The Pharmaceutical Benefits Advisory Committee has recommended several new cancer treatments while delivering a stinging rejection to pharmaceutical company MSD’s eight-year quest for streamlined pembrolizumab access across multiple tumour types.

In its July 2025 meeting outcomes, the PBAC approved key oncology submissions including durvalumab for limited-stage small cell lung cancer and osimertinib for stage III EGFR-positive non-small cell lung cancer.

However, the committee delivered an outright rejection to MSD’s “multi-cancer funding model” that would have provided immediate PBS access to all registered KEYTRUDA indications for advanced or metastatic cancers.

The PBAC said the proposal “did not establish a reliable basis for the financial estimates” and concluded “a further price discount would be required to ensure cost-effectiveness”.

MSD Australia & New Zealand managing director Chifumi Umeda expressed frustration at the decision, stating: “It’s simply not good enough that after eight years of churn, the committee’s answer to the pleas of the Australian cancer community for more affordable and equitable access to cancer care is an outright ‘no’.”

“For almost a decade the PBAC has continually shifted the goal posts on multi-cancer funding, making it impossible to find an equitable solution for Australian cancer patients.”

“Without a clear change in approach by the Federal Government, there does not appear to be a path forward for multi-cancer funding in Australia,” she said.

The pharmaceutical giant said its proposal would have benefited an estimated 700 eligible cancer patients immediately, with 5,200 more gaining access over four years, including patients with 11 rare cancer subtypes currently without PBS-funded immunotherapy options.

The PBAC noted the proposal was restricted to TGA-registered indications and “would not provide access to some patient groups in which there is a significant unmet clinical need, such as rare cancers” – a justification MSD called “bewildering” given the proposal aimed to remove access barriers for certain rare cancers.

Currently, each new indication requires separate PBAC assessment, with the average time from TGA registration to PBS listing being 447 days, according to the company.

Of 35 registered indications, only 15 were partially or fully PBS-funded despite 40 reimbursement submissions, it said.

The committee also rejected nivolumab plus ipilimumab for both hepatocellular carcinoma and microsatellite instability-high colorectal cancer, citing insufficient evidence of superiority over current treatments.

Pembrolizumab faced additional rejections for advanced endometrial cancer, with the PBAC concluding the clinical evidence didn’t demonstrate equivalence to existing treatments dostarlimab and durvalumab.

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