New Migraine Drugs Approach Approval

Insightsfeature October 16, 2019

New Migraine Drugs Approach Approval Preventive, Acute Therapies Provide Options, Could Drive Additional Cost More than 39 million About 30% Americans suffer from of patients migraine, costing an don't get relief estimated $36 billion from common in lost productivity treatments.2 each year.1

Relief may be in sight for those patients, with several new migraine drugs poised to enter the market over the next few months. At the same time, the new medications could raise costs for payors.

Migraine is marked by intense headache, nausea, light and/or sound sensitivity, and vision changes. The market for new treatments is expected to be strong given that the debilitating condition is the third most prevalent illness in the world and about 30 percent of patients don’t get relief from the most common treatment, triptans.1,2

New Treatments on the Horizon The U.S. Food and Drug Administration (FDA) approved Reyvow, as an acute treatment, last week.3 Four additional therapies are nearing the end of the approval process, three of which are treatments for acute migraine, while the fourth is a preventive.

Pending and Just-Approved Migraine Drugs

Drug Projected Use Review Stage Expected Approval

Reyvow oral Acute Approved Oct 11, 2019 N/A

ubrogepant oral Acute Pending FDA approval Q4 2019

rimegepant oral Acute Pending FDA approval Q1 2020

BHV-3500 intranasal Acute Late-stage trial Q2 2021

eptinezumab intravenous Prevention Pending FDA approval Q1 2020 (preventive) Reyvow An oral therapy, Reyvow falls into the “ditan” therapy class. In phase III clinical trials, patients taking Reyvow did not experience the blood vessel constriction and cardiovascular issues experienced by those on many current treatments such as triptans, and therefore avoided side effects such as chest and throat tightness. The drug is expected to work for patients who experience visual disturbances, as well as those who don’t.4

Reyvow falls into a new class of migraine treatments called "ditans."

CGRP Inhibitors Three calcitonin gene-related peptide (CGRP) inhibitors were approved in 2018 as injectable prophylactics and have now launched: Aimovig (erenumab-aooe), Ajovy (fremanezumab) and Emgality (galcanezumab). Emgality received additional FDA approval for treatment of cluster headaches and was designated a Breakthrough Therapy for that indication.

Of the four CGRPs in the pipeline, two are oral medications, one is meant to be administered nasally, and the fourth is an infused therapy for migraine prevention. These drugs interrupt the pain-sensing mechanism and their advantage over traditional treatments is that they don’t cause chest or throat tightness, which is helpful for those who cannot take more commonly used, less-expensive generic triptans.5

• Ubrogepant Users in phase III trials experienced migraine relief within two hours of ingestion, lasting for up to 48 hours.5 The FDA is reviewing a new drug application (NDA) for ubrogepant.5

• Rimegepant This drug is being developed as an acute treatment (as well as a preventive) that affects the biochemistry and biomechanism of migraine. In phase III trials, patients were pain free as quickly as one hour of taking rimegepant and remained so for at least 48 hours.6 The therapy is currently undergoing FDA review as an acute treatment.

• BHV-3500 This is the first CGRP inhibitor to be administered as a nasal spray. During late-stage trials, BHV-3500 delivered pain relief within two hours of inhalation that was sustained for at least 48 hours.7,8

• Eptinezumab A prophylactic treatment, eptinezumab is a CGRP inhibitor delivered as a quarterly antibody infusion in which patients reported 75 percent fewer migraine-days after treatment.9,10 The FDA is reviewing a biologics license application for eptinezumab.11

It is unclear what the launch price for any of the acute migraine treatments in the pipeline will be, but it is almost certain that the cost of treating migraine is likely to increase significantly in comparison to triptans for payors and plan members. The CGRP inhibitors approved with an indication for migraine prevention, Emgality, Aimovig and Ajovy, have a list price of $575 each a month.12,13,14 Cost Management Considerations

Among the CGRP inhibitor treatments for migraine already in the market, Ajovy and Emgality are preferred on our Standard Control Formulary. Payors can also consider implementing utilization management measures to help ensure that lower-cost alternatives are tried first and that patients are directed to appropriate formulary options.

It’s important to ensure that patients have access to the most clinically appropriate medications and that payors have the right cost management tools in place to address the impact on trend. That’s why we constantly monitor the pipeline and proactively develop There is still much to be and offer strategic cost management tools. Prior to launch, we seek input from external thought leaders to help model potential impact. learned about the safety Dedicated resources, including experienced clinicians, closely follow and effectiveness of the and evaluate the drug pipeline to assist with decisions regarding new drugs, and whether appropriate formulary placement and potential designation as a specialty drug. At launch, new-to-market review and an assessment of efficacy depends on clinical appropriateness inform strategic plan design options, such as types, frequency or tiered placement, and utilization management, including use of prior duration of symptoms. authorization and step therapy requirements.

Our goal is to develop and implement the best approach to deliver lowest net cost to help payors better manage specialty spend while ensuring appropriate patient access.

Troy Brennan, M.D. Executive Vice President, Chief Medical Officer, CVS Health

1. https://migraineresearchfoundation.org/about-migraine/migraine-facts/. 2. https://www.biopharmadive.com/news/allergan-cgrp-ubrogepant-data-nda-fda-market/522437/. 3. https://www.prnewswire.com/news-releases/lillys-reyvow-lasmiditan-the-first-and-only-medicine-in-a-new-class-of-acute-treatment-for-migraine-receives-fda-approval-300937322.html. 4. https://migraineagain.com/new-migraine-medication-lasmiditan/. 5. https://www.drugs.com/nda/ubrogepant_190311.html. 6. https://www.biohavenpharma.com/science-pipeline/cgrp/rimegepant. 7. https://www.biohavenpharma.com/science-pipeline/cgrp/bhv-3500. 8. https://www.prnewswire.com/news-releases/biohaven-achieves-targeted-therapeutic-exposures-of-bhv-3500-a-third-generation-small-molecule-cgrp-receptor-antagonist-300788789.html. 9. https://www.alderbio.com/pipeline/eptinezumab/. 10. https://www.fiercebiotech.com/biotech/alder-builds-case-for-cgrp-migraine-drug-eptinezumab. 11. https://www.practicalpainmanagement.com/resources/news-and-research/fda-accepts-alder-biopharmaceuticals-bla-eptinezumab. 12. https://www.lillypricinginfo.com/emgality. 13. https://www.aimovig.com/paying-for-aimovig/. 14. https://www.drugs.com/medical-answers/cost-migraine-drug-ajovy-3445564/.

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Image source: Licensed from Getty Images, 2019.