Suitability

An applicant seeking public funding for a medical service or technology or an amendment to an existing service provides a completed application form and preliminary information to the medical services Health Technology Assessment (HTA) team in the Department of Health and Aged Care (the department).

The department will assess the application to determine its suitability to proceed through the Medical Services Advisory Committee (MSAC) process.

Assessment Pathways

There are three main assessment pathways by which an application may progress through the MSAC process—the standard pathway, the expedited pathway, and the direct pathway. These pathways determine whether an application is required to be considered by one or both of MSAC’s Sub-Committees before progressing to MSAC.

The two sub-committees that support MSAC are the:

PICO Advisory Sub-Committee (PASC), which is focussed on confirming the population, intervention, comparator, and outcomes (PICO) of the proposed medical service or technology. The PICO is a core element of MSAC’s appraisal process as it sets out the parameters upon which the health technology assessment is based.

Evaluation Sub-Committee (ESC), which is focussed on providing advice to MSAC on the quality, validity, and relevance of the clinical evidence and economic assessment provided in the assessment report.

MSAC is also supported by HTA groups contracted by the Department, and by clinical experts.

Applications on the standard pathway are considered by both PASC and ESC before progressing to MSAC. Occasionally an application on the standard pathway may need to be considered by PASC more than once before the PICO Confirmation is finalised. Applications on the expedited pathway bypass PASC and are considered by ESC and MSAC, while applications on the direct pathway are not considered by either sub-committee, instead progressing directly to MSAC.

The Department will decide, in consultation with the MSAC Executive if required, the most appropriate pathway for each suitable application to progress through the MSAC process.

Consultation

Targeted and public consultation will occur on completed application forms found suitable for MSAC consideration. The completed application form will be uploaded to the MSAC website and remain on the individual application webpage. This provides an opportunity for stakeholders, including health professionals, consumers, carers, and competitors to comment on the application (public consultation). In addition, the department alerts relevant health professional and consumer groups who may have an interest in the application (targeted consultation).

In confidence material may be redacted from the application form prior to publication, where agreed between the applicant and the department. The timeframes for publication of the application form and commencement of targeted consultation are determined by the assessment pathway.
The closing dates for receipt of consultation input for consideration by PASC and MSAC are available on the MSAC website (MSAC - PASC, ESC, MSAC Key Dates). For further information see MSAC consultation process.

PICO Confirmation

An application on the Standard Pathway will have a PICO confirmation developed by an HTA group contracted by the Department (with input from the applicant), then considered and ratified by PASC.

Application Assessment

An Assessment Report is developed by the applicant or by an HTA Group contracted by the department. The Assessment Report presents the evidence that supports the application, comprised of clinical literature and an economic evaluation. The Assessment Report is specific to the population(s) and indication(s) specified in the application form and PICO Confirmation (where applicable) and must be developed consistent with the Guidelines for preparing assessment reports for MSAC.. Applicant developed assessment reports are critiqued by an independent HTA group prior to consideration by ESC.

If the applicant needs MSAC assurance that the clinical claim is correct before investing extensively in an economic evaluation, an optional two stage Assessment Report is available.

MSAC Appraisal

MSAC undertakes a rigorous and transparent appraisal of the evidence presented to them, including that provided by ESC (if applicable) before advice is provided to Government for consideration. This ensures that Government supports cost effective, evidence-based, best practice care.

In addition to providing advice to government, a Public Summary Document (PSD) is published on the application webpage. The PSD captures the MSAC outcome for the application and provides the evidentiary basis and the rationale for the MSAC’s advice to the Minister for Health.

Once ratified by the MSAC, the PSD is emailed to the applicant who may provide a short (non-advertorial) comment for publication with the PSD. The applicant may also request correction of factual errors (if any) and redaction of information they consider commercially sensitive prior to publication. The department will correct any confirmed factual errors and make agreed redactions prior to publishing the PSD on the webpage.

Withdrawal

An applicant may request that its application to MSAC be withdrawn at any time.

Applicants should note that where MSAC has completed its considerations of an application and the applicant seeks to withdraw that application:

a. following consultation with the applicant, the outcomes, recommendations and/or advice of MSAC will either be withheld or published in whole or in part; and

b. the advice of MSAC pertaining to the application may be provided to Government.

Post MSAC Consideration for public funding

Only after Government consideration of advice from MSAC is a decision made on whether a proposed service or technology is publicly funded.

MSAC is a non-legislative committee, and so its advice is not binding. The Minister for Health will decide whether public funding will be granted.