Who is involved in making NICE guidance recommendations and what evidence do they look at?

Jane Cowl, Senior Public Involvement AdviserTommy Wilkinson, Advisor (Health Economics), NICE International

Who decides what NICE will recommend?

Specialist staff employed by NICE True or False?

The Department of Health True or False?

Independent committees of experts True or False?

Independent committees of NICE staff & experts True or False? NICE employed administration staff True or

False? NHS England True or False? Clinical Commissioning Groups True or False? NHS finance managers True or False?

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

Guidance development phases

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Reviews of research evidence (all NICE guidance) Grey literature and unpublished data Economic modelling Manufacturers submissions Expert testimony (patient and professional) Stakeholder consultation (all NICE guidance) Occasional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

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

The nature of evidence

Acknowledgement: Dr Sophie Staniszewska, RCN Research Institute, University of Warwick

Patient evidence

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

The value of patient evidence

What insights does patient evidence offer us?Personal impact of living with a condition People’s preferences and valuesOutcomes that patients want from treatment or care Impact of treatment or care on outcome, symptoms, physical and social functioning, quality of lifeRisks, benefits and acceptability of a treatment or serviceEquality issues and considerations for specific sub-groups

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

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.

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

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

Health Economics at NICE

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

Cost effectiveness and the ICER

New treatment

Current treatmentCOSTS

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

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

Quality-Adjusted Life-Years

Assessing cost effectivenessThe Threshold

Cost per QALY

1

£10K £20K £30K £40K £50K

0

• Innovation• Uncaptured

health gain

• Features of condition• Equity judgments• Availability of treatments

• Uncertainty

Assessing cost effectivenessWeighing up the benefits, harms and costs

Cost (£)

Effect (QALYs)

New treatment more expensive...

... but some savings from reducedneed for care in future

New treatmentmore effective...

... but harmful side effects for some people

New treatment

Currentpractice

Treatment options in the shaded region are judged to

provide good value for money (are ‘cost effective’)

Assessing cost effectivenessValue for money

Cost (£)

Effect (QALYs)

New treatment dominates

New treatment dominated

High extra cost;low QALY gain

Low extra cost;high QALY gain

£/Q

ALY

£/QALY

Cost-per-QALY threshold(‘willingness to pay’)

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 reporthttp://www.nice.org.uk/aboutnice/howwework/socialvaluejudgements/socialvaluejudgements.jsp