The federal government has abandoned plans that threatened PBS access to Australia's two most widely used high-efficacy multiple sclerosis therapies – at least for now.
Australians living with multiple sclerosis will retain subsidised access to ocrelizumab and ofatumumab after federal health minister Mark Butler confirmed the medicines would remain on the Pharmaceutical Benefits Scheme – at least for now.
The announcement ends weeks of uncertainty over proposed pricing changes that industry warned could have made continued PBS supply commercially unviable.
The government has also asked the Pharmaceutical Benefits Advisory Committee (PBAC) to undertake a review of how high-efficacy MS medicines are being used on the PBS and whether their current listings and therapeutic relativities reflect contemporary clinical evidence.
It is understood the move to take the drugs away from the PBS would leave patients without subsidised access to these drugs, and bills of up to about $30,000 per course of treatment. They would also face the real threat of ceasing treatment due to cost.
Approximately half of Australians receiving treatment for relapsing forms of MS are prescribed high-efficacy anti-CD20 monoclonal antibodies.
Ocrelizumab (Ocrevus, Roche Australia) and ofatumumab (Kesimpta, Novartis) were listed on the PBS In 2018 and 2021 respectively.
The PBS listing of a third anti-CD20 therapy, ublituximab (Briumvi, Neuraxpharm Australia Pty Ltd), in late 2025 at a substantially lower price triggered a review of pricing for other medicines in the therapeutic class under the PBS reference pricing framework, including ocrelizumab and ofatumumab.
Under this policy, medicines considered to have comparable safety and efficacy are grouped together, with the lowest-priced product establishing the benchmark reimbursement price for the class.
MS Australia welcomed both the decision to retain the medicines on the PBS and the broader review, saying it would provide greater confidence that future PBS decisions appropriately recognised the unique benefits of individual therapies.
The advocacy group said preserving access to a broad range of disease-modifying treatments was essential because MS was highly heterogeneous, with treatment decisions needing to be individualised according to disease activity, patient characteristics, lifestyle factors and risk profiles.
It said the outcome was a huge relief for thousands of Australians living with MS, their families, carers and clinicians, who had faced significant uncertainty about the future of their treatment access.
MS Australia director Sharlene Brown, who has been treated with ocrelizumab for more than seven years, said the announcement would allow patients to continue making treatment decisions with their neurologists without fearing that effective options would disappear.
“Continued PBS access means people can keep working with their neurologists to choose the treatment that is right for them, without the fear that effective options will be placed out of reach,” she said.
Manufacturers, however, expressed concern that the planned PBAC review could prolong uncertainty despite welcoming the minister’s decision to maintain PBS listings.
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Roche Australia general manager Dr Nic Horridge said the government’s announcement acknowledged that the proposed price reduction for ocrelizumab was “entirely unfeasible” and welcomed the minister’s repeated public support for continued PBS access.
“This development recognises that the price cut stipulated by the Department of Health was entirely unfeasible,” Dr Horridge said.
“I am pleased that common sense has prevailed and note Minister Butler’s repeated statements of support for these medicines to remain available through the PBS.
“However, it’s disappointing to hear that the Pharmaceutical Benefits Advisory Committee has recommended yet another review of high efficacy MS treatments.
“Based on the extensive and ongoing positive clinical evidence Roche submitted to the PBAC, it’s unclear as to what this review will achieve.
“Patients living with MS don’t need another review, they want confidence that they will continue to have access to these medicines.”
He said the episode exposed broader shortcomings in Australia’s medicines reimbursement system and renewed calls for PBS reform, warning delays to reform risked limiting access to innovative therapies available in comparable countries.
“Every day that reform is delayed jeopardises access to medicines that could be life-changing or life-saving,” said Dr Horridge.
“What this issue has highlighted is the need for a better system in Australia to ensure patients receive and retain equitable access to medicines that are widely available around the world.”
Novartis, which markets ofatumumab, also welcomed confirmation that the medicine would remain PBS-listed while the review proceeds but warned the process should not reduce future treatment choice.
Ad-interim Novartis ANZ country president Marco Muscardo said first-line access to a broad range of high-efficacy therapies remained critical so neurologists could tailor treatment to individual patient needs and circumstances.
“We are pleased that the Health Minister has confirmed that Kesimpta, and other MS treatments, will remain available on the PBS whilst a review takes place,” he 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. We await further detail from Government on the scope and process for the review.
“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.”
Ocrelizumab and ofatumumab are anti-CD20 monoclonal antibodies that selectively target B cells implicated in the autoimmune process underlying MS. Both are considered among the highest-efficacy disease-modifying therapies available for relapsing forms of the disease and are increasingly used early in the treatment course to reduce relapse rates, MRI disease activity and long-term disability accumulation.
Ocrelizumab has been PBS listed since February 2018 as an intravenous infusion, with a subcutaneous formulation added in December 2025. Ofatumumab is administered as a once-monthly self-injection, offering patients an alternative route of administration while delivering comparable high-efficacy disease control.
Multiple sclerosis affects more than 33,000 Australians, with approximately 85% diagnosed initially with relapsing-remitting disease.
Diagnosis typically occurs between 20 and 40 years of age, making it one of the leading causes of acquired neurological disability in young adults. Australia has one of the world’s highest MS prevalence rates, with the disease disproportionately affecting women and people living in southern states.
According to MS Australia’s latest prevalence and health economic impact report, the number of Australians living with MS has increased by 77% since 2010.
The condition now costs the Australian economy an estimated $3 billion annually, equivalent to almost $80,000 per person living with the disease, while almost 12,000 Australians with MS receive National Disability Insurance Scheme support.
The terms of reference and timing of the PBAC review have not yet been announced.
