Follow-up to Previous Reviews. Multiple Dosage Forms of Aripiprazole Prescribed Concomitantly

Transcription

1 15 October

2 Follow-up to Previous Reviews Multiple Dosage Forms of Aripiprazole Prescribed Concomitantly 2

3 Multiple Dosage Forms of Aripiprazole Prescribed Concomitantly Usual maximum FDA approved daily dose for aripiprazole (Abilify) is 30mg. Tablets available in the following strengths: 2, 5, 10, 15, 20, and 30mg Discmelt tablets available in the following strengths: 10, 15mg 3

4 Multiple Dosage Forms of Atypical Antipsychotics Prescribed Concomitantly Olanzapine 10/19/13 1/19/2014 Ziprasidone 9/1/14 11/30/14 Aripiprazole 3/1/15 5/31/ claims 869 unique recipients $246, claims 473 unique recipients $96, claims 2252 unique recipients $4,540,782 4

5 Multiple Dosage Forms of Atypical Antipsychotics Prescribed Concomitantly Claims Olanzapine 10/19/13-1/19/14 Ziprasidone 9/1/14-11/30/14 Aripiprazole 3/1/15-5/31/15 5

6 Multiple Dosage Forms of Atypical Antipsychotics Prescribed Concomitantly Recipients Olanzapine 10/19/13-1/19/14 Ziprasidone 9/1/14-11/30/14 Aripiprazole 3/1/15-5/31/15 6

7 Multiple Dosage Forms of Atypical Antipsychotics Prescribed Concomitantly $5,000,000 $4,500,000 $4,000,000 $3,500,000 $3,000,000 $2,500,000 $2,000,000 $1,500,000 $1,000,000 $500,000 $0 Total $ Paid $4,540,782 $246,340 $96,063 Olanzapine 10/19/13-1/19/14 Ziprasidone 9/1/14-11/30/14 Aripiprazole 3/1/15-5/31/15 7

8 Multiple Dosage Forms of Atypical Antipsychotics Prescribed Concomitantly Greater than FDA approved daily dose Olanzapine 10/19/13-1/19/14 Ziprasidone 9/1/14-11/30/14 Aripiprazole 3/1/15-5/31/15 8

9 Multiple Dosage Forms of Aripiprazole Prescribed Concomitantly Baseline Paid claims for oral aripiprazole between 3/1/2015 and 5/31/2015 were evaluated. 74 patients identified with two or more fills for two or more tablet strengths 62 (84%) on 30mg daily 12 (16%) on > 30mg daily 9

10 Multiple Dosage Forms of Aripiprazole Prescribed Concomitantly Patients receiving 30mg aripiprazole using multiple tablet strengths (n=62) 3 7 Contacting prescriber to round dose to one tablet daily Already changed to only one tablet strength No longer on aripiprazole No longer eligible for Medicaid 10

11 Multiple Dosage Forms of Aripiprazole Prescribed Concomitantly Plan: A letter with the following paragraph along with a Qty Override Form and Member Rx Profile was sent to prescribers of 10 members on 7/7/2015: The maximum FDA approved dose for aripiprazole is 30mg/day because safety and efficacy have not been established for higher doses. The DUR board is reviewing Idaho Medicaid participants who are receiving more than 30mg/day of aripiprazole using multiple tablet strengths. As of 8/12/2015, multiple strengths of aripiprazole tablets will no longer pay at the pharmacy without prior authorization. During a recent review it was noted that your patient, $MEMBER NAME, has been receiving more than 30 mg/day of aripiprazole using multiple tablet strengths. If you feel that it is clinically justified for your patient to remain on multiple strengths of aripiprazole tablets, please submit a quantity override prior authorization request for review by the department. A copy of this form is enclosed for your convenience. 11

12 Multiple Dosage Forms of Aripiprazole Prescribed Concomitantly Of the ten letters that went out only five were returned; however, no additional comments were written on the response form. 12

13 Multiple Dosage Forms of Aripiprazole Prescribed Concomitantly Questions/Comments??? 13

14 Ongoing Reviews Hepatitis C Update Buprenorphine and benzodiazepine DUR Patients Receiving > 1 Long-Acting Opioid Foster Children High Utilizers 14

15 Christopher K. Johnson PharmD. Idaho Medicaid Pharmacy Services Specialist 15

16 Hepatitis-C Review of requests for Hepatitis-C agents 1/1/2015 to 9/30/2015 Demographics: Total 70 Males: Mean age 51 y/o (Range: 21 to 67) Total 64 Females: Mean age 49 y/o (Range: 18-70) 16

17 Hepatitis-C 17

18 Hepatitis-C 18

19 Hepatitis-C 19

20 Hepatitis-C 20

21 Hepatitis-C 21

22 Hepatitis-C 22

23 Hepatitis-C 23

24 Hepatitis-C 24

25 Hepatitis-C 25

26 Hepatitis-C (Genotype) Messina, J. P., Humphreys, I., Flaxman, A., Brown, A., Cooke, G. S., Pybus, O. G. and Barnes, E. (2015), Global distribution and prevalence of hepatitis C virus genotypes. Hepatology, 61: doi: /hep

27 Hepatitis-C 27

28 Hepatitis-C Recently FDA approved agents (Bristol-Myers Squibb) Daclatasvir (Daklinza ) Genotype 3 Dalinza 60mg tablet once daily in combination with Sovaldi for 12 weeks. Optimum duration of therapy in patients with cirrhosis is not established. 28

29 Hepatitis-C Recently FDA approved agents (AbbVie Inc.) Ombitasvir/paritaprevir/ritonavir (Technivie ) Genotype 4 2 tablets (ombitasvir 12.5 mg/paritaprevir 75 mg/ritonavir 50 mg) orally once daily with a meal plus weight-based ribavirin (weight less than 75 kg, 1000 mg daily; weight 75 kg or more, 1200 mg daily; administered in 2 divided doses with food); continue treatment for 12 weeks. Treatment naive and unable to tolerate ribavirin: 2 tablets (ombitasvir 12.5 mg/paritaprevir 75 mg/ritonavir 50 mg) orally once daily with a meal for 12 weeks 29

30 Questions?/Comments? Hepatitis-C 30

31 Buprenorphine and Benzodiazepine DUR Suboxone Package Insert Buprenorphine in combination with benzodiazepines or other CNS depressants including alcohol has been associated with significant respiratory depression and death. Patients should be warned of the potential of selfadministration of benzodiazepines or other depressants while under treatment with Suboxone. 31

32 Buprenorphine and Benzodiazepine DUR March 1 May 31, Buprenorphine AND benzos Buprenorphine (no benzos)

33 Buprenorphine and Benzodiazepine DUR March 1 May 31, One Benzo Two Benzos Three Benzos Number of Patients (Total = 57) 33

34 Buprenorphine and Benzodiazepine DUR March 1 May 31, 2015 Which benzo prescribed concomitantly? clonazepam alprazolam diazepam lorazepam temazepam 19 34

35 Buprenorphine and Benzodiazepine DUR 30 Prescribers with >10 buprenorphine patients Benzo No Benzo 0 35

36 Buprenorphine and Benzodiazepine DUR DUR letter sent out on 7/2/

37 Buprenorphine and Benzodiazepine DUR 55 letters were sent out to Prescribers and a total of 15 came back as of 10/9/2015. Response Description No Response 1 I have reviewed the informationand do not believe an adjustment to the current therapy is necessary I attemptedto modify the therapy, but the patient response was not favorable Extremely useful to my practice 4 Somewhat useful to my practice 4 Not useful to my practice Responses 37

38 Buprenorphine and Benzodiazepine DUR Written Responses He is stable and safer than mixing street opiates with his benzo s. Patient no longer seeing me. He is stable, safer than using street drugs. Despite current prescriptions she knows she can not take benzodiazepines and I do not prescribe benzodiazepines or stimulants. Patient is drug testing before rx s written every month. Will discuss other prescription rx with her again. No known rationale. This is not an agent I prescribe in my buprenorphine opiate replacement therapy practice. 38

39 Buprenorphine and Benzodiazepine DUR Questions/Comments??? Next Step? 39

40 10/15/

41 Chronic Pain Management Standard Practice Long-acting opioid for primary throughout the day pain relief Short-acting opioid as needed for acute/breakthrough pain Duplication of long-acting may result in overdose and/or increase in side-effects 41

42 Patient Medication Profile Review 7 Patients identified who were receiving > 1 Long- Acting Opioid for > 2 months Letters sent on July 27 to prescribers for those 7 patients Included Patient Medication Profile Prescription Monitoring Program (PMP) Report 42

43 Letter Key Points Part of an overall opioid analgesic prescribing improvement project November 1, 2015 a hard edit for therapeutic duplication would be put into effect Need to consolidate to one agent OR Request prior authorization with justification and plan Described future initiatives > 1 short-acting Disallowing long-term short acting without long acting MED < or = to 120 mg/day 43

44 Patient # 1 48 year old female from Region 2 Diagnosis Other Chronic Pain Backache unspecified Lumbago LAO: Fentanyl and Morphine ER 44

45 Patient # 1 Prescription Fills May June 2015 August September /28 Methadone 5 mg # 90 8/22 Kadian 20 mg # 60 5/11 Morphine ER 15 mg # 84 9/21 Kadian 20 mg # 60 6/13 Morphine ER 15 mg # 84 9/23 Morphine IR 15 mg # 90 6/25 Fentanyl 12 mcg # 10 MED May 105mg MED June 73.8 mg MED August 40 mg MED September 85 mg 45

46 Patient #1 Response Received PA on 7/31 for Fentanyl as 2 nd LAO. Denied by RPh JG 46

47 Patient # 2 35 year old female from Region 4 Diagnosis Myalgia and Myositis LAO: Methadone and Morphine ER 47

48 Patient # 2 Prescription Fills May June 2015 August September /7 Hydromorphone2mg/ml # 25 8/9 Morphine ER 30 mg # 90 5/7 Methadone 10 mg # 90 8/9 Methadone 10 mg # 90 5/11 Morphine ER 30 mg # 90 8/9 Hydrocodone/APAP 10 mg # 180 5/11 Hydrocodone/APAP 10 mg # 180 8/27 Hydromorphone 2mg/ml # 25 6/10 Methadone 10 mg # 90 6/10 Morphine ER 30 mg # 90 6/10 Hydromorphone2mg/ml # 25 6/10 Hydrocodone/APAP 10 mg # 180 MED May 398 mg MED June 398 mg MED August 398 mg MED September No Claims 48

49 Patient # 2 Response Patient No fills September Per office nurse: Follow-up appointment with patient 11/4/2015. Will send chart notes after appointment. 49

50 Patient # 3 50 year old female from Region 5 Diagnosis Other Chronic Pain Joint Pain Shoulder Chronic Pain Syndrome LAO: Fentanyl Transdermal and Oxycontin 50

51 Patient # 3 Prescription Fills May June 2015 August September /15 Oxycontin 40 mg # 60 8/7 Oxycontin 40 mg # 60 5/15 Fentanyl 25 mcg # 10 8/7 Fentanyl 25 mcg # 10 5/15 Oxycodone 30 mg IR # 120 8/7 Oxycodone 30 mg IR # 120 6/12 Oxycontin 40 mg # 60 9/4 Oxycontin 40 mg # 60 6/12 Fentanyl 25 mcg # 10 9/4 Fentanyl 25 mcg # 10 6/12 Oxycodone 30 mg IR # 120 9/4 Oxycodone 30 mg IR # 120 MED May 360 mg MED June 360 mg MED August 360 mg MED September 360 mg 51

52 Patient # 3 Response No change Office nurse stated that follow-up appointment on 10/5/2015 to address change. Note that Fentanyl was approved in July 2013 because Oxycontin was ineffective. Oxycontin was to be discontinued. 52

53 Patient # 4 63 year old female from Region 5 Diagnosis Other Chronic Pain Pain in Limb LAO: Fentanyl Transdermal and Morphine ER 53

54 Patient # 4 Prescription Fills May June 2015 August September /14 MorphineER 30 mg # 90 8/11 MorphineER 30 mg # 90 5/14 Morphine ER 60 mg # 90 8/11 Morphine ER 60 mg # 90 5/14 Fentanyl 100 mcg # 15 8/11 Fentanyl 100 mcg # 15 5/14 Oxycodone IR 15 mg # 120 8/11 Oxycodone IR 15 mg # 120 6/13 MorphineER 30 mg # 90 9/11 MorphineER 30 mg # 90 6/13 Morphine ER 60 mg # 90 9/11 Morphine ER 60 mg # 90 6/13 Fentanyl 100 mcg # 15 9/11 Fentanyl 100 mcg # 15 6/13 Oxycodone IR 15 mg # 120 9/11 Oxycodone IR 15 mg # 120 MED May 510 mg MED June 510 mg MED August 510 mg MED September 510 mg 54

55 Patient # 4 Response No change in therapy Patient to be transferred over to the St. Luke s Pain Institute Note that Fentanyl was originally approved in December 2005 and has been continued to be approved for continuity of care. 55

56 Patient # 5 54 year old female from Region 5 Diagnosis Joint Pain Pelvis Chronic Pain Syndrome Sacrolitis, other Lumosacracal neuritis Other chronic pain Cervicalgia Lumbago LAO: Methadone and Morphine ER 56

57 Patient # 5 Prescription Fills May June 2015 August September /2 Morphine IR 30 mg # 90 8/6 Morphine IR 30 mg # 90 5/18 MorphineER 30 mg # 30 8/16 MorphineER 30 mg # 30 5/18 Morphine ER 60 mg # 30 8/16 Morphine ER 60 mg # 30 5/18 Methadone 10 mg # 90 8/16 Methadone 10 mg # 90 6/7 Morphine IR 30 mg # 90 9/5 Morphine IR 30 mg # 90 6/17 MorphineER 30 mg # 30 9/15 MorphineER 30 mg # 30 6/17 Morphine ER 60 mg # 30 9/15 Morphine ER 60 mg # 30 6/17 Methadone 10 mg # 90 9/15 Methadone 10 mg # 60 9/15 Methadone 5 mg # 30 MED May 420 mg MED August 420 mg MED June 420 mg MED September 420 mg 57

58 Patient # 5 Response Decrease in methadone dose from 30 mg per day to 25 mg per day Letter from physician 9/15/2015. I have been working with the patient with multimodal therapy to decrease her opioid requirements. I have started weaning down the patient s methadone dose with a plan to wean the patient off of methadone completely by November 1,

59 Patient # 6 61 year old female from Region 4 Diagnosis Cervicalgia Lumbago LAO: Methadone and Morphine ER 59

60 Patient # 6 Prescription Fills May June 2015 August September /1 Methadone 5 mg # 60 8/10 MorphineER 30 mg # 60 5/15 Morphine ER 30 mg # 60 8/10 Morphine ER 15 mg # 60 5/15 Morphine ER 15 mg # 60 8/13 Hydrocodone/APAP 10 mg # 180 5/21 Hydrocodone/APAP 10 mg # 180 8/24 Methadone 5 mg # 60 6/13 Morphine ER 30 mg # 60 9/8 Morphine ER 30 mg # 60 6/13 MorphineER 15 mg # 60 9/8 MorphineER 15 mg # 60 6/16 Hydrocodone/APAP 10 mg # 180 9/8 Methadone 5 mg # 60 6/24 Methadone 5 mg # 60 9/11 Hydrocodone/APAP 10 mg # 180 MED May 190 mg MED June 190 mg MED August 190 mg MED September 190 mg 60

61 Patient # 6 Response Physician to see patient on 10/14/2015 and will send follow-up notes 61

62 Patient # 7 59 year old male from Region 2 Diagnosis unspecified neuritis and radiculitis LAO: Oxycontin and Morphine ER 62

63 Patient # 7 Prescription Fills May June 2015 August September /16 Oxycontin 60 mg # 68 7/23 Oxycontin 60 mg # 68 5/20 Morphine ER 30 mg # 68 7/27 Morphine ER 30 mg # 68 5/15 Morphine ER 60 mg # 68 7/27 Morphine ER 30 mg # 68 6/18 Oxycontin 60 mg # 68 8/28 Oxycontin 60 mg # 68 6/18 Morphine ER 30 mg # 68 9/2 Morphine ER 30 mg # 68 6/23 Morphine ER 60 mg # 68 9/2 Morphine ER 30 mg # 68 MED May 360 mg MED June 360 mg MED August 360 mg MED September 360 mg 63

64 Patient # 7 Response Per chart notes 9/19/2015 discontinued Oxycontin. Increased MS Contin to 60 mg tid. Added Morphine IR 30 mg bid for breakthrough. Pain contract signed. This would decrease MED to 270 mg. Actual fill on 10/3/2015 no IR and continued to fill Morphine ER both 30 and 60 mg bid. 64

65 Foster Children High Utilizers Please refer to handout in packet 65

66 Current Interventions/Outcomes Studies Multiple dosage forms of oral paliperidone (Invega) prescribed concomitantly Physician Administered Drugs Second Generation Antipsychotic Use in Children 66

67 Multiple Dosage Forms of Oral Paliperidone (Invega) Prescribed Concomitantly Tablets available in the following strengths: 1.5mg 3mg 6mg 9mg Designed for once daily dosing (extended release formulation). Maximum FDA approved daily dose for paliperidone (Invega) is 12mg. Generics just became available September 2015 So far three manufacturers of generic: Actavis, Mylan, Patriot 67

68 Multiple Dosage Forms of Oral Paliperidone (Invega) Prescribed Concomitantly WAC(wholesale acquisition cost) prices of drug Brand Generic 1.5mg $28.33 $ mg $28.33 $ mg $28.33 $ mg $42.49 $

69 Multiple Dosage Forms of Oral Paliperidone (Invega) Prescribed Concomitantly 210 patients identified with at least one paid claim for oral Invega (claims evaluated from 7/1/15-9/30/15) 15 on only one tablet strength on two different tablet strengths

70 Multiple Dosage Forms of Oral Paliperidone (Invega) Prescribed Concomitantly Patients mg + 6mg tablets 3mg + 6mg tablets 3mg + 9mg tablets 6mg + 9mg tablets 70

71 Multiple Dosage Forms of Oral Paliperidone (Invega) Prescribed Concomitantly Monthly WAC drug cost for 30 day supply of 12mg/day dose Using two 6mg tablets: $1835 Using one 3mg plus one 9mg tablet: $2125 Plus have two monthly dispensing fees when using two different tablet strengths. Annual cost savings with using two 6mg tablets rather than one 3mg and one 9mg tablet (assuming $11.51 dispensing fee): $

72 Multiple Dosage Forms of Oral Paliperidone (Invega) Prescribed Concomitantly For 1.5mg plus 6mg tablets (7.5mg daily dose) Cost savings $5239 annually if round dose up to 9mg tablet once daily For 3mg plus 6mg tablet daily (9mg daily dose) Cost savings $5239 annually if use one 9mg tablet instead For 6mg plus 9mg tablets (15mg daily) Will need therapeutic justification for exceeding maximum FDA approved daily dose of 12mg 72

73 Multiple Dosage Forms of Oral Paliperidone (Invega) Prescribed Concomitantly Questions/Comments??? 73

74 Medications Billed as Medical Claims Since 2012, the Pharmacy Unit has reviewed 878 medical claim codes (primarily J-codes) that are medications administered as physician administered drugs Evaluated number and cost of paid claims as well as potential for inappropriate use 74

75 Medications Billed as Medical Claims Prior Authorization? 106 YES NO

76 Medications Billed as Medical Claims High utilization and low cost will not require prior authorization Examples: injectable morphine, Synvisc (knee injections), injectable methotrexate (first line therapy for many types of cancer) Also look at potential for inappropriate utilization (e.g. non-fda approved indications) 76

77 Medications Billed as Medical Claims Low utilization and high cost will likely require prior authorization Examples: botulinumtoxin, Xgeva, Vitrasert (ganciclovir intravitreal insert) Also look at potential for inappropriate utilization (e.g. non-fda approved indications) 77

78 Medications Billed as Medical Claims Some medications can be billed as EITHER a prescription drug claim or as a medical claim e.g. Synagis, immune globulins If the medication requires prior authorization if billed as a prescription drug claim, it will also require prior authorization if billed as a medical claim 78

79 Medications Billed as Medical Claims Now receive quarterly list of any new medications that can be billed as physician administered drugs (PAD) to determine if prior authorization should be required. Evaluate cost, anticipated frequency of use, potential for inappropriate use 79

80 Medications Billed as Medical Claims Example Lemtrada (aleumtuzumab) CD52-directed cytolytic monoclonal antibody indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS). Because of its safety profile, the use of Lemtrada should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS. 80

81 Medications Billed as Medical Claims Example Lemtrada (aleumtuzumab) First course: Dose is 12mg/day on 5 consecutive days. Second course: Dose is 12mg/day on 3 consecutive days given 12 months after first treatment course. Cost of first course of therapy: WAC (wholesale acquisition cost) $98,750 Recommendation: Require prior authorization 81

82 Medications Billed as Medical Claims Examples of Denials Botulinumtoxin for off-label indications: fecal incontinence, gastroparesis, excessive salivation. Entyvio for non-fda approved indication: hypereosinophilic syndrome (approved for treatment of Crohn s disease and ulcerative colitis) Supprelin implant for precocious puberty (alternative more cost effective therapy had not been tried) 82

83 Medications Billed as Medical Claims Pharmacists are reviewing these medications Even though claims are actually billed as medical claims Medication expertise Experience in reviewing requests for medical necessity as well as knowledge of alternative therapies Started to track time spent on this task weekly 83

84 Medications Billed as Medical Claims Example of Cost Savings Intervention: Lumizyme (algulocosidase alfa) Treatment of Pompe disease (hydrolytic lysosomal glycogenspecific enzyme) Patient is obese Reviewed package insert as well as clinical trial that used ideal body weight rather than actual body weight in obese patients with no change in clinical outcome Contacted prescriber who agreed it was reasonable to reduce the dose based on ideal body weight Patient doing well on reduced dose cost savings is $143,780 annually 84

85 Medications Billed as Medical Claims 85

86 Idaho Medicaid 86

87 OIG Report Second-Generation Antipsychotic Drug Use Among Medicaid-Enrolled Children: Quality-of-Care Concerns DHHS Office of Inspector General March

88 Premise of Study Drug class is widely used to treat children enrolled in Medicaid Second Generation Antipsychotics (SGA) have serious side effects Little clinical research has been done 88

89 States Included in Study California Florida Illinois New York Texas These states represented 39% of the total Medicaid payments for SGAs in

90 Methodology Board-certified child and adolescent psychiatrists reviewed medical records related to the sampled claims Objectives Quality of Care Concerns Non-medically Accepted Indications Prescribed for conditions described in black box warning 90

91 Results Too Young 17% Side Effects 7% Quality of Care Concerns 67% Taken Too Long 34% Wrong Dose 23% Wrong Treatment 41% Poor Monitoring 53% Too Many Drugs 37% 91

92 Medically Accepted Indications-FDA Approved* Drug Indication -1 Indication-2 Indication -3 Aripiprazole Schizophrenia Bipolar Irritability Associated with Autism Olanzapine Schizophrenia Bipolar Paliperidone Schizophrenia Quetiapine Schizophrenia Bipolar Risperidone Schizophrenia Bipolar Irritability Associated with Autism * Indications at time of study (2011) 92

93 SGAs Without FDA Approval for Children Asenapine* Clozapine Iloperidone Lurasidone Olanzapine/fluoxetine Ziprasidone * now indicated for bipolar 1 disorder 93

94 Uses Supported by One or More of 3 Drug Compendia Risperidone Behavioral syndrome- mental retardation Pervasive developmental disorder 94

95 Qualifying Statement It is difficult to conduct the clinical trials needed to obtain FDA approval or compendia support for pediatric uses of drugs 95

96 FDA Boxed Warning (aripiprazole, quetiapine, and olanzapine/fluoxetine) WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS WITH ANTIDEPRESSANT DRUGS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ABILIFY is not approved for the treatment of patients with dementia-related psychosis [see WARNINGS AND PRECAUTIONS (5.1)].Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [see WARNINGS AND PRECAUTIONS (5.2)].In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see WARNINGS AND PRECAUTIONS (5.2)]. 96

97 Recommendations to CMS by the OIG Work with States to: Perform utilization reviews of SGAs prescribed to children Conduct periodic reviews of medical records associated with claims for SGAs prescribed to children Consider other methods of enhanced oversight of SGAs prescribed to children, such as implementing peer review programs 97

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99 Utilization Data March through August 2015 Refer to Handout for Details by Drug and Age Unique Recipients 5,688 Claims 17,322 Expenditures $ 4,862,907 99

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103 Unique Recipients 1200 Children Receiving SGAs March August 2015 by Drug and Age to 6 7 to to

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107 OIG Suggestions Utilization Review Focus Age Duration of Treatment Overall Drug Regimens Periodic Reviews of Medical Records Associated with Claims for SGAS prescribed to children Focus Clear prescribing rationale Proper monitoring Dosages properly adjusted Other Methods of Enhanced Oversight Peer Review Programs HEDIS measures voluntary reporting 107

108 Suggestion for Next Steps Focus on ages 0 to 6 Quetiapine low doses possibly used for sleep Partner with Optum Other???? 108

109 Children 0 to 6 Recipients Claims Aripiprazole Olanzapine Paliperidone 2 7 Quetiapine Risperidone Ziprasidone

110 Low Doses of Quetiapine Potentially Used as a Hypnotic Unique Recipients Claims Expenditures Quetiapine 25 mg $ 7, Quetiapine 50 mg $ 29, $ 36,

111 Second-Generation Antipsychotic Use in Children Questions/Comments??? 111

112 Study Proposals for Upcoming Quarters: Top 150 Utilizers of Opioids Comparison to previous years Evaluate for the following criteria > 1 Long-Acting Opioid for > 2 months > 1 Short-Acting Opioid for > 2 months Short-Acting Opioid > 2 months with no Long-acting Opioid Short-Acting Opioid > 2 months with Short-Acting > 50% of Total Opioid dose Total morphine equivalent daily dose (MED) > 120 mg 112

113 Study Proposals for Upcoming Quarters: Opioid and benzodiazepine concomitant use Atypical Antipsychotics in children 6 years of age 113

114 Study Proposals for Upcoming Quarters: New CF Drugs Kalydeco and Orkambi Review overall cost of therapy (including all medications as well as hospitalizations and outpatient care costs) for CF patients now on Kalydeco or Orkambi Since 8/1/2015 we have 6 paid claims for 4 recipients for Orkambi and 3 paid claim for 2 recipients for Kalydeco totaling $166,

115 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 115

116 Prospective DUR Report Idaho Medicaid Program ProDUR Message Report September 2015 ProDUR ProDUR Message Message Message Severity Count Amount Drug To Drug 1 1,517 $490, ,025 $6,172, ,736 $16,939, $83.80 Drug To Gender 1 55 $22, ,092 $242, Drug To Known Disease 1 70,414 $14,363, ,642 $64,349, ,942 $70,728, Drug To Pregnancy 1 11 $1, $ A 9 $ B 52 $3, C 159 $17, D 9 $ X 5 $39.00 Duplicate Therapy 0 117,442 $33,248, Min Max 0 27,088 $6,681, Too Soon Clinical 0 21,962 $5,239, ALL 908,170 $218,502, Total Number of Claims with Messages 222,908 Average ProDUR Message Per Claim

117 DUR Fall Newsletter Clinical Alerts and Quarterly Trends Brainstorm for new topics 117

118 DUR Board Meeting October 15,