Connecticut Medical Assistance Pharmacy Program Drug Utilization Review (DUR) Program DUR Board Meeting

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1 March 2018 Minutes ATTENDEES Board Members Present: Kenneth Fisher, R.Ph. (Chair), Keith Lyke, R.Ph., Bhupesh Mangla, MD, Richard Gannon, Pharm.D., Ram Illindala, MD, Dennis Chapron, PharmD., Carol Drufva, R.Ph. Ex Officio Non Voting Member Present: Heather Kissinger, Pharm. D. (HID), Jason Gott, R.Ph. (DSS), Carly Whitehouse, PharmD (DXC) Guests: Folger Tuggle (Bioverativ), Donna Bischoff (Indivor), Scott Hocking (Spark Therapeutics), Candace Gura (Celgene), Lisa Libera (Teva), Beth D Arubrosia (Novartis), Paul Liberty (Bristol Myers Squibb) 1. INTRODUCTORY BUSINESS Ken Fisher called the meeting to order at 6:40 p.m. 2. Previous Meeting Minutes The December 2017 DUR meeting were approved with the following changes: o Page 1, header section, change 2016 to 2017 o Page 5, criteria 27, bullet 2, change April to March 3. Follow Up from Previous Meeting The Board reviewed section 3 titled Follow up from the December. Follow up 1, a request was made to perform a targeted intervention on Lyrica utilization for the FFS population. Heather stated that an intervention was performed during the February 2018 cycle and 720 letters were sent out for criteria The intervention targeted patients who were receiving Lyrica without first attempting a trial with gabapentin. The Board requested to research new criteria that identifies patients who are receiving gabapentin or pregabalin and warn about the risk of abuse. Rich stated that development of criteria around abuse of these products has to be done carefully because some patients who utilize these products do have legitimate neuropathic pain. Dennis questioned whether there was a step therapy requiring patients to have a trial with gabapentin prior to receiving pregabalin. Jason stated that step therapy for this does not currently exist and it would have to be approved by the Office of Policy Management (OPM). Heather stated she would work with Jason to determine if this is something the Board could request and would follow up during the June meeting. Dennis questioned which classes of medications have step therapy in place for the FFS program. 1

2 March 2018 Minutes Carly and Jason listed the following classes; the statins, the cytokine antagonists, acne agents, Proton Pump Inhibitors (PPIs), and antimigraine agents. Follow up 2, a request was made to look into the interaction between triptans and safinamide and report back during the March meeting to determine if triptans should be added to Util B before approving criteria #27. Heather referred the Board to section 8, page 17 and stated that the prescribing information for safinamide does not list all serotonergic agents as contraindicated with safinamide and there is no discussion of possible triptan interaction in the FDA Medical Review or the Clinical Pharmacology Biopharmaceutics Review for safinamide. It was recommended to create a separate criteria regarding the potential interaction between safinamide and the triptans, rather than adding the triptans to the current serotonin syndrome criteria for safinamide, if the Board agreed that a criteria should be created for the potential drug drug interaction. The Board voted to approve the original criteria for safinamide/serotonergic agents and to table the safinamide/triptans criteria until the June DUR Board meeting for further consideration. Follow up 3, a request was made to add columns to the Top 50 Prescribers of Controlled Substances Report to show number of unique recipients and total quantities dispensed for each prescriber. Heather referred the Board to section 9 of the DUR meeting packet and stated those requested changes were made to the report. The report was now sorted by quantity dispensed, rather than number of prescriptions. 4. Criteria Trend Summary Heather discussed the criteria trend analyses tables included in the DUR Board meeting packet. The tables list the number of criteria exceptions found before and after DUR intervention letters are mailed. Criteria are suppressed for patients who are selected for intervention for 6 months after letters are mailed so that prescribers do not receive the same letter for the same patient month after month. In almost all cases the number of criteria exceptions noted 7 months after DUR letters were mailed was reduced as compared to the number of exceptions prior to letters being mailed. Dennis asked what the ratio between codeine prescriptions and tramadol prescriptions were in the pediatric population. Heather stated that the number of codeine prescriptions was higher than the tramadol prescriptions but would follow up with 1 st QTR 2018 prescription counts during the June meeting. 5. Program Summary Review The Board reviewed the program summary for 4 th quarter Heather stated that compared to the 3 rd QTR 2017 prescription claims cost increased by approximately $5 million, the number of prescriptions increased by approximately 60,000, the number of unique recipients receiving a prescription increased by approximately 15,000 and the average paid per prescription decreased by approximately $1.50 during 4 th QTR Top 50 Medications by Total Cost The Board reviewed the Top 50 medications by total price for 4 th quarter

3 March 2018 Minutes The Board commented that Lyrica was listed as the 11 th most costly medication for 4 th QTR Dennis requested to know when Lyrica would be available as a generic. Heather stated she would look into the request. 7. Intervention Activity Report Heather reviewed the Intervention Activity Report included in the DUR Board packet. It was stated that the Intervention Activity Report is a monthly summary of the distribution of letters mailed to prescribers and also summarizes the main criteria that were reviewed during 4 th QTR In October 2017, 2,844 profiles were reviewed and 1,657 letters were sent. The main intervention reviewed for the adult population was: Underutilization of Antipsychotics (405 letters) Lock in criteria (583 letters) The main intervention reviewed for the pediatric population was: Metformin Related Criteria (174 letters) In November 2017, 2,819 profiles were reviewed and 1,661 letters were sent. The main intervention reviewed for the adult population was: Concurrent use of Stimulants and Opiates (419 letters) Lock in criteria (423 letters) The main intervention reviewed for the pediatric population was: Pediatric Psychotropic Medication Max Dosing (176 letters) In December 2017, 2,823 profiles were reviewed and 1,392 letters were sent. The main interventions reviewed for the adult and pediatric populations were based on the top 1000 profiles with the highest risk scores. The Lock in criteria review generated 458 letters. 8. RetroDUR Criteria New Criteria The following criteria as written in the DUR Board packet were approved by the DUR Board 1. Opioid Cough & Cold Medications / Therapeutic Appropriateness Heather stated she would query the utilization of hydrocodone products in the pediatric population to compare against the number of codeine and tramadol prescriptions for 1 st quarter Keith stated that he does see some prescriptions for liquid hydrocodone products for pediatric patients and in some instances they are large quantities. Dennis inquired about the potential issue with hydrocodone in 2D6 ultra rapid metabolizers. 3

4 March 2018 Minutes Rich explained that hydrocodone is both a 2D6 and 3A4 substrate and that the problem occurs with the 2D6 ultra rapid metabolizers in that they convert large amounts of hydrocodone to hydromorphone, which puts them at risk for overdose. 2. Semaglutide / Overutilization 3. Semaglutide / Nonadherence 4. Semaglutide / Medullary Thyroid Carcinoma & MENS II 5. Semaglutide / Therapeutic Appropriateness (Black Box) 6. Semaglutide / Pancreatitis 7. Semaglutide / Therapeutic Appropriateness 8. Pregabalin CR / Overutilization DPN 9. Pregabalin CR / Overutilization PHN 10. Pregabalin CR / CKD 4, 5, ESRD & Hemodialysis 12. Pregabalin CR / Thiazolidinediones 14. Pregabalin CR / Nonadherence 15. Semaglutide / Insulin and Insulin Secretagogues 16. Semaglutide / Pregnancy / Delivery, Miscarriage & Abortion 17. Semaglutide / Therapeutic Appropriateness 18. Semaglutide / Renal Impairment 19. Lesinurad/Allopurinol / Overutilization 20. Lesinurad/Allopurinol / Lesinurad 21. Lesinurad/Allopurinol / Severe Renal Impairment 22. Lesinurad/Allopurinol / Mild to Moderate Renal Impairment 23. Lesinurad/Allopurinol / Tumor Lysis Syndrome & Lesch Nyhan Syndrome 24. Lesinurad/Allopurinol / Severe Hepatic Impairment 25. Lesinurad/Allopurinol / Nonadherence 27. Lesinurad/Allopurinol / CYP2C9 Inducers 28. Lesinurad/Allopurinol / Epoxide Hydrolase Inhibitors 29. Lesinurad/Allopurinol / Hormonal Contraceptives 30. Lesinurad/Allopurinol / Aspirin > 325 mg/day 31. Allopurinol / Thiazides 32. Lesinurad/Allopurinol / Therapeutic Appropriateness Pediatrics The following criteria was tabled during the December 2017 DUR meeting and approved during the March 2018 DUR meeting: 1. Safinamide / Serotonergic Agents The following criteria were tabled by the Board during the March DUR meeting with requested follow up: 11. Pregabalin CR / CKD 3 The Board requested to know if there was guidance for dosage adjustment that could be included in the alert message for CKD Pregabalin CR / Heart Failure 4

5 March 2018 Minutes The Board requested to know the incidence of capillary permeability, peripheral edema, and exacerbation of congestive heart failure in patients who receive pregabalin. 2. Safinamide / Triptans The following criteria were approved as amended during the March DUR meeting: 26. Lesinurad/Allopurinol / Moderate CYP2C9 Inhibitors Change 2D6 to 2C9 in the alert message The following criteria were rejected by the Board during the March DUR meeting: 33. Lesinurad/Allopurinol / CYP3A4 Substrates The following criteria were tabled by the Board during the March meeting until further information regarding point of sale processing for this medication could be determined: 34. Voretigene neparvovec rzyl / Therapeutic Appropriateness (0 1 yoa) 35. Voretigene neparvovec rzyl / Therapeutic Appropriateness 36. Voretigene neparvovec rzyl / Therapeutic Appropriateness 37. Voretigene neparvovec rzyl / Cataracts 38. Voretigene neparvovec rzyl / Increased Intraocular Pressure 39. Voretigene neparvovec rzyl / Endophthalmitis 40. Voretigene neparvovec rzyl / Therapeutic Appropriateness 41. Voretigene neparvovec rzyl / Therapeutic Appropriateness 9. Top 50 Pharmacies and Prescribers of Controlled Substances The Board reviewed the top 50 pharmacies and prescribers of controlled substances report for 4 th QTR Heather stated that new columns were added to the report the number of unique recipients per prescriber who received a controlled substance as well as the total quantities dispensed for each prescriber. The report was sorted by quantity dispensed. 11. Quarterly Opioid Utilization Trends The Board reviewed the Opioid Utilization Report for 4 th QTR It was mentioned that cost and utilization continue to trend downward. Carol questioned if overdoses related to opioids have increased or decreased in Connecticut and stated that a decrease in prescription opioids might mean an increase in illicit opioid use. Rich stated that the 2017 overdose statistics for Connecticut are most likely available now. Heather stated she would follow up with the 2017 Connecticut opioid overdose information during the June meeting. Keith inquired about the utilization of medical marijuana within the Connecticut Medicaid population and if there was a correlation between the decrease in prescription opioid use and potential increase in medical marijuana use. 5

6 March 2018 Minutes Jason stated it is not possible for DSS to track medical marijuana utilization as that falls under the Department of Consumer Protection (DCP). Rich stated that the DCP is working on comparison of prescribers to show prescribing rates of opioids compared to their peers but currently he is not aware that DCP or the Prescription Monitoring Program (PMP) tracks diagnoses for use of medical marijuana. 12. Quarterly Newsletter The Board reviewed the March 2018 DUR newsletter and approved with no changes. The Board made the following suggestions for potential future newsletter topics; generic pipeline list, hepatic metabolizing enzyme polymorphisms, e prescribing and ideas to decrease polypharmacy, and de intensification or de prescribing of medications by class. New Business 2018 DUR meeting dates Heather stated that a draft of the FFY 2017 Annual CMS report would be sent to the Board one month prior to the June meeting for review. The scheduled date for delivery of the draft is May 17 th. It was requested that the Board members review the report and come prepared to discuss during the June 14 th DUR meeting. The remainder of the 2018 DUR Board meeting dates were confirmed as the following: o June 14 th o September 13 th o December 13 th The meeting was adjourned at 7:55 pm. 6

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