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Utah Medicaid Dur Report June 2020 Cgrp Antagonists

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Utah Medicaid Dur Report June 2020 Cgrp Antagonists UTAH MEDICAID DUR REPORT JUNE 2020 CGRP ANTAGONISTS FOR ACUTE TREATMENT OF MIGRAINE: NURTEC ODT (RIMEGEPANT) UBRELVY (UBROGEPANT) Report Finalized in May 2020 Report Presented in June 2020 Drug Regimen Review Center Valerie Gonzales, Pharm.D., Clinical Pharmacist Jeffrey Sperry, Pharm.D. Candidate Elena Martinez Alonso, B.Pharm., MSc MTSI, Medical Writer Lauren Heath, Pharm.D., MS, BCACP, Assistant Professor (Clinical) Vicki Frydrych, B.Pharm., Pharm.D., Clinical Pharmacist Jacob Crook, MStat, Data and Statistical Analyst Joanne LaFleur, PharmD, MSPH, Associate Professor University of Utah College of Pharmacy, Drug Regimen Review Center Copyright © 2020 by University of Utah College of Pharmacy Salt Lake City, Utah. All rights reserved 1 Contents Introduction ................................................................................................................................................. 3 Table 1. Nurtec ODT and Ubrelvy Indication and Dosing .................................................................. 3 Methods ....................................................................................................................................................... 4 Disease Overview ......................................................................................................................................... 4 Table 2. Migraine Diagnostic Criteria of the International Classification of Headache Disorders .... 5 Pharmacotherapy for Migraine Headache ............................................................................................... 6 Table 3. American Headache Society Clinical Guidance for Treatment of Adults with Migraine ..... 9 Place in Therapy ......................................................................................................................................... 10 Table 4. Pharmacokinetic Parameters for Nurtec OCT and Ubrelvy ............................................... 10 Clinical Studies ........................................................................................................................................ 12 Safety ......................................................................................................................................................... 15 Table 5. Safety Concerns for Oral CGRP Receptor Antagonists ...................................................... 16 Prior Authorization Considerations ............................................................................................................ 19 Existing Prior Authorization Criteria for CGRP Antagonists .................................................................... 20 Summary .................................................................................................................................................... 21 References .................................................................................................................................................. 22 Appendix .................................................................................................................................................... 26 Table 1. Dose Adjustments with Enzyme or Transport Inhibitors/Inducers ................................... 26 2 Introduction Rimegepant (Nurtec ODT) and ubrogepant (Ubrelvy) are among the relatively new drug class of calcitonin gene-related peptide receptor antagonists (CGRP-RAs) developed for the treatment of migraine. These two agents are approved for the relief of active migraine with or without aura in adults (ie, acute/abortive migraine therapies). Previously approved CGRP antagonists are indicated for the prevention of migraine (eptinezumab, erenumab, fremanezumab, galcanezumab). Rimegepant and ubrogepant are not indicated for migraine prevention; though rimegepant has positive preliminary results for migraine prevention in a recently completed phase 2/3 study, with sponsor plans to submit supplemental application for a label extension.1 Rimegepant (75 mg) and ubrogepant (50 mg or 100 mg) are taken at the onset of migraine symptoms. A second dose of ubrogepant can be taken if needed (eg, if symptoms persist or return) 2 hours following the first dose; the maximum dose of ubrogepant is 200 mg per 24 hours.2,3 Since the maximum dose per day of rimegepant is 75 mg, a second rescue dose a couple hours following the first dose is not an option. Safety is established for treating up to 8 migraines per month with ubrogepant, and up to 15 migraines per month with rimegepant. Nurtec ODT is an orally disintegrating tablet (ODT) to be placed on or under the tongue, whereas Ubrelvy is a conventional oral tablet. Dose adjustments or restrictions for each medication are dependent on drug interactions involving cytochrome P450 (CYP) 3A4 metabolism or breast cancer resistant protein (BCRP) and/or P-glycoprotein (P-gp) meditated pathways. Table 1 provides the strengths, indication, and dosing for the use of rimegepant and ubrogepant. This report reviews the place-in-therapy for the acute CGRP-RAs for migraine treatment and outlines potential safety concerns. Prior authorization (PA) discussion points and potential criteria are provided. Abortive products for migraine with preferred status on the Utah Medicaid Preferred Drug List (PDL) include Relpax (eletriptan) tablets, and generic rizatriptan and sumatriptan tablets, with quantity limits in place for these agents. Nurtec ODT and Ubrelvy are designated as non-preferred on the PDL. A drug class-specific PA is currently in place for all CGRP antagonists, acute and preventive therapies. Details of the PA are discussed on page 20 of this report. There were less than 5 pharmacy claims for ubrogepant use in the fee-for-service Medicaid population and 0 for rimegepant (based on claims data from September 2019 through April 2020). Table 1. Nurtec ODT and Ubrelvy Indication and Dosing Ubrelvy (ubrogepant) tablets Nurtec ODT (rimegepant) § Strengths: 50 mg, 100 mg § Strength: 75 mg Dosage § Configuration: boxes of single-unit § Configuration: blister pack with 8 orally Forms dose as a count of 6, 8, 10, 12, or 30 disintegrating tablets. tablets per box Approved Indicated for acute treatment of migraine with or without aura in adults Indication • Dosage: 50 mg or 100 mg; may take a • Dosage: 75 mg Dosinga second dose if needed, separated by at • Maximum is 75 mg/24-hours least 2 hours after the initial dose • Safety of treating > 15 migraines per 30-day • Maximum dose is 200 mg/24-hours period is not established 3 Table 1. Nurtec ODT and Ubrelvy Indication and Dosing • Safety of treating > 8 migraines per 30- • Open blister pack with dry hands; avoid day period is not established pushing the tablet through foil; take • Dose adjustments are required if used in immediately after opening the blister pack combination with CYP3A4 • Avoid use with strong inhibitors of CYP3A4; inducers/inhibitors; BCRP and/or P-gp avoid a second dose within 48 hours of the transport inhibitors; and for hepatic or first when used with moderate inhibitors of renal impairment (see Table 1 of the CYP3A4; avoid use with strong/moderate Appendix for details); avoid with strong inducers of CYP3A4 or inhibitors of P-gp or CYP3A4 inducers BCRP transporters a See Table 5 for dose adjustments related to renal or hepatic insufficiency. See Table 1 of the Appendix for dose adjustments related to concomitant medications. Abbreviations: BCRP, breast cancer resistance protein; CYP, cytochrome P450 enzyme; ODT, orally disintegrating tablet; P-gp, P-glycoprotein Methods Background information regarding migraine disease state and guidance or position statements by key organizations regarding pharmacological treatment of migraine were sought at the following websites: I. For treatment guidelines we searched websites of the American Academy of Neurology (https://www.aan.com/policy-and-guidelines/guidelines/), and the American Headache Society (https://americanheadachesociety.org/resources/guidelines/). II. For professional prescribing information (ie, product labeling) we searched the drug sponsor’s website for each product’s most up-to-date package insert. III. Evidence-based drug information databases, Micromedex and Lexicomp Literature searches for reviews and randomized controlled trial (RCT) information were performed in OvidMedline and in Epistemonikos, searching rimegepant OR ubrogepant as keywords; see the Appendix for search strategies. Disease Overview Migraine is a common primary headache disorder. Findings from the 2018 National Health Interview Survey (NHIS) showed that approximately 16% of American adults experienced migraine or severe headache over a 3-month recall period, with prevalence disproportionately higher in women than in men (21% vs. 11%, respectively).4 In the pediatric population, prevalence increases with increasing age.5 The estimated prevalence of migraine in children and adolescent males is 6% and in females is 9.7% according to population-based studies.6 Migraine symptoms can reduce quality of life, and negatively affect school and work productivity or social engagements.7,8 Most patients with migraine rate their pain level as severe.7 Approximately 20% of patients with episodic migraine suffer from moderate to severe headache-related disability.9 Of the subpopulation experiencing high-frequency migraines (chronic migraine), approximately 50% have moderate to severe disability.9 According to a 2017 survey (Migraine in America Symptoms and Treatment Study), 96% of patients (out of 3930 respondents)
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