Medicines

Oncology lobby group pushes for PBS pan-tumour subsidies

Wednesday, 15 Aug 2018


A new oncology lobby group supported by the pharma industry says that at least 3,500 patients are self-funding non-PBS listed cancer medicines at an average cost of $60,000 annually.

The National Oncology Alliance (NOA) says the figures from a “data on file” survey of oncologists, make a strong case for reform of the Pharmaceutical Benefits Advisory Committee decision-making process to extend PBS subsidies for high cost novel treatments to multiple cancer types.

NOA Co-Chair Professor John Zalcberg, a medical oncologist and head of Cancer Research Program, Monash University, said the findings were “confronting” and showed the need for urgent reform of drug subsidy system.

“Our health system must evolve to a point where it keeps up with advances in science and empowers clinicians to treat their patients with what they believe will help their patients beat cancer – not what our current system limits their access to,” said Professor Zalcberg in a NOA statement.

The NOA, which has been established as an offshoot of advocacy group Rare Cancers Australia, says it wants to see a PBAC process that recognises cancer therapies approved for one indication may be life changing for people with other types of cancers, beyond what the treatment is already be reimbursed for on the PBS.

“For instance, creating a follow-on subsidy pathway for additional indications for new cancer treatments will streamline the resource burdens on the PBAC, government and industry, and address some of the commercial and administrative challenges that can stall applications for reimbursement and ultimately access to treatment,” it says.

The NOA suggests a provisional PBS listing through managed access as a solution where there is a high level of uncertainty in a PBAC submission for a rare cancer indication, “with additional real-world evidence needed to build the case for eventual PBS listing.”

Its statement comes ahead of a PBAC special meeting on 17 August that will consider new options for pan-tumour subsidies of PD-1 and  PD‑L1 checkpoint inhibitor immunotherapies.

In its calls for submissions on the issue, the PBAC said it was likely that checkpoint inhibitors would be useful for treating a range of cancers, but the limited trial results the PBAC had considered to date suggested that treatment responses were not uniform across different types of cancers, different ages and different patient populations.

“In addition, the results for different immunotherapies have been inconsistent as to whether it is necessary to classify patients by PDL1 tumour marker expression for effective treatment. Moreover, in most cases, results from trials were still early in terms of estimating overall and comparative benefits, factors of key importance for PBS reimbursement decision-making.”

NOA Co-Chair Mr Richard Vines said the PBAC meeting should be the first step in a move away from a “one size fits all approach” to cancer drug PBS listings.

‘Whilst August 17 is a great start, and PD-1/PD-L1 medicines are the first cab off the rank for the PBAC to find new pathways for, there are many other innovative oncology medicines that have potential across multiple cancer types. This inquiry should be the beginning of a more flexible approach to reimbursement, ensuring patients don’t miss out.”

In its submission to the meeting, MOGA said the pan-tumour PBS listing model “has the potential to result in more rapid and equitable access to checkpoint inhibitors for individuals with cancer, particularly those individuals with rarer cancers.”

“However, this approach may expose some individuals to treatments that are ineffective and potentially harmful if there is a lack of evidence to support their use for certain indications,” it noted.

The MOGA submission said there was not a strong rationale to extrapolate evidence of effectiveness of checkpoint inhibitors from one form of cancer to another.

“The degree of benefit of checkpoint inhibitors varies vastly between different tumour types. Extrapolation of evidence of effectiveness between late stage or early stage cancers also has little rationale. For example, activity of checkpoint inhibitors in late stage cancers may not equate to an increased chance of cure in early stage cancers.”

There was also no definitive biomarker than can be used to predict benefit from treatment with PD-1 and PD-L1 inhibitors at this stage that is accurate enough across all tumour types, the MOGA statement noted.

According to its website, Rare Cancers Australia is supported by pharma industry sponsors including Astrazeneca, Bayer, BMS, GSK, Janssen, Lilly, Novartis, Pfizer and  Roche.

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