Proposal for a Cost Recovered Pathway for Medical Services Advisory Committee Applications

Overview

The Department of Health invites submissions in relation to a proposal to introduce a cost recovered pathway for applications received from commercial entities seeking reimbursement decisions from the Medical Services Advisory Committee (MSAC).

This proposal is to introduce a cost recovered pathway for the following application types received, from commercial entities:

• codependent technologies (medical services and health technologies that are subsidised under both the Medicare Benefits Schedule (MBS) and another subsidy program, such as the Pharmaceutical Benefits Scheme (PBS) or the Prostheses List (PL));
• high-cost, highly specialised therapies funded under National Health Reform Agreement (NHRA) for delivery in state and territory public hospitals;
• blood products to be included on the National Products Price List (NPPL);
• medical devices considered by MSAC for inclusion on the PL;
• health technologies seeking a new or amended MBS listing (this may be a standalone request or may relate to a prostheses listing); and
• health technologies funded under other established non-MBS programs such as the National Diabetes Services Scheme (NDSS).

Applications from non-commercial entities such as representative groups and professional medical colleges seeking subsidy under the MBS will not be subject to cost recovery fees.

This proposal includes the option for a delegate to waive fees where the applicant can demonstrate that they meet specified public interest and financial unviability criteria.

Applications that meet the criteria for the cost recovered pathway will benefit from the standardisation of MSAC timeframes including:

• 6 weeks for triage and suitability;
• 4 months for PICO Advisory Sub-committee (PASC) consideration;
• 24 weeks from receipt of a complete submission to MSAC for consideration; and
• 8 weeks for release of MSAC minutes to the applicant.

Why your views matter

The Department is inviting responses from those who are likely to be affected by this proposal. This consultation process will:

• help the Department understand the impacts of the proposal to recover the cost of certain MSAC applications on Industry; and
• assist with further development of the proposal including with planning for implementation.

The Department is inviting responses via a survey that contains a number of questions. The survey also offers respondents the opportunity to expand on various aspects of the questions via free text responses.

We invite you to lodge a submission on this paper by no later than close of business on 18 February 2022 through the Consultation Hub.

The survey on the Consultation Hub closes on 18 Februay 2022.

You will not be able to lodge your response after this date.

What happens next

The Department will consider recommendations from the final report on House of Representatives ‘Inquiry into approval processes for new drugs and novel medical technologies in Australia’ titled The New Frontier – Delivering better health for all Australians that was tabled on 25 November 2021, along with the consultation outcome, to inform the proposal for Government consideration.

Feedback will also assist in planning the implementation approach and identifying any unintended consequences for introduction of cost recovered HTA pathway for MSAC.

Implementation of the proposal including changes to process would be subject to Government consideration and agreement and would require passage of legislation to enable charging.

If the proposal is agreed by Government, future consultation would occur through the Cost Recovery Implementation Statement (CRIS) to ensure stakeholder concerns and regulatory impacts are addressed, prior to the commencement of charging.

Guidance and education material including cost recovery administrative guidelines, MSAC process framework and overall process maps and timelines will be developed to ensure smooth transition and successful implementation of the cost recovered pathway.