Second CGRP inhibitor listed by TGA


By Mardi Chapman

7 Nov 2019

Fremanezumab (Ajovy)  is now listed on the Australian Register of Therapeutic Goods (ARTG) for the prevention of migraine in adults and is up for consideration for PBS listing at this month’s meeting of the PBAC.

The migraine community are hopeful the CGRP inhibitor, marketed by Teva, will be recommended for PBS subsidy, as its competitor galcanezumab (Emgality, Eli Lilly) was earlier this year.

As reported previously in the limbic, a submission to PBAC for a third drug erenumab (Aimovig) has been withdrawn by its manufacturer in frustration over funding restrictions.

Sydney neurologist Associate Professor Susan Tomlinson told the limbic the drugs were “critically important” to improving the management of a debilitating disease.

“We are really hoping that the PBAC appreciates what a big problem chronic migraine is and that the economic burden of the disease has implications for the community.”

“Migraine has been historically overlooked on health agendas because it is a very common problem. And it’s a lifelong problem.”

“Although it isn’t a terminal illness it actually causes significant disability in patients and usually affects them in their most productive years between about 18 and 55.”

“So the burden of impact is reflected not just in the direct costs of medical bills and tablets but also the indirect costs and the effect on productivity at work and in the home.”

She said the important factor was that the CGRP inhibitors were migraine-specific drugs.

“We haven’t had specific migraine medications in the past for these people with frequent or daily headache. There have been medications developed for other reasons that appear to have some limited effectiveness in migraine prevention.”

Associate Professor Tomlinson said the patient focus shouldn’t be on taking ad hoc medication for episodic headaches.

“If patients are having frequent migraine they should really have a preventative and the choice at the moment really depends of the patients other medical background and the tolerability of the drug,” she said.

“CGRP inhibitors are preventives. There is evidence they are helpful in preventing episodic migraine, but the TGA has approved them for use in chronic migraine and the criteria is 15 or more headache days a month of which eight of those days should be migraine type headaches.”

“So these are only approved at the moment for the more severe patients with chronic migraine abut they are also effective in people with less severe or episodic migraine.”

“At the moment we are limited by the prescribing restrictions and at the moment, the cohort where these will be most useful will be those with chronic migraine.”

She added that every patient with migraine should have a migraine management plan.

“So even if they have infrequent migraine, they should know what the right drugs to take are, and at the right time. And they should also receive education about factors to avoid triggering episodes, etc.”

Fremanezumab is the first in its class with flexible dosing options – quarterly (675mg) or monthly (225mg) injections by pre-filled syringe.

“Part of the advantage of having either a monthly or a quarterly injection is that patients can forget about it for the rest of the month or the next three months and patients like that option,” she said.

Dr Tomlinson declared she has served on a steering committee for Teva, the compoany that markets fremanezumab, for which compensation was received.

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