Health Minister backs second tumour-agnostic funding, extending to MSD cancer drug

Marking a second major win for cancer patients, Federal Health Minister Mark Butler has confirmed a tumour-agnostic* listing of MSD’s immune checkpoint inhibitor Keytruda (pembrolizumab) on the Pharmaceutical Benefits Scheme (PBS), effective 1 September 2026.

The milestone decision follows the first tumour-agnostic funding of Bristol Myers Squibb’s (BMS) cancer drugs Opdivo (nivolumab) and Yervoy (ipilimumab) in March. The Keytruda decision is expected to benefit more than 10,000 newly eligible Australians over the next four years across certain advanced and metastatic cancers.

“This has been a very long time in the making with many years of advocacy by so many patients, clinicians and patient groups,” said Christine Cockburn, CEO of Rare Cancers Australia (RCA). “Keytruda is one of the most common drugs our community has had to crowdfund to access over the years. Not any more. This makes TWO immunotherapies available for use in pan-tumour.”

Until now, access to Keytruda through the PBS has depended on separate health technology assessments (HTAs) for each individual cancer indication. The therapy is registered on the Australian Register of Therapeutic Goods (ARTG) for 29 advanced and metastatic indications across different cancer types, but only 13 were previously PBS-listed.

Under the new tumour-agnostic approach, clinicians will have discretion to prescribe the therapy 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, giving clinicians greater flexibility in determining appropriate treatment for individual patients.

The shift is particularly significant for patients with rare and ultra-rare cancers, which account for approximately 25% of diagnoses. For these cancers, pharmaceutical companies are unable to support phase 3 randomised controlled trials (RCTs) due to low patient numbers. This leads to challenges in generating the conventional evidence required for individual indication-based funding.

Evidence from the DART trial showed that dual therapy with Opdivo and Yervoy delivered durable responses across 53 rare and ultra-rare tumour types, with more than 10% of patients achieving progression-free survival of ≥2 years.

Associate Professor Sumitra Ananda, Medical Oncologist at the Peter MacCallum Cancer Centre and Epworth HealthCare, said oncologists and patients have advocated for a new approach to immunotherapy funding for many years.

“This is an important moment that may expand immunotherapy access for thousands of Australians and give doctors the discretion to make appropriate evidence-based treatment decisions,” said Associate Professor Ananda. “The announcement will help make this immunotherapy treatment option more affordable and potentially remove the financial burden that patients with advanced or metastatic cancer may face.”

The PBS listing coincides with the registration of Keytruda for certain patients with chemotherapy-resistant ovarian cancer. This will allow immediate funded access for approximately 80 eligible women with advanced or metastatic ovarian cancer, without the average delay for medicines between a TGA registration and PBS listing of more than 700 days.

Chifumi Umeda, Managing Director, MSD Australia & New Zealand, commented “MSD has spent a decade working with the cancer community to arrive at this important day. It has been a long and winding road, but the result is affordable and equitable access to this immunotherapy for eligible Australians.”

Owen Smith, General Manager of BMS in Australia and New Zealand, said “Patients with rare and less common cancers have historically faced a lack of funded treatment options. We welcome the news that additional immunotherapy treatment options for Australians living with advanced or metastatic cancer will soon be funded through the PBS as part of this multi-indication listing.”

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

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