Health Technology Assessment: Current issues and future challenges

Health Technology Assessment:Current issues and future challenges Helen Chung Technical Adviser Centre for Health Technology Evaluation 25 October 2007

Overview • Why is HTA here to stay? • How are NICE appraisal recommendations made? • Current issues for NICE appraisals • Future challenges • How to find out more

Health systems are under pressure … Clinical capacity and ambition Health system objectives and resources Users expectations Health Policy Growth in health technology

How does HTA help respond to the pressure? • Health systems, like any organisation, need rational purchasing processes • They need to establish whether the incremental benefit of new technologies is worth what the health system is being asked to pay • Payers and patients need to establish the optimal use of new and existing technologies

NICE Guidance Programmes Technology Appraisals Interventional Procedures Centre for Technology Evaluation Service Delivery Guidelines Clinical Practice Guidelines Centre for Clinical Practice Public Health Interventions Public Health Programmes Centre for Public Health Excellence

What is a NICE Technology Appraisal? • A review of clinical and economic evidence leading to recommendations on the appropriate use of new and existing technologies for the NHS in England and Wales • Mandatory funding direction

Dept. of Health Welsh Assembly Government Which technologies are appraised? • Is the technology likely to result in a significant: • health benefit, across NHS as a whole? • impact on NHS service priorities? • impact on NHS resources? • Will NICE guidance add value?

TopicSelection – disease areas Published technology appraisals (n=93) by ICD classification

Published appraisals (cumulative)

How are technology appraisals developed? • Principles • Stakeholders • Decision makers • Factors in decision making • Process • Methods

Guiding principles for NICE guidance • Robust • underpinned by a sound evidence base • Inclusive • Genuine consultation of stakeholders • Transparent • evidence and conclusions in the public domain • Independent • developed by external advisory committees

Who is involved? Consultees and commentators include: • Patients and carers • Healthcare professionals • Manufacturers and comparator manufacturers • Academic institutions and research groups • Primary care trusts • Governmental departments The public also have the opportunity to comment on consultation documents

Who makes the decision? • The Appraisal Committee makes recommendations to NICE on how the technology should be used in the NHS. • This standing committee is independent of NICE and has members from a variety of backgrounds: • doctors, nurses, pharmacists • NHS managers • health economists • statisticians • lay representatives

Cost-effectiveness Extent of uncertainty Legal and policy constraints Social Value Judgements ethics, equity, rights • Innovation, Features of the condition • Wider costs & benefits Factors in decision making NICEDECISIONS

Process • Two Processes • Single Technology Appraisal ( STA) • Multiple Technology Appraisal ( MTA)

Referral Publication Independent assessment Consultation on evidence Submissions from consultees • 1st Committee meeting • preliminary recommendations Multiple Technology Appraisals Process Review Consultation on preliminary recommendations 2st Committee meeting  final guidance Appeal (or not)

Invitation Publication Appeal (or not) Clarification Evidence Review 8 weeks Preliminary recommendations Evidence Submission Committee meeting 8 weeks Experts Clarification Consultation Scoping Review 4 weeks Committee meeting Final guidance [ 26-34 weeks] STA Process

Methods • Setting the question: • scoping and decision problems • Appraisal of the evidence • Clinical effectiveness • Cost effectiveness

Scopes and decision problems • Population • Intervention • Comparators • Outcomes • Economic analysis • Other considerations

Clinical effectiveness Types of evidence • randomised controlled trials • observational studies, case series • expert opinion Techniques for assessment: • systematic reviewing • critical appraisal • evidence synthesis

More effective and less costly More effective and more costly Less effective and less costly Less effective and more costly Comparison of two alternative treatments Cost Difference + _ Effect Difference + _

Initial QALY loss due to side effects New treatment Currenttreatment QALYs gained The Quality Adjusted Life Year 1 Health-related quality of life 0 Length of life (years)

Assessing Cost Effectiveness 1 Probability of rejection 0 50 10 20 30 40 Cost per QALY (£’000)

Common issues in appraisal decisions • Completeness and quality of evidence • Are the relevant patient populations included in the trials? (eg. rapid change in clinical practice) • Do some patient subgroups respond better than others? • Guidance can only be within marketing authorisation • The comparator – need for indirect comparisons? • Relevant outcomes – surrogate outcomes • Response-based continuation rules • Uncertainty about long term benefits, adverse effects and costs (eg. early termination of RCTs)

Recent developments at NICE • April 2005 merger Health Development Agency • Split sites in London and Manchester • Increased focus on implementation • Social Value Judgement papers • Topic selection (admin) managed by NICE • Single Technology Appraisals • Short Clinical Guidelines

What about when there’s no NICE guidance? • Good practice guidance on managing the introduce of new healthcare interventions and links to NICE technology appraisal guidance (Department of Health, December 2006) • If a new intervention is not referred to NICE, this does not imply any judgement on whether it is clinically cost effective • A key role of the NHS is to make decisions about the use of new interventions and this has always been the case • NHS bodies should continue to use existing arrangements to access publicly available evidence and to determine local policies for the managed entry of the new intervention • Same for those referred but guidance not yet produced • It is not acceptable to cite a lack of NICE guidance as a reason for not providing a treatment

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Health Technology Assessment: Current issues and future challenges