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 and Aged Care ( the 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 can 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 assessed via a HTA framework, and the department may utilise 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?

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 any funding advice provided by MSAC for the medical service can be implemented.

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:

Suitability: 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, funding mechanism, and 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.

Population Intervention Comparator Outcome (PICO) Confirmation: the PICO Confirmation is developed by an 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.

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.

Appraisal: This step is where MSAC undertakes a rigorous and transparent appraisal of the evidence presented to it 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 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, to ensure the most appropriate pathway can be identified.

There are three main MSAC pathway options:

• Standard Pathway - default pathway that includes consideration by PASC, ESC and MSAC.
• Expedited Pathway - an application can bypass PASC and progress straight to the development of an Assessment Report for ESC and MSAC consideration.
• Direct Pathway – an application can progress straight to the development of an Assessment Report and consideration by MSAC.

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 PASC, ESC, MSAC 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 process
• Targeted and public consultation
• PICO confirmation development by an HTA Group
• Applicant comments on the PICO confirmation
• PASC Meeting (PICO confirmation ratification).

Following the PASC meeting a ratified PICO is provided to the applicant and subsequently published on the MSAC website. The department aims to provide the ratified PICO Confirmation to the applicant within 6 weeks following the PASC meeting. This is the end of the ‘pre-assessment’ stage, and it is at the applicant’s discretion when the completed assessment report is submitted to the department for consideration at an MSAC meeting.

The ‘assessment’ stage is measured from when the completed assessment report is submitted to the department, through to the application’s consideration at an MSAC meeting and should take approximately 22 weeks. During this period the following occurs:

• Targeted and public consultation
• Quality check of the assessment report
• Development of a commentary on the assessment report (if applicant developed)
• Applicant comments on the commentary or Department Contracted Assessment Report
• ESC Meeting
• ESC report development
• Applicant comments on ESC report and consultation input
• MSAC Meeting

Following the MSAC meeting a Public Summary Document is developed that 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. The department aims to provide the ratified PSD to the applicant within 8-10 weeks post the 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 through which the majority of applications will progress. 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.

Note: The Process Framework is currently under review and will require amendments, as there have been numerous changes to MSAC processes since it was first introduced, including the recent introduction of the Health Products Portal. As such, while the approach to health technology assessment and assessment pathways described in the Framework is broadly accurate, reference to specific processes, such as the Application Progression Record, are no longer valid. It is therefore recommended that the Framework be read in conjunction with other information available on the MSAC website.

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 decision can 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 for Health 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. In respect of the Medicare Benefits Schedule, this is generally through amendment to regulations and/or other instruments for the listing of the recommended service on the MBS, and usually occurs in accordance with the most appropriate budget cycle.

For further information, please refer to Post MSAC process.

Can I produce a submission-based application?

Submission based assessments (SBA) are available at the assessment stage of the process and are referred to as Applicant Developed Assessment Reports (ADARs). Although an applicant may indicate they would like to submit an ADAR, 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 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 an 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.

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 and meeting agendas.

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
Department of Health and Aged Care
MDP 960
GPO Box 9848
CANBERRA ACT 2601
Email: hta@health.gov.au

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 reports and/or other related matters please contact the Department of Health HTA Team at:

HTA Team
Department of Health and Aged Care
MDP 960
GPO Box 9848
CANBERRA ACT 2601
Email: hta@health.gov.au

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 better 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 MSAC and PBAC Secretariats in determining if an application requires advice by both MSAC and PBAC.

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

MSAC Consultation FAQ

When does consultation occur?

Consultation usually starts once the department finds an application suitable to progress through the MSAC process and it is published on the PASC, ESC or MSAC agenda.

There are two main points in the process where consultation input is important:

1. Prior to the meeting of the PICO Advisory Subcommittee (PASC).
2. Prior to MSAC’s consideration of the application.

To remain informed of when pre-PASC and pre-MSAC consultations open and close, ensure you are subscribed to the Bulletin on the MSAC website homepage. Generally, pre-PASC consultation will open when the PASC agenda is published on the MSAC website and pre-MSAC consultation will open when the ESC or MSAC agenda is published on the MSAC website. When consultation opens for a particular application depends on what pathway the application follows through the MSAC process. For more information see Is the MSAC consultation process the same for every application?

Pre-PASC

PASC’s main task is to confirm the PICO for an application. The PICO confirmation is a critical part of MSAC’s appraisal process. PICO stands for Population, Intervention, Comparator and Outcome and describes:

• who would be able to use the proposed health service or technology (Population)
• the proposed health service or technology and how it would be used (Intervention)
• how the health condition is currently managed in Australia (Comparator)
• how the effect of the health service or technology will be measured (Outcome).

To ensure PASC can consider consultation input that addresses the PICO, the department must receive the input five (5) weeks before the PASC meeting. The closing date for consultation input for each PASC meeting is available on the MSAC website Key Dates webpage.
Once PASC agrees the PICO confirmation, the department publishes the PICO confirmation on the application page on the MSAC website.

Pre-MSAC
To ensure MSAC can consider consultation input on an application, the department must receive the input by the closing date. The closing date for consultation input ahead of each MSAC meeting is:

• available on the MSAC website
• listed in the ESC and MSAC Bulletins. You can subscribe to the Bulletin on the MSAC website homepage.

MSAC may not consider consultation input received after the closing date.

What happens to consultation input?

The department normally shares consultation input with:

• MSAC and its subcommittees (the PICO Advisory Subcommittee and the Evaluation Subcommittee)
• the applicant.

The department shares consultation input received from organisations in full. If the department finds personal information about a third party in the input, the department will redact this information before sharing it.

The department shares consultation input received from individuals with MSAC and its subcommittees. Before sharing this input, the department will redact information that may allow identification of the respondent or a third party.

The department only shares consultation input from individuals with the applicant in summary form. This summary does not include personal information about the individuals who provided the input, or about third parties. This summary is also provided to MSAC and its subcommittees.

From time to time the department may also share consultation input with:

• Health Technology Assessment (HTA) Groups, to inform their reports to MSAC. The department contracts HTA Groups to prepare documents that help MSAC with its appraisal. If the department shares consultation input with an HTA Group, it is in the same form as that given to MSAC and its subcommittees.
• Representatives from state and territory governments, where the application is for a service to be delivered through public hospitals. If the department shares consultation input with state and territory representatives, it is in the same form as that given to the applicant.

When giving consultation input to the department, individuals and organisations should not:

• include information or opinions that they would not want shared as described above
• include personal information about third parties. A third party refers to someone other than the person providing the input, such as a medical practitioner or relative.

Personal information includes a broad range of information, or an opinion, that could identify an individual.

Publication of consultation input
The department publishes on the MSAC website:

• the PICO confirmation
• a Public Summary Document (PSD), which sets out MSAC’s advice to the Minister and summarises MSAC’s reasoning.

The department includes a summary of consultation input in these documents. This summary:

• does not include personal information about individuals
• may cite the names of organisations who provided input and the content of that input. Organisations should not include information or opinions in consultation input that they would not wish to see in the public domain.

As a health care consumer, how can I comment on an MSAC application?

Consumers and carers can give valuable information to MSAC. Before appraising an application, MSAC tries to seek the views of relevant consumer organisations about the application. MSAC also welcomes input from individuals. Input from consumers and carers with lived experience of the medical condition(s), health services, or technologies relevant to an application is particularly helpful.

Consultation on MSAC applications usually starts once the department finds an application suitable to progress through the MSAC process and is published on the PASC, ESC or MSAC agenda. The department creates an application webpage on the MSAC website and uploads a copy of the application form. The department also puts a copy of, or link to, an MSAC consultation survey on the webpage.

From 31 May 2024, the department will transition to a new MSAC consultation survey on the OHTA Consultation Hub. During this transition period:

• some applications will continue to use the old survey form. You can download this form from the application webpage.
• Where an application has transitioned to the new survey:
  • a link to the survey on the OHTA Consultation Hub will be available on the application webpage
  • you can also access the survey directly through the OHTA Consultation Hub.

There are multiple ways in which individual consumers and carers, and organisations representing consumers and carers, can give consultation input to MSAC. For more information see How can I give consultation input to MSAC?

If you have questions about providing input to MSAC, contact the Consumer Evidence and Engagement Unit. You can contact the Unit by email: htaconsumerengagement@health.gov.au.

As a health professional, how can I comment on an MSAC application?

Consultation on MSAC applications usually starts once the department finds an application suitable to progress through the MSAC process and is published on the PASC, ESC or MSAC agenda. The department creates an application webpage on the MSAC website and uploads a copy of the application form. The department also puts a copy of, or link to, an MSAC consultation survey on the webpage.

MSAC seeks consultation input from organisations representing health professionals by:

• Conducting targeted consultation with health professional organisations identified by the applicant and/or the department as having a potential interest in the application. There may be opportunities for health professionals to input to MSAC through these professional bodies.
• Requiring applicants seeking a listing on the Medicare Benefits Schedule (MBS) to get a statement of clinical relevance. The statement of clinical relevance:
  • is from a professional organisation representing the group(s) of health professionals who deliver the proposed service
  • confirms that this organisation considers the service or technology to be clinically relevant.

MSAC conducts targeted consultation with the organisation(s) that provided the statement of clinical relevance.

MSAC also welcomes consultation input from individual health practitioners. Input from practitioners with experience of the proposed health services or technologies, or of comparator services or technologies, is particularly helpful.

There are multiple ways in which individual health practitioners or medical/health organisations can give consultation input to MSAC. For more information see How can I give consultation input to MSAC?

How can I give consultation input to MSAC

From 31 May 2024, the department will transition to a new MSAC consultation survey, which is housed on the OHTA Consultation Hub. Eventually, the department will use this survey for all MSAC applications.

During the transition period:

• some applications will continue to use the old survey form. You can download this form from the application webpage.
• Where an application has transitioned to the new survey:
  • a link to the survey on the OHTA Consultation Hub will be available on the application webpage
  • you can also access the survey directly from the OHTA Consultation Hub.

MSAC welcomes consultation input on applications from interested individuals, groups, or organisations. Input can be provided by:

• Completing and submitting a consultation survey via the OHTA Consultation Hub (this is the preferred method, where available).
• Downloading and completing a consultation survey form and sending it to the department.

  by email to: commentsMSAC@health.gov.au

  or by mail to:

  MSAC Secretariat
  Department of Health and Aged Care
  MDP 900
  PO Box 9848
  Canberra ACT 2601, Australia

• Emailing or writing to the Department via the addresses above, outlining the key points that you wish MSAC to consider. If sending consultation input via email or in writing, please include the application reference number.
• Producing a video or audio recording and emailing the department:
  • the recording file or
  • a link to the recording file hosted on an accessible platform such as YouTube or Vimeo. MSAC is unable to view videos place on TikTok
  • a transcript of the recording.

Please note that MSAC only accepts recordings that are no longer than 10 minutes in duration.

How do I know if MSAC is considering an application on which I may wish to comment?

To find MSAC applications on which you may wish to comment consider:

• Subscribing to the MSAC email Bulletin on the MSAC website homepage. As a subscriber, you will receive email notifications about meeting agendas for MSAC and its subcommittees. These set out:
  • which applications PASC, ESC, or MSAC will consider at their next meeting
  • the closing date for consultation input on these applications.
• Searching the MSAC website for key terms. For example, if you are looking for applications about diabetes, use the ‘Search MSAC.gov.au’ facility to search for the word diabetes. This should bring up applications with diabetes in the title, both current and past.
• By looking at the ‘MSAC consultations’ tab on the OHTA Consultation Hub.
• By going to the ‘MSAC Applications’ pages on the MSAC website and reviewing the application webpages. The website lists old applications (that will no longer be open for consultation) first. So, it is best to start on the last page and work backwards.

If you believe there is an application progressing through MSAC that you wish to comment on, but you cannot locate it, you can email: commentsMSAC@health.gov.au. Give us as much information about the application as possible, and the department will try to help you find it.

What sort of information should I include in my consultation input?

The sort of information respondents might include in consultation input will depend on who is providing the input and which survey they are completing. From 31 May 2024, the department is transitioning to a new MSAC consultation survey, available through the Office of Health Technology Assessment (OHTA) Consultation Hub. Initially the department will use the survey for applications going to the PICO Advisory Subcommittee in August 2024. Eventually, the department will use this survey to consult on all MSAC applications.
The new MSAC consultation survey directs sub-sets of questions to several types of respondents. For example, there is a sub-set of questions for:

• consumers, carers, and other interested individuals
• health practitioners and health academics
• consumer organisations
• medical, health and other (non-consumer) organisations.
  

These sub-sets of questions seek similar information. There are prompts under most questions that give examples of the types of information MSAC may find helpful. Reviewing these prompts should help you to complete the survey questions.
If a new consultation survey is not available for the MSAC application you are interested in, you can still give us your input by email or post. For more information see How can I give consultation input to MSAC? When giving consultation input:

• Consumer organisations and people with experience of the medical condition(s), health services or technologies relevant to an application might address
  • Your experience with the health condition that the proposed health service or technology relates to.
  • How the health condition that the proposed health service or technology relates to is currently treated or managed.
    • What are the benefits and/or challenges of existing treatment/management?
  • Who should be able to access the proposed health service or technology if it is funded?
  • Where patients already have access to the proposed health service or technology:
    • Is access limited, for example, due to geography or out-of-pocket costs?
    • If yes, what impact does this have on people with the health condition?
  • If the medical service or technology received public funding, how would this impact consumers and carers?
    • What do you see as the benefits of the proposed health service or technology?
    • What do you see as disadvantages of the proposed health service or technology?
• Health professionals, health academics, and medical, health and other (non-consumer) organisations might address:
  • Key aspects of the PICO, such as the patient population(s) of interest, existing intervention(s) against which the proposed technology or service might be compared, and the outcomes to be assessed.
  • How public funding of the proposed health service or technology might affect current practice, including patient access to services.
  • Experience with the proposed health service or technology and what the perceived benefits and challenges were for both clinicians and patients.
  • Research of relevance to the application.
  • Views on pricing or, where the proposal relates to an item on the Medicare Benefits Schedule (MBS), the proposed MBS fee.
  • Views on item descriptors (where the proposal relates to an MBS item).

The above are suggestions only. Individuals and organisations are free to provide consultation input on any aspect of the MSAC application and/or PICO Confirmation. Focus your consultation input on the core issues that you think PASC and MSAC should consider.

If you are a consumer or consumer organisation and need assistance, support and guidance is available by emailing htaconsumerengagement@health.gov.au

Is there anything I should not include in my consultation input?

The department shares consultation input with the applicant and with MSAC and its subcommittees, either in summary form or in full. The department may also share consultation input with:

• HTA Groups, to inform their reports to MSAC. The department contracts HTA Groups to prepare documents that help MSAC with its appraisal.
• Representatives from state and territory governments, where the application is for a service to be delivered through public hospitals.

For more information on how the department shares your consultation input see What happens to consultation input?

When giving consultation input to the department, individuals and organisations should not:

• include information or opinions that they would not want shared with the parties described above
• include personal information about third parties. A third party refers to someone other than the person providing the input, such as a medical practitioner or relative.

In addition, the PICO Confirmation and Public Summary Document (PSD) for the application may cite input from organisations. This may include the name of the organisation and opinions expressed in the organisation’s consultation input. The department publishes both documents on the MSAC website. Organisations should keep this in mind and not include information or opinions that they would not wish to see in the public domain.

What is the timeframe for providing consultation input to MSAC?

Consultation usually starts once the department finds an application suitable to progress through the MSAC process and it is published on the PASC, ESC or MSAC agenda. There are two main points in the MSAC process where consultation input is important:

1. Before the meeting of the PICO Advisory Subcommittee (PASC)

2. Before MSAC considers the application.

To remain informed of when pre-PASC and pre-MSAC consultations open and close, ensure you are subscribed to the Bulletin on the MSAC website homepage. Generally, pre-PASC consultation will open when the PASC agenda is published on the MSAC website and pre-MSAC consultation will open when the ESC or MSAC agenda is published on the MSAC website. When consultation opens for a particular application depends on what pathway the application follows through the MSAC process. For more information see Is the MSAC consultation process the same for every application?

Pre-PASC
PASC’s main task is to confirm the PICO for an application. The PICO confirmation is a critical part of MSAC’s appraisal process. PICO stands for Population, Intervention, Comparator and Outcome and describes:

• who would be able to use the proposed health service or technology (Population)
• the proposed health service or technology and how it would be used (Intervention)
• how the health condition is currently managed in Australia (Comparator)
• how the effect of the health service or technology will be measures (Outcome).

To ensure PASC can consider consultation input that addresses the PICO, the department must receive the input five (5) weeks before the PASC meeting. The closing date for consultation input for each PASC meeting is available on the MSAC website.
Once PASC agrees the PICO confirmation, the department publishes the PICO confirmation on the application page on the MSAC website.

Pre-MSAC
To ensure MSAC can consider consultation input on an application, the department must receive the input by the closing date. The closing date for consultation input ahead of each MSAC meeting is:

• available on the MSAC website
• listed in the ESC and MSAC Bulletins. You can subscribe to the Bulletin on the MSAC website homepage.

MSAC may not consider consultation input received after the closing date.
In addition to the calendars, consultation deadlines are published in the MSAC Bulletin. You can subscribe to the MSAC Email Bulletin on the MSAC website homepage and receive email alerts about which applications are going to each meeting of MSAC and its subcommittees, along with related consultation deadlines.

What should I do if I cannot lodge my consultation input by the due date?

In most instances, PASC will not consider consultation input received after the pre-PASC closing date. The department will give MSAC this input for consideration when MSAC is assessing the application.

MSAC considers all consultation input received by the pre-MSAC consultation closing date. This includes consultation input that was considered by PASC. MSAC may not consider consultation input received after the pre-MSAC closing date. It is, therefore, important to ensure you give us your consultation input before the deadline.

It you are finding it difficult to meet the pre-PASC consultation deadline, consider submitting your input in two parts:

• give us your input addressing the PICO questions before the PASC consultation close date
• give us any additional input before the pre-MSAC consultation close date.

There is no need to complete the consultation survey form in its entirety. Just complete the questions that are relevant to the input you want to give. If you do not want to complete the survey, you can give us input in other ways. For more information see How can I give consultation input to MSAC?
For example, an email with a few sentences addressing the main points you wish to make is sufficient and may be a more time-effective option.

If after considering these strategies you still cannot give us your input by the closing date, you can email commentsMSAC@health.gov.au to ask for an extension. Please note the maximum period of extension is 10 business days, less for some applications.

How do I find out what happened to an application that I commented on?

Once it has finalised its appraisal of an application for public funding, MSAC publishes a Public Summary Document (PSD). The PSD sets out MSAC’s advice to the Minister and summarises MSAC’s reasoning. MSAC may:

• support public funding
• not support public funding or
• defer consideration.

The Government will decide whether to fund the health service or technology, taking MSAC’s advice into consideration.

The department publishes PSDs about three (3) months after the meeting at which MSAC considered the application. You can find the PSD on the relevant application webpage on the MSAC website.

Is the MSAC consultation process the same for every application?

No. The consultation process described on the MSAC Consultation Process page applies to applications on the standard MSAC pathway. These applications go to the PICO Advisory Subcommittee and the Evaluation Subcommittee, before progressing to MSAC.

In some instances, an application may:

• bypass PASC and go straight to ESC. Consultation on these applications does not start until the department knows at which meeting ESC will consider the application. The ESC Bulletin will tell you when consultation on these applications opens and closes.
• Bypass both PASC and ESC, progressing straight to MSAC. Consultation on these applications does not start until the department knows at which meeting MSAC will consider the application. You may still give us your input on applications going straight to MSAC, but the time for input is shorter. The MSAC Bulletin will tell you when consultation on these applications opens and closes.

You can subscribe to the MSAC Bulletin on the MSAC website homepage. Once subscribed, the department will notify you of applications going to PASC, ESC and MSAC.

Does MSAC conduct any other type of consultation?

From time-to-time MSAC may decide to hold a stakeholder forum. This may occur either before or after the MSAC meeting. MSAC holds stakeholder forums to explore questions that it may have about an application or emerging technology.

MSAC invites representatives from relevant professional and consumer organisations to attend stakeholder forums. MSAC may also invite individuals with relevant knowledge and expertise. Following a stakeholder forum, MSAC publishes a record of the forum on the relevant application webpage on the MSAC website.