The information provided in the MSAC Guidelines is intended to inform the creation of:
- an application form for consideration of a medical service/technology by MSAC
- a PICO confirmation for a medical service/ technology considered by PASC
- an applicant developed assessment report (ADAR)
- a department contracted assessment report (DCAR)
- a commentary on an ADAR.
For more information on the MSAC Guidelines, and the MSAC Guidelines Review, please see the MSAC Guidelines webpage
For more information on the MSAC process, please see the MSAC Process webpage.
You can download the full MSAC Guidelines below.
Guidelines for preparing assessments for MSAC (PDF 13435 KB)
Guidelines for preparing assessments for MSAC (Word 9802 KB)
MSAC Application Form - for Applicants
An Application Form should be lodged for all requests for public funding, regardless if funding is being sought under the MBS or an alternative funding program/arrangement. An Application Form can be submitted by the medical profession, medical industry and others seeking Australian Government funding for a new medical service (or change to an existing service).
For MBS-related applications, please obtain a ‘Statement of Clinical Relevance’ from the most relevant professional medical college/society, where they succinctly state their ‘in-principle’ support for the proposed service.
The Statement of Clinical Relevance can be in the form of a simple email, from an authorised officer in the most relevant professional college/society. The email should succinctly state they support commencement of a process towards MSAC/Government consideration of a particular application. Specifically, whether the proposed service is regarded as being ‘clinically relevant’ by that sector of the Australian medical profession (i.e., is the proposed service [be it a test or treatment] regarded by the profession as being 'necessary' in the management of the medical condition).
MSAC application forms are lodged through the Health Products Portal (HPP).
The HPP provides online MSAC application forms for MBS eligible services and health technologies, and for other services or health technologies.
The MSAC Application Form will require applicants to:
- complete a PICO set document (to be uploaded to the HPP); and
- enter additional data into the HPP.
MBS Application PICO set document template (PDF 163 KB)
MBS Application PICO set document template (Word 35 KB)
Other MSAC Application PICO set document template (PDF 129 KB)
Other MSAC Application PICO set document template (Word 32 KB)
In addition to uploading the PICO set document, applicants will also be required to provide responses to questions within the HPP environment. These will mainly cover information that isn’t captured in the PICO set document (e.g. applicant and clinical expert’s details, regulatory information etc.).
On lodgement of an MSAC Application Form in the HPP, a PDF document will be generated which will contain all data entered directly into the HPP, including the file names of any uploaded documents (such as the PICO set document). This ‘Full Application’ PDF provides applicants with a record of their lodged application form. An example of the PDF document generated when an MSAC Application Form is lodged is provided below and can be used to provide applicants with an indication of the data they are required to enter directly into the HPP:
MBS Application example Full application v1.0 (PDF 253 KB)
Other MSAC Application example Full application v1.0 (PDF 251 KB)
An Application Summary document will also be generated in the HPP and be available to download. This document will be a redacted version of the Full Application Form, with some sensitive information such as individual’s names and contact details removed. This Application Summary document, along with the uploaded PICO set document(s) will be the version of MSAC Application Form published on the MSAC website if the application is deemed suitable to progress through the MSAC process.
A template of the Application Summary document is included below and provides an indication of the information the HPP will automatically redact from the Full Application Form.
MBS Application Summary v1.0 (PDF 366 KB)
MBS Application Summary v1.0 (Word 63 KB)
Other MSAC Application Summary v1.0 (PDF 355 KB)
Other MSAC Application Summary v1.0 (Word 60 KB)
For further information on the HPP, please visit https://hpp.health.gov.au. Here you can view user guidance on using the HPP, upcoming webinars and navigate to the HPP to complete your lodgements. For specific information on lodging an MSAC application in the HPP, including guidance on how to complete the application form, please view our knowledge article at https://hpp.health.gov.au/article-details/?id=688171a7-da57-4ca0-9b66-14e57389ccfc.
For further support, please email HPP.support@health.gov.au.
Please note, completing an Application Form does not guarantee an application will continue through the MSAC process. Once submitted, an Application Form, undergoes internal assessment by the Department to determine if it is suitable to progress through the MSAC process and, if so, which pathway it will follow.
PICO Confirmation Template - for HTA Groups
The PICO Confirmation Template contains guidance for the development of a PICO confirmation. Additional guidance for the completion of this document can be found in Section 1, TG 2 – PICO, of the MSAC Guidelines.
PICO Confirmation Template (PDF 434 KB)
PICO Confirmation Template (Word 134 KB)
PICO Confirmations are prepared by a Health Technology Assessment (HTA) Group with close collaboration and input from the Applicant. The PICO Confirmation is considered by the PICO Advisory Sub-Committee (PASC) of MSAC.
Assessment Reports
Assessment Reports for consideration by the MSAC Evaluation Sub-Committee (ESC) and MSAC can be developed by the Applicant or the Department may contract an HTA Group to develop the assessment report, in consultation with the applicant.
Applicant-Developed Assessment Report (ADAR) - for applicants
Applicants can decide to prepare their own Assessment Report. The ADAR should align with the PICO Confirmation and the MSAC Guidelines, using the ADAR template.
ADAR Assessment Report Template (PDF 1836 KB)
ADAR Assessment Report Template (Word 943 KB)
Department-Contracted Assessment Report (DCAR) - for HTA Groups
If agreed with the applicant, the Department can contract an HTA Group to prepare an Assessment Report that is aligned with the PICO confirmation and the MSAC Guidelines, using the DCAR template.
DCAR Assessment Report Template v1.1 (PDF 1951 KB)
DCAR Assessment Report Template v1.1 (Word 1012 KB)
ADAR Commentary- for HTA Groups
The purpose of the commentary is to critically appraise the approach taken in the ADAR and identify strengths and weaknesses in the evidence or approach used. The Commentary is prepared by the HTA Group.
ADAR Commentary v1.1 (PDF 349 KB)
ADAR Commentary v1.1 (Word 79 KB)
Submitting Application Forms, ADARs and DCARs
For guidance on lodgement dates for each document to their respective meeting, please see the meeting calendars on the MSAC Website
Application Forms
The HTA Team processes applications after the MSAC application lodgement cut-off date. These can be found on the MSAC website, under the Dates for Applicants
MSAC applications are lodged through the Health Products Portal (HPP). To sign into the HPP visit https://hpp.health.gov.au.
Important information about the HPP:
- You must have a myGovID, (an Australian Government recognised identity), linked to an organisation via Relationship Authorisation Manager (RAM) to access the HPP. For information on upcoming maintenance activities, please visit the MyGovID website.
- For security purposes, the inactivity timeout is set at 15 minutes from a user’s last interaction. This means that users that have not performed an interaction within the previous 15 minutes, will be logged out.
- HPP is fully functional when accessed from recent versions of Google Chrome (version 80+) or Microsoft Edge (version 86+), on a PC running Windows 10.
ADARs
Please note, prior to lodgement of an ADAR it is necessary for you to have submitted an MSAC Application Form and been found suitable to enter the MSAC process.
ADARs are lodged through the Health Products Portal (HPP). To sign into the HPP visit https://hpp.health.gov.au.
Applicants are required to notify the Department of their intent to lodge an ADAR. This is done via lodgement of a Notice of Intent (NOI) in the HPP. Notification of intent to submit an ADAR facilitates timely progress of the ADAR to the relevant MSAC meeting as it allows the Department to commence contracting a commentary on the ADAR.
The notification deadline (and ADAR submission deadline) is available on the PASC, ESC, MSAC Key Dates webpage. If you are lodging an integrated codependent submission to MSAC and PBAC, please lodge according to the timings and process available on the PBS website.
DCAR
Please note, prior to commencement of a DCAR, it is necessary for you to have submitted an MSAC Application Form and been found suitable to enter the MSAC process.
As DCARs are prepared by HTA Groups, it is not necessary for you to lodge an Assessment Report. However, it is necessary to notify the Department that you would like a DCAR to be developed according to the Notification Deadlines found on the PASC, ESC, MSAC Key Dates webpage.
Framework for the MSAC Assessment of Radiopharmaceuticals - for Applicants
If you are applying for public funding for a new or amended MBS item and your proposed MBS item descriptor(s) refers to a specific radiopharmaceutical or a set of radiopharmaceuticals, please consult the Framework for the MSAC Assessment of Radiopharmaceuticals. Please note, you will be required to provide additional information about this radiopharmaceutical or radiopharmaceuticals in your Application Form and the Framework explains these additional information requirements in greater detail and puts them in the context of the application and evaluation process.
Framework for the MSAC Assessment of Radiopharmaceuticals (PDF 286 KB)
Framework for the MSAC Assessment of Radiopharmaceuticals (Word 36 KB)
The following Figure can also be consulted for a summary of whether the Framework is applicable to your application, and if so, what further information (as specified in the Framework) is needed.
Abbreviations: ARTG = Australian Register of Therapeutic Goods; MBS = Medicare Benefits Schedule; RP = radiopharmaceutical; TGA = Therapeutic Goods Administration
Consultation Survey
MSAC conducts targeted and public consultation on applications found suitable to progress through the MSAC process. To assist public consultation, the department publishes an application webpage on the MSAC website and uploads:
- a copy of the MSAC Application Form
- a copy of the PICO Confirmation (when/if available).
For information on the MSAC consultation process, including:
- how to give us your consultation input and
- how the department uses and shares the input received
Deadlines by which you must give us your consultation input for each PASC and MSAC meeting are available on the MSAC website Key Dates page.
From 31 May 2024, the department will transition to a new MSAC consultation survey, which is housed 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.