1. Who is involved in making NICE guidance recommendations and what evidence do they look at? Jane Cowl, Senior Public Involvement Adviser Tommy Wilkinson, Advisor (Health Economics), NICE International

2. Who decides what NICE will recommend?  Specialist staff employed by NICETrue or False?  The Department of HealthTrue or False?  Independent committees of expertsTrue or False?  Independent committees of NICE staff & expertsTrue or False?  NICE employed administration staffTrue or False?  NHS EnglandTrue or False?  Clinical Commissioning GroupsTrue or False?  NHS finance managersTrue or False?

3. Who decides what NICE will recommend? Independent committees  Chair  At least 2 lay members  Health and social care professionals (specialists and generalists)  Care providers and commissioners  Technical experts e.g. health economist 2 types: standing committees and topic specific groups Staff provide technical and administrative support

4. Evidence informing committee’s work  Reviews of research evidence (all NICE guidance)  Grey literature and unpublished data  Economic modelling  Manufacturers submissions  Expert testimony (patient and professional)  Stakeholder consultation (all NICE guidance)  Occasional additional consultation or fieldwork with practitioners and patients NICE recommendations based on best available evidence

5. The right type of evidence for the question The question dictates the most appropriate study design, for example  'What is the cause of this disease?' Cohort, case-controlled study  ‘What does it feel like?’, ‘What is important to you?’ or ‘What is your experience of care’ Qualitative research  'What is the most clinically effective therapy?' Randomised controlled trial (RCT)  ‘What works best in diagnosing the condition?’ Observational study or RCT Includes systematic reviews of studies where available

6. The nature of evidence Patient evidence Clinical evidence High quality patient care (Relevant, effective, acceptable, appropriate) Economic evidence Acknowledgement: Dr Sophie Staniszewska, RCN Research Institute, University of Warwick

7. Patient evidence

8. The value of patient evidence What insights does patient evidence offer us?  Personal impact of living with a condition and experience of care  People’s preferences and values  Outcomes that patients want from treatment or care  Impact of treatment or care on outcome, symptoms, physical and social functioning, quality of life  Risks, benefits and acceptability of a treatment or service  Equality issues and considerations for specific sub-groups

9. Evidence from experience of care Focus group discussions with people who self-harmed – they were not routinely offered anaesthesia for suturing wounds in the emergency department Nothing in the published research to indicate this was an issue The NICE guideline addresses the issue in its recommendations Example – people who self-harm

10. Patient perspectives – impact and challenges  Examples of positive influence of patient evidence on: Scoping and review questions Evidence reviews Guidance recommendations Research recommendations  Challenges Ensuring patient voices are heard The weighting of patient evidence Synthesising with clinical and economic evidence

11. Health Economics at NICE

12. Why consider health economics? If the NHS spends more on one thing, it has to do less of something else (on the margin) Could we do more good by spending money in other ways? The ‘opportunity cost’ is the value of the best alternative use of resources Opportunity Cost

13. Cost effectiveness and the ICER New treatment Current treatment COSTS value of extra resources used CONSEQUENCES (EFFECT) value of health gain I Incremental: extra, additional C Cost: How much do we have to pay? E Effectiveness: What do we get (in QALYs)? R Ratio: unit per unit e.g. km/h - we use cost per QALY “COST EFFECTIVENESS” MEANS TO REFER TO COSTS AND EFFECTS

14. Measuring health outcome – QALY What is a quality-adjusted life-year (QALY)? –combines both length of life (LY) and health-related quality of life (QA) into a single measure of health gain –The amount of time spent in a health state is weighted by the quality of life (QoL) score attached to that health state –QoL is usually scored with ‘perfect health’=1 and death=0 1 QALY =one year of ‘perfectly healthy’ life for one person =two years of life with QoL of 0.5 for one person =one year of life with QoL of 0.5 each for two people

15. Quality-Adjusted Life-Years health-related quality of life (utility) time (years)

16. Assessing cost effectiveness Weighing up the benefits, harms and costs Cost (£) Effect (QALYs) New treatment more expensive...... but some savings from reduced need for care in future New treatment more effective...... but harmful side effects for some people New treatment Current practice

17. Treatment options in the shaded region are judged to provide good value for money (are ‘cost effective’) Assessing cost effectiveness Value for money Cost (£) Effect (QALYs) New treatment dominates New treatment dominated High extra cost; low QALY gain Low extra cost; high QALY gain £/QALY Cost-per-QALY threshold (‘willingness to pay’)

18. Considerations beyond efficiency “Decisions about whether to recommend interventions should not be based on evidence of their relative costs and benefits alone. NICE must consider other factors when developing its guidance, including the need to distribute health resources in the fairest way within society as a whole.” NICE Social Value Judgement report http://www.nice.org.uk/aboutnice/howwework/socialvaluejudgements/socialvaluejudgements.jsp

19. How this all works in practice: the interactive group task You will be the technology appraisal committee You have a difficult decision to make regarding a treatment for macular degeneration Different members will be required to represent a different perspective: Group A Clinical Group B Public Group C Health Economics

20. Choices available to the committee: Option A: Approve, recommending that the drug(s) are used to treat the “best eye only” Option B: Approve, recommending that the drug(s) can be used in both eyes that are affected by the condition Option C: Recommend that funding for the drug should not be made available on the NHS (decline) How this all works in practice: the interactive group task

21. Perspectives: Clinical: Is the recommendation reflecting the evidence base? How certain are we that the clinical effect seen in RCTs will be reflected in practice? Public: Have all views been taken into account? Have we thought more broadly about how this might affect patients, their families and the wider public? Health Economics: Could we do more good by investing elsewhere in the NHS? How this all works in practice: the interactive group task