reviewofhealthtechnologyassessmentinaustralia.docVIP

Review of Health Technology Assessment in Australia Submission by Medical Technology Association of Australia May 2009 1. Executive summary 3 2. About the medical technology industry 4 3. Understanding medical technology 5 4. How HTA for medical technology works now in Australia – an industry perspective 7 4.1. Overview 7 4.2. Therapeutic Goods Administration 8 4.3. Medical Services Advisory Committee 9 4.3.1. Background 9 4.3.2. Duration of assessment 10 4.3.3. Medical practitioners as a source of MSAC applications 10 4.3.4. Industry as a source of MSAC applications 10 4.3.5. Processing MSAC applications and references 11 4.3.6. Recommendations and outcomes of applications and references to MSAC 13 4.3.7. Clinical evidence 14 4.3.8. Timetable for the processing of applications to MSAC 15 4.3.9. Appointment of Advisory Panels 15 4.3.10. Interim funding 15 4.4. Prostheses and Devices Committee and related bodies 16 4.5. Horizon scanning 20 5. Exploring international models of HTA and their application to an Australian model for medical technology 21 5.1. International models 21 5.2. Australian Pharmaceutical Benefits Scheme 25 6. An optimal HTA process framework for Australia 29 6.1. Overview 29 6.2. Structure of HTA model 31 6.3. Role of HTA body 31 6.4. Operations of HTA body 36 6.5. Coverage with evidence development 40 6.6. Adaptation of global HTA to Australia 41 6.7. Horizon scanning 42 6.8. Monitoring of HTA implementation 42 7. Reforms to reimbursement processes 43 7.1. Background 43 7.2. Prostheses List reforms 44 7.3. Australian Refined Diagnosis Related Groups (AR DRGs) 48 8. Term of Reference No 1 – simplification and better co-ordination of Commonwealth health technology assessments 52 9. Term of Reference No 2 – improving role clarity and addressing duplication between processes 54 10. Term of Reference No 3 – enhancing post marketing surveillance mechanisms to ensure ongoing safety and efficacy 56 10.1. Definitions 56 10.2