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CGRP Monoclonal Antibodies: access, and coverage

Disclaimer: This information is provided as a general overview of a complex topic. It can be hard to know which medicines you would have to pay for yourself. There might also be changes in Patient Support Programs (PSP) and this information may become outdated. For specific questions, ask your insurance company or the manufacturer of the medication  PSP.

Bringing this article to your doctor may help your conversation.

What is CGRP and how is it related to migraine? 

CGRP (calcitonin gene-related peptide) is a substance that is naturally present in our bodies. It plays many roles, including stimulating sensory nerves, which causes pain, and dilating blood vessels. Research has shown that CGRP plays a role in migraine [1]. Blocking CGRP, or the receptor it links to with an antibody could treat migraine [1]. (See more HERE for our summary PDF LINKIN 915).

How many CGRP monoclonal antibodies (also known as MABs) are available in Canada? Are they different?

There are currently 4 MABs approved by Health Canada.

1. Aimovig (erenumab)

2. Ajovy (fremanezumab)

3. Emgality (galcanezumab)

4. Vyepti (eptinezumab)

Who pays for these medications?

There are two main payers: public drug plans (government) and private insurance plans (through an employer).

Private insurers make their own decisions. Some private payers have decided to cover CGRP antibodies, usually with clinical criteria (headache frequency, previous medication failure).

Public insurers (linked to provincial Health Ministries) make decisions based on recommendations by an agency called CADTH [2].

All the medications listed above are available in Canada. Many private insurance companies have included these medications on their drug plans although the criteria from one insurance company to another may vary.

We are hopeful all options will soon be covered by the provincial drug programs across Canada in the coming months. We will provide regular updates on our website and through social media channels. As of July 2022, all jurisdictions in Canada have added fremanezumab (Ajovy) to their public drug plans with the exception of P.E.I and the Yukon. In all cases, before coverage takes effect, paperwork must be submitted by your doctor and approved demonstrating you have tried and failed other migraine medications.

Patients do have the option to pay out of pocket with no financial support from the government or insurance companies*.Share your voice about the importance of having access to medications and improving care for people living with migraine. Take a few minutes of your time and send a letter to your local elected official and Minister of Health through our seamless new advocacy platform. The process is seamless and simple!! Learn how here [ https://migrainecanada.org/advocacy/ [3] ]

Patient Support Programs

Manufacturers commonly offer Patient Support Programs (PSPs) to support patients and healthcare professionals.

Enrollment is initiated by your physician and these programs usually include:

  • Financial support, often to bridge the patient’s while reimbursement is secured through the insurance company.
  • Support may also be given to provide financial support to patients who have a co-pay.
  • Financial support to patients paying out of pocket (up to 20% co-pay)
  • Note: All requests are reviewed on an individual basis by the patient support program.

You cannot contact the Patient Support Program by yourself. Your doctor has to prescribe the CGRP antibody to you and fill in a form. You will need to consent to the program and sign the form. Providing a list of the preventive medications you have tried before with the doses, how long you tried them, and the result will be very helpful for your physician. Once the clinician has submitted the paperwork, a representative from the company will reach out to you.

General criteria for PSP financial assistance and private plan coverage (may vary from one company to the other):

  • 8 days or more of migraine per month
  • Two or more previous trials of migraine preventives with failure or intolerance
  • Some insurance companies ask for a trial of Botox before trying a CGRP antibody.

Out of Pocket (Patient Pays)

Once a product is approved by Health Canada, patients with a prescription can pay for their medication(s) out of pocket. The CGRP’s are more expensive than the older medications (most are generic) and we encourage you to shop around by phoning a few pharmacies in your city/town. Prices may be different from one compared to another.

It is also important to call the manufacturer’s Patient Support Program to see if you may be eligible for some financial support (could be up to 20%) and will be assessed on case-by-case basis for financial assistance.

Can I predict if my public or private drug plan will cover CGRP antibodies?

Most  plans will cover CGRP antibodies if: 

  • You have tried and failed or not tolerated at least 2 medications for migraine [1] prevention. See our list of preventives [4]
  • You have 8 or more migraine days per month (4 weeks)

Do I have to see a neurologist to get a CGRP antibody prescription?

No. Officially, the clinician  prescribing the CGRP antibody must be “experienced in the treatment of migraine.” There is NO official requirement for a specialist. Many family doctors and nurse practitioners  are competent to treat migraine. Of course, not all family doctors will feel comfortable with a new and costly drug. This will be a learning curve. 

How can I monitor the frequency of my migraines? 

Knowing how often you have headaches is important. Consider using a headache diary to count days where you feel migraines. You could use a paper calendar [5] or a smartphone app such as the Canadian Migraine Tracker [6].

How long will the CGRP antibody be covered by the PSP? 

Usually, until your insurance company has made a decision regarding coverage. Then, you will switch from the PSP to the insurance company. You may have to pay part of the price. Some PSPs provide a co-pay, which means that they will cover the cost that your insurance does not cover (for example, 80% paid by your insurance, 20% paid by the PSP). Changing to your insurance company will require more forms to fill in carefully. 

Note: the rules of the PSPs may change. Always check with the program for the most recent information.

Can I combine CGRP antibodies with Botox?  

Medically, yes. However insurance companies are trying to decline the combination. They will argue that antibodies have not been tested in combination with Botox, which is true, but the main reason is probably cost.

Here are a few arguments supporting the combination of Botox and CGRP MABs: 

  • Combining medications with different mechanisms to optimize the treatment of a disease is very common in medicine. 
  • There is no theoretical risk to combining Botox and CGRP MABs.
  • There are scientific arguments supporting this combination. Botox and CGRP do not act on the same nerve fibers and in theory they could work well together. Botox also inhibits the release of other peptides, not only CGRP.

Some patients with chronic migraine [7] who get a partial benefit from Botox have seen an additional benefit when adding an antibody. Evidence is being collected.

One argument against the combination of Botox and antibodies is the cost. Is that reasonable?

The combined cost of Botox and CGRP antibodies per year is less than $15 000. That may sound expensive, but other diseases are treated with more expensive therapies. Drugs for multiple sclerosis cost over 20 to $40 000 per year. Considering the fact that migraine is disabling (especially Chronic Migraine [7]), cost-effectiveness should be analyzed before declining co-therapy. How much is the ability to live your life worth? 

Hopefully we will have more research on this soon. Do not let your insurance company make medical decisions. Hopefully patients and doctors can unite to improve access to the best options. 

If I am doing much better, and do not have 8 days of migraine per month anymore, could the insurance company decide to stop paying for the CGRP antibodies? 

The use of “stopping rules” have been seen in the US and in some provinces with Botox. 

From a medical perspective, this does not make sense. For example, if someone takes a pill for blood pressure, and the blood pressure gets better, that is a success and the medication should be continued. The same applies to epilepsy, diabetes, and thyroid disease. Insurance companies may try to find ways to stop coverage, but the first priority should be the quality of life of patients. 

Still, if I am doing really well, could it be reasonable to stop the CGRP antibodies? Will I get rebound migraines? 

It may be reasonable to go longer between injections if you are doing much better. Since the antibodies will be cleared gradually from your blood, you should not see bad rebound migraines. They may come back slowly. If that happens the medication could be restarted. For more about the length of preventive therapy for migraine read here (See this post [8]).

Other associations are also providing information on CGRP Antibodies: 

REFERENCES

An excellent summary article has been written by Dr. Stewart Tepper:

Tepper SJ. History and Review of anti-Calcitonin Gene-Related Peptide (CGRP) Therapies: From Translational Research to Treatment. Headache. 2018; 58 Suppl 3:238-75.

A full reference list for CGRP antibody trials and clinical evidence can be found here (PDF CGRP references [11]). 

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