Australians living with MS face an anxious wait to find out whether medications integral to their daily functioning will remain on the PBS for the long term.
This week, sponsors Roche and Novartis and MS Australia flagged the prospect that two of the most commonly prescribed monoclonal antibodies on the market, ocrelizumab and ofatumumab, could have their listings pulled over a pricing dispute.
Roche Australia general manager Dr Nic Horridge said the department of health had indicated “a substantial price cut” was needed for therapies including ocrelizumab, sold as Ocrevus, to maintain subsidised status.
And while Minister for Health and Ageing Mark Butler said on Wednesday he was “deeply concerned” about the prospect of patients losing access and that he wanted both therapies to stay listed, the topic stoked fear for countless patients.
On social media some said the situation was “very concerning”, “worrying” and “terrifying” as they workshopped letters to their local MPs to campaign for the therapies to retain their listings.
The saga is the latest reminder of tensions between the government and manufacturers when it comes to listing medicines in Australia, and the reality that price negotiations do not always get settled successfully.
Health minister Mark Butler.
Roche pointed to “archaic pricing structures” which threatened to jeopardise patient access to effective treatments. Novartis, maker of ofatumumab (Kesimpta) argued changes that made patients switch to another therapy for non-clinical reasons risked “disrupting care and could result in a relapse or disease progression”.
the limbic asked the health minister and his department about how the pricing of the therapies came under review and for any response to patient concerns about a loss of access.
They did not directly answer these questions, but a department spokesperson said in a statement: “The pricing of these drugs will be discussed at the next PBAC meeting in July. The Department is unable to pre-empt any decision of the Committee”.
“PBS-listed drugs for the treatment of relapsing-remitting multiple sclerosis include alemtuzumab, cladribine, fingolimod, natalizumab, ocrelizumab, ofatumumab, ozanimod and ublituximab.”
Price negotiations under the microscope
The inner workings of health technology assessment processes have been in focus throughout this year as medicine sponsors have walked away from price negotiations despite the committee recommending their therapies for listing [link here].
The review of pricing for ocrelizumab and ofatumumab occurred just over six months after another MS therapy, ublituximab (sold as Briumvi) hit the PBS at a lower price. The public summary document for the treatment showed a cost comparison analysis with ocrelizumab, ofatumumab and fingolimod, which has various generic formulations available.
“As the PBAC determined that Briumvi is likely non-inferior (‘no worse than’) in terms of efficacy and safety compared to available alternatives, the price of Briumvi has been based on a cost-minimisation analysis compared to the least costly alternative therapy,” research fellow in Health Technology Assessment at the University of Melbourne, Dr Joseph Carrello, told the limbic.
“As generics and biosimilars are now entering the market, this has pulled the accepted price down.”
Pricing tensions over ocrelizumab and ofatumumab come as the broader medicines industry continue to highlight concerns about Australia’s PBS listing processes, which they say are too slow and not fit for purpose.
Dr Carrello said that while Australia’s HTA system did have issues that needed resolving, political pressures from the US and its ‘Most Favoured Nation’ policy were likely having more of an impact on appetite for new listings.
“There’s a risk that companies won’t bring their new drugs here to list on the PBS, so may restrict access for Australian patients – but that risk is not exclusive to Australia. Across Europe and in the UK, there’s also talk of that,” he said.
Eli Lilly’s decision earlier this year to abandon plans to list Mounjaro for type 2 diabetes was one example illustrating how sponsors can simply walk away from PBS price negotiations if the terms don’t suit them.
“In the context of ‘most favoured nation’, if they agreed to one price in Australia, then the US wouldn’t charge any more than that. The US is a much bigger market, and diabetes is so prevalent, that would potentially be a major issue for them [Lilly],” Dr Carrello said.
When it comes to MS therapies, both Roche and Novartis said this week they were committed to continuing negotiations to ensure their therapies remain listed.
“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,” Roche’s Dr Horridge said.
“We recognise the uncertainty this process is creating for patients and clinicians, and the potential consequences if these treatments are removed from the PBS,” Novartis said in a statement.
“We are open to working with government to ensure Kesimpta remains on the PBS, so MS patients can continue on treatment without disruption.”