Frequently Asked Questions

Page last updated: 31 May 2019

What is the Medical Services Advisory Committee (MSAC)?

The Medical Services Advisory Committee (MSAC) is an independent non-statutory committee established by the Australian Government Minister for Health in 1998.

MSAC appraises new medical services proposed for public funding, and provides advice to Government on whether a new medical service should be publicly funded (and if so, its circumstances) on an assessment of its comparative safety, clinical effectiveness, cost-effectiveness and total cost, using the best available evidence. Amendments and reviews of existing services funded on the Medicare Benefits Schedule (MBS) or other programmes (for example, blood products or screening programmes) are also considered by MSAC.

For further information, please refer to What is MSAC?

What is the purpose of MSAC?

The MSAC process helps to ensure:
  • That the Australian Government supports cost-effective, evidence-based, best practice health care;
  • All Australians have access to subsidised medical services that have been shown to be safe and clinically effective; and
  • The sustainability of the Australian health care system.

When is the MSAC process needed?

If a medical service is not covered under the MBS, applications can be made to the Department of Health (department) to consider whether the service warrants public funding. The department uses MSAC as a mechanism to gain independent scientific advice.

What is Health Technology Assessment (HTA) and how is it demonstrated?

Health Technology Assessment (HTA) is a range of processes and mechanisms that use scientific evidence to assess the quality, safety, efficacy, effectiveness and cost effectiveness of health services. HTA is commonly applied to pharmaceuticals (including vaccines), diagnostic tests, medical devices, surgically implanted prostheses, medical procedures and public health interventions.

HTA is essential to MSAC in its deliberations and appraisal of whether new medical technologies and procedures (in comparison to alternative/existing interventions) are safe, effective and cost-effective for the Australian people. Overall HTA helps ensure taxpayers’ money supports health care that achieves the maximum health improvement at the lowest cost.

Applications for public funding that require assessment via a HTA framework are those where the net clinical impact is able to be measured. This enables a comparative assessment of the clinical consequences of the application to be conducted as well as a comparison of cost.

Applications for public funding which may warrant consideration through an alternate (non-HTA) pathway include those which are non-material in nature (either financially or administratively) or when the use of a HTA approach is simply not feasible due to the difficulty of measuring (directly or indirectly) the net impact of the clinical health outcomes of the proposal.

MSAC generally only considers applications that can be accessed via a HTA framework, and the department utilises a panel of providers for this purpose (the HTA panel).

For further information, please refer to What is a HTA? and MSAC Process Framework.

How does HTA link to medicines or devices in Australia?

All therapeutic goods used in the provision of medical services must be assessed by the Therapeutic Goods Administration (TGA) and included on the Australian Register of Therapeutic Goods (ARTG) before they can be marketed in Australia. This ensures the quality, safety and efficacy of medicines and also ensures the quality, safety and performance of medical devices.

MSAC accepts that devices or technologies listed on the ARTG have established safety and efficacy and, in general, MSAC does not support public funding for a service that uses a therapeutic good for indications beyond those for which it was included on the ARTG.

An application to MSAC can be lodged before relevant therapeutic goods are listed on the ARTG provided that the applicant has evidence that the relevant sponsor has commenced the TGA process, but confirmation of ARTG listing is required before MSAC can complete its own appraisal of the corresponding medical service.

For further information, please refer to Australian Government HTA Processes and What is a HTA?

Who can make an application for public funding?

Applications can be made to the department by the medical profession, medical industry and others with an interest in seeking Australian Government funding for a new medical service or change to an existing service.

What are the key steps for the MSAC process?

There are four key steps in the MSAC process:
  1. Triage: ensures the applicant is aware of the MSAC process, likely pathway and evidence expectations. It also involves the department verifying the availability of evidence for assessment, determination of whether the application is suitable for consideration by MSAC and discussion of what would be the most efficient pathway through which the application will be progressed. Targeted public consultation on the completed application form will also be undertaken.
  2. Population Intervention Comparator Outcome (PICO) Confirmation: the PICO Confirmation is developed by a HTA Group and the relevant clinical algorithms to progress an assessment are determined. At the end of this step, the applicant, department and the PICO Advisory Sub-committee (PASC) aim to have an agreed PICO to undertake a systematic review of the evidence and generate an economic evaluation/model.
  3. Application Assessment: Evidence outlined in the PICO confirmation is presented in an Assessment report. The assessment report is then reviewed by the Evaluation Sub-committee (ESC) to identify the gaps and level of uncertainty in the evidence, in formulating advice on public funding. ESC will also provide advice on the quality, validity and relevance of internal and external assessments for applications being considered by MSAC.
  4. Appraisal: This step is where MSAC undertakes a rigorous and transparent appraisal of the evidence presented to them by ESC before advice is provided to Government for consideration. MSAC will consider a wide range of information, including the assessment report assessing the evidence; the independent critique of the report, feedback from the applicant, the ESC report on the evidence; any feedback on the ESC Report provided by the Applicant and/or other relevant parties; and the individual expertise of MSAC members.
MSAC’s advice to the Minister is made public on the MSAC website via a Public Summary Document (PSD), which explains the rationale for MSAC’s advice.

For further information, please refer to MSAC Application Process and MSAC Process Framework.

The application form looks long - must I complete all of it?

The application form has been enhanced to ensure sufficient information is provided by the applicant upfront, which is required for the MSAC process to work effectively and efficiently. The information collected in the application form will, for example, inform suitability and the PICO Confirmation development. Without this information suitability cannot be determined, and the application will not be able to progress through MSAC process.

What is an Application Progression Record (APR)?

An Application Progression Record (APR) will be developed for each application and will summarise the application’s MSAC pathway and its predicted milestones, including the project timeframes. The APR is a key summary document that will be acknowledged by the department and the applicant prior to an application’s progression through the MSAC process.

How long does the MSAC process take?

The length of time of the MSAC process is particular to each application, and will depend on a number of factors including the time it takes to determine suitability and the MSAC pathway that the application follows. For example a pathway that involves more than one PASC consideration will take longer than just one or no PASC consideration. It is in an applicant’s interest to put forward an application with a solid evidence base, so as to ensure the most appropriate pathway can be identified.

There are three MSAC pathway options:
  • Standard - default pathway that includes one PASC meeting;
  • Comprehensive - an application that requires at least two PASC meetings; and
  • Expedited - an application that can bypass PASC and progress straight to the development of an Assessment report for ESC and/or MSAC consideration.
The assessment phase of the MSAC process does not vary as greatly as the pre-assessment phase. Once the department receives an assessment report (either submission based or contracted), the assessment phase of the MSAC process takes approximately 4 months and then approximately 6 weeks between ESC and MSAC consideration. The department advertises clear assessment deadlines for applicants on its website. These deadlines can be found at MSAC - ESC Calendar Key Dates and PASC Calendar Key Dates.

When does the clock start?

The department considers the time taken by an application in the process to be in two stages, these being the ‘pre assessment’ and ‘assessment’ stages.

The ‘pre assessment’ stage is measured from when the completed application form is submitted to when the PICO confirmation for the application is considered at PASC and should take approximately 20 weeks. During this period the following occurs:
  • The suitability and triage process
  • Application Progression Record acknowledgement and finalisation
  • Targeted consultation
  • PICO confirmation development by an HTA Group
  • Applicant comment on the PICO confirmation
  • PASC Meeting (PICO confirmation ratification)
The clock stops when the PICO confirmation is ratified and while the assessment report is being developed. The clock starts again when the ‘assessment’ stage is commenced.

The ‘assessment’ stage is measured from when the completed assessment report is submitted to the application’s consideration at an MSAC meeting and should take approximately 22 weeks. During this period the following occurs:
  • Quality check of the assessment report
  • Applicant comment on the assessment report (if relevant)
  • Critique on the assessment report
  • Applicant comment on critique
  • ESC Meeting
  • ESC report development
  • Applicant comment on ESC report
  • MSAC Meeting
It should also be noted that the department offers an optional two stage assessment report pathway. Some Applicants may advise their preference for the submission of the clinical component of their submission based assessment before commencing the economic component. This would provide the benefit of the ESC and MSAC’s feedback on both the clinical evidence and the proposed structure of the economic model.

Some applicants have noted that in the past lengthy delays have been caused by having to resubmit applications as there has been uncertainty about the correct economic model to use. Confirming the clinical component and seeking advice regarding the appropriate economic model to use in the economic component would be very beneficial in these cases.

Stakeholders should note that this is an option only and that expected timeframes may be longer with this option, however it may be more effective and efficient in the long run in the application’s overall consideration.

How is the MSAC pathway of an application determined?

The MSAC pathway of each application is informed by the Process Framework and the quality of the application and will depend on an application’s complexity and novelty.

What is the most commonly expected MSAC pathway for an application?

The ‘standard’ application pathway is seen as the primary pathway in which the majority of applications will progress through. This will involve the development of the PICO Confirmation, consideration of the PICO Confirmation at one PASC meeting, and development of an assessment report (including independent critique) for consideration by ESC and MSAC.

What is the Process Framework?

The Process Framework governs how applications are categorised for MSAC. It is based on specific criteria, such as clinical novelty and complexity, and assists in determining how HTA will be applied. Complexity relates to the intricacy of the proposed service or technology, the societal implications, and the comprehensiveness of the evidence base for the application. The novelty of the application relates to the newness and originality of the service or technology. Both the complexity and novelty of an application will determine whether, and how many times, it needs to be considered by PASC before consideration by ESC and the MSAC.

For further information, please refer to MSAC Process Framework.

What if I have insufficient evidence for MSAC consideration?

The applicant is responsible for providing a list of relevant evidence (intended as a snapshot) in the application form. If the view of the medical profession is that there is a high probability from the outset that there is little, to no evidence to support the clinical claim of the applicant, or the applicant has presented their proposal too early in the evidentiary cycle, then it would not be appropriate for the application to commence the MSAC process. This decisioncan be revisited at a later date depending on how the evidence evolves.

If an 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.

For further information, please refer to MSAC Process Framework.

What is a Public Summary Document (PSD)?

The MSAC Public Summary Document (PSD) captures MSAC deliberations and key advice to the Minister. Once the MSAC has considered an application at an MSAC meeting, its advice will inform a decision by the Minister of Health (minister) in relation to public funding.

For further information, please refer to Post MSAC process.

Are MSAC’s recommendations guaranteed?

The discretion to list a new MBS service or amend an existing MBS service sits entirely with the Government.

For further information, please refer to Post MSAC process.

Is MSAC advice appealable?

MSAC advice is not subject to ‘appeal’ by the applicant. If a recommendation not to support public funding is made, applicants can resubmit a new application, which addresses the issues outlined in the PSD. The department will consider a resubmission in the same way as a new application to ensure that it has addressed these issues prior to the application commencing the MSAC process again.

For further information, please refer to Post MSAC process.

How long does implementation of an MSAC application take after MSAC consideration?

The Minister will decide whether public funding should be granted based on MSAC advice and advice from the department. Once approved by the Minister, the department will implement the decision of Government through amendment to regulations and/or other instruments for the listing of the recommended service on the MBS, generally in accordance with the most appropriate budget cycle.

For further information, please refer to Post MSAC process.

Has MSAC changed recently?

Since its inception, the MSAC has been subject to a number of reviews and reforms, being:
  • Health Technology Australia (HTA) Review (2009);
  • Quality Framework (to 2011);
  • Comprehensive Management Framework (to 2014);
  • MSAC Reform (to 2016); and
  • Ongoing initiatives.
The most recent MSAC reform began in June 2014, with extensive consultation about current processes and potential improvements being undertaking between May 2015 and February 2016. In March 2016 the key new Process Framework (insert hyper link to process framework) was finalised and ready for use. The Process Framework introduces a number of key changes to the MSAC process. These can be seen at MSAC Reform Key Differences Table.

Key to all MSAC reforms was the need to sustain and strengthen the policy agenda for the MBS. That is, ensuring access to cost-effective health services (including through MBS subsidies for clinically relevant services) alongside the increasing need to ensure the sustainability of the MBS in the face of rising costs and demands for medical services, especially complex technologies and devices.

What are the top changes I can expect as a result of the recent MSAC reforms?

The top five changes a stakeholder can expect as a result of the reforms are:
  • Process Framework - The Process Framework governs how applications are categorised for MSAC. It is based on specific criteria, such as clinical novelty and complexity, and assists in determining how HTA will be applied.
  • Application Form and associated Guidelines - the application form has been updated significantly to ensure sufficient information is provided by the applicant.
  • Targeted public consultation on the completed Application Form – targeted public consultation on the completed application form will occur with professional bodies/consumer organisations.
  • A PICO Confirmation (formerly known as Protocol) template – a PICO Confirmation will only be prepared by a HTA Group contracted by the department that substantially reduces the duplication within the current Protocol.
  • Critiques of assessment reports - all finalised assessment reports (not just submission based Assessment reports) will be provided to an independent assessment group for a critique.
  • Exit points – There will be a number of points in the MSAC process where the department and/or PASC, ESC or MSAC Executive may decide that it is not appropriate for an application to progress further in the MSAC process.

Is there a comparison of the old and new MSAC processes?

The new MSAC process has improved rigour, transparency, consistency and efficiency of departmental activities.

Major key changes to the MSAC process include: For a comparison of the pre-reform and reformed MSAC process see the MSAC Reform Key Differences Table.

Can I still produce a submission based application?

Submission based assessments (SBA) are only available at the assessment stage of the process. Although an applicant may indicate they would like to submit an SBA, the department will procure external expertise to validate the evidence, therefore, the department will make the final decision, aligning the decision with the Public Governance Performance and Accountability Act 2013 on whether the applicant has the expertise or the ability to engage a consultant to conduct the clinical the evaluation and economic evaluation.

For further information, please refer to MSAC Process Framework.

Can I ask for a particular Health Technology Assessment (HTA) Group?

Neither an applicant, nor the department can request a particular HTA Group to prepare an Assessment report.

When a HTA Group is chosen from the HTA Panel, the following is taken into account:
  • value for money (noting that this is not always price);
  • previous exposure to an application;
  • clinical experience; and
  • price.

Can I note any conflict with a HTA Group?

Yes, you may. All HTA Group staff who work on a specific application are required to declare any conflict of interest and the department will make the final decision on which HTA Group will prepare an assessment report for a specific application.

Can I / how do I become a member of the Health Technology Assessment and Research Support Panel?

The existing panel arrangements for services in relation to the Health Technology and Research Support Panel are in place until 4 December 2018. Organisation’s interested in applying/competing to be a member of new panel arrangements should check the Department’s website and AusTender from early 2018.

What if my application is under the 'old' MSAC process?

Applications that are already in the assessment or appraisal stages of the MSAC process post the December 2016 PASC meeting will be transitioned to the reformed process on a case by case basis as the content required and development of the assessment report is largely unchanged in the reformed process.

For further information, please refer to MSAC Process Framework.

What support will I get from the department throughout the MSAC process?

An applicant can expect to be supported via ongoing contact with a dedicated departmental official.

What ongoing MSAC information is available?

An MSAC bulletin is released to those stakeholders who have subscribed, advising them of new information in regards to the MSAC process or when information sessions will be held.

To subscribe to the MSAC Bulletin please use the following link: Subscribe.

What general materials/resources are available?

The MSAC website is the first port of call for material and information related to the MSAC, including how to submit an application for public funding and the process involved. Application managers can also be contacted via the below details for further assistance.

HTA Team
Australian Government Department of Health
MDP 960
GPO Box 9848

What do I do if I have feedback on an MBS item or I'm not sure something is really a 'new' service?

For information relating to MSAC, applications for public funding, MBS items, assessment report s and/or other related matters please contact the Department of Health HTA Team at:

HTA Team
Australian Government Department of Health
MDP 960
GPO Box 9848

What if I have a co-dependent application?

The MSAC and Pharmaceutical Benefits Advisory Committee (PBAC) Secretariats work together to develop a coordinated approach to co-dependent applications. This involves scheduling MSAC meeting dates to align with PBAC meeting dates to facilitate coordinated advice from both committees. Meeting dates have also been aligned between MSAC’s ESC and PBAC’s ESC, and in some cases joint ESC meetings are held to consider co-dependent applications.

The revised application form asks specific questions in relation to pharmaceuticals to assist the HTA Team in MSAC and the Secretariat Compliance Team in PBAC in determining if an application requires advice by both MSAC and PBAC.

For further information, please refer to What is a Co-dependent Technology?

What is the relationship between the MSAC reforms and the work of the MBS review taskforce?

The MSAC primarily considers new applications seeking MBS funding. The MBS Taskforce is reviewing existing MBS items and how these can be aligned with contemporary clinical evidence and practice. Where there is any cross linkage, dual consideration will be undertaken as and when required.