Cheap old drug enters MS PBS review as access battle continues

The Department of Health has outlined the scope and timelines of the Rapid review of PBS medicines for relapsing-remitting multiple sclerosis (RRMS), as recommended by the Pharmaceutical Benefits Advisory Committee (PBAC). It follows weeks of uncertainty over patient access to two PBS-listed multiple sclerosis (MS) therapies, Ocrevus (ocrelizumab) and Kesimpta (ofatumumab), amid an increasingly acrimonious pricing dispute with the government.

The dispute stemmed from a pricing negotiation where the Department of Health required Neuraxpharm to accept a 40% price cut 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 would withdraw Ocrevus from the Australian market if it had to take a significant price reduction.

The pricing confrontation has thrown renewed attention on how MS medicines are categorised and valued under the PBS. The rapid review will examine the medicines listed for RRMS across two tiers based on outcomes: a ‘lower-efficacy’ tier and a ‘higher-efficacy’ tier.

Interestingly, the older drug rituximab has been included in the ‘higher-efficacy’ tier for the review, despite more innovative therapies being available on the PBS. Its use for multiple sclerosis in Australia remains off-label and is not funded through the PBS.

Rituximab is, however, up to 95% cheaper than newer anti-CD20 medicines, including Kesimpta, Ocrevus and Briumvi. That pricing comparison does not take into account the confidential rebates pharmaceutical companies pay back to the government, which have become the government’s primary mechanism for controlling PBS expenditure. In 2024–25, industry repayments accounted for approximately 35% of total PBS costs returned to the government.

It is against this backdrop that the PBAC has commissioned the rapid review, which will examine whether the PBS restrictions and tiering of disease-modifying treatments for RRMS reflect current clinical evidence, TGA indications, international guidelines and practice. It will also identify important treatments that are unavailable or not PBS-listed.

At the same time, the review will explore how patients move between RRMS treatments, including switching, adherence and persistence, and whether treatment patterns vary by patient group or location. It will also consider patient preferences and practical barriers to accessing and using different treatments.

The PBAC Chair is expected to hold a stakeholder meeting in August with peak clinical and consumer groups and relevant pharmaceutical sponsor companies. However, some stakeholders have not been notified of this date in August yet. A public consultation will also be issued this month.

The draft report developed by an external Health Technology Assessment (HTA) evaluation group will be shared with stakeholders between 25 November and 2 December, before the PBAC considers the report at its intracycle meeting on 9 December.

‘In-confidence’ PBAC minutes are due to be provided to selected pharmaceutical sponsors, and clinical and consumer groups on 22 January 2027, with the PBAC outcomes scheduled for publication on 29 January 2027.

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