News & Research

Migraine Prevention With CGRP Drugs: Cost, Safety

migraine-prevention-cgrpYou’ve probably heard that monoclonal antibodies that inhibit CGRP are the exciting treatment in development for migraine prevention, but details have been scarce. New Migraine Drugs Promise Relief—But at a Steep Price is a different look at the drugs than has been published thus far. I’ve hit some highlights below and added my own thoughts, too.

Migraine Prevention is Costly & Access is Restricted

  • Monoclonal antibodies are made from living cells and are expensive to produce. They are among the most expensive drugs on the market right now.
  • Experts the writer interviewed gave cost estimates of between $8,000 and $20,000 per year. The CEO of Alder BioPharmaceuticals, which is one company working to develop these drugs, compared them to antibodies used to lower cholesterol. Those cost $14,000 a year when they came out. “I suspect we might be in that ballpark,” said Alder’s CEO.
  • Insurance companies tend to restrict drugs with hefty price tags. Think about the hoops people have to jump through for Botox, which costs insurance companies $6,000 to $10,000 per year.
  • Like with Botox, many insurance companies will likely require patients to fail trials of other medications before approving them for these new drugs. It’s likely that Botox will be one of those drugs that patients have to fail.

My Thoughts on Cost

  • How many insurance policies will simply exclude these drugs? Writing this post prompted me to see what Botox costs with my current insurance coverage (which I’m quite happy with). I assumed I would have to pay 30% of the cost. Nope, Botox is not covered at all. Even if it my doctor says I need it and even if it’s the only drug in the world available for my condition, my insurance will not cover Botox. Will they really cover an even more expensive drug?
  • Although studies are looking at both episodic and chronic migraine, I wonder how difficult it will be to get insurance companies to cover the drugs for people with episodic migraine. Drug coverage restrictions often center around quantity, but what are the rules are for a drug where quantity is always the same? If a drug has FDA approval for episodic migraine, can insurance companies require that a person have a minimum number of migraine attacks per month before they’ll cover it? If so, will this ultimately mean only people with chronic migraine get the drug?
  • On the bright side, these new drugs are likely to bring down the cost of Botox.

 

Drug Safety is Still in Question

  • These drugs are in Phase 2 trials. Half of drugs fail in Phase 3 studies or do not receive FDA approval.
  • When Phase 3 trials test the drugs on thousands more patients, dangerous side effects could be discovered.
  • We don’t know what the long-term effects of inhibiting CGRP will be.
  • CGRP is distributed throughout the body and is involved in many process, including regulating blood flow and wound-healing.

My Thoughts on Safety

  • Thus far, studies have shown a low side effect risk for these drugs. This is encouraging, but studies have had limited numbers of participants. More people using the drugs—both in late-stage trials and, if approved, in widespread use—will be required before we can really know what the side effects will be.
  • The very novelty that makes these drugs exciting also makes them scary—CGRP hasn’t been inhibited before. What will the long-term effects of the drugs be? How will they impact other physiological processes? What will research find after the drugs have been in use five years? fifteen? thirty?
  • I probably wouldn’t be thinking much about the long-term safety if it weren’t for recent studies linking anticholinergic drugs to dementia and cognitive impairment. Anticholinergics have been used widely for at least 70 years, but the first of these studies (that I can find) was published just 11 years ago. How many people were negatively affected by these drugs before the link was found?

I’m still excited about the potential of the drugs, but my concerns weigh heavily. Maybe these worries will shake out by the time the drugs are available in a few years. Right now, I don’t see myself clamoring to try them as soon as they’re available… although if my migraine attacks are back to being severe by then, I’ll probably camping out to secure my place toward the front of the line.

9 thoughts on “Migraine Prevention With CGRP Drugs: Cost, Safety”

  1. Can’t wait to try this new vaccine. Have had bad migraines since 1988. Have now been on disability from my job for past 10 months. Also besides migraines I get bad cluster migraines. Am willing to be in drug trial. Can give my Dr contact if needed.

  2. Commenter above asked four months ago and might have already found a trial…
    But I see this today and can tell you that my family member started a CGRP phase 3 trial last week, at the New England Institute for Neurology & Headache in Stamford, CT.
    We are not living in CT, but this is worth the traveling for us.
    For us the chance of a less disabled life is, without question, worth traveling, & any long term risk.
    They are running several different studies.
    Good luck!

  3. How can I find a CGRP trial to see if I qualify? I’ve tried googling different topics and can’t find one. I’ve had migraines for the last 20 years, have a baby to take care of, and need help! Thank you for any suggestions!

    1. You need to contact your Neurologist with your migraines They should know if they have the study.
      This has been a great relief to me. Good luck I believe they have them all over.

  4. Whose Phase 3 CGRP trial did you get into? I’ve been turned down for every trial I’ve applied for because of: 1) Too many headaches per month, or 2) Tried too many preventative drugs.

  5. I am also starting the third phase trial for CGRP. I want my life back this is awful .I have had the Botox 3×9 months. I had reactions from Botox each time. I do have good migraine meds that work

  6. I’m participating in phase 3 trial CGRP soon also. go in mid-June for initial discussion about trial. i am excited. i’ve lost so much due to chronic migraine i am willing to risk long-term risks for short term gain. i’ve taken so many preventatives over the past 30 years it is ridiculous. if one actually works, i’m going for it. Although I respect your caution and thoroughness of researching this and thinking about it calmly and methodically.

  7. I just finished a double blind / open-label CGRP study for Amgen. During the open label phase I received a fairly low dose of the drug, and immediate effects were difficult to quantify, but I do feel I regained much of the life I lost. I am starting a phase 3 trial soon. I experienced no side effects and I guess I’m willing to risk problems later down the road for less pain now. The cost is definitely a concern!

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