Comments on the MSAC draft paper
Technical Guidelines for preparing assessment reports for
the Medical Services Advisory Committee –
Service Type: Investigative
(Version 1.3)
29 May 2015
mtaa.org.au
Medical technology for a healthier Australia
www.mtaa.org.au
Level 12, 54 Miller St, North Sydney
NSW 2060 Australia
PO Box 2016 North Sydney
NSW 2059 Australia
P (+612) 9900 0650
F (+612) 9900 0655
E [email protected]
The Medical Technology Association of Australia (MTAA) welcomes the opportunity to
respond to the draft Technical Guidelines (Investigative)1 released by the Department of
Health on behalf of the Medical Services Advisory Committee (MSAC).
MTAA acknowledges that this approach will promote transparency, consistency and
procedural fairness and, if implemented appropriately, will enable MSAC to assess the
complete body of evidence to determine overall benefits and costs associated with a
proposed service. This approach is alignment with the HTA Review recommendations.2
However, due to the complexity of evaluating co-dependent technologies the draft MSAC
Guidelines has failed to recognise the several issues as outlined in the previous MTAA
response to MSAC relating to draft MSAC Technical Guidelines (Therapeutic) – copy
enclosed.
These issues include:
 It maintains the fundamental framework of the current MSAC evaluation process for
applications that require a full HTA (PASC, ESC and MSAC meetings, and public
consultation)
 Implementation of the risk assessment methodology occurs early in the evaluation
process
 Formal recognition of the necessity to appropriately consider technologies which meet a
high unmet clinical or economic need
 Introduction of coverage with evidence development (or ‘conditional approval’) for eligible
technologies
 Risk rating used to identify the type and degree of risk which will determine:
o the most appropriate evaluation pathway (standard, fit-for-purpose or rapid
review)
o the relevant clinical and economic endpoints and data sources to be considered in
the evaluation of available evidence
o the relevant clinical and economic variables to be included in an agreed protocol
for coverage with evidence development.
MTAA recommends that for the co-dependent technology evaluation and assessment
process the following issues should be considered:
 Alignment of committee meeting dates to streamline PBAC and MSAC assessments –
co-dependent submissions require consideration by two or more advisory committees
and communicating new processes to stakeholders takes time and effort particularly
regarding co-dependent submissions. Further, PBAC recommendation is provided at 17
weeks cycle, whereas MSAC assessments usually take years.
1 Draft Guidelines for Preparing Investigative Assessment Reports for the Medical Services Advisory Committee (MSAC) (the Investigative Guidelines) (Version 1.3) April
2015.
2 Review of Health Technology Assessment in Australia December 2009. Available:
www.health.gov.au/internet/main/publishing.nsf/Content/AF68234CE9EB8A78CA257BF00018CBEB/$File/hta-review-report.pdf.
Page 2 of 4




New processes to provide integrated advice to government – MSAC cycles should align
with the annual Federal Budget.
Application of fit-for-purpose pathway for co-dependent technologies.
Capacity and work load of MSAC – with rapid increase in number of co-dependent
technology applications, MSAC Reform and MBS Reviews.
Impact of PBAC and MSAC reforms i.e. new processes are still being phased in on draft
Guidelines.
MTAA proposes maintaining the scope, structure and underlying principles of the existing
MSAC framework, but recommends adopting further refinements to more accurately address
the distinct attributes of medical technology.3 MTAA urges broader implementation of the
proposed risk assessment methodology and introduction of a ‘rapid review’ option to extract
further efficiency gains without sacrificing rigor, financial exposure or patient health
outcomes, thereby improving the relevance and timeliness of the resulting MSAC
recommendations.
MTAA welcomes the opportunity to continue to work with the Department of Health on
refining the effectiveness of MSAC evaluation and assessment processes when applied to
different types of medical technologies. MTAA offers its support to future workshops and
consultations.
Attachment: MTAA Comments on the MSAC draft paper. Technical Guidelines for preparing
assessment reports for the Medical Services Advisory Committee – Service Type:
Therapeutic (Version 1.00) February 2013.
3 The National Institute of Health and Care Excellence (NICE) Interventional Procedures Guidance. Available: https://www.nice.org.uk/about/what-we-do/ourprogrammes/nice-guidance/nice-interventional-procedures-guidance.
Page 3 of 4
Copyright © 2012 Medical Technology Association of Australia Limited (MTAA)
To the extent permitted by law, all rights are reserved and no part of this publication covered by copyright may be reproduced or copied in any
form or by any means except with the written permission of MTAA Limited.
Page 4 of 4