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CGRP Medications - Emgality, Ajovy, Aimovig, Vyepti and others

 Emgality pen

CGRP therapies are a new type of medication used to prevent and treat migraine attacks.

The medication blocks a protein called calcitonin gene-related peptide (CGRP). CGRP may cause inflammation and pain in the nervous system of people who have migraine attacks.

CGRP migraine medications are also called anti-CGRP, CGRP inhibitor and CGRP antagonist treatment.

 

How CGRP is used to treat migraine

People with migraine may have more CGRP in their blood. This chemical has been studied for more than 25 years. It’s thought to be a significant factor in the sequence of events necessary to trigger a migraine attack.

CGRP may help cause migraine attacks. It also worsens headache pain and makes it last longer. CGRP migraine treatments work in one of two ways to stop or treat migraine pain:

  • They block the sites in and around the brain where CRGP must attach to work. (Aimovig)
  • They bind to CGRP and prevent it from working. (Emgality, Ajovy and others)

 

How CGRP treatment is taken

There are currently five medications available, and a number of others in development, to prevent migraine based on blocking CGRP. All of these medications are designed to be used as preventatives to reduce the number of attacks, while Nurtec may be used as either a preventative and/or an abortive when attacks occur.

 

Currently available in Australia:

As these medications are new or relatively new to the market, they often need to be special ordered by the pharmacy. 

 

Note:

*Update* The Emgality shortage is now listed as resolved on the TGA database (as of 13/3/24), with anecdotal reports of community members getting scripts filled. 

However Ajovy is still listed on the TGA website as having limited availability. This applies to both the autoinjector and prefilled syringe versions of Ajovy and is expected to last until the end of April 2024 due to the increase in demand. It is recommended to speak to your neurologist or GP (for continuing scripts).

Teva recommends contacting different pharmacies (who may have access to different wholesalers), to attempt to obtain the medication.

 

In late stage development, not yet available in Australia:

  • atogepant (Aquipta in Australia, or Qulipta in the US) Note: Abbvie advised while the medication has been approved by the TGA, it will not be released into the Australian market at this time as it was not recommended for inclusion onto the PBS. No further information was available if the company was going to reapply as per 5/2/24.
  • ubrogepant (Ubrelvy, available in the US)
  • zavegepant

 

Aimovig, Ajovy and Emgality are taken by an injection monthly with a needle or automatic pen. This is similar to how some people with diabetes take insulin. Ajovy also has an alternative dosage option, which is injected quarterly.

Vyepti is a 30 minute infusion for which you will need to go to a clinic to get every three months.

Nurtec is available in a dissolving wafer form, and may be taken once per day during an attack, or every other day as a preventative. 

The gepants under development are mostly tablets, zavegepant is being developed as a nasal spray.

 

How much does CGRP treatment cost?

 

Aimovig

In Australia, Aimovig is available on a private prescription between $750 and $850 a month. All free trials have ended. A discount program enables you to get 140mg (2 x 70mg pens) for $695. To do this you need to:
1. Email your prescription to [email protected]
2. Order and pay for your Aimovig at http://aimovig.phusionpayments.com.au/ including nominating which pharmacy you will collect from.
3. Take the hard copy of your prescription to your pharmacy for dispensing. 

Novartis has decided to remove Aimovig from consideration for listing on the PBS. 

 

Emgality

Emgality was listed on the PBS from 1 June 2021. However, the vast majority of people will still only be able to access it via a private prescription.

You can get Emgality on a private prescription from either a neurologist or a GP. There are no restrictions or limitations for private prescriptions, so no minimum number of migraine days or drugs you need to try first. Your doctor will need to log on to the Lilly portal for doctors – https://mylilly.com.au/ – and print out a voucher for you to take to the pharmacist. Then the pharmacist will need to order it in for you (it generally won’t be in stock). The recommended retail price is $263 per month with the discount voucher. Without the discount voucher the price varies considerably but is around $600 a month. 

From 1 June, those who meet the following criteria will be able to get Emgality on the PBS. 

  • You must have Chronic Migraine (15 headache days, 8 of which are migraine days) for at least six months. 
  • You must have failed three older medications like propanolol, topiramate and amitryptiline
  • You must be managed for medication overuse headache
  • You must be under the care of a neurologist
  • Your neurologist must initiate treatment (your GP can do continuing scripts)
  • You cannot get both Emgality and other CGRP's or Botox on the PBS. 

If you qualify for Emgality on the PBS you must achieve a 50% reduction in migraine frequency and severity to continue to get it on the PBS after the first 6 months. You will be charged the maximum PBS co-pay rate of $31.60 or $7.70 with a concession card (as of 1st January 2024). As pharmacies are able to choose to provide a discount (for medicines priced between $31.60 and $48.10), and the amount of that discount, the price of medicines may depend on the pharmacy. READ MORE

 

Ajovy

Ajovy was listed on the PBS from 1 August 2021 for chronic migraine patients.  An expanded listing occurred from 1 November 2023 to include high frequency episodic migraine patients.  However, some people will still only be able to access it via a private prescription.

You can get Ajovy on a private prescription from either a neurologist or a GP. There is an access program for Ajovy called Momentum, and you can get signed up for this through your neurologist. This will allow you to purchase Ajovy for $299 per month instead of the normal rrp of $850 per month. You can get access to this program from either your neurologist or GP, but it is very unlikely your GP will have the brochures with the information you need on how to order. Ask your doctor to call Teva Medical Information on 1800 288 382 and they should be able to send out the brochure that you need and assist them with any other questions they have. 

From 1 Nov 23, those who meet the following criteria will be able to get Ajovy on the PBS. 

  • You must have Chronic Migraine or High Frequency Episodic Migraine (8 Migraine days per month for at least six months). 
  • You must have failed three older medications like propanolol, topiramate and amitryptiline
  • You must be managed for medication overuse headache
  • You must be under the care of a neurologist
  • Your neurologist must initiate treatment (your GP can do continuing scripts)
  • You cannot get both Ajovy and other CGRP’s, or Botox on the PBS. 
  • To access the quarterly dose option requires scripts to be supplied as "Reg 49" (prev Reg 24) and may require additional authority.

If you qualify for Ajovy on the PBS you must achieve a 50% reduction in migraine frequency and severity to continue to get it on the PBS after the first 6 months. You will be charged the maximum PBS co-pay rate of $31.60 or $7.70 with a concession card (as of 1st January 2024). As pharmacies are able to choose to provide a discount (for medicines priced between $31.60 and $48.10), and the amount of that discount, the price of medicines may depend on the pharmacy. READ MORE

 

Vyepti

Vyepti® (eptinezumab) is TGA approved and now available to prescribe in Australia for the preventive treatment of migraine in adults. It is administered as a 30-minute IV infusion every 12 weeks.

Vyepti was listed on the PBS in Aug 2023, however as it requires infusion, any additional out-of pocket costs can be discussed with your treating neurologist.

From 1 Aug 23, those who meet the following criteria will be able to get Vyepti on the PBS. 

  • You must have Chronic Migraine (15 headache days, 8 of which are migraine days) for at least six months. 
  • You must have failed three older medications like propanolol, topiramate and amitryptiline
  • You must be managed for medication overuse headache
  • You must be under the care of a neurologist
  • Your neurologist must initiate treatment (your GP can do continuing scripts)
  • You cannot get both Vyepti and another CGRP, or Botox on the PBS. 

If you qualify for Vyepti on the PBS you must achieve a 50% reduction in migraine frequency and severity to continue to get it on the PBS after the first 6 months. You will be charged the maximum PBS co-pay rate of $31.60 or $7.70 with a concession card (as of 1st January 2024) for the medication, additional treatment costs may apply. READ MORE

 

Nurtec

Nurtec® (rimegepant) is TGA approved and available to prescribe for the acute and/or preventative treatment of migraine attacks in adults.

Unfortunately, Nurtec is not yet listed on the PBS, and is only available through private prescription (packs of 2 or 8). Either a neurologist or a GP is able to prescribe Nurtec.

While the price of Nurtec will vary depending on pharmacy it is expected to cost approximately $250-$300 per 8 wafers.

 

When will these medications be available on the PBS?

There are three steps before a medication can be listed on the PBS, allowing us to get it for $31.60 or $7.70 with a concession card (as of 1st January 2024). As pharmacies are able to choose to provide a discount (for medicines priced between $31.60 and $48.10), and the amount of that discount, the price of medicines may depend on the pharmacy. READ MORE

  1. It needs to be recommended by PBAC (the pharmaceutical benefits advisory committee – an independent body that decides what should be on the PBS or not)
  2. The drug company needs to negotiate price and restrictions with the Department of Health
  3. The listing needs to be approved by the Minister for Health, and if it is over $20m a year, the full cabinet. 

At this point, Emgality, Vyepti, and Ajovy are listed on the PBS for the restricted group of patients outlined above. Aimovig has been withdrawn from consideration for the PBS, although we remain committed to fighting for it.

Ajovy has the widest criteria, including high frequency episodic patients, while the other approvals have been for chronic patients only.

Note: Lilly has  advised they are no longer pursing their application for treatment-resistant episodic patients (that is, people with less than 15 migraine days per month but enough that they need a preventative, who have also failed three other preventatives) to access Emgality on the PBS.

Pfizer has advised that they are currently preparing a revised application for Nurtec to be reconsidered by PBAC.

 

 What Are The Risks?

All the effects of CGRP migraine treatments are not yet known. There may be some long-term risks that can happen in some people.

The most common CGRP migraine treatments have to be injected. This can cause pain. Additionally, an injection site on the skin can get infected. Washing your hands, cleaning the site, and using new needles each time is important. Additionally, we know:

  • Aimovig may cause allergic reactions, constipation, and high blood pressure
  • Emgality can cause allergic reactions, which may cause difficulty breathing
  • Ajovy may cause itchiness or a rash
  • Vyepti may cause allergic reactions, or a stuffy nose
  • Nurtec may cause allergic reactions, nausea, indigestion or stomach pain

Many have noticed that their migraine pattern and symptoms change once starting a CGRP treatment. There are many common symptoms which are believed not to be side effects of the drugs, but rather migraine symptoms that are more noticeable in the absence of a headache, such as fatigue and nausea.

Weight gain and loss have also been reported, some of which may be attributable to appetite and increased ability to exercise as a result of better management of migraine. Weight gain is more frequently noted with Emgality; weight loss with Ajovy; and Aimovig has fairly equal reports of gain, loss or no change.

Hormonal changes (particularly changes to periods), and hair loss, have also been noted anecdotally and may be due to the way CGRP interacts with hormones, but further research is required.

If you have anxiety or depression, as most people with migraine do, it is a good idea to work with your psychologist on adjusting your perspective when starting CGRP therapies. Because the response can be quite rapid, some people find their anxiety increased as they are still bracing for the next attack which doesn't come. Additionally, for many who had lost all hope of effective treatment, the anxiety of these new treatments possibly not working can be overwhelming. Give yourself permission to be well, and try not to over-think whether you are experiencing side effects or whether the medication is working or not.   

You may also find that your triptan medications do not work as well as they used to. This is because the CGRP dilated the vessels in your brain, and the triptan would constrict them; with the CGRP being blocked the triptan doesn’t have as much impact.

CGRP plays a key role in dilating or widening your blood vessels. This helps to balance blood pressure. It is theorised that migraine medications that lower CGRP levels may cause side effects that affect your blood pressure and heart, but no research or clinical trial has recorded significant cardiovascular problems as yet. If you are on blood pressure or heart medications be sure to discuss this with your doctors before beginning CGRP treatment. Aimovig has recently added high blood pressure to its list of side effects.

CGRP is also involved in other body mechanisms. For example, it helps with wound healing and plays a role in some of the digestive organs. It’s not yet known if blocking this chemical protein could affect wound healing or trigger digestive disorders. Some people may be more prone to getting head colds.

All of the CGRP monoclonal antibodies have been designed to not impact on the immune system. They just use the immune system for delivery. Your immunity is not suppressed, and you are not more vulnerable to bacteria or viruses, including COVID-19.

 

Can I use CGRP therapies if I am pregnant?

Discuss the pros and cons with your doctor. There are some concerns as these medications are so new and CGRP plays an important role in pregnancy. The CGRP treatments were tested on monkeys in clinical trials with no adverse effects noted. For this reason, the TGA has classified these medications as Pregnancy Category B1. There have been no studies of CGRP treatments in human pregnancies, but some limited case reports (that is, a report of a single patient experience) of CGRP treatments used by women while they were in the first trimester have reported no significant issues. Read more about treatment options during pregnancy at the Association of Migraine Disorders.

 

What are the benefits?

CGRP migraine treatments may work for people who have debilitating and/or frequent migraine attacks.

A 2018 study found that almost a third of people tested had 50 percent fewer migraine attacks. Their migraine symptoms also lasted fewer days. In other research, a third of the people with migraine had up to 75 percent improvement. Similarly, Migraine Australia found in a survey of our members that 36% of people had a 75% reduction in frequency and severity. CGRP treatments have also proven to be effective for people who did not have success with other medications.

Some migraine medications stop working as well if they’re used for some time. Response to CGRP medications gets better with time for most people. In rare cases, some may develop resistant antibodies to the medication, and will need to switch to a different one. Migraine is a very big spectrum, caused by different genes and triggers. No one migraine medication works for everyone, but failing one CGRP mediation does not mean all of the CGRP medications will not work for you.

The injectable CGRP migraine treatments that are currently available are only needed once a month, or once every three months. This makes it easier to not miss a dose.

 

Summary

CGRP migraine treatment is a new type of treatment. It may work better for some people with migraine than other kinds of medications.

CGRP migraine treatments give people relief by preventing migraine attacks from happening, and by reducing the length and severity of attacks. Side effects are generally mild. 

Like any medication, CGRP treatment may not be right for you. Talk to your doctor to find out; they may recommend trying it for a few months. 

Keep a migraine diary before starting a CGRP medication and for the first few months of taking it so you can measure how well it works for you. Let your doctor know of all changes in symptoms and any side effects you may have.

 

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