FDA Approves New Migraine Drug What You Should Know about Aimovig

Migraineurs have been anxiously awaiting the news that the “FDA approves new migraine drug”. So it’s no surprise that there are many questions now on their minds. There are lots of messages and questions posted about it in Facebook groups and message boards since the announcement of Amgen Novartis’ approval of Aivomig last Thursday.

Aivomig is the first of its class CGRP receptor antagonist to be approved. In fact, some people are already receiving prescriptions for it from their doctors.

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A Longer History Than Most Realize

CGRP is a protein peptide that was discovered to play a crucial role in migraine headaches as far back as the mid 1980s. The first thing scientists did was to develop drugs that targeted the peptide itself. This turned out to be toxic to some of the participants in the early stages of testing and they were quickly abandoned. They then turned their sights to controlling the CGRP by blocking the receptors within the brain, thus “receptor antagonist.”

The First of Their Kind, But What Does This Mean?

The receptor antagonists are a new class of drugs and the first drug to target the cause of migraine, but they are not the long awaited cure that so many are hoping for. They have shown great results in each clinical trial with an average of 50% of participants reporting a marked drop in the number of headaches and headache days. It also comes without many side effects, In fact, the only reported side effect is pain at the injection site. This is more promising than the triptans were when they came out over 20 years ago.

How is Aivomig Delivered?

This is one of the first things people on the internet are asking. There have been many stories about CGRP receptor antagonists and each of them in development are delivered into your system in different ways: monthly injections, infusions Injection of Medicationevery three months, shots given for acute migraine, and pill form for pediatric patients.

To clear up all the confusion, I will simply say that Aivomig is a monthly shot that comes in the form of a delivery pen which is similar to the newer injectibles for diabetes.

CGRP receptor antagonist remain adhered to the CGRP receptors for a long period of time, thus a daily dose is not needed. Pill form should be approved in a more convenient pill form for pediatrics in about a year, with the same form for adults expected soon afterwards.

For those with latex allergies, Aimovig is available in a pre-filled syringe.

How Much is it, and Will Insurance Cover It?

While the drug should be available now, it comes along with a huge price tag: $6900/year for each patient. That’s about $575 per dose. While some consider that a small price to pay for relief, others are scrambling to figure out how to pay for it or praying that insurance companies will pick up the cost.

Let’s be clear, insurance companies have been very quiet on whether or not they will cover CGRP receptor antagonists. Patient Records/InsuranceCoverage is expected to come on a case-by-case basis, at least to begin with. It is also expected that only patients with a well documented failure with drugs like hypertensives, anticonvulsants, triptans and Botox have not helped will be approved.

While the price you would pay out-of-pocket for drug like Imitrex and Maxalt is the same or higher than $575/mo. That is not the same price that insurance companies will pay for a covered drug. The costs of new drugs and the insurance allowance have to be agreed on by both the insurance company and the drug makers.

That being said, they pay considerably less for the existing drugs than it cost to manufacture the CGRP receptor antagonists. That means that there may be a considerable lag in coverage. Still, if these new drugs deliver on the promise shown in the drug trials, I would expect companies to begin to work them into their formulary (list of drugs covered) for 2019.

The good news is that some people in the forums I listed earlier are reporting that they have been approved. Keep in mind, however that these are people with well documented histories of failure with other methods of treatment.

Free Trial of Aimovig

It has also been reported that patients who receive a prescription will receive the drug at no cost for two months. It is not clear how long this free offer will remain in effect, so if you are interested in trying Aimovig, you should make an appointment with your doctor or headache specialist right away!

Long Term Effects and Safety

The Food and Drug Administration (FDA) approves drugs based on clinical trials and the best educated guesses as to long term safety by the scientists involved in developing the drug. This does not mean that they have tested it for long term effects. This is not only true with Aimovig, but with most every drug that the FDA approves.

Triptans came out the same way and people flocked to their doctors none-the-less to give them a try. There are many drugs that you may have taken where long term effects were unclear. This should not stop you from trying Aimovig for frequent or chronic migraines.

The Wrap Up

News that the FDA approves new migraine drug is something that many of us have been waiting for many years. It’s only natural that people are a little leary of the news as well.

Most other drugs that are used to treat migraines come with many bothersome side effects, some of which have long termed Doctor's Consultationconsequences. The studies that have been done on CGRP receptor antagonists, like Aimovig, however, have been very promising.

There have been little side effects reported in all these trials, the worst of which is injection site pain. Long term side effects of Aimovig are not known at this time, however, the scientists who are

with CGRP in the body and who have developed and tested the drugs do not expect there will be long term effects.

Being a new drug that is expensive to produce, the cost of Aimovig is a bit high and there is no guarantee that insurance companies will add it to their formulary any time soon. Coverage, for now, is on a case by case basis.

You are more likely to be approved for coverage if your migraines and treatments have been well documented. If they have, you should talk to your doctor about a prescription while there is still a two-month free trial available from Amgen Novartis.

I hope that this article has been helpful to you. As always, you should discuss any treatment with your medical professional.

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