Government backs down in MS drug standoff – for now

Federal Health Minister Mark Butler has confirmed that two multiple sclerosis (MS) therapies, Ocrevus (ocrelizumab) and Kesimpta (ofatumumab), will remain on the Pharmaceutical Benefits Scheme (PBS), ending weeks of uncertainty over patient access following an increasingly acrimonious pricing dispute.

The announcement follows mounting pressure on the Federal Government to “guarantee” that the disease-modifying therapies (DMTs) would continue to be reimbursed, amid growing concern that government cost-cutting measures had produced unintended consequences for patients.

The dispute intensified after the Department of Health required Neuraxpharm to accept a forty percent (40%) price reduction as a condition of securing PBS listing for its MS therapy, Briumvi (ublituximab), in January 2026. That decision placed Australia’s MS treatment landscape on a collision course, with Roche becoming particularly vocal in warning it could withdraw Ocrevus from the PBS.

The government’s decision to maintain access to both medicines has been welcomed across the MS community.

“This is an incredibly important and deeply reassuring outcome for thousands of Australians living with multiple sclerosis (MS), their families, carers and clinicians, who have faced significant uncertainty about the future of their treatment access,” said Rohan Greenland, CEO of MS Australia. “Continued access to a broad range of PBS-listed treatments is essential so that neurologists and people with MS can make timely, personalised treatment decisions that give each person the best chance of maintaining their health, independence, workforce participation and quality of life.”

However, the Pharmaceutical Benefits Advisory Committee (PBAC) has set intentions to review how these drugs are being used on the PBS and ensure the listings and therapeutic relativities remain consistent with the contemporary evidence base. The review will examine whether the current listings and therapeutic relativities remain aligned with the contemporary evidence base and is expected to conclude before the end of the year, when a final decision will be made.

The decision also raises the prospect of Neuraxpharm challenging the pricing outcome imposed on Briumvi’s PBS listing and opening discussions with the PBAC over whether the 40% price reduction demanded by government represents a fair valuation of its therapy within the same class of MS treatment landscape.

“The PBAC recommends a rapid review be completed by December this year and I have accepted that advice,” Minister Butler said.

Marco Muscardo, Ad-Interim Country President of Novartis ANZ, said “While we note the Government’s decision to undertake another review of PBS-listed MS medicines, we are concerned that this process could ultimately result in limiting patient access to treatment options that people living with MS rely on. It is critical that Australians continue to have first-line access to a broad range of PBS-listed treatment options, including high-efficacy therapies such as Kesimpta, so that treatment decisions can be tailored to individual patient needs and circumstances.”

The short-term resolution of the pricing dispute comes amid a broader debate over pharmaceutical pricing and the future direction of Australia’s medicines policy.

Public Health Association of Australia (PHAA) CEO Adjunct Professor Terry Slevin and Australian Fair Trade & Investment Network (AFTINET) convener Dr Patricia Ranald recently wrote to Minister Butler criticising Medicines Australia’s push to “value” innovative medicines on the PBS in line with the Most Favoured Nation (MFN) pricing policy.

“We urge the government to continue to resist these pressures. We do not accept the claim that US consumers are subsidising lower prices in other countries. The truth is that the US is the only advanced industrialised country which does not have a system to regulate the wholesale price of medicines,” they wrote. “The US government and pharmaceutical companies are trying to coerce other governments to raise wholesale prices to the US level, which would undermine affordable access to medicines and increase costs for governments and consumers. Conceding to these demands would undermine the foundations of the PBS.”

Although the immediate MS drug pricing dispute has been resolved, the broader policy contest remains far from settled. How the implementation of the Health Technology Assessment (HTA) Review recommendations is negotiated between the government and Medicines Australia as part of the next Strategic Agreement is expected to be one of the medicines sector’s most consequential policy challenges.

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