Relief for migraine patients but access headaches remain

Lilly’s Emgality (galcanezumab), a preventive calcitonin gene-related peptide (CGRP) therapy for migraine, has been added to the Pharmaceutical Benefits Scheme (PBS) for patients experiencing eight or more migraine days per month. The revised access conditions align with those already in place for Teva’s Ajovy (fremanezumab).

The change comes as migraine continues to affect an estimated 4.9 million Australians. The expanded PBS listing is expected to support around 135,000 people annually, with patient out-of-pocket costs reducing from more than $500 per prescription to the standard pharmacy co-payment.

Migraine Headache Australia lead Carl Cincinato said affordability remains a central barrier to effective care.

“For people with migraine, it’s often not whether the treatment exists. It’s whether they can afford to start and stay on it,” he said. “Many Australians still face delays, eligibility hurdles, out-of-pocket costs, and challenges reaching a headache specialist.”

Under current PBS arrangements, patients are not permitted to receive Emgality and Botox concurrently. Where both therapies are used, one must be funded privately by the patient.

Since November 2024, general practitioners (GPs) have been able to initiate PBS-listed biologic migraine therapies in consultation with a specialist, marking a shift from the previous model in which only neurologists could prescribe. That earlier restriction contributed to delays in treatment access for patients unable to secure timely specialist appointments.

The pathway to PBS listing for this class of medicines has been protracted for manufacturers. Novartis withdrew Aimovig from the PBS process in 2019 after repeated funding delays. Teva’s Ajovy received a recommendation for listing in March 2020, while Lilly’s Emgality was recommended earlier, in October 2019. Despite these milestones, both therapies were not listed on the PBS until 2021, following sustained advocacy from patient groups.

Even after inclusion on the PBS, commercial and supply dynamics have remained tightly constrained. Annual PBS funding caps, set by the federal government and the Department of Health for manufacturers including Teva and Lilly, are typically reached within the first quarter of each year. Once those thresholds are exceeded, manufacturers effectively absorb the cost of additional supply, a mechanism that has been associated with supply pressure and delays in bringing new therapies to market.

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