Questions for Your Doctor Regarding CGRP

During the flurry of news articles about the upcoming and anticipated CGRP drugs for migraine treatment, we decided to ask our contributors what questions they would ask their doctors. Their questions have been compiled below and can be printed or referenced for your own visit with your doctor.

Approval and brands

Do we know which of the drug companies will be the first to earn approval from the FDA? [editorial note: No]

I am eager to know what we will call them as a whole (like we use "triptans"). While we're on the topic, what are the trade/brand names that have already been decided on?

What is the current projected date for the first approval?

Eligibility & other medications

Some articles have mentioned possible respiratory side effects, would being an individual who is prone to respiratory infections, bronchitis, or pneumonia “disqualify” you from trying the treatment?

There will not be long term health information available for years, will individuals with other health issues be able to use it (fibro, lupus, endometriosis etc)?

Can it be used in addition to Botox or would you have to wean off Botox before being able to start using the CGRP infusions or intramuscular (im) injections?

Would the types of abortive medications you could use while using CGRP infusions or im injection be limited?

Are there any other medications that would need to stop or be "flushed" from the system?

Does this appear promising for more complicated migraine patients like those with sensory aura, brainstem aura, vestibular migraine, or hemiplegic migraine or have best results been seen in migraine patients without aura?

Many of the studies appear to focus on CGRP's role in migraine head pain. Would this treatment affect or prevent other symptoms of migraine as well? Would you recommend it for patients who don't list head pain as their most disabling symptom?

Is there any insight into why some people are "super responders" and others aren't?

Route of Administration

There won’t be head to head data for years to come, how would you decide on using the infusion or im injection version of the medication?

If you chose the im injection version, would you be able to self-administer at home instead of having the doctor’s office perform the injections?

Many of the drugs are subcutaneous injections rather than IV, is there a chance we may get auto-injectors for home use?

Side effects

Is there a time frame that one should use them for, before determining if they work for them?

When will they know if it will affect immune compromised individuals?

Some articles have compared CGRP infusions or im injections to the drug methysergid, which was pulled off the market, are there valid grounds for concern that the drug will have similar side effects?

Insurance & Coverage

Would insurance cover the cost of the medicine?

Would you have to ‘qualify’ like you do with Botox (by failing a certain amount of other treatments)?

Have the companies discussed any payment assistance programs such as the one offered by Botox?

How do you predict it will work to come into the office for injections? Will we have to seek insurance approval each time, or just once or twice a year?

Because of the concern about high cost, what will the procedure be to attempt to make insurance companies cover it, when that first drug is approved?

Will you just prescribe and/ or administer (injections) and we cross our fingers, or would it be best to send letters of explanation to our insurance companies right away indicating our need?

How accessible will the new drugs, as they are released, be to the average or low income person?

Does it make sense to refer to these meds as "game changers" if only an elite few can afford them?

Do you see an effort being made to attempt to lower costs, or will some who are in desperate need simply be left out?

For those who participated in a CGRP clinical trial, do they have a better chance of getting insurance to cover it since they already know it will be successful and have established the need for it by being eligible for the studies?

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