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. Guidance development phases Implementation of guidance Guidance quality assurance and publication Draft guidance development and consultation Evidence reviews and economic analysis Scope development and consultation

5. Evidence informing committee’s work  Reviews of research evidence (all NICE guidance)  Grey literature and unpublished data  Economic modelling  Manufacturers submissions  Expert testimony (patient and professional)  Stakeholder consultation (all NICE guidance)  Occasional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

6. 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?’ or ‘What is important to you?’ 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 e.g. RCTs where available

7. 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

8. Patient evidence

9. Where do we get patient evidence from?  RCTs and other quantitative research  Qualitative research  Both published research and grey literature (e.g. patient surveys)  Patient testimonies and commentaries  Committee members  Consultation

10. The value of patient evidence What insights does patient evidence offer us?  Personal impact of living with a condition  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

11. New information 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

12. Adding to the evidence base Example – Psoriasis Clinical research told us the amount of psoriasis was what most affected the quality of life. Patients told us that the location of the flare-up (e.g. face or joints) was more significant.

13. Narrative to contextualise quantitative research Example – promoting physical activity Public health guidance included focus on girls and young women aged 11-18 Evidence from 15 UK qualitative studies of adolescent girls on main barriers and facilitators to being physically active Informed recommendations on supporting girls and young women and helping them to be physically active

14. 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

15. Health Economics at NICE

16. 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

17. 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

18. 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

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

20. Assessing cost effectiveness The Threshold Probability of rejection Cost per QALY 1 £10K£20K£30K£40K£50K 0 Innovation Uncaptured health gain Features of condition Equity judgments Availability of treatments Uncertainty

21. 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

22. 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’)

23. 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