Idaho Medicaid Drug Utilization Review Program

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


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


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

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm153525.htm.




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


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


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


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


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


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


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).


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

Idaho Medicaid Drug Utilization Review Program

Documents

Transcript of Idaho Medicaid Drug Utilization Review Program