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On May 17, 2018, the U.S. Food and Drug Administration approved Aimovig (erenumab). Aimovig is the first in an eagerly-awaited new class of migraine treatments called CGRP antagonists.1

We wrote a two-part series about the CGRP class earlier this year. These links will allow you to explore much more about their mechanism of action and potential market.

Key facts:

  • Aimovig is approved to treat chronic migraine, acting to prevent migraine attacks. Other CGRP antagonists are being developed to treat acute migraine (those already in-progress).2

  • In trials Aimovig reduced the number of average monthly migraine days by 1-2 days per month vs. placebo.3

  • Aimovig is administered once per month via self-injection.4

  • Members will access Aimovig through standard retail pharmacies.

  • Aimovig has a Wholesale Acquisition Cost (excluding discounts) of $6,900 per year – much lower than many analysts were expecting ($8,500 – $10,000).5

OptumRx is ready to manage these new medications

At OptumRx we have been closely monitoring these drugs for the last two years as they have moved through the development pipeline. Our clients benefit from the combined expertise of our clinical pharmacists, physician specialists, and pharmacotherapy experts who have crafted rigorous utilization management (UM) criteria specifically for Aimovig.

As part of our First Mover Initiative, Aimovig’s potential formulary position with respect to prior authorization criteria has already been reviewed and approved by the independent OptumRx and UnitedHealthcare P&T Committees including:

  • Prior Authorizations (Notification)
  • Specialist vs. Primary Care prescribing & consultation
  • Quantity Limits
  • Step Therapy to lower cost alternatives
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Contracting strategies

In addition, OptumRx also employs market-differentiated contracting strategies specifically designed to properly manage high-cost medications.

Before we begin negotiations with a manufacturer, we coordinate closely with our clinical teams to receive their recommendations. Once these are established, we move to the contracting phase with manufacturers. Our primary objective: to achieve the lowest net cost possible consistent with the clinical team’s recommendations.

Conclusion

OptumRx closely monitors and evaluates the drug development pipeline landscape for all upcoming brand, first-time generic, and biosimilar drug approvals. This constant vigilance extends into the post-approval world, with clinical surveillance, and our cost management strategies.

As a result of these preparations, Aimovig-specific coverage, tiering decisions, and formulary management programs for all lines of business are already being implemented.

Please consult with your consultant or OptumRx representative to learn more about these steps, as well as the resources, programs and clinical assistance members will need to manage their new medications effectively, safely, and with confidence.

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References

  1. FDA News Release: FDA approves novel preventive treatment for migraine. May 17, 2018. At: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm608120.htm
  2. New England Journal of Medicine. Clinical Practice: Migraine. Aug. 10, 2017. At: http://www.nejm.org/doi/full/10.1056/NEJMcp1605502
  3. American Journal of Managed Care. Amgen, Novartis Announce Positive Results of Erenumab Trial for Episodic Migraine. April 20, 2018. At: http://www.ajmc.com/newsroom/amgen-novartis-announce-positive-results-of-erenumab-trial-for-episodic-migraine
  4. Seeking Alpha. Amgen And Novartis Aimovig FDA Approval Gives First Mover Advantage, Will That Be Enough? May 21, 2018. At: https://seekingalpha.com/article/4175753-amgen-novartis-aimovig-fda-approval-gives-first-mover-advantage-will-enough
  5. Fierce Pharma. Amgen's Aimovig won its first-in-class migraine nod. Will payers step up to the $6,900 price? May 17, 2018. At: https://www.fiercepharma.com/pharma/amgen-wins-blockbuster-nod-for-first-class-migraine-med-aimovig
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STATEMENT REGARDING FINANCIAL INFLUENCE:
This article is directed solely to its intended audience about important developments affecting the pharmacy benefits business. It is not intended to promote the use of any drug mentioned in the article and neither the author nor OptumRx has accepted any form of compensation for the preparation or distribution of this article.

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