Emgality Approved for Migraine Prevention—Lilly Says Free for Some Insured Patients

Eli Lilly and Company received approval from the U.S. Food and Drug Administration (FDA) to market Emgality™ (galcanezumab-gnlm) for migraine prevention in adults on September 27, 2018. Emgality is the latest CGRP blocker for the prevention of migraine.1 Earlier this year, the FDA approved Aimovig™ (erenumab-aooe) and Ajovy™ (fremanezumab-vfrm).

What are CGRPs?

CGRP (calcitonin gene-related peptide) is a newly identified protein that has been discovered as a key component in some migraine attacks. CGRP is considered a neurotransmitter (a chemical messenger) and is present throughout the brain and body. Researchers have found that levels of CGRP are higher during a migraine attack, which led to the development of products to block the protein.

Emgality offered free to those with insurance

As part of their patient support program, Lilly is offering a year’s worth of Emgality treatment to those with commercial insurance, hoping to capture a significant portion of the migraine community despite being the third anti-CGRP to market. Offering the product free for a year will also allow time for the company to work with insurance companies on coverage, while providing those with migraine a new option for prevention.1

Lilly has stated that Emgality will be available in pharmacies soon. The list price of the drug is $575 monthly, or $6,900 annually.1

Emgality reduces migraine days

Emgality is a monoclonal antibody that targets CGRP, binding to the protein and inhibiting its activity. The CGRP blocker was studied in Phase III clinical trials in patients with episodic and chronic migraine. In the trial involving people with episodic migraine (4-14 migraine days a month), a third of patients saw their migraine days decrease by at least 75%, and two-thirds experienced a decrease of at least 50%. In people with chornic migraine (at least 15 migraine days a month), 28% had their migraine days cut in half, compared to 15% of those on placebo.1

Migraine prevention with a monthly injection

Emgality is a once-monthly injection that can be self-administered under the skin (subcutaneously). The recommended dose is an initial “loading” dose of 240 mg, given as two 120 mg injections, and a monthly maintenance dose of 120 mg.1,2

While the FDA approval is specifically for adults with migraine, Emgality has also been studied in cluster headache. Data from early clinical trials suggests that Emgality may also provide relief from cluster headache.3

Side effects

Some patients in clinical trials experienced a hypersensitivity (allergic reaction) to Emgality, which can cause rash, itching, difficulty breathing, and swelling of the mouth, lips, tongue, or throat. The most common side effects experienced by patients taking Emgality in clinical trials were injection site reactions, such as soreness and redness.2

View References
  1. Lilly's Emgality™ (galcanezumab-gnlm) Receives U.S. FDA Approval for the Preventive Treatment of Migraine in Adults. PR Newswire. Available at https://www.prnewswire.com/news-releases/lillys-emgality-galcanezumab-gnlm-receives-us-fda-approval-for-the-preventive-treatment-of-migraine-in-adults-300720720.html. Accessed 9/28/18.
  2. Emgality label. Available at http://pi.lilly.com/us/emgality-us-ppi.pdf. Accessed 9/28/18.
  3. Highleyman L. Galcanezumab Offers Help for Cluster Headache and Migraine. Available at https://www.medpagetoday.com/meetingcoverage/ahs/73836. Accessed 9/28/18.

Comments

View Comments (5)
  • ChronicallyEverything
    4 months ago

    This is what I was talking about. I think this is the reason behind why federal programs are denied so many of these free or reduced cost programs. It’s basically where’s the money going and nobody wants the govt asking. It’s crazy. It’s mostly on generics, but I believe new drugs like these can also fit the model.

    https://www.bloomberg.com/graphics/2018-drug-spread-pricing/

  • ChronicallyEverything
    4 months ago

    None of these savings plans works with Medicare, Medicaid or TriCare. I suspect it has to do with the thing that prescription drug companies do with pharmacy rebates, kickback, middleman and the thing called the “spread”. I’m just now learning about it myself. It’s this crazy system of payouts and payoffs and ppl getting money that patients should be getting in savings but they aren’t. The govt doesn’t participate in those programs so that’s why govt insurance can’t get the savings I think.

  • Shadow
    4 months ago

    I have a medicare part D plan that does not cover Emgality but apparently, I cannot get any savings. Why?

  • ccf23
    4 months ago

    Thats my question too. I have been waiting anxiously for these new drugs to come out primarily so I can get back to work. It makes no sense for Medicare plans to exclude the drug. And why do the drug companies exclude us? I am so happy for the people who are doing well on the CGRP meds, but what about the rest of us who don’t have commercial insurance and can’t afford it. I sent an application for financial assistance to one drug company, and when I called to check on the status I was told they just put it in my file as duplicate paperwork. I know we have to fight for these things but sometimes every day is a fight just to deal with the pain, nausea, etc. Sorry I am venting. I try to remember that everything happens for a reason.

  • Joanna Bodner moderator
    4 months ago

    You are not alone in this frustration! I know Ajovy states on their site **Together we can identify programs to help you lower your costs, access other resources and get answers to your insurance coverage questions.

    This includes patients with government insurance (including Medicare and Medicaid) and those uninsured or underinsured. If you have any questions, you can call Aimovig Ally™ at 1-833-AIMOVIG (833-246-6844).**

    I have not noticed if Emgality or Ajovy state anything specifically for those w/o commercial ins., they too have toll free numbers on their site. Maybe it is worth exploring to see if they can offer any assistance if you have not already! I truly wish you all the best!

  • Poll