Why PBAC rejects multi-cancer funding for immunotherapy drugs

Pharma News: The Pharmaceutical Benefits Advisory Committee (PBAC) has rejected proposals for broad, multi-cancer funding of PD-(L)1 checkpoint inhibitors, including BMS’ Opdivo (nivolumab) and MSD’s Keytruda (pembrolizumab), for current or future indications approved by the Therapeutic Goods Administration (TGA).

Earlier this year, eleven cancer advocacy groups urged Health Minister Mark Butler to support a multi-cancer funding initiative for these immunotherapies. However, the PBAC has opted for a “simplified PBS listings within tumour types” rather than pursuing a broad multi-cancer (pan-tumour) funding agreement.

Rare Cancers Australia (RCA) CEO, Christine Cockburn, sees this rejection as yet another blow to patients who would benefit from these therapies. She stated, “Our patients continue to wait, self-fund or die whilst this industry and government negotiate. The suggestion from the PBAC that reform could occur ‘within tumour types’ is simply reverting to the status quo. This is not innovation and more importantly, it is not helping Australians living with life threatening cancer.

She added, “RCA is on the record as advocating for pan-tumour listings since 2017 and this latest development is simply another example of the participants arguing over the life-jacket whilst the patient is in the water drowning.”

Pharmaceutical company MSD expressed disappointment with the PBAC outcome, stating, “The proposed process for listings within tumour types may still be onerous, entail a high degree of complexity, and may not necessarily deliver better access for patients.”

Since Keytruda’s initial addition to the Australian Register of Therapeutic Goods (ARTG) in 2016 for advanced melanoma, the TGA has expanded its use to cover 30 different indications across various cancer types and stages. To date, Keytruda has been assessed by the PBAC 36 times, securing PBS listings for 15 indications. In contrast, in the United States, Keytruda is registered and funded for 40 indications. On average, it takes 447 days after ARTG registration for an indication to receive reimbursement through the PBS.

The PBAC acknowledged that broad listings would require a Risk Sharing Arrangement (RSA) to ensure cost-effectiveness and control total government expenditure. The Committee also indicated that significant price reductions from current PBS prices would likely be necessary for broader funding to proceed.

In the 2022-23 financial year, PD-(L)1 inhibitors represented a significant investment, exceeding $1 billion. Most of this expenditure has been allocated to Opdivo and Keytruda, though net spending is reduced through Special Pricing Arrangement rebates.

A broad funding proposal, the PBAC cautioned, must address risks, including direct harm and intangible consequences like fostering false hope or failing to meet patient needs. The PBAC emphasised that while PD-1 and PD-L1 inhibitors may be effective for various cancers, clinical trial results have shown variable responses depending on cancer type, patient age, and other factors. Therefore, the medicine’s value for money is not uniform across all cancers.

The Committee raised concerns that broad access could lead to inappropriate treatment use, particularly in cases where PD-(L)1 inhibitors may not be beneficial. It suggested restricting use to TGA-approved indications, noting that separate arrangements may be needed for rare cancers lacking TGA registration.

Additional criteria for broad PBS listings include no support for proposals that demand higher prices than what the PBAC has already recommended as cost-effective. The Committee also noted that preliminary assessments indicate PD-(L)1 inhibitors’ efficacy for future indications is likely to be lower than for current ones, suggesting that a lower cost-effective price will be required for new indications.

The PBAC has initiated discussions with the Medical Oncology Group of Australia (MOGA) “to develop clinically appropriate PBS listings for PD-(L)1 inhibitors that ensure evidence-based and cost-effective treatment practices”.

In its statement, MSD remarked, “We will review the outcomes statement in detail before re-engaging with the PBAC, Department of Health, MOGA, and Federal Minister for Health and Aged Care.”

“Ultimately, the success or otherwise of the proposed PBS listing approach for PD-1/PD-L1 inhibitors will depend on whether it delivers on the objective of more timely and equitable access to immunotherapy for Australian cancer patients, including those with rare and less common cancers,” the company added.

As of August 1, 2024, seven PD-(L)1 inhibitors are listed on the PBS: Roche’s Tecentriq (atezolizumab), Merck’s Bavencio (avelumab), Medison Pharma’s Libtayo (cemiplimab), GSK’s Jemperli (dostarlimab), AstraZeneca’s Imfinzi (durvalumab), BMS’ Opdivo (nivolumab), and MSD’s Keytruda (pembrolizumab). Meanwhile, BeiGene’s Tevimbra (tislelizumab) and AA-Med’s toripalimab are currently under evaluation by the TGA.

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