Migraine medicine shortage resolved, yet limitations remain

Pharma News: The Therapeutic Goods Administration (TGA) has announced the resolution of the shortage status for Eli Lilly’s CGRP therapy, Emgality (galcanezumab), an essential migraine prevention medicine.

Carl Cincinnato, Director of Operations at the Brain Foundation and Migraine & Headache Australia, expressed relief in response to this announcement. Last month, a joint call from the Brain Foundation, Migraine & Headache Australia, the Australian and New Zealand Headache Society, and Painaustralia urged immediate action to address the supply shortage.

“Many Australians living with frequent migraine have been devastated by the unprecedented shortage of this critical migraine prevention medication,” Mr Cincinnato told Health Industry Hub. “The inability to access these preventative treatments risked not only a relapse into chronic migraine but also significantly affected their overall quality of life, leading to increased chronic pain, anxiety, depression, and disability.”

The journey for listing migraine treatments on the Pharmaceutical Benefits Scheme (PBS) has been fraught with challenges. Novartis withdrew Aimovig (erenumab) from the PBS process in 2019 due to funding delays, while Teva’s Ajovy and Lilly’s Emgality faced a protracted approval process. Despite being recommended for reimbursement in March 2020 and October 2019 respectively, it wasn’t until 2021 that both medicines were listed on the PBS, thanks to significant lobbying from patient advocacy groups.

However, the PBS listing for Emgality and Ajovy comes with limitations – a PBS funding cap set at 10,000 patients. Demand often exceeds availability within a few short months of the year and the cap provides no commercial incentives for the companies to meet the demands.

Migraine Australia has previously voiced concerns, fearing that the “excessive restrictions and wholly inadequate cap on CGRP therapies and Botox for migraine may lead to drug companies withdrawing them from the market”.

Mr Cincinnato reiterated to Health Industry Hub, “We will continue to monitor supply and represent the patient community who are taking proactive steps to manage their health and wellbeing despite frequent and debilitating migraine attacks.”

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