New Prostheses List pathways proposed


Feedback from AusBiotech’s medtech members is sought as the Department of Health proposes an ‘Abbreviated pathway’ within its newly proposed three-tiered approach to the assessment of Prostheses List (PL) applications.

The Department of Health’s 'Prostheses List Reforms – Consultation Paper No 3' outlines the three-tiered approach as:

  • New: Tier 1: Abbreviated pathway: where the device is medium or lower-risk, is a well-established technology, and is substantially similar in characteristics, intended use and clinical effectiveness to other devices listed on PL in the existing grouping with the benefit set up based on the reference pricing; assessments are largely undertaken by the Department with the relevant expertise and knowledge in medical devices
  • Tier 2: Clinical/Focused health technology assessment (HTA) Pathway
  • Tier 3: Full HTA Pathway (MSAC)

As an integral part of the broader multi-year HTA processes, the PL listing pathways must ensure fit-for-purpose processes to ensure timely access for private health insurance members to medical device innovation.

The PL is one policy lever that Government uses to encourage innovation within the medtech sector, particularly from Australian medical device companies. In place since 1985, the PL has been subject to numerous reforms, however, pathways to list an item have not evolved at the same pace as broader changes for assessing medical technologies in other Australian Government HTA processes. 

This consultation reflects the ‘design’ stage of the reforms to the listing process and puts forward ideas to establish three separate pathways to list existing technology, a variation or upgrade to existing technology, and novel technology.

In response, AusBiotech’s key recommendations include:

  • Remove the requirement for all Class III devices to go through a focused HTA, and determine the appropriate listing pathway based on the type of clinical and economic claims rather than TGA device classification;
  • Implement parallel process of TGA approval and PL submission assessment for all three listing pathways;
  • Retain the Prostheses List Advisory Committee, to ensure a balance of interests for final decision making in all three proposed listing pathways by providing consistent and coherent PL listing advice to the Minister;
  • Consistent with other Government policies and programmes, reward local innovation by reducing or refunding cost recovery fees of all three listing pathways for PL applications of medical devices backed with Australian innovation;
  • Ensure processes are predictable through clear and mutually exclusive listing pathway criteria and guidelines for applications, as well as pre-listing consultations;
  • Increase transparency around listing decisions by publishing application summary documents;
  • Manage post-listing monitoring and PL de-listings via clear and transparent criteria; and
  • Timelines and milestones for all three listing pathways must be clearly defined, predictable and reflective of the varying complexity of the three pathways to PL listing.

It is expected that the implementation of the new pathways will commence from July 2022. Prior to that, we expect to see another consultation paper detailing the scope, criteria, governance arrangements, timelines and cost-recovery fees.

AusBiotech members are invited to give feedback on its draft response by Monday 21 February; request a copy by emailing Karen Parr, AusBiotech Communications Director. Read the full Department of Health consultation papers here.

AusBiotech has previously submitted responses to the Prostheses List reform, accepting that some reform may be needed to the PL, it that it was but small in nature. The organisaton was pleased to see that the Department has maintained the PL, and the benefits and the value it brings to innovators and patients. Read AusBiotech’s submissions here.

Fuelled by a value-driven healthcare environment, the medtech (devices and diagnostics) reimbursement landscape can certainly present a wide spectrum of challenges for early-stage and emerging SMEs. Join a panel of experts at AusBiotech’s BiotechTalks: Regulatory and Reimbursement 101: the pathway to commercialisation, to learn about the processes that are essential for commercial success in Australia and internationally, and to ask your questions on how these reforms may impact the sector. Free of charge for AusBiotech members, register now for this webcast on 31 March 2022.