World-first PBS win: Health Minister backs tumour-agnostic funding of BMS cancer drugs

Marking a world-first shift in cancer care, Federal Health Minister Mark Butler has confirmed a tumour-agnostic* listing of Opdivo (nivolumab) and Yervoy (ipilimumab) on the Pharmaceutical Benefits Scheme (PBS) effective 1 March.

“In the almost four years I’ve been Health Minister, this is one of the most exciting announcements I’ve had the privilege of making. It is going to make a huge difference in giving hope and extended lives to literally thousands and thousands of Australians who are battling advanced cancer,” said Minister Butler. “This [announcement] I’m assured is a world first.”

The landmark decision caps more than a decade of advocacy, tracing back to a request from former Federal Health Minister Greg Hunt to explore tumour-agnostic funding models.

A/Professor Rachel Roberts-Thomson, oncologist at Queen Elizabeth Hospital in Adelaide, anticipates that the PBS listing will benefit many patients including those with advanced lung cancer, bowel cancer, melanoma and some rare cancers.

“This marks a real turning point for the treatment of patients with cancer in Australia,” said A/Professor Roberts-Thomson.

While other countries have experimented with innovative reimbursement mechanisms, including Belgium’s 2017 agreement granting automatic reimbursement for PD-(L)1 inhibitors upon European Medicines Agency (EMA) approval, the Australian move goes further. Unlike Belgium, which limits funding to registered indications of the drug, the PBS listing extends beyond specific Therapeutic Goods Administration (TGA) labels, establishing a true tumour-agnostic framework.

Under this world-first approach, clinicians have the discretion to prescribe these therapies according to the “best available evidence at the time”, including for retreatment, extended treatment durations, and rare cancers where regulatory submissions are unlikely. Importantly, the PBS listing will also remove the previous “once-in-a-lifetime” limitation for use of these medicines in advanced or metastatic cancers.

Rare Cancers Australia (RCA) CEO, Christine Cockburn, described the milestone as a historic turning point following years of advocacy.

“We commend Minister Butler for making a landmark decision that prioritises patient outcomes over outdated system constraints and delivers a more equitable chance at life beyond cancer,” Cockburn said. “This is a defining moment for the Australians diagnosed with a rare and less common cancers – a step towards a system where access to treatment is no longer determined by a person’s tumour type, geographic location or bank balance.”

Medical Oncology Group of Australia (MOGA) Chair, A/Professor James Lynam, added “We know how important access to a broad range of appropriate therapeutic options is for people living with advanced cancers. As clinicians, we welcome the opportunity to provide those in our care with expanded treatment options. We will continue to individualise our patient’s care to ensure decisions are made thoughtfully, considering both potential benefits and risks.”

The human impact is evident in stories like that of Queensland woman Taylor Kirkwood, diagnosed with Stage IV metastatic bowel cancer in 2019 at just 27. When her disease progressed after surgery and chemotherapy, she gained access to an immunotherapy clinical trial recommended by her doctors.

“I was grateful I was able to take part in a clinical trial recommended by my doctor. It’s encouraging to see more treatment options become available to people like me,” Kirkwood said.

RCA sees the announcement as a turning point in breaking down long-standing barriers.

“This decision proves that meaningful reform is possible when government takes a pragmatic and patient-centred approach and patients, clinicians, industry and policy-makers work together to tackle access barriers,” added Cockburn. “I would like to recognise the many patient advocates in our community, including our Co-Founders Kate and Richard Vines, who started advocating for pan-tumour eight years ago.”

According to Owen Smith, General Manager of Bristol Myers Squibb (BMS) ANZ, the PBS listing arrives at a pivotal moment amid debates over the implementation of the Health Technology Assessment (HTA) Review recommendations.

“We have been working towards a multi-indication PBS listing for nivolumab and ipilimumab with the PBAC since 2017,” Smith said. “We have maintained momentum throughout this period as we have always understood the importance and impact of expedited access for Australian patients.”

RCA remains optimistic that this PBS listing decision signals a broader transformation in how Australia evaluates and reimburses cancer therapies.

“Our focus remains on ensuring fast and fair access to treatments for every person with a rare cancer, by maintaining this momentum. What we hope for now is a clear path for other medicines to be listed in this way,” commented Cockburn. “If we are serious about equity and improved cancer outcomes, we need a system that embraces innovation, clinical judgement and timely decision-making. Australians with cancer cannot afford delays when life-changing treatments are within reach.”

*Also referred to as pan-tumour or multi-cancer

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