New Treatments Update

Last updated on 19 August 2022. 

In this update:

  • Introduction to this new class of treatment
  • PBS Listing & Availability Update
    • Aimovig (erenumab)
    • Emgality (galcanezumab)
    • Ajovy (fremanezumab)
    • Vyepti (eptinezumab-jjmr) [NEW]
  • Timing Expectations
  • Our Response to COVID-19

 


 

A new category of treatments has recently been developed to prevent migraine attacks from occurring. These are the Calcitonin Gene-Related Peptides (CGRP) monoclonal antibodies. We have spoken to our community about these new migraine treatments in the past. View this article for more information about the anti-CGRPs or watch a presentation from a headache specialist to learn more about CGRP and other new treatments for migraine.

In Australia, four different manufacturers have applied for Therapeutic Goods Administration (TGA) approval and several have also applied for Pharmaceutical Benefits Scheme (PBS) coverage within the past 2 years. The process can be complicated and time-consuming. Understandably there is some confusion over the availability and access to these treatments.

Below is an update of the current status of each of them:

  • Aimovig (erenumab)
  • Emgality (galcanezumab)
  • Ajovy (fremanezumab)
  • Vyepti (eptinezumab-jjmr) [NEW]

 

Aimovig

After several failed attempts Novartis withdrew their application for Aimovig coverage on the PBS. The cost for one month treatment and the full dosage of 140ml is $695. Aimovig is only available via a private prescription. Patients order online and have their order shipped to a local pharmacy for pickup.  Novartis stated that they will provide an extra dose free with the first order.

Emgality

In July 2019, the Pharmaceutical Benefits Advisory Committee (PBAC) recommended the inclusion of Emgality (galcanezumab) on the PBS for people with chronic migraine who have unsatisfactorily tried at least three prevention therapies. Emgality was the first medicine of its class to have received a positive recommendation from the PBAC.

With the announcement of the 2021-22 budget, the Federal Government announced that as at 1st June 2021, Emgality would be available on the PBS. Patients must fulfill the following criteria to be eligible for PBS coverage:

  • the patient has chronic migraine
  • three other treatments have failed the patient (for example through a lack of efficacy or intolerable side effects)
  • the script is prescribed by a neurologist

Emgality has an existing program for patients which will continue for those who are not eligible for PBS coverage. The treatment for ineligible patients will cost $263 per month. For those who are able to receive PBS coverage, the monthly cost is $41.30. For concession card holders it’s $6.60.

Ajovy

On 1st August 2021 Ajovy (fremanezumab) was listed on the PBS for chronic migraine patients 15 months after it had received a positive recommendation from the PBAC.

A new prescription from a neurologist will be required to access PBS pricing.

If you aren’t eligible under the PBS criteria, you can still access Ajovy through the Momentum program with a private prescription. The Momentum program allows you to access Ajovy at a reduced price. When you receive your private prescription, your doctor will provide you with the next steps to purchase Ajovy.

Additional information is available from your neurologist. Alternatively, if your neurologist is not aware or if you are not seeing a neurologist then you can contact Teva and request details be directly sent to your doctor. Teva can be reached on Phone: 1800 AU TEVA (1800 28 8382) Email: MedInfo.ANZ@tevapharm.com

Vyepti

Vypeti is another CGRP monoclonal antibody that uses a different method of administration. It is administered intravenously (IV) once every 3 months or four times per year.

Vyepti has been approved in Australia. A private prescription from a treating neurologist has an estimated cost to the patient of between $1,700 and $1,800 per quarter.

Read our comprehensive article about Vyepti >>

19 August 2022 update

We are pleased to announce that Vyepti® has received a positive recommendation by the PBAC to be listed on the PBS.

The government and manufacturer will now enter into negotiations to finalise pricing details before the listing is made available to patients eligible for PBS access.

The PBAC has recommended that Vyepti should be available on the PBS for chronic migraine patients who have found at least three other preventive medications to be ineffective or intolerable. They have also recommended that it should be added to the risk-sharing arrangement that exists for Ajovy and Emgality. This means that all three medications would share the same expenditure cap.

Until the listing is finalised, the Coordinated Access Network (CAN) is still in place. The CAN is a collaboration between Lundbeck and some private hospitals, and it allows new patients to receive their first infusion free of charge.

Thank you to everyone who made a PBAC submission to support Vyepti’s listing on the PBS. This recommendation wouldn’t have been possible without your ongoing support & advocacy. We hope to hear more news soon!

 

Timing Expectations

With Emgality and Ajovy listed on the PBS it paves the way for others to follow. This has been a long time coming with submissions first called for this new generation preventive treatment over 2 years ago with 1,800 submissions from the migraine community. There have also been several calls for submissions since then. Earlier this year Migraine & Headache Australia’s Carl Cincinnato testified in front of a Parliamentary Enquiry Hearing regarding the approval process of new drugs to share our community’s perspective and the impact of such delays.

The next steps for other treatments which have received a positive recommendation from the PBAC is for price negotiations between the manufacturer and the Department of Health to be agreed. These negotiations can take months or even years. We are hopeful that other CGRPs can follow the roadmap established by Teva (Ajovy) and Eli Lilly (Emgality), leading to faster approvals. This will provide patients with a range of options to discover something that best addresses their migraine disease.

In the meantime we hope this information provides some reassurance that progress is being made. We will continue to represent the patient voice in the need for fair access to proven and safe treatments for migraine.

Discover new treatments & research

Sign up for monthly email updates on the latest treatments, new research, events, news, expert presentations and trials running in Australia. Unsubscribe at any time.

Headache AustralianMigraine & Headache Australia is the only organization in Australia that aims to support the more than 5 million Australians affected by headache and migraine.
PLEASE HELP US BY DONATING TO OUR RESEARCH PROGRAM.