New Migraine Drugs Approach Approval

Preventive, Acute Therapies Provide Options, Could Drive Additional Cost

FEATURE
October 16, 2019
Executive Vice President and Chief Medical Officer, CVS Health
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Specialty Pharmacy Pipeline | Drugs to Watch

Anticipated Launches | Q4 2019 – Q1 2020

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More than 39 million Americans suffer from migraine, costing an estimated $36 billion in lost productivity each year.https://migraineresearchfoundation.org/about-migraine/migraine-facts/. 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, those 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.https://migraineresearchfoundation.org/about-migraine/migraine-facts/.,https://www.biopharmadive.com/news/allergan-cgrp-ubrogepant-data-nda-fda-market/522437/.

New Treatments on the Horizon

The U.S. Food and Administration (FDA) approved Reyvow, as an acute treatment, last week.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. 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 (preventive) Prevention Pending FDA approval Q1 2020
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 (preventive) Prevention Pending FDA approval Q1 2020

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.https://migraineagain.com/new-migraine-medication-lasmiditan/.

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.https://www.drugs.com/nda/ubrogepant_190311.html.

  • Ubrogepant
    Users in phase III trials experienced migraine relief within two hours of ingestion, lasting for up to 48 hours.https://www.drugs.com/nda/ubrogepant_190311.html. The FDA is reviewing a new drug application (NDA) for ubrogepant.https://www.drugs.com/nda/ubrogepant_190311.html.
  • 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.https://www.biohavenpharma.com/science-pipeline/cgrp/rimegepant. 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.https://www.biohavenpharma.com/science-pipeline/cgrp/bhv-3500.,https://www.prnewswire.com/news-releases/biohaven-achieves-targeted-therapeutic-exposures-of-bhv-3500-a-third-generation-small-molecule-cgrp-receptor-antagonist-300788789.html.
  • 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.https://www.alderbio.com/pipeline/eptinezumab/.,https://www.fiercebiotech.com/biotech/alder-builds-case-for-cgrp-migraine-drug-eptinezumab. The FDA is reviewing a biologics license application for eptinezumab.https://www.practicalpainmanagement.com/resources/news-and-research/fda-accepts-alder-biopharmaceuticals-bla-eptinezumab.

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.https://www.lillypricinginfo.com/emgality.,https://www.aimovig.com/paying-for-aimovig/.,https://www.drugs.com/medical-answers/cost-migraine-drug-ajovy-3445564/.

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.

patient in specs There is still much to be learned about the safety and effectiveness of the new drugs, and whether efficacy depends on types, frequency or duration of symptoms.
Patient in Specs There is still much to be learned about the safety and effectiveness of the new drugs, and whether efficacy depends on types, frequency or duration of symptoms.

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 and offer strategic cost management tools. Prior to launch, we seek input from external thought leaders to help model potential impact. Dedicated resources, including experienced clinicians, closely follow and evaluate the drug pipeline to assist with decisions regarding appropriate formulary placement and potential designation as a specialty drug. At launch, new-to-market review and an assessment of clinical appropriateness inform strategic plan design options, such as tiered placement, and utilization management, including use of prior authorization and step therapy requirements.

Want to learn more about the migraine drug pipeline? Ask Us
FEATURE
October 16, 2019
Executive Vice President and Chief Medical Officer, CVS Health

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This document contains references to brand-name prescription drugs that are trademarks or registered trademarks of pharmaceutical manufacturers not affiliated with CVS Health.

Image source: Licensed from Getty Images, 2019.

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