Barriers to Prostheses List entry mount as stakeholders raise concerns over new pathway for applications

MedTech News: An analysis of stakeholder feedback received in response to the Prostheses List (PL) Reforms Consultation Paper 3(b): Pathways for Applications to the Prostheses List has now been published.

A total of 18 submissions (9 from industry, 8 from insurers and 1 from a hospital group) were received in relation to the proposed 3-tiered application pathways and cost recovery proposal of the PL reforms.

Concerns raised centred largely around the lack of payor scrutiny in Tier 1 applications, Class III device ineligibility for Tier 1 pathway and a lack of reduction in the timeframe from application to PL listing despite a streamlined pathway approach.

At the recent MedTech22 conference led by MTAA, Jo Root, Policy Director at Consumers Health Forum of Australia, commented on the negative impact that will be generated from putting “too many barriers up”.

She said “Consumers want to see that they get access to new devices, that they don’t have any out of pocket costs, and that they get improved health outcomes.”

She also commented on the lack of health outcomes as a measurement for success of the PL Reforms. “There is not much about outcomes at all, and certainly not about health outcomes. That’s the missing component. That would be our success factor.”

Dean Breckenridge, Chief Policy Officer, Ramsay Health Care expressed his genuine concern. “We hear the rhetoric about why and what value we’re going to get for the additional price that we pay in the private sector versus the public. We get access to TAVI well before it’s funded [in the Prostheses List] because of the kindness and the good spirit of the device manufacturers and suppliers.

“You can’t afford to do that if you are getting squeezed and squeezed with your margins. So the goodwill will evaporate and it will just keep reinforcing the two different levels of access to clinical care – go to public and get the newest innovation, go to private and get technology from five years ago. That really deeply worries me and I think it’s going to get worse.”

When considering the potential negative impacts brought forward by the new cost recovery proposal, 56% of stakeholder submissions expect there to be negative impacts. Of most concern is that cost recovery fees may act as a barrier to sponsors, particularly smaller local medtech companies being unable to invest in the submission for inclusion on the PL, raising risks of limiting prospective patient access to novel medical technologies.

In response to the positive impacts of implementing cost-recovery for PL applications, 39% of submissions are expecting ‘some’ positive impacts and 17% responded neutrally with a ‘wait-and-see’ approach.

However, stakeholders argued that any potential positive impacts through increased savings would likely be offset by increased costs elsewhere.

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