‘A step backwards’: PBS MS review puts treatment access and cost under scrutiny

The Department of Health’s rapid review of PBS medicines for relapsing-remitting multiple sclerosis (RRMS) has put the future of treatments under scrutiny. But clinicians warn that the government’s push to contain costs must not come at the expense of continuity of care or access to newer therapies.

Professor Todd Hardy, Neurologist at Concord Hospital and Co-Director of the MS Clinic at the Brain and Mind Centre, told Health Industry Hub that the purpose and scope of the rapid review remains somewhat unclear. Yet the circumstances surrounding the review offers an opportunity to address challenges exposed by the recent threat of delisting Roche’s Ocrevus (ocrelizumab) and Novartis’ Kesimpta (ofatumumab).

One of the most consequential issues is how the PBAC determines the value and price of MS therapies. Historical price comparators no longer reflect the clinical landscape.

“While fingolimod was considered high efficacy 10 years ago, it no longer is,” said Professor Hardy. “If the government is too restrictive about criteria and pricing, then there is a fear that in the future companies may not even bother to launch new therapies in Australia.”

While the government is under pressure to reduce costs, clinicians are concerned that any savings could come at the expense of patient care. Professor Hardy cautioned that the review could still result in medicines being withdrawn, even if the process is more consultative.

Perhaps the most contentious issue raised ahead of the review is the inclusion of rituximab in the higher-efficacy tier despite it being an older drug.

Professor Hardy confirmed that there was a clinical rationale for considering it. Evidence from Scandinavia supports its use for RRMS, while studies comparing rituximab and Ocrevus have suggested comparable efficacy. He also acknowledged the financial attraction of a “much cheaper drug” for the government.

“My problem with that is if they’re planning to withdraw ocrelizumab and replace it with rituximab, then that’s still disruptive to patients,” he explained. “If you’ve been stable on a particular therapy for a long time and then you’re switching to another therapy, even though it may be in the same class, there’s potential for poor tolerability or disease progression, which is more than expected because MS is a heterogeneous disease.”

He added, “Rituximab has a higher rate of complications, higher rates of infections and hypogammaglobulinemia. To go back to rituximab is a step backwards.”

The possibility of subcutaneous rituximab appears to have been another unexpected development. The issue had not previously featured in discussions with the PBAC during the delisting controversy and Professor Hardy questioned the clinical evidence base for such a move.

Clinicians would not be left without alternatives if Ocrevus were removed from the PBS. But the availability of other treatments does not make the removal of an established therapy clinically neutral. The central issue is not simply whether another drug exists, but whether patients can switch without compromising treatment stability, tolerability or access.

Professor Hardy made clear that switching would not be the preferred outcome, but said that “if it ended up being the outcome of the review process, then we would move to ublituximab, another anti-CD20 therapy”.

The recent MS dispute demonstrated that clinicians and patient advocacy groups are prepared to challenge policy decisions that threaten access to established therapies, and that government officials may have underestimated the strength of that response.

“The government found out through this existing scare that there is a very vocal MS community out there,” Professor Hardy emphasised. “Maybe they are learning that there needs to be a lot more discussion and input from consumers, doctors and MS bodies to ensure that any changes are considered carefully.”

In reimagining healthcare across the entire patient journey, Health Industry Hub^TM is the only one-stop-hub uniting the diversity of the Pharma, MedTech, Diagnostics & Biotech sectors to inspire meaningful change.

The Health Industry Hub^TM content is copyright protected. Access is available under individual user licenses. Please click here to subscribe and visit T&Cs here.