Source: PharmaDispatch Author: Paul Cross

Hepatitis Australia has raised concerns about the "unintended consequences" of the proposed new PBS cost recovery fee structure and the "new processes they purport to fund."

In its submission to the Department of Health's PBS and funded vaccine Cost Recovery Implementation Statement, the organisation has made a number of detailed recommendations, including for fee exemptions.

It recommends fee exemptions for public health PBS listings, including for PBAC submissions seeking to extend current listings to small populations for whom there are no alternatives. It says the proposed exemption for medicines with an orphan designation is not sufficient.

It says the Department needs to consider "protections" to ensure the new fees and proposed submission pathways do not "have a negative population health impact arising from a delay or inability to access treatments and vaccines."

"Hepatitis Australia is particularly concerned that significantly higher fees in combination with new prioritisation processes may disadvantage those smaller population groups who stand to benefit from modifications to existing listings on the PBS and NIP, giving rise to inequitable health outcomes," it says.

It continues, "Small but significant changes to the NIP or PBS may become subject to significant delays in approval due to the combination of de-prioritisation and high processing fees. The potential is for these delays to contribute to avoidable advanced liver disease and deaths or new avoidable infections.

"A public health measure to expand access to a vaccine through the National Immunisation Program (NIP) or a population health initiative to expand access to medicines through the Pharmaceutical Benefits Scheme (PBS) for additional smaller populations may fail if the processing fees are disproportionate to additional revenue flowing to pharmaceutical companies."

The organisation says it supports cost-recovery in principle and "appreciates" the need for a fast-track process for breakthrough medicines particularly in areas of high unmet need.

"We argued for such a process during the significant time spent waiting for the PBS listing of the March 2016 listing of DAAs for hepatitis C treatment," it says.

"However, fast-tracking of any ‘block-buster’ medicines should not be to the detriment of other listings. Other listings should also be supported by the higher fee arrangements to allow dynamic and ongoing interactions during the submission process. Therefore, while we expect the application of higher fees will specifically provide for additional resourcing for faster access for 'block buster’ medicines, there should be no diminution of resourcing and timeliness for non-category one medicines."

"Under the existing system the principles of universality and equity of access to timely and affordable medicines is understood, but this new process in combination with higher fees may put that into doubt without robust KPIs and appropriate processes for waivers of fees where prohibitive to progressing a listing."

The organisation says the Department should adopt "clear KPIs for minimum and maximum listing times for progress of an application to a PBAC meeting, and the time from when a positive PBAC recommendation has been received to PBS listing. This should clearly specify whether these timeframes will be different based on fee status or priority status. Hepatitis Australia considers the current KPIs are insufficient."

It also questions the magnitude of the new fees, particularly in relation to vaccines.

"It is also unclear as to why obtaining advice from ATAGI on the relevant patient population for a particular public health outcome related to vaccination is so much more expensive than advice from the PBAC itself which has a significantly larger committee and bureaucracy supporting it, outsourced evaluations and two subcommittees to progress through."

It concludes by calling for a commitment to post-implementation review. "The community needs to be reassured that the introduction of these new fees and arrangements has supported timely and affordable access to medicines, rather than delayed them. The comparisons should include pre-PBAC and post PBAC timeframes," it says.