Overview

1. Medical Services Advisory Committee (MSAC) ReformsMr Chris CarlileAssistant SecretaryMedicare Financing and Listing BranchMedical Benefits Division

2. Overview • MSAC – What is it? • MSAC Reform - How did we get here? • Key stages of MSAC process • Challenges we are addressing • Key principles and objectives of MSAC reform • Reform activities underway

3. MSAC – What is it? • MSAC is a Ministerially appointed, independent, scientific advisory committee • Established 1998 to advise Government on the strength of evidence relating to safety, effectiveness and cost-effectiveness of new medical technologies and procedures • Meets three times a year

4. MSAC Reform- How did we get here? HTA Review reported in late 2009. Key recommendations: • Speed up MSAC by establishing a submission-based assessment (SBA) process with critiques • Be more flexible in dealing with complex & novel technologies • Open, transparent and integrated system • Improved applicant & stakeholder input mechanisms • MSAC processes changed effective January 2011

5. Key features during change • Consistency in rigour of assessment • Structured approach to applications • Significant engagement with applicants • Public consultation • Transparency

6. Medical Services Advisory Committee MSAC is supported by two sub-committees: • PASC: Protocol Advisory Sub-committee • ESC: Evaluation Sub-committee MSAC and its sub-committees are further supported by: • The Health Expert Standing Panel (HESP) • Contracted Assessment Groups

7. Key stages of MSAC process • Expression of interest (pre-assessment) • Application development • Development of a protocol • Public consultation • Consideration by Protocol Advisory Sub-Committee (PASC) • Development of the Assessment Report • Clinical and Economic evaluation • Consideration by ESC • Consideration by MSAC

8. Challenges we are addressing • One-size-fits-all model • Same degree of rigour may not be warranted for all applications, e.g. minor changes • Increasingly clear that parts of the process can be unnecessarily complex for some (most?) applications • Duplication and complexity • Commensurate attribution of risk

9. Key principles of MSAC reform • Applicants, in consultation with the Department, can choose their optimal pathway for MSAC assessment; • The risk associated with these choices is shared between the Department and the applicant; and • The roles and requirements of the applicant and Department are clearly defined.

10. Reform objectives • Streamline and simplify existing processes for applicants • Enable the applicant to have ownership of assessment decisions relating to their application • Share the risk of assessment decisions between the Department and the applicant • Consistent with the Government’s deregulation agenda

11. Reform activities underway Pre-assessment • Identified as a key activity for reform • Ensures the information needed is provided early in the process to allow MSAC processes to work more smoothly • Development of guidelines to support: • The initial application form • The development of a protocol • Development of fact sheets and FAQs • Website redesign

12. More reform activities underway Assessment pathway options • Assessment pathways choices include: • Greater role for applicant in protocol development • Focusing PASC consideration • Choices for development of the Assessment Report • A risk management framework has been developed to support applicant decisions

13. More reform activities underway • Trials underway for • Redesign of website • Simplified application form • Applicant participation in PASC meetings • Resubmissions with minor amendments directly to MSAC/ sub-committees

14. Further reforms • Welcome and encourage feedback on reform activities identified. • Seeking your ideas on what other areas of the MSAC process could be streamlined or simplified.

15. Contact details HTA hotline – (02) 6289 7550 HTA email – hta@health.gov.au MBS reviews – mbsreviews@health.gov.au MSAC website – www.msac.gov.au