Applicant engagement in the Medical Services Advisory Committee (MSAC) process is critical. MSAC seeks information and advice from the Applicant at key points throughout the process. In addition to engaging with the Applicant, MSAC also consults other interested parties, such as medical and consumer organisations. The MSAC Consultation Process provides further information.
Below is an overview of Applicant engagement points throughout the MSAC process.
Individuals and organisations considering lodging an MSAC application are encouraged to contact the MSAC secretariat in the first instance to discuss the proposed application. This is particularly the case where the potential application is for a high cost therapy for delivery through public hospitals, where the therapy or service involves novel technologies, where the application will need to be considered by both PBAC and MSAC (co-dependent application), or where the potential Applicant is unfamiliar with MSAC and its processes and would like additional guidance.
The secretariat may suggest a pre-application meeting between the potential Applicant and Departmental officers to facilitate information exchange and ensure a shared understanding of requirements.
The secretariat can be contacted in the first instance by email: HTA@health.gov.au
Application form receipt and suitability review
Once an application is accepted as suitable for the MSAC process, MSAC commences targeted and public consultation, which includes publishing the completed application form on the MSAC website. See MSAC Consultation Process for further information.
While an application is being reviewed to ensure that it is suitable for MSAC, the MSAC Secretariat will seek the Applicant’s advice on whether the completed application form contains ‘in-confidence’ material that needs to be redacted prior to publication.
If the application is found suitable to progress through MSAC the Applicant will receive an email advising them and outlining the MSAC assessment pathway that has been identified as appropriate. In most cases, new applications will progress through the two MSAC sub-committees—the PICO Advisory Sub Committee (PASC) and the Evaluation Sub Committee (ESC)—before being considered by MSAC. Resubmitted applications may bypass PASC and/or ESC in some circumstances. If you have concerns about the allocated MSAC pathway you should discuss this with the Department. The Department may seek pathway advice from the MSAC Executive if required.
The majority of MSAC applications require a PICO Confirmation. The PICO Confirmation is a core element of the Health Technology Assessment (HTA) as it sets out the parameters upon which the assessment is based. For example, the PICO will identify the patient population(s) of interest, existing intervention(s) against which the proposed technology or service will be compared, and the outcomes to be assessed. The Department usually contracts an HTA Group to develop the PICO Confirmation.
The Department will organise a teleconference with the Applicant and the HTA Group at the beginning of the PICO development process and the Applicant will continue to engage with the HTA Group, via the Department, by responding to queries and providing information and advice.
Applicants are given a copy of the draft PICO Confirmation before the PICO Advisory Sub-committee (PASC) considers the document. Included in the draft PICO Confirmation is a summary of consultation comments received up until that time. Copies of consultation feedback from organisations will also be provided. The Applicant will have an opportunity to comment on both the draft PICO Confirmation and the consultation feedback.
An Applicant can elect to be present at the PASC meeting for consideration of their application and make a short five-minute presentation.
Once the PICO Confirmation has been ratified by the PASC it is published on the MSAC website for public consultation leading up to ESC and MSAC.
Applicants can develop an Assessment Report (known as an Applicant Developed Assessment Report or ADAR) or the Department can contract an HTA Group to develop the report (known as a Department Contracted Assessment Report or DCAR). All assessment reports, whether an ADAR or a DCAR, should align with the PICO Confirmation and the MSAC Guidelines, which can be found on the Documents for Applicants and Assessment Groups webpage.
After an ADAR is submitted, the Department contracts an HTA Group to critique the ADAR. This critique of the ADAR is referred to as the Commentary. Prior to its consideration by the Evaluation Sub-committee (ESC), a copy of the Commentary is given to the Applicant for comment. ESC considers the Applicant’s comments along with the ADAR and the Commentary.
The Department will organise a teleconference with the Applicant and the HTA Group shortly after the group is contracted to develop the DCAR. There will be ongoing engagement with the Applicant, via the Department, throughout the DCAR development process, with the Applicant responding to queries and providing information and advice on issues that arise.
Prior to consideration of the DCAR by the Evaluation Sub-committee (ESC), Applicants are provided a copy of the Assessment Report and an opportunity to comment. ESC considers the Applicant’s comments along with the DCAR.
The Applicant is provided the ESC Report (including meeting outcomes) for comment prior to consideration by MSAC. When the ESC Report is sent to the Applicant, a summary of consultation feedback received on the application is included, along with copies of consultation feedback received from organisations.
When appraising the application, MSAC considers the Applicant’s comments on the ESC Report and on consultation feedback, along with other documents related to the application.
In certain circumstances, MSAC may request an Applicant (or their representative) to present orally during the MSAC meeting at which their application is being considered (referred to as ‘a hearing’). Hearings are limited to applications that meet two or more of the following criteria:
- The application is requesting public funding for a service/technology that MSAC or its sub-committees view as highly specialised or would be disruptive to the healthcare system.
- Significant issues (clinical or financial) have been raised by MSAC, its sub-committees, or the Department during the evaluation of the application.
- Public funding for the requested service/technology would likely have significant patient benefit.
- MSAC has initiated the hearing.
If an Applicant believes their application meets two or more of the above criteria, they may request a hearing. The request will be considered by the MSAC Executive and the Applicant will be advised of the outcome.
Post MSAC Consideration
MSAC is not a decision making body, but rather provides advice to the Minister for Health. A Public Summary Document (PSD) explains the rationale for MSAC’s advice and is published on the MSAC website. PSDs are generally published approximately three (3) months after the MSAC meeting at which the application was considered.
Prior to publication, the Applicant is given an opportunity to comment on the PSD and to identify ‘in-confidence’ material that needs to be redacted. Once comments and redactions are agreed with the Department, they are incorporated into the PSD before it is published.