Thousands of Australians with multiple sclerosis could lose subsidised access to ocrelizumab and ofatumumab as a PBS pricing dispute heads to the PBAC.
The future of two of Australia’s most widely used multiple sclerosis therapies hangs in the balance after proposed PBS pricing changes raised the prospect of them being delisted, risking the access to treatment for thousands of patients.
Should it go ahead, it is understood the move will leave patients without subsidised access to these drugs, and bills of up to about $30,000 per course of treatment. They will 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.
Both agents are widely used as first-line therapy because of evidence from long-term real-world studies suggesting early initiation is associated with lower rates of disability progression.
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.
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.
While neither Roche or Novartis would comment on pricing, other industry sources have revealed this could mean price reductions of up to 50% for ocrelizumab and ofatumumab.
It is understood both Roche and Novartis have declined the revised pricing, on the basis it would be commercially unsustainable.
The matter has now been referred to a confidential session of the Pharmaceutical Benefits Advisory Committee meeting next week. The PBAC will then advise federal health minister Mark Butler on whether there are sufficient clinical or policy grounds for the medicines to remain on the PBS despite the pricing dispute.
Patient advocacy group MS Australia, Roche Australia and Novartis have urged the federal government to maintain PBS access to ocrelizumab (Ocrevus, Roche Australia) and ofatumumab (Kesimpta, Novartis).
MS Australia’s deputy CEO Dr Julia Morahan said preserving a broad range of PBS-listed disease-modifying therapies (DMTs) was critical because MS was a heterogeneous disease and treatment response varied considerably between individuals and over time.
“Our focus is advocating strongly for continued access to life-changing, high-efficacy medications on the PBS,” Dr Morahan said.
She said restricting access to ocrelizumab and ofatumumab would limit clinicians’ ability to tailor therapy and adapt treatment throughout the course of disease, potentially compromising long-term outcomes.
The organisation also argued that the benefits of high-efficacy therapy extend beyond clinical outcomes.
It cited recent Australian health economic analyses indicating that effective DMTs reduce healthcare utilisation, delay disability, lessen reliance on the National Disability Insurance Scheme and help people remain employed and socially engaged.
Roche Australia’s general manager Dr Nic Horridge said the DoHDA had stipulated “a substantial price cut for the most commonly used MS medicines, including Ocrevus, to remain on the PBS”.
“This cut, should it stand, would make it impossible to keep Ocrevus on the PBS and would lead to the Australian Government removing Ocrevus from the PBS,” Dr Horridge said.
“Minister Butler and his department understand what is at stake. At their direction, the Pharmaceutical Benefits Advisory Committee will meet next week to provide advice on viable and sustainable pricing of the most commonly used MS medicines, including Ocrevus.
“We know Minister Butler understands that multiple sclerosis is a disabling disease and that he is committed to ensuring Australians receive and retain access to the best medicines.”
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The potential delisting of ocrelizumab by the government, including a new subcutaneous formulation added to the PBS by Mr Butler last December, would have far-reaching consequences for thousands of MS patients, their families and medical teams, said Dr Horridge.
“Archaic pricing structures risk disrupting the continuity of treatment for thousands of MS patients. Many patients would be required to start a new medicine which may not work as well for them, or cause them to face financial hardship to continue optimal treatment,” he said.
“Actions such as this will harm industry’s ability to bring new medicines in the future, meaning Australia could fall further behind global standards of care.”
“We echo the call from MS experts and advocates for the Minister to ensure that Australians with MS continue to receive affordable access to the best medicines – now and into the future.”
Novartis similarly warned that removal of ofatumumab from the PBS could destabilise patients who are well controlled on treatment and create additional challenges for people in regional and remote Australia, where specialist neurological services and infusion facilities are less accessible.
In a statement to The Medical Republic, the company said switching stable patients because of pricing policy rather than clinical need could increase the risk of relapse or disease progression while adding pressure to other parts of the healthcare system.
“This situation highlights broader issues with the PBS, where pricing policies can be applied without thorough consideration of the impact to patient access and other parts of the healthcare system, including hospitals and the NDIS,” said the statement.
“Ensuring people can continue to access the treatment that is right for them, without unnecessary disruption, is essential to supporting better health outcomes and a sustainable healthcare system.
“We recognise the uncertainty this process is creating for patients and clinicians, and the potential consequences if these treatments are removed from the PBS. It is important that any decision fully considers the clinical, psychological and practical implications for people living with MS.
“We are open to working with government to ensure Kesimpta remains on the PBS, so MS patients can continue on treatment without disruption.”
Dr Morahan told TMR that wading into the debate over drug pricing and industry negotiations was not something MS Australia did lightly – in fact it is understood this is the first time it has taken such action.
“Our focus is however, in advocating strongly for continued access to life-changing, high-efficacy medications on the PBS,” she said.
“These are extremely effective, these two particularly … and we know that they have the capacity to dramatically alter the course of disease.”
Dr Morahan warned that removing the drugs from the PBS would be a big step backwards.
“It really is. There are other medications, but as I said before, everybody’s MS is different, and we have a large proportion of people that are very stable on these medications, and switching to another medication might, might be fine for some people, but could very well not be as effective.
“We prefer just to keep what we know it works for these people, it’s a significant number of people, we have to keep the status quo.”
TMR sought comment from Mr Butler’s office, asking questions about the price negotiations, including the key question: “Who is responsible for making the decision to delist the medicines from the PBS and is there additional consultation around this other than the PBAC? When is this decision likely to take affect if it goes ahead?”
The response from Mr Butler’s office was to provide a quote snipped from a transcript taken during a doorstop interview the minister conducted on Wednesday morning.
“I’m deeply concerned about this. I’m pleased that the Pharmaceutical Benefits Advisory Committee, which is the committee of experts that have overseen the PBS for many, many years, are considering this issue at this month’s meeting,” Mr Butler said in response to a journalist’s question about the dispute.
“Obviously, I want to see these medicines stay on the PBS. They’re providing great support to many, many patients living with MS. I’ll leave that work to go through its usual course with the PBAC, but obviously I want to see these medicines stay on the PBS and continue to provide that support to patients.”
