Neurologists call for action on stalled PBS listing of CGRP therapies

Headache

By Michael Woodhead

18 Nov 2020

A/Prof Richard Stark

Headache specialists have made a plea to the government to resolve the impasse over PBS listing of CGRP therapies for migraine.

Although two of the three TGA approved CGRP therapies have received a positive recommendation from the PBAC, a key obstacle to listing is the insistence by the government that they be included in a cap along with Botox, according to the Australia and NZ Headache Society.

But such a grouping is inappropriate because the drugs have different modes of action, says ANZHS President Associate Professor Richard Stark in a submission to the House of Representatives Inquiry into approval processes for new drugs and novel medical technologies in Australia.

In his letter, he says neurologist members of the ANZHS now have considerable practical experience in using the CGRP therapies for prophylaxis migraine and have found they fulfil an unmet need and have lived up to the potential seen in clinical trials for efficacy and tolerability.

“Headaches which do occur tend to be milder briefer and more responsive to acute medication,” he writes, noting they also reduce overuse of other secondary analgesics.

Associate Professor Stark, Deputy Director of Neurology for Alfred Health, Melbourne, notes there are biological differences between the CGRP therapies and Onabotulinum Toxin-A (Botox), with different patient populations that respond to each.

“It is therefore difficult to understand how the CGRP monocolonal antibody therapies should be included in the same cap as Botox, purely due to being treatments for the same disease,” he writes.

The submission says neurologists find it frustrating to see pharmaceutical companies gain PBS listings for high cost drugs for rare conditions, while patients with a common disabling condition are missing out on an effective therapy.

“We recommend that for common conditions such as migraine the broad economic benefits of treatment under consideration including productivity, avoidance of absenteeism and ability to engage in the workforce … be given greater emphasis by the PBAC,” the letter concludes.

A similar plea is made in a submission by Migraine & Headache Australia and Brain Foundation, which calls on the inquiry to create a separate cap for CGRP therapies, as distinct from Botox.

“One Australian case series of erenumab (a CGRP treatment) in the real world, found that patients failing Botox could still be responders (greater than 50% improvement) to erenumab, which supports the different mechanism of action,” the submission states.

“If considered under the same cap as Botox for PBS, the cap would need to be significantly increased in number to allow for the fact that some patients would try one treatment, such as Botox for at least 6 months, prior to trying the next treatment, such as a CGRP monoclonal antibody, for at least 3 months.”

The submission also calls for the creation of a Migraine Centre Of Excellence based at a university teaching hospital to train and fund researchers and encourage neurologists to participate in scientific studies to advance headache care.

And a chronic migraine epidemiological study is needed as a basis for assessing the burden of migraine in Australia, it suggests. Based on the Headache-Attributed Restriction, Disability, Social Handicap and Impaired Participation (HARDSHIP) questionnaire, the study would be the critical first step in obtaining data to guide future research, practice and policy on chronic migraine in Australia.

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