Novartis withdraws Aimovig from PBS process

Migraine Australia are disappointed, but respect the decision by Novartis to withdraw their application for migraine prevention drug Aimovig from consideration at the November meeting of the Pharmaceutical Benefits Advisory Committee (PBAC) for listing on the Pharmaceutical Benefits Scheme (PBS).

Aimovig is a first-in-class monoclonal antibody that blocks the receptor for Calcitonin Gene Related Peptide (CGRP), a chemical which has been found to be a critical component in the sequence of events that results in a migraine attack. Two other medications, Emgality (Eli Lilly) and Ajovy (Teva) – both of which are still applying for listing on the PBS – work by targeting the peptide itself, rather than the receptor. These are the first ever medications specifically developed to prevent migraine attacks.

Most patients experience a reduction in migraine attack frequency and severity by around 50%. Some, dubbed ‘super responders’ have reduced attacks by over 75%, with approximately 3% of patients enjoying complete relief from migraine attacks.

Novartis has been making Aimovig available to Australian patients for free for over a year through patient trial programs. In that time, the drug has been rejected by the PBAC twice – not because it doesn’t work, or isn’t cost effective, but because there’s too many migraine patients and the cost to the budget is “high and uncertain”. Emgality was recommended on first application in the July 2019 meeting of the PBAC, but with a condition that is has to be under the same cap as currently exists for Botox for migraine. The Botox cap is exhausted each year with the small number of existing Botox patients.

Chair of Migraine Australia’s organising committee, Raphaella Crosby, says the decision of the PBAC is bullying the drug companies into giving away their drug for free.

“We just want our lives back, and these drugs can do that.

“To deny us a chance at a normal life, confined to welfare or constantly at risk of losing our jobs, unable to have a productive life, simply because there’s too many of us, is cruel and inexplicable,” Ms Crosby said.

Migraine is one of the most debilitating conditions in the world, estimated by Deloitte Access Economics to affect 4.9 million Australians, and cost the Australian economy $35 billion per year. The PBAC estimated Aimovig would cost the budget $100m over the first 6 years for 200,000 patients, with excessive eligibility restrictions. No offset appears to have been calculated for decreased welfare costs, decreased costs to the health system, or the increased productivity across the economy.

“It is not clear if the problem is the PBAC dismiss migraine as ‘just a headache’, or something else, but we are really unhappy about the way we are being treated.

“It is disrespectful to the millions of Australians whose lives are completely sacrificed to this genetic, incurable disorder, and destroys the first glimmer of hope we’ve ever had.

 “We understand the decision of Novartis not to be bullied by the PBAC, and thank them for their amazing support of the migraine community,” Ms Crosby said. 

Migraine Australia is a new patient advocacy and support organisation being created by people living with migraine. We started with an organising committee at the end of July, and are currently in the process of appointing a board and registering as a charity. We will continue to work with stakeholders to seek a removal of any caps or restrictions on all the new anti-CGRP medications, and other new migraine medications currently in the development pipeline.

• Aimovig will still be available on private prescription, costing approximately $800 a month.

• Patients currently on the Patient Familiarisation Program (PFP) will continue to receive Aimovig for free until April 30, 2020.

• Affected patients are urged to talk to their neurologist about their options, and join the Migraine Australia Chat Group on Facebook for support.

You may also like New study finds doctor-pharmacist partnership significantly reduces patient harm