Comments on the MSAC draft paper
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 reception@mtaa.org.au 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
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