CGRP Approved, Now What?

CGRP Approved, Now What?

The first calcitonin-gene-related peptide (CGRP) blocker, Aimovig, was approved by the FDA on May 17, 2018. This is the first medication developed specifically to prevent migraine. Clinical trial results have shown minimal side effects and more than half of patients experience some level of reduction in migraine days per month.

Aimovig has become available to patients much faster than the average drug, which is fantastic. However, advocates fear that doctors and insurance companies were not prepared for the demand that exploded within days of FDA approval. A month after approval some patients have received the drug, while others are stuck in red tape. Below, I try to break-down the most asked questions about CGRP and access.

How do I get a prescription?

Dr. Amaal Starling, headache specialist at the Mayo Clinic, gives the following advice for what you can do now that will help you and your doctor to decide if a CGRP drug is right for you:

  • Make sure you are seeing a headache specialist or neurologist, if not, make an appointment with one tomorrow!
  • Keep a headache diary. Use an app or an old school calendar, mark all days that you have ANY headache, not just the really bad ones. Have a monthly tally of headache days ready for when you see the headache specialist or neurologist.
  • Make a comprehensive list of all prescription medications that have failed to treat your migraine. Have this ready for your headache specialist or neurologist as well.

Eligibilty and side effects

There have been a lot of questions about who is eligible to receive the new CGRP drugs. Here's a summary of information for those with cluster attacks, children with migraine, and patients who have been taking Botox, as well as the known side effects.

CGRP and cluster

The effects of CGRPs on the prevention of cluster attacks is still in clinical trials being performed by the pharmaceutical company Eli Lilly and showing good results. Amgen’s Aimovig only received approval by the FDA for the treatment of migraine. For those who have cluster, hopefully your day will come soon!

CGRP and children

Aimovig is NOT approved for use in children. Clinical trials recently began with pediatric patients.

CGRP and Botox

Clinical trials excluded the use of Botox while taking Aimovig. There is a theory that both medications target CGRP. Some doctors may want there to be a gap period between your last round of Botox injections and your Aimovig injection as a precaution, although it is not contraindicated. Some patients have also been told that their insurance is unlikely to cover both, however, each insurance company is different. Call your insurance company before canceling any upcoming Botox appointments.

CGRP and pregnancy

As with many clinical trials, women who were pregnant were excluded. Because the effects Aimovig may have on a fetus are unknown, your doctor may ask you to take a pregnancy test before writing a prescription.

Side effects

  • Constipation
  • Injection site reaction – the skin around the injection site may become red or irritated and typically resolves on its own.
  • Latex allergy – A dry rubber latex derivative is used in the injection device. For those with a latex allergy, consult with your doctor. Having an allergist on hand when the first injection is given is an option, depending on the severity of your allergy.

How do I get two months of Aimovig for free?

If your doctor prescribes Aimovig, you could be eligible to take part of a program, called Aimovig Ally, that provides patients with two months of the medication for free. This program expires at the end of 2018. There is paperwork that you and your healthcare provider have to fill out and can be found here. Your doctor’s office will submit the form to start the process.

Based on Aimovig's website, if you have “commercial” insurance, you are eligible. This includes healthcare provided by your employer or through the Affordable Care Act (Obamacare). However, if you receive healthcare benefits through Medicare or Medicaid, it is unlikely that you will be eligible. Massachusetts residents are also not eligible due to a law in that state.

Will my insurance company cover Aimovig?

While some contracts between insurance companies and the pharmaceutical company have been signed, it will take time for each insurance carrier to determine if/how they will cover Aimovig. Here’s what you can do now to find out:

  • Call your insurance company now to ask if they are covering Aimovig. If so, have them look at your specific plan and ask them to tell you how much it will cost you. If you have a high deductible, you may have to meet that financial obligation before insurance will cover even part of the cost of the medicine.
  • If your insurance company says they are NOT covering Aimovig, it’s possible that they will add it in the months to come – so keep calling back. Or ask for a supervisor who may have more detailed information.
  • As mentioned above, your insurance plan may cover part of the cost ($575 per month) but depending on your plan you may have to pay a portion of the expense out of pocket. Aimovig has a co-pay assistance program (which is separate from the two month free Aimovig Ally program).

Worried about access to CGRPs?

Many migraine patient advocacy groups are working to address patient access issues. You are not alone and you deserve access to care that is appropriate for the disease you have. As resources and information become available, we'll be sure to update you.

  • First, you and your doctor have to decide if this is the right treatment for you to try, depending on where you are in your migraine journey.
  • Many insurance companies will require prior-authorization.
  • Your insurance company to cover and approve it. Even if Aimovig is on their list of approved drugs, they still may deny it. They may set up internal rules that require you to have tried and failed other migraine therapies before they will approve Aimovig. It’s a practice called step-therapy and generally puts the onus on you, the patient, to prove what medications you have been on in the past.
  • If your insurance company does deny coverage of Aimovig, their website has an Appeals Letter and a Letter of Medical Necessity that your doctor’s office can use to help you appeal their decision.

Setting expectations

Lastly, with all the hype around CGRPs it's easy to get your hopes up. However, Aimovig is not a cure. There is still no cure for migraine disease. Make sure you set your expectations appropriately. There are three other pharmaceutical companies who are developing CGRPs that are still in trials. If Aimovig doesn’t work for you, just keep in mind that one of the other three may give you some relief, but it's also possible this class of drugs won't work for you.

If you need background on CGRP, has a lot of resources on this groundbreaking preventative drug for migraine disease.

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