PBAC decision looms for tumour-agnostic immunotherapy funding

After eight years of debate involving industry, clinicians, and patient advocacy groups, hope may be on the horizon for a Pharmaceutical Benefits Advisory Committee (PBAC) recommendation to list BMS’ Opdivo (nivolumab) and Yervoy (ipilimumab) on the Pharmaceutical Benefits Scheme (PBS) in a tumour-agnostic* setting.

In August, the PBAC outright rejected a tumour-agnostic funding proposal for MSD’s Keytruda (pembrolizumab). By contrast, it deferred a decision on BMS’ proposal, with the company noting at the time that it was “navigating a prompt pathway to approval” and expecting a status update by mid-October.

The science underpinning these funding models is evolving rapidly. Advances in genomics now allow cancers to be categorised by genetic alteration rather than tissue of origin, enabling targeted therapies for small patient populations across multiple tumour types. Yet, many of these treatments rely on single-arm trials without a standard-of-care comparator, creating uncertainty around safety, efficacy, and cost-effectiveness – challenges that complicate health technology assessment (HTA) deliberations.

Other countries, however, have found ways forward. Tumour-agnostic funding models were first introduced in Europe in 2017 and are now deployed by several nations to improve access while providing budget predictability.

Recent research supports adopting a “life-cycle” cost-effectiveness framework for tumour-agnostic medicines, in which economic models are continuously updated with real-world evidence to guide decisions on appraisal, re-appraisal, and de-adoption.

Patient advocacy groups continue to call for faster, fairer access. Rare Cancers Australia (RCA), in its latest report Now it’s personal: Access and equity for all, urged the government to subsidise treatments across multiple cancer types without requiring separate applications for each type.

For patients like Gemma, living with a rare bowel cancer, the disparities are deeply personal. She said, “My experience highlighted a significant disparity in the availability and affordability of essential medications in Australia. For instance, my initial drugs were not covered by the Pharmaceutical Benefits Scheme (PBS), costing me an astonishing $6,742 a month.

“The situation becomes even more disheartening when considering the cost of adding immunotherapy to my treatment plan, which would exceed $60,000 – despite being on the PBS for other mutations of bowel cancer, just not mine. If this isn’t inequity, I’m not sure what is. I hope to see the day when our healthcare system doesn’t discriminate against cancer types.”

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

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