F 10M10F11M11F12M12F13M13F14M14F15M15F16M16F17M17F0
0.5
1
1.5
2
2.5
3
3.5
4
4.5
Number of Participants by Age and Sex
42
ADHD
Bipolar/Episodic Mood Disorders
Reactive Attachment Disorder
Oppositional Defiant Disorder
Adjustment Reaction/Disorder
Anxiety Disorders
Conduct Disorder/Disturbance
Disorders of Impulse Control
Posttraumatic Stress Disorder
Autistic Disorder
Pervasive Development Disorder
Depressive Disorders
Schizophrenic/Psychosis Disorders
Borderline Personality Disorder
0 5 10 15 20 25
Diagnosis for Children Meeting Red Flag Threshold
Number of Children
All children had multiple diagnoses
43
Prescriber CharacteristicsNumber of Prescribers per patient
(antipsychotics only)• Single prescriber 18 (65%)• Two prescribers 6 (23%)• Three prescribers 3 (12%)
Number of Patients Meeting Criteria/Prescriber• Single patient = 21• 2 patients = 1• 3 patients = 2• 4 patients = 1• 5 patients = 1
44
Drug Combinations in Patients Meeting Red Flag Threshold
airpiprazole and chlorpromazine
aripiprazole and haloperidol
aripiprazole and olanzapine and risperidone
aripiprazole and quetiapine
aripiprazole and risperidone
aripiprazole and risperidone and ziprasidone
aripiprazole and ziprasidone
olanzapine and quetiapine and risperidone
olanzapine and risperidone
quetiapine and risperidone
risperidone and ziprasidone
0 1 2 3 4 5 6 7 8 9
Number of Patients
45
Next Steps ?
46
Synagis UpdateIdaho Medicaid’s outpatient prescription drug
program authorized payment for eligible patients for the 2012-2013 RSV season as of December 1, 2012.
Many hospitals started dosing Synagis in November 2012. Doses given in the hospital are subtracted from the total doses approved by Idaho Medicaid outpatient prescription drug program.
AAP recommends a maximum of five monthly doses – recommend utilizing Idaho specific epidemiology to maximize drug benefit. After the fifth dose of Synagis, most patients will have adequate RSV antibody titers for six to seven weeks. The antibody levels do not plummet to zero thirty days after the fifth Synagis dose.
47
Synagis Update
48
Season Start DatesDec 11 2005Dec 21 2003Dec 22 2008Dec 31 2007Jan 3 2010Jan 9 2004Jan 11 2009Jan 13 2001Jan 14 2000Jan 15 2006Jan 19 2002Jan 21 2011
Synagis Update
49
Season End DatesMar 28 2004Apr 10 2006Apr 13 2003Apr 24 2005May 5 2008May 6 2001May 7 2011May 9 2010May 12 2002May 19 2012May 24 2009May 28 2007
Synagis Update
50
In Idaho, Respiratory Syncytial Virus (RSV) season officially began the week ending December 8, 2012. The definition for season onset is adapted from the National Respiratory and Enteric Virus Surveillance System (NREVSS). RSV is considered widespread in Idaho in the first of two consecutive weeks during which the reported total percent of specimens testing positive for antigen is ≥ 10%.
Revatio Use in ChildrenOn August 30, 2012, the U.S. Food and Drug
Administration (FDA) sent out a safety announcement recommending against the use of Revatio in children with pulmonary hypertension. (handout in packet)
Revatio claims in Idaho Medicaid patients were reviewed prior to and after the announcement for comparison.
51
Revatio Use in Children6/1/2012- 8/31/201212 claims
5 patients
$11,368
10/1/2012 – 12/31/2012
5 claims
3 patients
$4,015
52
3 patients continued from pre-announcement
Zero new patients post-announcement
Revatio Use in Children
53
Revatio became available generically as sildenafil 20mg tablets in November 2012.
Five different generic manufacturers.
WAC brand (wholesale acquisition cost) - $20.41
WAC generic (wholesale acquisition cost) – as low as $1.16
Proposed Studies for Next Quarter:P&T Committee Narcotic Analgesic Studies –
Next StepsUse of Psychotropic Medications in Foster
Children – Next StepsTwo(2) or more concomitant stimulant medications
long-acting plus short-acting okMigraine Prevention
Prophylaxis Utilization in Chronic Triptan UtilizersBotulinumtoxin ProductsTestosterone enanthateTestosterone cypionateAntipsychotic Indication Evaluation- Hold for
FutureAAP and DVTs- Hold for future
54
P&T Committee Narcotic Analgesic Studies – Next Steps
55
Use of Psychotropic Medications in Foster Children The U.S. Government Accountability Office
released the results from a study that they performed examining the rates of psychotropic medications for foster and nonfoster children in 2008.
It was determined that HHS Guidance Could Help States Improve Oversight of Psychotropic Prescriptions.
56
ADHD Drugs Anti-depressants Mood Stabilizers Atypical Antipsychotics0%
5%
10%
15%
20%
25%
30%
35%
40%
36%
23%
13%
21%
9%
6%
0%
4%
Percent of Foster and Non-Foster Children Psychotropics by Drug Class
Calendar Year 2011
% Foster Children% Non-foster Children
Total foster =2785Total Non-Foster = 106,024
57
Use of Psychotropic Medications in Foster Children: Next StepsTwo(2) or more concomitant stimulant
medications long-acting plus short-acting ok
58
Migraine PreventionProphylaxis Utilization in Chronic Triptan
UtilizersSee packet for summary handout
59
Botulinumtoxin ProductsBotulinumtoxin products are excluded from
coverage by the outpatient pharmacy prescription drug program – these medications are only administered by health care professionals and are not safe for patients to pick up and “brown bag” to the doctor’s office.
Botulinumtoxin products are currently payable without prior authorization on the medical side using J codes.
60
Botulinumtoxin Products
61
Trade Name
# claims 12/01/2011 – 11/30/2012
$ for claims 12/01/2011 – 11/30/2012
Botox 478 $405,615
Dysport 21 $14,286
Myobloc 23 $11,133
Xeomin 3 $647
Totals
525 $431,681
Botulinumtoxin Products
62
Will review profiles of patients with paid claims on the medical side to assess what the botulinumtoxin is most likely being used for (e.g. cervical dystonia, migraines).
Even though Botox does not require prior authorization at this time, the department has been receiving prior authorization requests for Botox for migraines. Need to develop criteria for Botox’s place in therapy as it is not first-line therapy. FDA approved for chronic migraines for patients with at least 15 days of migraines per month with each migraine lasting at least four hours.
Testosterone ProductsTestosterone enanthateTestosterone cypionate
63
Antipsychotic Indication Evaluation- Hold for Future
64
AAP and DVTs- Hold for future
65
Prospective DUR ReportHistory Errors:
• DD – drug-to-drug• PG – drug to pregnancy• TD – therapeutic
duplication• ER – early refill• MC – drug-to-disease
Non-History Errors:• PA – drug-to-age• HD – high dose• LD – low dose• SX – drug-to-gender
66
Prospective DUR ReportIdaho Medicaid ProgramProDUR Message Report
December-12
ProDUR ProDUR Message MessageMessage Severity Count Amount
Drug To Drug 1 1,926 $449,951.28 2 14,152 $2,627,612.23 3 70,762 $11,968,147.90Drug To Gender 1 155 $38,527.92 2 73 $2,738.48Drug To Known Disease 1 63,381 $8,079,221.73 2 240,698 $40,079,557.61 3 299,645 $49,081,346.38Drug To Pregnancy 1 74 $1,358.33 2 18 $170.80 A 7 $63.38 B 98 $20,479.73 C 224 $16,355.88 D 42 $6,954.37 X 55 $2,766.16Duplicate Therapy 0 116,382 $22,561,821.67Min Max 0 31,735 $6,183,543.49Too Soon Clinical 0 21,475 $3,922,520.03ALL 860,902 $145,043,137.37 Total Number of Claims with Messages 211,935 Average ProDUR Message Per Claim 4.06
67
DUR Winter NewsletterCopy of Fall Newsletter in packetBrainstorm for new topics
68
Medicaid Update
69