Medical Devices: Generating and Using Real-World Observational Data for Decision-Making on Value

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1 Medical Devices: Generating and Using Real-World Observational Data for Decision-Making on Value CADTH Symposium 2017, Ottawa Mark Campbell Associate Director Medical Technologies Evaluation Programme

2 About NICE: improving outcomes for people Evidence-based guidance and advice for health, public health and social care Information services for commissioners, practitioners and managers Quality standards and performance metrics for those providing and commissioning health, public health and social care

3 Medical Technologies Evaluation Programme Diagnostics Assessment Programme new NICE programmes in addition to existing Interventional Procedures Programme Recognised lack of capacity Need for bespoke methods Need for broad support from industry sector and other key stakeholders 2014 Observational Data Unit

4 Methods approaches All forms of evidence accepted, no quantity or quality threshold Cost consequences economic evaluation, assumes that intervention clinically (at least) non-inferior to comparator

5 Combination products Device Imaging technology Digital technology In vitro diagnostic Evidence generation NICE Scientific Advice Research facilitation in response to guidance research Guidance Medical technologies Diagnostics Interventional Procedures Technology Appraisal Advice Adoption support tools to promote implementation Medtech innovation briefings (MIBs) Health apps briefings NICE Pathway

6 NICE non-drug outputs Type Annual (total) Note Interventional Procedures Guidance 30 (574) Safety and efficacy of procedure Medtech innovation briefings 40 (102) Medical technologies guidance 7 (32) Diagnostics guidance 7 (27) Or or or Advice which summarises evidence and place in therapy contain no Typically early signal or simple products Value assessment for clinically non-inferior, resource-releasing devices and simple diagnostics ~25% recommend further research - > research protocol and facilitated research (2-4/year) Value assessment for complex diagnostics ~50% recommend further research - > research protocol and facilitated research (2-4/year) Technology appraisal guidance Infrequent Value assessment for devices which offer more benefit at additional cost Guidelines Library of ~200, continually being updated Defines interventions which should (or shouldn t) be offered as part of a standard public health, NHS or social care pathway.

7 Observational Data Unit Build on existing NICE activities: Register creation and development to support Interventional Procedures Guidance Facilitating collaborative research in response to medtech/diagnostics guidance Established in 2014 in response to data collection and analysis activities commissioned from NICE by NHS England Supports development of evidence on new interventions (chiefly under NHS England Commissioning through Evaluation (CTE) scheme) Enabled NICE to develop dedicated capacity and expertise in this area, and likely to continue to develop/expand

8 Commissioning Through Evaluation (CTE) main features Services are not routinely commissioned Evaluates potentially promising specialised treatments for which current evidence is insufficient to support routine commissioning within NHS. Enables limited number of procedures to be funded, within selected centres for limited time-frame while data is collected For NICE and External Assessment Centres 2 stages Primary data collection Secondary data analysis

9 Current CTE projects Selective dorsal rhizotomy to reduce spasticity in children with cerebral palsy (SDR) Selective Internal Radiation Therapy (SIRT) for treatment of primary or metastatic hepatic carcinoma Stereotactic ABlative Radiotherapy (SABR) for oligometastases, relapsed pelvic/spine and primary hepatocellular cancer Percutaneous mitral valve leaflet repair (using MitraClip) for mitral regurgitration for patients with heart failure Patent Foramen Ovale Closure for the prevention of recurrent stroke Left Atrial Appendage Occlusion for the prevention of stroke In development Argus II retinal prosthesis system for retinitis pigmentosa Pipeline of topics developing via NHS England commissioning policy process

10 Observational data use and development Advice (MIBs) Interventional Procedures Guidance Medical technologies guidance Diagnostics guidance Identified and assessed Relied upon for committee decision-making Recommended or generated Frequently Frequently Often Often Contain no Contain no Yes Yes Yes Yes - 28 specific registries (some relating to multiple IPGs) recommended as method of data capture - 15 involved in updating guidance + methods development using routinely available data Yes, and as 1 option in response to research Yes, as 1 option in response to research (DG7 SeHCAT, DG5 SonoVue) or conditional (DG21 Integrated sensor-augmented pump therapy systems)

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