The MSAC Guidelines Review
The MSAC Guidelines and associated Assessment Report templates were reviewed to ensure assessment processes are aligned with best practice in health technology assessment for therapeutic and investigative health technologies and services. The Review looked at the Therapeutic Guidelines (version 2.0, March 2016) and Investigative Guidelines (version 3.0, July 2017), consolidating them into one document now referred to as ‘Guidelines for preparing assessments for the MSAC (Version 1.0, May 2021)’ (the Guidelines). The Guidelines also provide guidance for newer technologies, including genetic testing for heritable diseases and other screening tests. The assessment templates have been updated to align with the Guidelines.
The Guidelines for preparing assessments for the MSAC (Version 1.0, May 2021) and Templates, found on the Guidelines Tab should now be used.
There will be a transition period where documents prepared using either the Therapeutic Guidelines (version 2.0, March 2016) and/or Investigative Guidelines (version 3.0, July 2017), OR the Guidelines for preparing assessments for the MSAC (Version 1.0, May 2021) and associated Templates, will be accepted. The period of transition will be different for each document going to PASC, ESC and MSAC meetings. Figure 1 sets out which version of the Guidelines and Templates must be followed, for documents going to each meeting.
For guidance on lodgement dates for each document to their respective meeting, please see the meeting calendars online.
Figure 1. The transition timeframe diagram for the transition into the New MSAC Guidelines and associated Templates – based on committee meeting dates.
Please note which version of the Guidelines should be followed to prepare the associated document, for which meeting. For guidance on lodgement dates for each document to their respective meeting, please see the meeting calendars on the online.
Assessment GroupsThe following forms, templates and guidelines are to be used by Assessment Groups when developing the PICO confirmation, Assessment Reports and Critiques of Assessment Reports in the MSAC process.
PICO confirmation template and guidelinesThe PICO confirmation (formally Protocol) template is available below. The template includes guidelines for the development of a PICO confirmation.
PICO Confirmation Template (PDF 988 KB)
PICO Confirmation Template (Word 75 KB)
All PICO confirmations will be prepared by an Assessment Group with close collaboration and input from the Applicant. The PICO confirmation will be considered by the PICO Advisory Sub-Committee of MSAC.
Assessment Report Guidelines (Investigative and Therapeutic)The Guidelines for preparing Assessment Reports for MSAC (Investigative and Therapeutic Guidelines) and associated Assessment Report templates are intended to provide practical information on how to present evidence to MSAC when seeking Australian Government funding of a medical service. Although the Guidelines have been written for Applicants and Health Technology Assessment Groups from the medical profession and industry, they are also intended to provide information to other interested stakeholders, including clinical and patient groups, and the general community.
It should be noted that the text within the Assessment Report templates have been written in red hidden text which provides instructions or suggestions for completing the different sections of the template. It is envisaged that this will assist the members of the Evaluation Sub-Committee and MSAC by providing information in a standard format.
Investigative Guidelines for Preparing Assessment Reports (PDF 3216 KB)
Investigative Guidelines for Preparing Assessment Reports (Word 2390 KB)
Therapeutic Guidelines for Preparing Assessment Reports (PDF 2032 KB)
Therapeutic Guidelines for Preparing Assessment Reports (Word 1114 KB)
Assessment Report TemplatesBelow are the Assessment Report templates to be used by applicants and assessment groups for both submission based and contracted assessments. Guidelines for this template are above.
SBA or Contracted Assessment Report Template - Investigative (PDF 1013 KB)
SBA or Contracted Assessment Report Template - Investigative (Word 695 KB)
SBA or Contracted Assessment Report Template - Therapeutic (PDF 670 KB)
SBA or Contracted Assessment Report Template - Therapeutic (Word 577 KB)
Critique TemplatesBelow is the critique template to be used by assessment groups when critiquing assessment reports (both submission based and contracted). Guidelines for this template are within the document.
Assessment Report Critique Template - Investigative (PDF 547 KB)
Assessment Report Critique Template - Investigative (Word 240 KB)
Assessment Report Critique Template - Therapeutic (PDF 443 KB)
Assessment Report Critique Template - Therapeutic (Word 196 KB)
Clinical Utility Card ProformaBelow is the Clinical Utility Card Proforma (CUC Proforma) to be used by applicants and assessment groups for assessment reports related to genetic testing for heritable mutations. See Application 1411.1 for an example.
To apply for public funding using the CUC Proforma, intending Applicants are required to first provide a completed Application Form (using the Application Form Template). This part of the usual MSAC process helps inform a determination, as part of the suitability process, of whether the Clinical Utility Card proforma and process might apply. It is recommended that the proposed populations and proposed interventions are defined in the Application Form consistent with the approach recommended in the CUC Proforma.
CUC Proforma (PDF 180 KB)
CUC Proforma (Word 101 KB)
CUC Glossary (PDF 112 KB)
CUC Glossary (Word 79 KB)
Integrated codependent submissions for tumour-agnostic or pan-tumour cancer medicinesThe MSAC Executive has commissioned and endorsed the following two complementary documents to provide context and background into the emerging area of testing biomarkers to help determine eligibility for cancer medicines to be used in metastatic cancer across solid tumour types. Although primarily directed at one such example, these documents are also intended to help applicants and assessment groups consider those aspects which might also be relevant to other examples in this emerging area.
Discussion paper on pan-tumour biomarker testing to determine eligibility for targeted treatment
Discussion paper (PDF 1524 KB)
Discussion paper (Word 304 KB)
A review of the current testing methodologies for the detection of mismatch repair deficiency in tumours
Review paper (PDF 902 KB)
Review paper (Word 85 KB)