The anti-CGRP fremanezumab (Ajovy) has finally been listed on the PBS, but the tight criteria for subsidy may deny access for many chronic migraine patients, according to some advocates.

From 1 August, neurologist-treated patients averaging 15 or more headache days per month, with at least eight days of migraine, can access fremanezumab via the PBS, so long as they have experienced an inadequate response, intolerance or contraindication to at least three prophylactic migraine medications and are not receiving PBS-subsidised BOTOX or CGRP antagonists for chronic migraine.

Neurologist Associate Professor Richard Stark told the limbic he was pleased to see fremanezumab had made the PBS following the listing of galcanezumab (Emgality) in June.

“We’ve now got two CGRP antibodies that are available on the PBS, and certainly I have had patients on Ajovy who have been self-funding and they will no longer be faced with the dilemma of whether to switch away from a drug that’s been effective for them to another one that they might not be sure about how it will work, so for them it will make a big difference,” he said.

Regarding the eligibility criteria, Associate Professor Stark said they were “as good as we could hope for”.

“It is true that Ajovy and Emgality are effective for people with migraines that are not as frequent as 15 headache days a month, and I would be pleased if the criteria could be adjusted accordingly,” he said.

“But it clearly would involve making it available to a larger number of people, obviously at greater expense to the budget. So while from the neurological perspective we would like to see it made available to as many people as possible, I do understand that, realistically, it would be best to get it made available to the more severely affected patients first up and then work on expanding it from there.”

Inappropriate restrictions

Migraine Australia Founder and Campaigns Director, Dr Raphaella Crosby welcomed the development, but said the access criteria that match galcanezumab’s could prevent the majority of Australia’s 400,000 chronic migraine patients from receiving PBS-funded treatment.

“The restrictions we’re seeing for these drugs are the ones that were negotiated for BOTOX years ago,” Dr Crosby told the limbic, noting that BOTOX was the closest thing the PBAC had to a comparator migraine drug.

While BOTOX was considered a chronic migraine treatment, it was really a “headache treatment”, she explained.

“These new drugs are treatments for migraine, which is a much more complicated condition, not limited to or defined by headaches. So they’ve compared it against the wrong thing.”

In fact, “about a quarter of migraine patients don’t have significant headaches”, she said. These patients “might get 15 migraine days, but they don’t have enough headache days to qualify under the very strict definition that’s been used for the restrictions around this drug”.

Additionally, migraine patients can experience auras, numbness, fatigue, visual disturbances and migraine hangover, which, with or without headaches, can severely impact patients’ quality of life and ability to function.

Preventative treatments such as fremanezumab, galcanezumab and erenumab (Aimovig) can be “the difference between being completely debilitated and not, being able to work and not, being able to do basic household chores and look after the kids and feed their families and not,” Dr Crosby said.

Erenumab had its PBS funding application withdrawn in 2019 by sponsor Novartis after two PBAC rejections.

Under the PBS, patients can purchase fremanezumab for $41.30 or $6.60 with a healthcare or pension card and can continue to do so if they achieve and maintain a 50% or greater reduction from baseline in the number of migraine days per month, according to Migraine Australia.

Those who are ineligible for PBS funding may buy the drug for $284 a month via Teva’s  access program, Momentum, instead of the normal $850 a month.