New Treatments Update

Last updated on May 28, 2021. 

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 Friday April 24th 2020 the PBAC delivered a positive recommendation for Ajovy (fremanezumab) to be listed on the PBS for the prevention of chronic migraine.

Benet Irish, General Manager at Teva Pharma Australia who manufacture Ajovy said:

“The positive recommendation marks an important milestone to realise our ambition of enabling migraine patients in Australia to have access to this next generation of innovative medicines. In these challenging times, it is important more than ever that we support people with chronic conditions to manage their condition. We therefore want to reassure the migraine community that we are working closely with the government to enable PBS reimbursement as soon as possible.”

Following this positive recommendation, Teva said that they will continue to work closely with the government to enable eligible patients to have access to Ajovy via the PBS in the near future. No dates can be confirmed at this stage but with the approval of Emgality we are hopeful that Ajovy will be announced soon.

In the meantime, Ajovy have updated their pricing and access for patients.

A patient program called Momentum allows eligible patients with a prescription to access Ajovy for free. Here are some details about the program.

“Patients enrolled in the Momentum Program will be eligible to receive AJOVY at $0.00 per unit* from 1 June 2021 until 31 July 2021, or until AJOVY is listed on the PBS, whichever comes first.†  The program provides a maximum of 2 units of AJOVY per patient on a monthly dose and a maximum of 3 units of AJOVY per patient on a quarterly dose, unless the program is extended beyond 31 July 2021.†

*This price is Teva Pharma Australia Pty Ltd’s (Teva’s) recommended retail price only for patients enrolled in the AJOVY Momentum Program, and prices may differ from pharmacy to pharmacy. Teva will provide each participating pharmacy with a service fee at fair market value for each AJOVY dispensing event.

†Teva has the right to extend or change this program at any time. Reasonable notice will be provided in advance of any changes to the AJOVY Momentum Program. You can opt out of the program at any time, however, if you do opt out, you should speak with your doctor to discuss your treatment options.”

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 a flyer directly or for one to be 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. It has already been approved overseas by US regulators and it was recently announced in a global release from the manufacturer (Lundbeck) that approval has also been sought in Australia. Timings for TGA approval and application to the PBS have not been disclosed.

Timing Expectations

With Emgality now 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 Ajovy which has 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 approval will occur in 2021 for the next CGRP to be added to the PBS and that others will follow the roadmap so that patients will be given a range of options to discover 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.

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.
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