Follow-up to Previous Reviews. Buprenorphine and benzodiazepine

Transcription

1 14 April

2 Follow-up to Previous Reviews Buprenorphine and benzodiazepine 2

3 Buprenorphine and Benzodiazepine DUR Payment block went in to effect 1/6/16 requiring prior authorization for payment for either buprenorphine or benzodiazepine with overlapping days of service. 3

4 Buprenorphine DUR Total # of participants on oral buprenorphine Participants who paid cash for an opioid while on oral buprenorphine 4

5 Buprenorphine DUR /1/15-8/31/15 9/1/15-11/30/15 12/1/15-2/29/16 buprenorphine patients concomitant benzo while on buprenorphine cash paying opioids while on buprenorphine cash paying opioids AND concomitant benzo while on buprenorphine 5

6 Buprenorphine and Benzodiazepine DUR day follow-up on patients identified 9/1/15 11/30/15 with overlapping days of service (buprenorphine/benzodiazepine) Same prescriber-justified benzo usage Same prescriber-discharged from practice for non-compliance with therapy Same prescriber-discontinued benzo Different prescriber-justified benzo usage Different prescriber-discontinued benzo No response recevied 6

7 Buprenorphine and Benzodiazepine DUR Buprenorphine and benzodiazepine Dec 2015 Feb Same prescriber-justified benzo usage Suboxone prescriber discontinued or is weaning benzo Patient no longer on buprenorphine but continuing benzo Paying cash for benzo while on buprenorphine 7

8 Buprenorphine and Benzodiazepine DUR Detail on patients paying cash for benzo while on buprenorphine 8 No PA received for benzo, different prescriber than buprenorphine 6 3 No PA received for benzo, same prescriber for benzo/buprenorphine Buprenorphine prescriber stated patient should not be on benzos but patient getting benzos from different prescriber 8

9 Buprenorphine and Benzodiazepine DUR Questions/Comments??? 9

10 Ongoing Reviews Glucocorticoids, Inhaled Hepatitis C Update 10

11 Glucocorticoids, Inhaled On March 1, 2016, changes were made to the Idaho Enhanced Prior Authorization Program (EPAP) and changes were instituted in the POS System. On February 24, 2016, letters were sent to 635 Prescribers regarding 1,339 patients who had been receiving either Pulmicort Flexhalers or Flovent. 11

12 Glucocorticoids, Inhaled 12

13 Glucocorticoids, Inhaled (2/2016) 13

14 Glucocorticoids, Inhaled (3/2016) 14

15 Glucocorticoids, Inhaled Questions/ Comments??? 15

16 1 st Quarter

17 Hepatitis-C DUR 17

18 Hepatitis-C DUR 18

19 Hepatitis-C DUR 19

20 Hepatitis-C DUR 20

21 Hepatitis-C DUR 21

22 Hepatitis-C DUR 22

23 Hepatitis-C DUR 23

24 Hepatitis-C DUR 24

25 Hepatitis-C DUR 25

26 Hepatitis-C DUR 26

27 Hepatitis-C DUR 27

28 Hepatitis-C DUR 28

29 Hepatitis-C DUR 29

30 Hepatitis-C DUR 30

31 Hepatitis-C DUR Questions/Comments?? 31

32 (American Drug Utilization Review Society) February 25-27, states represented at meeting. 32

33 ADURS Annual Meeting Managed Care Proposed Regulations (Federal/State View) Paul L. Jeffrey PharmD (State View-Massachusetts) Discussed challenges with State Medicaid Pharmacy Programs and their Managed Medicaid partners Proposed changes and challenges Collection of rebates for MCO drugs MCO drug utilization review complies with FFS standard Prior Authorization process meets FFS standard Communication between State and MCO PA process IT processes not compatible for different MCO groups/state 33

34 ADURS Annual Meeting Managed Care Proposed Regulations (Federal/State View) Lindsey Browning Senior Policy Analyst (Federal View) Review of managed care regulation that will impact DUR programs MCOs covering outpatient drugs must operate DUR program and coordinate with state s DUR program 14 day Fee-for-service period while beneficiaries select a health plan States must develop a comprehensive quality strategy that identifies specific quality metrics and performance targets for improvement. Updated every 3 years (MCO and FFS) Regulations to empower states to conduct greater oversight of subcontracted entities. 34

35 ADURS Annual Meeting Oklahoma s Hepatitis-C Program Bethany Holderread, PharmD Reported a pre and post PA program for hepatitis-c agents PA program improved non-adherence from 19% to 7% Reported significant increase in medication adherence without higher overall costs Program challenges: Involvement with Prescribers, pharmacies, patients, obtaining SVR results, compliance monitoring, and accurate therapy start dates. 35

36 ADURS Annual Meeting New Drugs 2016 Tom Frank, Pharm.D. BCPS Enteresto (sacubitril/valsartan)-novartis Praluent (alirocumab)-regeneron Repatha (evolocumab)-amgen Jardiance (empagliflozin)-boehringer Ingelheim Corlanor (ivabradine)-amgen 36

37 ADURS Annual Meeting Pipeline Preview 2016 Maria M. Lowe, Pharm.D., BCPS Oncology Infectious Diseases Cardiovascular Central Nervous System Endocrine 37

38 38

39 ADURS Annual Meeting Key Points: Oncology continues to be a fast-paced area of development 9 oncology approvals in 2014, 13 in 2015 Lots of movement with multiple myeloma and lung cancer Large price tags remain an issue 39

40 ADURS Annual Meeting Pipeline Trends: Themes of 2015: Priority Review Vouchers Developers of treatments for a neglected disease receive a voucher for priority review from the FDA to be used with a product of its choice or sold to another developer Voucher Purchases 7/2014: Sanofi and Regeneron for $67 million 11/2014: Gilead for $125 million 5/2015: Sanofi for $245 million 8/2015: AbbVie for $350 million 9/2015: AstraZeneca for undisclosed amount 40

41 ADURS Annual Meeting Key Points: Infectious Diseases: Direct Acting Antivirals Market is growing and changing rapidly. SVR12 cure rates at >95% after 12 weeks of treatment Current studies are reporting cures within 6 weeks Focus on expanding to multiple genotypes 41

42 ADURS Annual Meeting Bio-similars: The Medicaid Perspective Steve Liles, Pharm.D. Multiple biologicals will be losing patent protection Remicade, Neulasta, Synagis, Pulmozyme, Epogent/Proctrit, Humira, Enbrel, Rituxan, Xolair Biologics Price Competition and Innovation Act (BPCIA) Allows for approval of biologics through abbreviated pathway ( 351k ) Legislative Intent establish bio-similars pathway balancing innovation and consumer interests 42

43 ADURS Annual Meeting Bio-similar Highly similar to reference product with no clinically meaningful differences in safety, effectiveness, purity, potency. BPCIA Patent Dance Goal foster negotiations and agreements between reference and biosimilar manufacturers without litigation. Concept multiple steps of notification and response throughout approval process Problem varying interpretations of requirements leading to litigation 43

44 ADURS Annual Meeting CMS discussion with John Coster Ph.D., Rph CMS Hepatitis C letter (November 5, 2015) Managed Care Organizations and State Medicaid programs. 44

45 ADURS Annual Meeting Questions/Comments? 45

46 Current Interventions/Outcomes Studies Cystic Fibrosis (CF) Kalydeco and Orkambi Second-Generation Antipsychotic Use in children < 6 years old Ophthalmic Antibiotic/Steroid Combinations Skeletal Muscle Relaxants 46

47 Cystic Fibrosis (CF) Kalydeco and Orkambi Thirteen patients identified with paid claims for either Kalydeco or Orkambi between 11/01/15 and 01/31/16. Orkambi - 10 Kalydeco

48 Cystic Fibrosis (CF) Kalydeco and Orkambi Background The CFTR gene provides instructions for making a protein called the cystic fibrosis transmembrane conductance regulator. This protein functions as a channel across the membrane of cells that produce mucus, sweat, saliva, tears, and digestive enzymes. 48

49 Cystic Fibrosis (CF) Kalydeco and Orkambi Background The channel transports negatively charged chloride ions into and out of cells which controls the movement of water in tissues which is necessary for the production of thin, freely flowing mucus. Mucus is a slippery substance that lubricates and protects the lining of the airways and digestive system. 49

50 Cystic Fibrosis (CF) Kalydeco and Orkambi Lots of different things can go wrong when making the cystic fibrosis transmembrane conductance regulator protein. 50

51 Cystic Fibrosis (CF) Kalydeco and Orkambi Classes of Mutations 51

52 Cystic Fibrosis (CF) Kalydeco and Orkambi Kalydeco approved by FDA on 1/31/2012 Approved for the following mutations in the CFTR gene for cystic fibrosis patients 2 years and older: G551D, G1244E, G1349D, G178R, G551S, R117H, S1251N, S1255P, S549N, S549R Not effective in patients homozygous for the F508del mutation in the CFTR gene. $259,161 annually for usual adult dosage. First claim paid by Medicaid: 8/24/

53 Cystic Fibrosis (CF) Kalydeco and Orkambi Orkambi approved by FDA on 7/02/2015 Approved for cystic fibrosis patients 12 years and older who are homozygous for the F508del mutation in the CFTR gene. First claim paid by Idaho Medicaid: 8/10/2014 $318,727 annually for usual adult dosage. Pipeline Many other CF drugs in investigational trials. 53

54 Cystic Fibrosis (CF) Kalydeco and Orkambi 13 Kalydeco or Orkambi Patients Identified between 11/01/15 1/31/ Medicaid is only insurance Primary insurance with Medicaid as secondary 6 Had primary during the past year but now only Medicaid 54

55 Cystic Fibrosis (CF) Kalydeco and Orkambi Total Medicaid expenditure for these 13 patients the year prior to starting Orkambi or Kalydeco: $759,886 Average PMPY expenditure: $63,324 Range: $448 to $284,688 Note: Multiple patients have or had primary insurance that paid for the majority of treatment cost. 55

56 Cystic Fibrosis (CF) Kalydeco and Orkambi Questions or Comments 56

57 Idaho Medicaid 4/14/

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

59 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 59

60 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% 60

61 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 61

62 Study Design Reviewed medication profiles of children that were 5 years or younger during calendar year 2015 and had at least one claim for a second generation (atypical) antipsychotic 62

63 Demographics 49 children met criteria Gender Female 9 (18%) Male 40 ( 82%) None were foster children Prior Authorizations in place for 19 children 17 age 2 dosage form 2 indication 63

64 Number of Children Number of Children Age Characteristics Age During Study Period Age Original Antipsychotic Start Age (years) During Study Period Age (years) Drug Start 64

65 Frequency (patients) Antipsychotic Received aripiprazole olanzapine quetiapine risperidone 65

66 Presumed Indication None Listed 7 Other Disorders of Psychological Development Intermittent Explosive Disorder Explosive Personality Emotional Disturbance of Childhood Oppositional Defiant Disorder 5 Conduct Disorder Bipolar 2 2 Sleep Disturbance Pervasive Development Disorder 3 3 Autism 19 Adjustment Disorder ADHD

67 Supported Indication FDA Indication No Compendia No Evidence/Guideline Supported 68

68 Diagnosis Grouping Pervasive Developmental Disorder Autism Disorder Asperger s Disorder Childhood Disintegrative Disorder Rett s Disorder Disruptive Behavior Disorders Oppositional Defiant Disorder Conduct Disorder Disruptive behavior not otherwise specified 69

69 Risperidone (Risperdal) FDA Approval Indication Autistic Disorder - Irritability Bipolar 1 Schizophrenia Age > 5 years > 10 years > 13 years Compendia Indication Age Behavioral syndrome Mental retardation > 5 Gilles de la Tourette s Syndrome > 6 Pervasive Developmental Disorder 5 12 years open label study 70

70 Aripiprazole (Abilify) FDA Indications Indication Age Autistic Disorder Psychomotor Agitation > 6 Bipolar 1, adjunctive > 10 Bipolar 1, monotherapy > 10 Gilles de la Tourette s Syndrome > 6 Schizophrenia > 13 Compendia: none 71

71 Quetiapine (Seroquel, Seroquel XR) FDA Indications Indication Age Manic bipolar 1 disorder, acute, monotherapy > 10 Schizophrenia > 13 Compendia: None 72

72 Olanzapine (Zyprexa) FDA Approved Indication Bipolar 1, Acute mixed or manic episodes Schizophrenia Age > 13 years > 13 years 73

73 Others with Limited FDA Approval Asenapine (Saphris) Olanzapine/fluoxetine (Symbyax) Bipolar 1, acute mixed or manic phase (monotherapy or adjunct) Bipolar 1, Depressed > 10 years > 10 years Paliperidone (Invega) Schizophrenia > 12 years 74

74 SGAs Without FDA Approval for Children clozapine (Clozaril, Fazaclo, Versacloz) Iloperidone (Fanapt) lurasidone (Latuda) ziprasidone (Geodon) brexpiprazole (Rexulti) 75

75 Drug Class Review: Second Generation Antipsychotic Drugs ⱡ Drug Effectiveness Review Project Comparative evidence is poor No head-to-head trials No effectiveness trials Results Compared with placebo, risperidone, aripiprazole, and olanzapine improved behavioral symptoms in children and adolescents with pervasive developmental disorders Risperidone and quetiapine showed efficacy in children and adolescents with disruptive behavior disorders. ⱡ November 2013 update 76

76 Practice Parameter American Academy of Child and Adolescent Psychiatry (AACAP): Practice Parameter for the Use of Atypical Antipsychotic Medications in Children and Adolescents (2011) These drugs are increasingly being prescribed to younger and younger children and disproportionately more frequently to males, to those in foster care and to those with Medicaid insurance 77

77 AACAP Due to the paucity of published information, practice parameter limited to recommendations for children ages 5 to 18 years Good evidence for Autism/PDD irritability for risperidone and aripiprazole Schizophrenia/psychosis for olanzapine, quetiapine and aripiprazole Tourette's/tics for risperidone Bipolar disorder for quetiapine 78

78 Summary of Indications Indication Evaluation Criteria Number Meeting FDA Approved 11 22% FDA Approved Indication, but below age Compendia Supported Compendia Supported, but below age Published Quality Evidence/Guidelines 11 22% 0 2 4% 2 4% Percentage Summary Indication not supported 22% Indication unknown 14% Supported Indication 27% yes indication, no age 37% Evidence/Guidelines, but below age 5 10% Indication Unknown 7 14% 79

79 Prescribers Physician Assistant Nurse Practitioner Adolescent Medicine Pediatrician Family Medicine Child and Adolescent Psychiatrist Behavioral/Developmental Specialist Psychiatrist 29% Specialists 27% Generalists 45% Mid-Level Pediatric Psychiatrist Number of Prescribers 80

80 Prescribers Meeting Best Practice Child and Adolescent Psychiatrists 60% Psychiatrists 43% Pediatricians 38% Physician Assistants 20% Nurse Practitioners 18% 81

81 Length of Therapy (as of December 31, 2015) 12 months or greater 29% Less than 6 months 47% 6-12 months 24% 82

82 Medication Dose Medication Mean Dose (mg) Range (mg) Risperidone to 4 Quetiapine to 100 Aripiprazole 6 1 to 20 Olanzapine 5 (1 patient) 83

83 Number of Children Concurrent Mental Health Diagnoses 17 children had additional mental health diagnoses 3 of the 17 had more than one additional diagnosis ADHD Anxiety Disorder Major Depresseive Disorder Post-Traumatic Stress 84

84 Concurrent Other Classes of Psychotropics 38 patients had 1-3 additional psychotropics 29 Stimulants 18 Alpha Adrenergic agents 6 Antidepressants 3 Mood Stabilizers 1 Benzodiazepine 1 Non-stimulant ADHD agent 85

85 86

86 1 st Quarter

87 Antibiotic/Steroid Ophthalmics Review the utilization of combination steroid/antibiotic ophthalmic agents. Chronic use can lead to cataracts, glaucoma, secondary infections, or delayed healing. Concerns from previous meetings of who is prescribing these agents and at what frequency. Specialist in ocular medicine should be prescribing most of these agents for chronic use. 88

88 Antibiotic/Steroid Ophthalmics 1 st Quarter of 2016 Data collection from specific therapeutic class code: Q6I-EYE ANTIBIOTIC - CORTICOID COMBO Demographics of Combinations Agents: Mean age: 17 (0 to 81) Females: 168 Males:

89 Antibiotic/Steroid Ophthalmics 90

90 Antibiotic/Steroid Ophthalmics 91

91 Antibiotic/Steroid Ophthalmics 92

92 Antibiotic/Steroid Ophthalmics 2 Family NP s All the rest from Ophthalmology/Optometrist 93

93 Antibiotic/Steroid Ophthalmics 94

94 Antibiotic/Steroid Ophthalmics In conclusion: The majority of antibiotic/steroid combinations appears to be utilized by ophthalmologist/optometrists. Chronic use of antibiotic/steroid combinations is prescribed by ophthalmologist/optometrists. Neomycin/Polymyxin/Dexamethasone and Tobramycin/Dexamethasone are most often prescribed. 95

95 Antibiotic/Steroid Ophthalmics Questions/??Comments 96

96 1 st Quarter 2016 DUR 97

97 Skeletal Muscle Relaxants Skeletal muscle relaxants are commonly use to treat the following conditions: Spasticity from motor neuron syndromes. FDA approved agents: baclofen, dantrolene, and tizanidine. Muscular pain or spasms from peripheral musculoskeletal conditions. Studies are limited to short term use for acute low back pain. Extended courses of medications should be reserved for patients clearly showing continued benefits from therapy without major adverse effects Diagnosis and Treatment of Low Back Pain: A Joint Clinical Practice Guideline from the American College of Physicians and the American Pain Society. Annals of Internal Medicine, Volume 147, Number 7, October 2,

98 Skeletal Muscle Relaxants Classification of Skeletal Muscle Relaxants P&T June 2014 Vol. 39 No. 6 99

99 Skeletal Muscle Relaxants There are no set guidelines as to which agents are preferred. Clinical judgment with proper understanding of the drug characteristics and patient-specific parameters should guide appropriate drug selection. IMS Health data from Reported that carisoprodol, cyclobenzaprine, and metaxalone accounted for more than 45% of all prescriptions written for the management of musculoskeletal pain. 1 1 Toth PP, Urtis J. Commonly used muscle relaxant therapies for acute low back pain: a review of carisoprodol, cyclobenzaprine hydrochloride, and metaxalone. Clan There 2004;26(9):

100 Skeletal Muscle Relaxants Drug utilization review of skeletal muscle relaxants Determine the total number of claims of skeletal muscle relaxants for 1 st Quarter Evaluate for potential chronic use: Days supply per claim for prescribed agents. Number of claims for unique patients. Cost for skeletal muscle relaxants. 101

101 Skeletal Muscle Relaxants 102

102 Skeletal Muscle Relaxants 103

103 Skeletal Muscle Relaxants 104

104 Skeletal Muscle Relaxants 105

105 Skeletal Muscle Relaxants 106

106 Skeletal Muscle Relaxants 107

107 Skeletal Muscle Relaxants 108

108 Skeletal Muscle Relaxants 109

109 Skeletal Muscle Relaxants 1 st Quarter of 2016 Total Claims= 9,050 Total Unique recipients=4,615 Total Cost= $157, % of clients had 1 claim/quarter. 64% of claims were for days supply. Could be data entry issue at the pharmacy level. Cyclobenzaprine and methocarbamol had an average days supply of 21 days. 110

110 Skeletal Muscle Relaxants Future DUR projects Determine the number of clients prescribed skeletal muscle relaxants chronically with narcotics agents and/or benzodiazepine's. Determine specific diagnosis for chronic treatment with skeletal muscle relaxants. Spasticity Chronic back pain 111

111 Skeletal Muscle Relaxants Questions/Comments?? 112

112 Study Proposals for Upcoming Quarters: Opioid and benzodiazepine concomitant use Low dose quetiapine Multiple dosage forms of quetiapine prescribed concomitantly 113

113 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 114

114 Prospective DUR Report Idaho Medicaid Program ProDUR Message Report March 2016 ProDUR ProDUR Message Message Message Severity Count Amount Drug To Drug 1 1,760 $748, ,075 $5,860, ,183 $19,683, $21.93 Drug To Gender 1 83 $10, ,098 $237, Drug To Known Disease 1 70,472 $13,811, ,411 $75,943, $81,882, Drug To Pregnancy $2, $5, A 6 $ B 56 $19, C 129 $18, D 5 $2, X 6 $ Duplicate Therapy 0 133,297 $40,350, Min Max 0 31,320 $10,530, Too Soon Clinical 0 23,739 $7,653, ALL 1,004,753 $256,761, Total Number of Claims with Messages 244,299 Average ProDUR Message Per Claim

115 DUR Board Meeting April 14,