Is the imposed PBS funding cap driving the migraine medicines shortage?

Pharma News: Australia finds itself grappling with an unparalleled shortage of migraine prevention medicines, leaving a significant impact on the lives of countless women nationwide. The shortage pertains to two drugs, Lilly’s Emgality (galcanezumab) and Teva’s Ajovy (fremanezumab), both integral to individuals suffering from chronic migraines.

Responding to this crisis, medical and consumer groups, including the Australian and New Zealand Headache Society, the Brain Foundation, and Migraine & Headache Australia, convened urgently this week for a high-stakes meeting.

Expressing deep concern over the shortage, Carl Cincinnato, Director of Operations at the Brain Foundation and Migraine & Headache Australia, emphasised the severe impact on patients’ lives.

“These groundbreaking medications, which are self-administered monthly through injector pens, have significantly improved the lives of patients by reducing the frequency and severity of migraine attacks,” he stated.

The shortage of Emgality stems from manufacturing issues identified by the U.S. Food and Drug Administration (FDA) at Eli Lilly’s Branchburg manufacturing plant. However, the ongoing reason for the Ajovy shortage from Teva remains unclear.

The annual PBS funding cap, imposed by the government and Department of Health on Teva and Lilly, is exceeded within the first quarter of each year. According to industry sources, this cap provides no commercial incentives for the company to meet the demands, prompting speculation about its role in the medicine shortages.

Mr Cincinnato commented on this possibility, stating to Health Industry Hub “If that is true, it would make a lot of sense. Because why else would manufacturers not provide migraine treatment for patients.”

The journey to list migraine treatments on the PBS has been arduous for the companies. Novartis withdrew Aimovig (erenumab) from the PBS process in 2019 after multiple funding delays. Ajovy was recommended for inclusion in March 2020, and Emgality in October 2019. However, it wasn’t until 2021 that both were PBS listed, with significant lobbying from patient advocacy groups.

A survey by Migraine & Headache Australia unveiled the profound impact of the medicine shortages on Australians, with some driving for hours to fill prescriptions, others resorting to contacting 30 pharmacies to secure necessary treatment. Individuals who had previously achieved remission now find themselves grappling with migraine relapse, adversely affecting their overall quality of life. Furthermore, a clinician engaged in shift work voiced concerns about their ability to attend to patients due to recurring headaches.

Migraine, the leading cause of disability for women under 50, poses a significant challenge as women actively engage in their careers and family responsibilities. Despite reports of a resolution by April 1st, concerns persist that the full supply may not be available.

Dr Elspeth Hutton, President-Elect of the Australian and New Zealand Headache Society, highlighted the ethical dilemma faced by clinicians, “who may be forced to choose between initiating treatment for new patients and preserving the limited supply for existing patients.”

The collective call to action from healthcare professionals and patient advocacy groups is clear: Mark Butler, Minister of Health, and the Department of Health must take immediate measures to resolve the supply shortage and safeguard the health and well-being of migraine patients across Australia.

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