1. 18 April 2013 1

2. February 21-23, 2013 Scottsdale, Arizona Representatives present from 40 state Medicaid programs 109 total participants 2

3. ADURS Round Table presentations from state Medicaid representatives Recurrent Issues Opioid therapy for non-malignant pain Psychotropic medications in children Suboxone therapy 3

4. ADURS Opening Session Health Care Reform: How States are Responding Speaker was from the National Conference of State Legislatures 4

5. ADURS Continuing Education Topics Collaborative Care – How to increase safe use of psychotropic medications in children and adolescents. Hemophilia 101 Medicaid Fraud and Abuse Managed Care Medicaid 5

6. ADURS Continuing Education Topics Carving the Prescription Benefit Back In to Medicaid 340(b) Programs New Drugs 2013 6

7. Follow-up to Previous Reviews Atopic Dermatitis P&T Committee Narcotic Analgesic Studies 7

8. 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. 8

9. Atopic Dermatitis 9 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.

10. Atopic Dermatitis 10 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)?

11. Atopic Dermatitis Educational Document included in the Packet 11

12. Atopic Dermatitis 12 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

13. Atopic Dermatitis #201 9 year old male 11 Elidel claims in one year; only 3 topical steroid claims in the same time period Still filling Elidel monthly. Family Medicine prescriber; no derm diagnosis in electronic profile. Send letter. 13

14. Atopic Dermatitis #5 39 yr male 10 Protopic claims in one year/ no topical steroid claims in the same time period. Family Medicine prescriber; only derm diagnosis is ICD- 9 757.39 specified skin anomalies. Protopic last filled 12-20-12 so do NOT send letter as not currently receiving it. 14

15. Atopic Dermatitis #8 60 year old female 9 Protopic claims in one year; no steroid claims. Family Medicine prescriber; diagnosis – eczema. Patient died in 2012 (pulmonary hypertension) so do not send letter. 15

16. Atopic Dermatitis #127 13 yr male 9 Elidel claims in one year; no topical steroids. Last paid claim for topical steroid was in 2006. Elidel last filled 1- 17-13. Pediatric prescriber; no derm diagnosis in electronic profile. Send letter. 16

17. Atopic Dermatitis #75 41yr female 8 Protopic claims; 1 steroid claim. Family Medicine; atopic dermatitis/eczema. Protopic was last filled 11-29-12 so do not send letter. 17

18. Atopic Dermatitis #399 7 Elidel claims in one year; zero steroid claims. Pediatrics; atopic dermatitis/eczema. Elidel last filled 9-19-12 so do not send letter. 18

19. Atopic Dermatitis Comments/Questions? 19

20. P&T Committee Narcotic Analgesic Studies 20

21. Participants Receiving Over 500 mg Morphine Equivalents per Day 21

22. Original Review Generated profiles for the top 150 recipients by total narcotic claim count from the recipients who had at least one narcotic claim in each of the 24 months of the period ending December 2011 Time Period: May 1, 2011 through December 31, 2011 All profiles were hand reviewed by Idaho Medicaid Pharmacists 22

23. Daily Morphine Equivalents 23 Lowest = 10 mg Highest = 2421 mg

24. Participants Receiving Over 500 Morphine Equivalents in 2011 Study Original study 5/1/2011 – 12/31/2011 30 participants > 500 morphine mg equivalents Follow-up study of these 30 participants 6/1/2012- 11/30/2012 24

25. Data on 30 Original Participants CharacteristicNumber of Patients Original participants still meeting threshold (> 500 mg MS equivalents) 6 Ineligible or Inactive for Idaho Medicaid 2 Deceased5 Incarcerated1 Current dose < 500 mg MS equivalents 16 25

26. Follow-up Request Letter (see packet) sent 2/13/2013 Included patient medication profile and Board of Pharmacy controlled substance report Requested Chart Notes and Documentation for most recent 6 months Evaluation and monitoring of pain relief Evaluation for improvement in daily function Potential misuse/abuse Current treatment plan Pain contract Random urine screen results 26

27. Participant Review 5 of 6 participants’ prescribers returned documentation Case Presentations Top User no longer receiving: Chris Johnson Most complex user: Jane Gennrich Remaining 4 users: Tami Eide 27

28. Current Interventions/Outcomes Studies Zolpidem High Dose Migraine Prevention Prophylaxis Utilization in Chronic Triptan Utilizers Botulinumtoxin Products Testosterone enanthate/cypionate (injectable) Psychotropic Medications in Foster Children Two (2) or more concomitant stimulant medications long-acting plus short-acting ok 28

29. Zolpidem High Dose On January 10, 2013 the United States Food and Drug Administration (FDA) notified the public of new information regarding the safety of certain drugs that contain zolpidem. (See packet for copy of Drug Safety Announcement) The NEW immediate release zolpidem dose for women is being lowered from 10 mg to 5 mg. The NEW extended release zolpidem dose for women is being lowered from 12.5 mg to 6.25 mg. For men, the new labeling recommends that the same lower doses be considered (zolpidem immediate release 5 mg or zolpidem ER 6.25 mg). 29

30. Zolpidem High Dose A report was run looking at paid claims between October 1, 2012, and December 31, 2012, to identify the number of Idaho Medicaid recipients who had received zolpidem: 30 Zolpidem Paid Claims 10/01/2012 – 12/31/2012 Male≥2 per dayFemale≥2 per dayPrescribers Ambien 5mg631022333209 Ambien 10mg4571514879 Ambien CR 6.25mg000 Ambien CR 12.5mg194744

31. Zolpidem High Dose Patients were selected if they had doses above the NEW recommended doses. Letters were sent to 877 prescribers about 1,984 patients on 1/18/2013. As of 4/16/2013, 246 responses have been received (28% response rate.) See packet for copy of the letter. 31

32. Zolpidem High Dose Criteria Paragraph On January 10, 2013, the Food and Drug Administration (FDA) published a safety announcement regarding the popular insomnia medication zolpidem (trade names Ambien, Ambien CR, Edluar, Zolpimist). The announcement included two important messages: First, the FDA provided new, lower bedtime dosing recommendations on zolpidem immediate and extended release products. Next, the FDA reminded the public about safety concerns around driving or performing other activities requiring alertness the morning after use. The risk of next-morning impairment is highest for women, who may eliminate the medication more slowly. Impairment is also greater in those taking the extended release formulation (Ambien CR/zolpidem ER). Manufacturers will be revising the product labeling to reflect the following: 1. The NEW immediate release zolpidem dose in women is being lowered from 10 mg to 5 mg. 2. The NEW extended release zolpidem dose in women is being lowered from 12.5 mg to 6.25 mg. 3. For men, the new labeling will recommend the same lower doses be considered (zolpidem 5 mg or zolpidem ER 6.25 mg). 32

33. Zolpidem High Dose : Note that providers may choose more than one selection per response. Reviewed and have or will modify the treatment126 Will use this information in care of future patients120 Information clinically useful: plan to monitor113 Reviewed and do not believe adjustment is needed72 Attempted to modify therapy unsuccessfully15 Not my patient, never has been5 33

34. Zolpidem High Dose: Comments of Interest “Patient is stable” (numerous similar responses) “will discuss with patient” “chronic sleep disorder. Pt. with chronic sleep problem nightly and does not sleep without zolpidem” “dose was initially changed, had worsening of symptoms and strongly favored higher dose” “attempts made to lower dosage or taper off without success. The pt listed are long term complicated pts and to effectively recess her has been reviewed previously. Thanks” “lower doses do not help. I still treat patients not studies.” 34

35. Zolpidem High Dose: Comments of Interest “He has multiple sclerosis. Ambien was discontinued. Where is the form for why my patient was abruptly stopped on Advair which had been effective and helpful for the pt, why was my input not important then.” “I will change my prescribing habits. Have only given 1 dose.” “I’m the physician. Waste of my time.” “I already know.” “Will change dose to Ambien 5mg” “Patient has not responded to a lower dose” “I did not prescriber this medicine to my knowledge” “Both patients were (are) pregnant” 35

36. Zolpidem High Dose: Comments of Interest “tolerates well, has taken since April 2009” “The benefits outweigh the risks” “I will attempt to modify therapy with pts as recommended” “But the patient is a male, not female” “He tolerates the current dose without side effects” “address at their next visit. Had already heard about the FDA announcement” “I am not an Idaho Provider. This is not my patient.” 36

37. Zolpidem High Dose 37 Zolpidem Paid Claims Male>1 per dayFemale>1 per dayPrescribers MAX QTY Month/Year12/123/1312/123/1312/123/1312/123/1312/123/13 Ambien 5mg3855341182711519102150Q02 Ambien 10mg30530171010108235130639558Q02 Ambien CR 6.25mg000808Q01 Ambien CR 12.5mg171138343533Q01 Payment Amount to Pharmacy: 12/12 - $25,787; 3/13 - $24,555

38. Zolpidem High Dose Thoughts/Comments? 38

39. Migraine Prevention Idaho Medicaid paid over $770,000 worth of pharmacy claims for the Triptan class of medication in 2012. There were more than 7,200 claims paid for in 2012. The question the Idaho DUR Board is beginning to investigate is “Are these medications being used appropriately and are recipients getting the appropriate treatment for the prevention of migraines?” 39

40. Migraine Prevention Epidemiology Migraines affect approximately 11% of the adult populations in Western Countries. In the United States, more than 30 million people have at least 1 migraine per year. Gender Before puberty more common in boys than girls. In people over 12 years of age, the prevalence increases in both males and females peaking at age 30-40 years. The ratio of female-to-male increases from 2.5:1 at puberty to 3.5:1 at age 40. 40

41. Migraine Prevention: recipients with paid triptan claim between 1/1/2012 and 12/31/2012 Gender (Idaho Medicaid Population) Overall Average Age: 35 (range 4 – 78) Average Age Females: 35 (range 6 – 68) Average Age Males: 31 (range 4 – 78) 41

42. Migraine Prevention: recipients with paid triptan claim between 1/1/2012 and 12/31/2012 42

43. Migraine Prevention: recipients with paid triptan claim between 1/1/2012 and 12/31/2012 43

44. Migraine Prevention: recipients with paid triptan claim between 1/1/2012 and 12/31/2012 44

45. Migraine Prevention Epidemiology Race Caucasians > African Americans > Asians Geography Americas > Europe/Middle East > Asia > Africa Economic Impact Estimated at more than $2.5 billion per year in cost of medical care (Direct costs) Estimated at more than $13 billion per year in loss of productive time (Indirect costs). 45

46. Migraine Prevention Medical Diagnosis (based on direct questionnaires) 1989 – 38% of sufferers 1999 – 48% of sufferers Prognosis Chronic condition with severity and frequency diminishing with advancing age. Treatment Abortive Preventative 46

47. Migraine Prevention Preventative Therapy Taken in absence of headache with the goal of reducing the frequency and severity of the migraine, make acute attacks respond better to abortive therapy, and ultimately improve the patient’s quality of life. 3 primary classes of medications that are effective: antiepileptics, antidepressants, and antihypertensives. Botulinum toxin A will be discussed in greater detail in slides to follow. Please refer to handout in packet regarding the evidenced based guideline update. 47

48. Migraine Prevention Idaho Medicaid Numbers In 2012 there were 5,022 unique recipients with a Migraine Diagnosis in their electronic medical record. Of these 5,022 recipients, 1,258 had a triptan claim in their profile. Side note: In 2012 there were 2,367 unique recipients with a triptan claim Of these 1,258 recipients, 281 (22%) had a claim for one of the Level A Medications as described in the Evidence- based guideline update. 48

49. Migraine Prevention Next Steps??? 49

50. Migraine Prevention 50

51. 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 on the medical side using the J codes listed on a future slide. There are four commercially available products at this time; they are not therapeutically equivalent and they have different dosages and different FDA approved indications. 51

52. Botulinumtoxin Products While Idaho Medicaid does not cover medications for cosmetic uses (e.g. wrinkles), at this time there is no diagnosis verification or medical review for J0585, J0586, or J0587 to assure that the botulinumtoxin is being prescribed for a medical diagnosis rather than for a cosmetic indication. Therefore, the Pharmacy Unit at Idaho Medicaid has done a DUR (Drug Utilization Review) project evaluating diagnoses of patients who have paid claims for botulinumtoxin in the past 3 months. 52

53. Botulinumtoxin Products Procedure Code Trade Name Generic Name and Billing Units Prior Authorization Required? # Claims 12/01/2011 – 11/30/2012 $ for claims 12/01/2011 – 11/30/2012 J0585Botoxonabotulinumtoxin A, 1 unit NO478$405,615 J0586Dysportabobotulinumtoxin A, 5 units NO21$14,286 J0587Myoblocrimabotulinumtoxin B, 100 units NO23$11,133 J0588Xeominincobotulinumtoxin A, 1 unit YES (as of August 2012) 3 (prior to August 2012) $647 TOTALS525$431,681 53

54. Botulinumtoxin Products Trade Name Generic Name and Billing Units FDA approved indications Botoxonabotulinumtoxin A, 1 unitUrinary incontinence Migraines Spasticity Cervical dystonia Hyperhidrosis Blepharospasm Strabismus Overactive bladder (new – January 2013) Cosmetic (not covered by Idaho Medicaid) 54

55. Botulinumtoxin Products Trade Name Generic Name and Billing Units FDA approved indications Dysportabobotulinumtoxin A, 5 units Cervical dystonia Cosmetic (not covered by Idaho Medicaid) Myoblocrimabotulinumtoxin B, 100 units Cervical dystonia Xeominincobotulinumtoxin A, 1 unit Cervical dystonia Blepharospasm 55

56. Botulinumtoxin Products Patients with paid claims for botulinumtoxin between 10/01/2012-12/31/2012: 98 Diagnoses Cerebral Palsy: 49 42 children, 7 adults Cervical dystonia, torsion dystonia, or upper limb spasticity: 28 Traumatic brain injury/intracranial hemorrhage with muscle spasms: 12 Migraines: 5 Misc: 4 (details on next slide) 56

57. Botulinumtoxin Products Diagnoses Misc: 4 Patient #7 – dysphagia Patient #20 – spina bifida Patient #91 – closed fracture of vertebral column, muscle spasm Patient #77 - blepharospasm 57

58. Botulinumtoxin Products MIGRAINES References Botulinum Toxin A Treatment for Chronic Headache and Chronic Migraine. Center for Evidence-based Policy: Medicaid Evidence-based Decisions Project. Oregon Health & Science University. February 2012. Botox Prescribing Information. Allergan, Inc. Revised 01/2013. 58

59. Botulinumtoxin Products MIGRAINES General Conclusions from Medicaid Evidence-based Decisions Project Overall, the evidence for the effectiveness of BTX-A on chronic migraine is inconsistent, with the studies that do show a benefit finding the improvement small and potentially clinically insignificant. 59

60. Botulinumtoxin Products MIGRAINES General Conclusions from Medicaid Evidence-based Decisions Project Key Question 1: Does BTX-A reduce the frequency, severity, or duration of chronic headaches of migraines? The largest available study (N=1384) evaluated onaBTX-A and found a small but statistically significant decrease in the mean number of headache days per month (-8.4 versus -6.6) and in the mean number of migraine days/month (-8.2 versus -6.2). Although statistically significant, the small size of the treatment effect relative to placebo suggests that this may not be clinically significant. 60

61. Botulinumtoxin Products MIGRAINES General Conclusions from Medicaid Evidence-based Decisions Project Key Question 2: Does BTX-A improve qualify of life in patients who have chronic headaches or migraines? Only three trials assessed any aspect of QOL (quality of life) in the treatment of chronic tension type headache. The smallest found significant improvement in QOL in the treatment group compared to placebo at both 30 and 90 days. A second trial found some reductions on affective distress outcomes compared to placebo at four weeks, but these were not sustained at eight weeks. The third found no significant difference between treatment and placebo groups in sleep duration. 61

62. Botulinumtoxin Products Migraine patient #6 58 year old female Long history (many years) of migraines 2010: 20 ER visits/office visits specifically for migraines Jan 1- Sep 30, 2011: 11 ER visits/office visits specifically for migraines Botox started: 9/30/2011 Receiving Botox approximately every 3 months: 1/20/12, 4/13/12, 7/5/12, 11/02/12 No ER visits/office visits for migraines Oct 1 – Dec 31, 2011 8 ER visits/office visits for migraines in 2012 Has been on verapamil and nadolol 2010 – present One paid claim for triptan 7/19/2010 62

63. Botulinumtoxin Products Migraine patient #18 51 year old female 2010: 9 ER/office visits specifically for migraines Jan 1 – Sep 30, 2011: 7 ER/office visits specifically for migraines Botox started: 9/30/2011 Receiving Botox approximately every 3 months since then 2 more ER/office visits for migraines Oct 1 – Dec 31, 2011 9 ER/office visits specifically for migraines in 2012 Has been on propranolol 2010 – present 63

64. Botulinumtoxin Products Migraine patient #18, con’t Received prior authorization request for Botox in February 2013 – prescriber states “she has had an excellent response to Botox” but ER visits have not changed between 2010 and 2012. Also received prior authorization request for Maxalt in August 2012 (which was approved) but was only filled once. Request stated “Patient has been using Maxalt since 2008 with good results” but even though patient has been on Medicaid since 2008, she has only one paid claim for Maxalt in 2012. 64

65. Botulinumtoxin Products Migraine patient #12 24 year old female History of viral meningitis as well as physical abuse with injury to neck/upper back Prophylactic medications tried – divalproex and amitriptyline Rescue medications used – tramadol described as being effective, also filling hydrocodone/acetaminophen (no triptans) Botox given 10/08/2012 and 12/20/2012. No ER visits for migraines either before or after Botox therapy. 65

66. Botulinumtoxin Products Migraine patient #40 48 year old male Botox given 7-05-12 and 12-07-12 4 office visits specifically for migraines in 2010; 1 office visit and 1 ER visit in 2011 for migraines 3 office visits for migraines in 2012 prior to Botox; none afterwards Triptan was approved for patient back in 2007 but only filled once. Other medical history – has pacemaker. 66

67. Botulinumtoxin Products Migraine Patient #87 36 year old female. Botox given 10-11-2012 (only once). Also has diagnosis of cervicalgia with frequent physical therapy appointments On topiramate and sumatriptan regularly. No ER visits for migraines. 67

68. Botulinumtoxin Products MIGRAINES Have been receiving prior authorization requests for Botox for migraines as it has been assumed by some physicians that prior authorization is required. In general, insufficient documentation is being sent especially quantifying the number of migraines per month and the duration of headache/migraine per day. Inadequate description of success/failure of both prophylactic and abortive medications to treat migraines. 68

69. Botulinumtoxin Products Recommendations for Botox used for chronic headaches/migraines Require prior authorization for botulinumtoxin for treatment of chronic headaches and migraines. Prior authorization form has been created (see copy in your packet). Implementation date would be July 1, 2013. Therapeutic criteria: 1. Quantification of headaches/migraines prior to botulinumtoxin therapy. Botox is FDA approved for the treatment of 15 or more chronic headaches per month with each headache lasting at least 4 hours. Per package insert: Safety and efficacy has not been established for prophylaxis of episodic migraine (14 headache days or fewer per month). 69

70. Botulinumtoxin Products Recommendations for Botox used for chronic headaches/migraines Therapeutic criteria: 2. What has been tried prior to botulinumtoxin – including prophylactic therapy and treatment of migraines. a) Should prophylactic trials of at least one or two agents be required ? b) Documentation of fills of abortive medications at least monthly for the previous three months ? 70

71. Botulinumtoxin Products Recommendations for Botox used for chronic headaches/migraines Therapeutic criteria: If approved, initial approval would be for two injections (given 3 months apart). This duration was used in the clinical studies that the FDA reviewed to approve Botox for chronic headaches. Idaho Medicaid would then require additional documentation including quantification of migraines after botulinumtoxin therapy as well as utilization of migraine treatment medications (e.g. triptans), ER utilization, office visits for migraines, and any adverse reactions to Botox. Sample Prior Authorization form for Botox for Migraines/Chronic Headaches included in packet. 71

72. Botulinumtoxin Products CEREBRAL PALSY Botox is injected into spastic or stiff muscles where it blocks transmission between the nerves and the affected muscles which relaxes the muscle and reduces stiffness. Once the muscles are relaxed, therapists are able to stretch the muscles. Children under the age of six respond best to this treatment as it is especially effective in children who have not developed fixed joint contractures. Benefits of therapy include improvement in range of motion, tolerance to wearing braces, and developmental improvements in crawling, standing, and gait. Duration of effect is typically four months. Side effects include flu-like symptoms and weakness of the legs. 72

73. Botulinumtoxin Products DYSTONIAS Dystonias are involuntary muscle contractions that cause repetitive movements or distorted postures. Cervical dystonia – contractions cause the head to twist and turn to one side or pull forward or backward Blepharospasm – involuntary spasms causing eyelids to close 73

74. Botulinumtoxin Products TREATMENT OF OVERACTIVE BLADDER OR URINARY INCONTINENCE Botox is approved for treatment in adults who have an inadequate response to or are intolerant to anticholinergic medications. There were no patients receiving Botox for this indication during the three months of this DUR. 74

75. Botulinumtoxin Products TREATMENT OF MUSCLE SPASMS s/p MAJOR HEAD TRAUMA No specific FDA indication for this situation. Treatment of cervical dystonia or upper limb spasticity does not specify etiology of dystonia or spasticity. 75

76. Botulinumtoxin Products 76

77. Botulinumtoxin Products Botulinumtoxin – Recommendations for other indications besides chronic headaches/migraines Overactive bladder Urinary incontinence Upper limb spasticity Cervical dystonia Severe axillary hyperhidrosis Blepharospasm Strabismus 77

78. Botulinumtoxin Products 1. Require prior authorization for all botulinumtoxin products ? 2. Grandfather current patients vs. request chart notes to document effectiveness and safety of current therapy ? Same decision for all indications ? 3. Proposed implementation date: July 1, 2013 78

79. 79

80. Injectable Testosterone DUR Topical formulation of testosterone requires a prior authorization Diagnosis of Testicular hypo function (hypogonadism) Idaho Medicaid does not authorize payment of medications for sexual dysfunction Initial requests are approved for 3 months with follow- up lab results. 80

81. Injectable Testosterone DUR Injectable testosterone does not require a prior authorization Appropriate use per diagnosis not evaluated Multiple medical non-FDA indicated uses Controlled substance with potential for abuse Performance enhancer 81

82. Injectable Testosterone DUR Questions: Are testosterone injections being prescribed appropriately? Are there duplicative treatments between outpatient pharmacy benefit and medical benefit (J-codes)? 82

83. Testosterone DUR Evaluated injectable testosterone use in 2012 Testosterone cypionate Testosterone Enanthate Compared prescriptions and medical procedure codes with common diagnosis for use 257.2 Testicular Hypo function 257.9 Testicular Dysfunction Unspecified 83

84. Testosterone DUR 2012 Results Age: 0- 75 years Average of 41 years Average days supply: 28 days ( range: 14-34 days Average dispensed quantity: 4 mls (range: 1-10 mls) The most prescribed: Testosterone cypionate 200mg vial Pharmacy Data: Total 152 clients with 532 claims 4 female Medical Data: Total 104 clients with 533 claims 6 female Duplicative Data: Total of 15 clients with both Pharmacy and Medical claims 5 clients had pharmacy/medical claims on the same dates 84

85. 85

86. 86

87. 87

88. Testosterone DUR Conclusions Pharmacy 15.7% of clients without a documented diagnosis or unapproved diagnosis Medical 7.6% of clients without a documented diagnosis or unapproved diagnosis 33% of clients with duplicative claims noted between medical and pharmacy claims for the same billing dates. Prior Authorization of injectable testosterone for therapeutic diagnosis may be required to evaluate appropriate use and maintain consistency across the two programs 88

89. 4/18/2013 89

90. 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 90

91. 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 91

92. 92

93. 4/18/2013 93

94. Study Methodology Children in Foster Care ages 0-17 Claims review of any foster child receiving an ADHD Drug between 11/1/2012 and 1/31/2013 94

95. Stimulants Included amphetamine salt combo Adderall XR (amphetamine salt combo extended release) dexmethylphenidate Focalin XR (dexmethylphenidate extended release) dextroamphetamine IR/ER Procentra (dextroamphetamine) Vyvanse (lisdexamfetamine) Metadate CD (methylphenidate) Methylin Chew tabs (methylphenidate) methylphenidate ER (Concerta generic) Methylin solution (methylphenidate) methylphenidate IR methylphenidate ER (Ritalin SR generic) methylphenidate ER (Ritalin LA generic) Daytrana (methylphenidate) Quillivant XR (methylphenidate) 95

96. Non-Stimulants Included Strattera (atomoxetine) Clonidine Kapvay (clonidine extended release) Guanfacine Intuniv (guanfacine extended release) 96

97. Methodology Limitations “Snap-Shot” in time – did not include drug and dose changes before or after except as noted below Excluded from analysis any child that did not have 2 continuous months of stable (same) drug therapy Exception: if less than two months because of new start between 12/24/2012 and 1/31/2013 then following month was looked at in electronic record for evaluation of continuation No medical history or profile review completed 97

98. Final Evaluation Numbers 759 children in original data pull 187 with less than 2 months of any drug 572 evaluated 98

99. Treatment Patterns *12 children’s therapy counted in 2-4 different entities included an IR/ER combination of one of the entities, not counted here 99

100. One Drug/One Dose Summary Stimulants (67% of patients) Most Used Stimulants 49 % methylphenidate ER 26% amphetamine salt combination ER 11 % received only an IR formulation Non-Stimulants (33% of patients) atomoxetine (Strattera)22% clonidine IR32% guanfacine IR30% guanfacine ER (Intuniv) 15% 100

101. Mixture of ER and IR Dosage Forms 45 total patients (including 12 counted elsewhere) methylphenidate ER plus IR47% dexmethylphenidate XR plus IR18% amphetamine salt combo XR plus IR11% Combo of different chemical entities24% 101

102. Same Chemical Entity with More than One Strength Total Patients = 22 Stimulants = 20 Methylphenidate ER 16/20 (80%) Non-stimulants = 2 Dosing 36% exceeded daily dose guidelines 7/16 methylphenidate ER patients 1 lisdexamfetamine (Vyvanse) patient 102

103. Summary of Two Different Chemical Entities 109 patients 61% ER stimulant and IR non-stimulant Most common methylphenidate ER with clonidine methylphenidate ER with guanfacine 16% ER stimulant and ER non-stimulant Most common Vyvanse (lisdexamfetamine) with Intuniv (guanfacine) methylphenidate ER with Intuniv Adderall XR (amphetamine salt combo) with Intuniv The dose was maximized for one or both of the agents in 18 patients ( 17%) 103

104. Summary of Three Different Chemical Entities 19 patients had three different chemical entities 6 patients had an ER stimulant + ER non-stimulant + IR non-stimulant 4 included a combination of clonidine plus Intuniv (guanfacine ER) 5 patients had an ER stimulant plus 2 IR non-stimulants All of these included guanfacine + Strattera (atomoxetine) Dose was maximized in one or all agents in only 3 patients 104

105. Patient with Four Different Chemical Entities dexmethylphenidate IR 5 mg daily dexmethylphenidate XR 15 mg daily clonidine 0.2 mg daily guanfacine 5 mg daily atomoxetine 40 mg daily 105

106. Duplicate Therapy Two different long-acting stimulants = 5 patients dexmethylphenidate ER + Daytrana (methylphenidate) = 1 dexmethylphenidate ER + methylphenidate ER = 1 Vyvanse (lisdexamfetamine) + methylphenidate ER = 2 Two different short-acting stimulants = 1 patient Two different long-acting non-stimulants = 1 patient Two different short-acting non-stimulants = 12 patients clonidine + atomoxetine = 6 guanfacine + atomoxetine = 5 clonidine + guanfacine = 1 Three different non-stimulants = 1 patient clonidine + guanfacine + atomoxetine TOTAL = 20 patients 106

107. Next Steps ? Profile and medical history review of outliers ? Evaluation of number and specialty of prescribers ? Other 107

108. Proposed Studies for Next Quarter: P&T Committee Narcotic Analgesic Studies – Next Steps Use of Psychotropic Medications in Foster Children – Next Steps Three (3) or more concomitant mood stabilizer medications Hepatitis C Agents Antipsychotic Indication Evaluation- Hold for Future AAP and DVTs- Hold for future 108

109. P&T Committee Narcotic Analgesic Studies – Next Steps 109

110. 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. 110

111. 111

112. Use of Psychotropic Medications in Foster Children: Next Steps Three (3) or more concomitant mood stabilizer medications 112

113. Hepatitis C Agents Incivek and Victrelis Review past 6 months of data for usage Are patients that started on therapy continuing therapy? Will be requesting chart notes to determine why patients discontinued therapy (e.g. intolerable side effects vs. non- responders to therapy based on viral counts) vs. non- compliance. Will look for trends in patients that discontinued therapy (e.g. does rate vary between practices or geographically) Are patients on TRIPLE therapy with ribavirin and interferon? Check for adherence to all three medications. Audit for checking viral counts at appropriate time intervals 113

114. Hepatitis C Agents Incivek and Victrelis Look at quarterly trends in usage since Incivek/Victrelis were approved by the FDA in May 2011 as patients were not started on double therapy (ribavirin/interferon) as the specialists were waiting for triple therapy to be available. In the future an all oral regimen is going to be available for treatment of Hepatitis C so there may be patient “warehousing” again. 114

115. Antipsychotic Indication Evaluation- Hold for Future 115

116. AAP and DVTs- Hold for future 116

117. 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 117

118. Prospective DUR Report Idaho Medicaid Program ProDUR Message Report March-13 ProDUR Message SeverityCountAmount Drug To Drug11,696$464,457.99 214,228$2,471,750.95 373,113$12,541,653.63 Drug To Gender1220$76,867.77 22,699$319,980.77 Drug To Known Disease168,820$10,040,216.19 2242,531$44,050,971.97 3305,006$52,254,965.87 Drug To Pregnancy1100$1,348.97 225$840.03 A8$106.64 B104$11,723.20 C204$18,054.61 D24$2,068.05 X50$1,416.20 Duplicate Therapy0119,918$35,587,342.92 Min Max032,097$6,412,192.38 Too Soon Clinical022,077$4,131,301.25 ALL 882,920$168,387,259.39 Total Number of Claims with Messages 215,450 Average ProDUR Message Per Claim 4.10 118

119. DUR Spring Newsletter Copy of Winter Newsletter in packet Brainstorm for new topics 119

120. Medicaid Update 120