EUnetHTA WP7 research and analysis activity 1: Final report An analysis of HTA and reimbursement procedures in EUnetHTA partner countries: final report Disclaimer: EUnetHTA is supported by a grant from the European Commission. The sole responsibility for the content of this document lies with the authors and neither the European Commission nor EUnetHTA are responsible for any use that may be made of the information contained therein. 1 of 152 EUnetHTA WP7 research and analysis activity 1: Final report Contents Contents ..................................................................................................................... 2 Abbreviations ............................................................................................................. 8 Executive Summary ................................................................................................. 11 Background ....................................................................................................... 11 Aims .................................................................................................................. 11 Methods ............................................................................................................ 11 Results .............................................................................................................. 12 Conclusions ...................................................................................................... 13 Introduction .............................................................................................................. 15 Chapter 1: Methods of the research ......................................................................... 18 Overall aim ........................................................................................................... 18 Scope of the work ................................................................................................. 18 Identification of relevant procedures ..................................................................... 18 Collection of documents ....................................................................................... 18 Data extraction ..................................................................................................... 19 Figure 1: The data collection and data extraction procedure ............................ 20 Case studies ......................................................................................................... 20 Write up and analysis ........................................................................................... 20 Chapter 2: Overview of data received ...................................................................... 22 Key messages ...................................................................................................... 22 Description of the data received ............................................................................... 22 Countries and agencies providing data ................................................................. 22 Figure 2: Overview of HTA activity .................................................................... 23 Case study 1: Involvement of the regions in national HTA in Spain .................. 24 Case study 2: The Italian Network of HTA ........................................................ 25 Assessment and evaluation .................................................................................. 26 Figure 3. Countries with agencies carrying out assessment of REA and appraisal of REA (pharmaceuticals (left) non-pharmaceuticals (right)) ............. 27 Case Study 3: Assessment and appraisal in Croatia ........................................ 27 Inpatient and outpatient ........................................................................................ 28 Other restrictions to types of technologies assessed ............................................ 28 Number of topics................................................................................................... 29 Figure 4: Number of topics considered in each country per year (% countries) 29 Type of initial assessment carried out for pharmaceutical technologies ............... 30 Figure 5: Approach to initial assessment of pharmaceuticals (% countries) ..... 30 Figure 6: Time taken to complete an assessment or evaluation of a pharmaceutical topic (% countries) ................................................................... 31 Type of assessment carried out for non-pharmaceutical health technologies ...... 31 Figure 7: Approach to initial assessment of non-pharmaceutical health technologies (% countries) ................................................................................ 32 Figure 8: Time taken to complete an assessment or evaluation of a non- pharmaceutical health technology assessment (% countries) ........................... 33 Information from other jurisdictions used to support national procedures ............. 33 Chapter 3: Horizon scanning and topic selection procedures .................................. 34 Key messages ...................................................................................................... 34 2 of 152 EUnetHTA WP7 research and analysis activity 1: Final report Description of horizon scanning systems to support topic selection and workload planning .................................................................................................................... 34 Figure 9. Countries carrying out horizon scanning ............................................ 35 Description of topic selection procedures ................................................................. 36 Topic selection: Responsibility for choosing assessment topics ........................... 36 Figure 10. Responsibility for choosing the assessment topics .......................... 36 Case study 4: Responsibility for selecting assessment topics at ZIN in the Netherlands ....................................................................................................... 37 Figure 11. Map showing responsibility for topic selection resting with the HTA agency pharmaceuticals (left); non-pharmaceutical health technologies (right)) .......................................................................................................................... 38 Topic selection criteria .......................................................................................... 38 Figure 12: Topic selection criteria applied (% countries with criteria) ................ 39 Predictability of timing of assessment initiation ..................................................... 40 Figure 13. How far in advance does an agency know it will need to carry out an assessment? (% countries) ............................................................................... 41 Case study 5: Predictability of assessment in Croatia ....................................... 41 Information from other jurisdictions used to support horizon scanning and topic selection ............................................................................................................... 42 Analysis of horizon scanning and topic selection procedures .................................. 42 Horizon scanning procedures ............................................................................... 42 Pharmaceuticals ................................................................................................ 43 Non-pharmaceutical health technologies .......................................................... 43 Topic selection procedures ................................................................................... 43 Figure 14: Number of topics completed by agency involvement in procedure – pharmaceuticals ................................................................................................ 45 Figure 15: Number of topics completed by agency involvement in procedure – non-pharmaceutical health technologies ........................................................... 46 Pharmaceuticals ................................................................................................ 47 Non pharmaceutical health technologies .......................................................... 47 Figure 16: Topic selection procedures .............................................................. 48 Case study 6: Topic selection and prioritisation procedures for the Spanish Network ............................................................................................................. 49 Topic types ........................................................................................................... 49 Pharmaceuticals ................................................................................................ 49 Non-pharmaceutical health technologies .......................................................... 50 Recommendations for Horizon Scanning and Topic selection procedures .............. 52 Chapter 4: Scoping................................................................................................... 53 Key messages: ..................................................................................................... 53 Description of scoping procedures ........................................................................... 53 Timing of scoping procedures ............................................................................... 53 Responsibility for defining scope contents ...........................................................