1. 17 January 2013 1

2. Follow-up to Previous Reviews Immune Globulin (IV and SC) Atopic Dermatitis 2

3. Immune Globulin (IV and SC) Additional Responses to DUR letters sent in August 2012 One 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

4. Immune Globulin (IV and SC) Additional Responses to DUR letters sent in August 2012 Adult 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

5. Immune Globulin (IV and SC) Additional Responses to DUR letters sent in August 2012 Pregnant 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

6. Immune Globulin (IV and SC) Recommendations from October 2012 DUR meeting 1. 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

7. Immune Globulin (IV and SC) Medical Claims Claims paid on medical side between 8/01/2011 and 7/31/2012 $288,410 116 claims 24 patients Average cost per prescription: $2486 7

8. 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

9. Immune Globulin (IV and SC) Pharmacy Claims Reviewing outpatient prescription claims between 8/01/2011 and 7/31/2012 $279,527 79 claims 14 patients Average cost per prescription: $3538 9

10. 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

11. 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

12. Atopic Dermatitis The 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

13. Atopic Dermatitis Treatment 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

14. Atopic Dermatitis Treatment 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

15. Atopic Dermatitis 15

16. Atopic Dermatitis In 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

17. Atopic Dermatitis 17

18. 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.

19. Atopic Dermatitis 19

20. Atopic Dermatitis 20

21. Atopic Dermatitis 21 # of claimsAge-bothAge-ProtopicAge-Elidel 111.58 ± 10.6211.97 ± 12.2311.09 ± 9.79 213.20 ± 15.5619.79 ± 20.9610.51 ± 11.77 310.65 ± 7.9114.50 ± 13.7013.06 ± 11.91 415.33 ± 15.094.00 ± 2.8317.60 ± 15.59 5 to 1120.48 ± 20.3118.36 ± 19.0719.87 ± 20.66

22. Atopic Dermatitis 22

23. Atopic Dermatitis 23

24. Atopic Dermatitis 24 More than 6 claims for Elidel or Protopic in one year Patient Number Patient Age (years)Drug # Claims for Elidel/Protopic # Claims for Topical SteroidPrescriber Diagnosis in Electronic Profile 6415Elidel1124Dermatologistatopic dermatitis 26914Elidel11 P.A. atopic dermatitis, eczema 2019Elidel113Family MedicineNo derm diagnosis 538Protopic100Family MedicineNo derm diagnosis 265Elidel915N.P.eczema 1969Protopic99Dermatologist atopic dermatitis, eczema 861Protopic90Family Medicineeczema, psoriasis 12712Elidel90PediatricsNo derm diagnosis 7313Elidel88Family Medicineeczema 15610Protopic88Allergist atopic dermatitis, eczema 7541Protopic81Family Medicine atopic dermatitis, eczema 20310Elidel711Dermatologisteczema 3994Elidel70Pediatrics atopic dermatitis, eczema

25. Atopic Dermatitis 25

26. Atopic Dermatitis 26

27. Atopic Dermatitis 27

28. 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?

29. Atopic Dermatitis 29 Recommendations of DUR Board

30. Current Interventions/Outcomes Studies P&T Committee Narcotic Analgesic Studies National Summit on Opioid Safety Psychotropic Medications in Foster Children Two (2) or more concomitant antipsychotics Synagis Update Revatio 30

31. National Summit on Opioid Safety October 31- November 1, 2012 Seattle, Washington 31

32. Principles for more selective and cautious opioid prescribing* Principles for All Chronic Non-Cancer Pain Patients 1. Self-care is the foundation for effective chronic non- cancer pain care 2. Your relationship with the patient supports effective self-care 3. Guide care by progress toward resuming activities 4. 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.

33. Principles for more selective and cautious opioid prescribing* Principles When Considering Long-term Use of Opioids 1. Put patient safety first 2. Think twice before prescribing long-term opioids for axial low back pain, headache and fibromyalgia 3. Systematically evaluate risks 4. Consider intermittent opioid use 5. Do not sustain opioid use long-term without decisive benefits 6. Keep opioid doses as low as possible 33* These principles are not intended for palliative care of chronic pain at end of life.

34. 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 precautions 3. Avoid prescribing opioids and sedatives concurrently 4. Revisit discontinuing opioids or lowering dose 5. Identify and treat prescription opioid misuse disorders 34* These principles are not intended for palliative care of chronic pain at end of life.

35. Principles for more selective and cautious opioid prescribing* Prepared by the faculty of the National Summit for Opioid Safety The 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.

36. 1/17/2013 36

37. Red Flags Five (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 ok Three (3) or more concomitant mood stabilizer medications Psychotropic polypharmacy (2 or more agents) for a given mental disorder prescribed before utilizing psychotropic monotherapy 37

38. Implementation of Red Flags Retroactive Evaluation Identify outliers Profile Review DUR Board Intervention Targeted education Re- evaluation individuals overall Further Action Point of service edits Informational (soft) – pharmacist override Hard Stop 38

39. 39

40. 40

41. Study Parameters and Results Children in Foster Care ages 0-17 Time Period 4/1/2012 through 9/30/2012 49 patients were identified with fills for two or more different antipsychotics during time period 26 patients received > or = 60 days concurrently Other patients received for limited time period (1-2 fills) or sequentially 41

42. Number of Participants by Age and Sex Meeting Criteria 42

43. 43

44. Prescriber Characteristics Number of Prescribers per patient (antipsychotics only) Single prescriber 18 (65%) Two prescribers 6 (23%) Three prescribers3 (12%) Number of Patients Meeting Criteria/Prescriber Single patient = 21 2 patients = 1 3 patients = 2 4 patients = 1 5 patients = 1 44

45. Drug Combinations in Patients Meeting Red Flag Threshold 45

46. 46

47. Synagis Update Idaho 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

48. Synagis Update 48 Season Start Dates Dec 112005 Dec 212003 Dec 222008 Dec 312007 Jan 32010 Jan 92004 Jan 112009 Jan 132001 Jan 142000 Jan 152006 Jan 192002 Jan 212011

49. Synagis Update 49 Season End Dates Mar 282004 Apr 102006 Apr 132003 Apr 242005 May 52008 May 62001 May 72011 May 92010 May 122002 May 192012 May 242009 May 282007

50. 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%.

51. Revatio Use in Children On 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

52. Revatio Use in Children 6/1/2012- 8/31/2012 12 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

53. 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

54. Proposed Studies for Next Quarter: P&T Committee Narcotic Analgesic Studies – Next Steps Use of Psychotropic Medications in Foster Children – Next Steps Two(2) or more concomitant stimulant medications long-acting plus short-acting ok Migraine Prevention Prophylaxis Utilization in Chronic Triptan Utilizers Botulinumtoxin Products Testosterone enanthate Testosterone cypionate Antipsychotic Indication Evaluation- Hold for Future AAP and DVTs- Hold for future 54

55. P&T Committee Narcotic Analgesic Studies – Next Steps 55

56. 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

57. 57

58. Use of Psychotropic Medications in Foster Children: Next Steps Two(2) or more concomitant stimulant medications long-acting plus short-acting ok 58

59. Migraine Prevention Prophylaxis Utilization in Chronic Triptan Utilizers See packet for summary handout 59

60. Botulinumtoxin Products Botulinumtoxin 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

61. Botulinumtoxin Products 61 Trade Name # claims 12/01/2011 – 11/30/2012 $ for claims 12/01/2011 – 11/30/2012 Botox478$405,615 Dysport21$14,286 Myobloc23$11,133 Xeomin3$647 Totals525$431,681

62. 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.

63. Testosterone Products Testosterone enanthate Testosterone cypionate 63

64. Antipsychotic Indication Evaluation- Hold for Future 64

65. AAP and DVTs- Hold for future 65

66. Prospective DUR Report History 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

67. Prospective DUR Report Idaho Medicaid Program ProDUR Message Report December-12 ProDUR Message SeverityCountAmount Drug To Drug11,926$449,951.28 214,152$2,627,612.23 370,762$11,968,147.90 Drug To Gender1155$38,527.92 273$2,738.48 Drug To Known Disease163,381$8,079,221.73 2240,698$40,079,557.61 3299,645$49,081,346.38 Drug To Pregnancy174$1,358.33 218$170.80 A7$63.38 B98$20,479.73 C224$16,355.88 D42$6,954.37 X55$2,766.16 Duplicate Therapy0116,382$22,561,821.67 Min Max031,735$6,183,543.49 Too Soon Clinical021,475$3,922,520.03 ALL 860,902$145,043,137.37 Total Number of Claims with Messages 211,935 Average ProDUR Message Per Claim 4.06 67

68. DUR Winter Newsletter Copy of Fall Newsletter in packet Brainstorm for new topics 68

69. Medicaid Update 69