NICE Technology Appraisals

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NICE Technology Appraisals
Meet the engine room

• The NICE Appraisals Team

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Meet the team

• Introduction to the team
• The appraisal process
• Whats new in the process
• Hints, tips and challenges

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Things should be made as simple as possible but
not simpler!
Albert Einstein
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The drug itself has no side effects but the
number of health economists needed to prove its
value may cause dizziness and nausea
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Technology Appraisals The process
Ruth Frankish Information Specialist
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Overview of the process

• Referral from the DoH
• Scoping
• Invitations to submit
• Consultee meetings
• Preparation of submissions
• Preparation of assessment report
• First meeting of committee - ACD
• Second meeting of committee - FAD
• Guidance

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Scoping, search for

• Background information epidemiology
• Current evidence base
• SRs, guidelines, etc
• Identification of consultees
• Patient, professional, industry trade
• Formulate the question
• Intervention, population comparators, plus
  other considerations
• Prepare draft for consultation

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Invitation to submit evidence

• Patient/carer, professional and manufacturer
• Submit information
• Clinical effectiveness
• Cost effectiveness
• Patient/user perspectives
• Current practice and use in the NHS
• NHS implications

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The Assessment Report

• Commissioned via NCCHTA
• Aberdeen - HSRU
• Birmingham - WMHTAG
• Liverpool - Dept. Pharm Therapeutics
• Sheffield - ScHARR
• Southampton/Exeter - Wessex/PENTAG
• York - NHS CRD
• Systematic review of the evidence and economic
  analysis

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Before first committee meeting

• Assessment Report sent to consultees for comment
• Evaluation report compiled
• Assessment Report
• Comments from consultees on Assessment Report
• Full professional and patient group submissions
• Manufacturer executive summaries
• Written perspectives from professional and
  patient experts
• Evaluation report sent to committee

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First Committee Meeting

• Overview lead by two committee leads for the
  technology
• Topic experts invited to attend committee meeting
• Assessment group representatives
• Patient/carer representatives
• Professional experts

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Appraisal Consultation Document

• Initial view from the committee
• Produced after first committee meeting
• Whole committee involved in drafting
• Official consultees invited to comment
• Has all the evidence been taken into account?
• Is this view an accurate reflection of the
  evidence put before the committee?
• Posted on website for information
• Website has facility for comment on the ACD

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Final Committee Meeting

• Discussion of comments received on the ACD
• All comments go to committee
• Discussion of revisions to ACD in light of
  comments
• Discussion of areas where there is lack of
  clarity or reasoning
• Preparation of the Final Appraisal Determination

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Final Appraisal Determination

• Final Appraisal Determination produced after
  final committee meeting
• Sent to consultees and posted on website
• Formal consultees may decide to appeal
• Subject to appeal, Institute issues guidance to
  the NHS

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Appeal

• Consultees may appeal on three grounds
• The Institute has failed to act fairly and in
  accordance with its published procedures
• The FAD is perverse in the light of evidence
  submitted
• The Institute has exceeded its powers
• If appeal upheld, Committee may be asked to
  reconsider the FAD
• If not, Institute can release guidance

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Technology AppraisalsWhats New?
Kathleen Dalby Nina Pinwill Technology
Appraisal Project Managers
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Background

• NICE established in April 1999
• Interim Guidance for Manufacturers and Sponsors
• Published December 1999
• Consultation on appraisal process
• Q3 / Q4 2000
• Updated process agreed by NICE Board
• 6 February 2001
• New process suite published
• March 2001

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Publications on the Process

• Technology Appraisal Process Suite
• Guide to the Technology Appraisal Process
• Guidance for Appellants
• Guidance for Patient/Carer Groups
• Guidance for Healthcare Professional Groups
• Guidance for Manufacturers and Sponsors

Copies available free of charge from
www.nice.org.uk
Replace Appraisal of New and Existing
Technologies Interim Guidance for Manufacturers
and Sponsors, December 1999
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Whats New?

• Defining features
• Consultation
• Transparency
• Time

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Whats New - Consultation

• Draft scope and provisional matrix of consultees
• Assessment Report - to consultees prior to 1st
  Appraisal Committee meeting
• Involvement of Health Authorities
• Wider consultation on ACD

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Whats New- Transparency

• Consultees receive Assessment Report protocol
• Consultees invited to information meeting
• Evaluation Report now includes
• Consultee comments on Assessment Report
• Professional and patient expert submissions
• Web publications
• Scope and matrix of consultees
• Assessment report protocol
• ACD
• FAD

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Whats New- Time

• Consideration of draft scope provisional matrix
  of consultees
• 2 weeks
• Preparation of Assessment Report
• Previous 6 weeks Now 10 weeks
• Consultee consideration of Assessment Report
• 2 weeks
• Consideration of appeal
• Previous 10 .Now 15 working days

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Any questions?
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Technology AppraisalsHints,Tips and Challenges
Dr Dogan Fidan Health Technology Analyst
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Points of Contact

• For process enquiries
• Project Manager
• For technical enquiries
• Technical Lead
• For policy enquiries
• Executive Lead or Appraisal Programme Director
• Publication and publicity
• Communications Lead
• All other enquiries
• Project Manager

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Format of Submissions

• Stick to the required length
• balance the contents
• dont shift towards appendices
• Clear and concise Executive Summary
• lt3 sides of A4
• Additional technical notes are useful
• especially for economic models
• Avoid coloured figures / pictures

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Effectiveness Data

• Appropriate comparators
• Should be current practice
• Unlicensed comparators should be avoided
• Appropriate patient groups
• Definition of the eligible group
• Subgroup analysis

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Effectiveness Data

• NICEs advice needs to be based on the best
  available evidence of clinical effectiveness
• randomised clinical trials
• non-randomised clinical trials
• observational studies
• uncontrolled/controlled observational studies

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Effectiveness Challenges

• Alternatives to RCTs
• Validating surrogate markers
• Improving Quality of Life assessments
• Limits to observational studies

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Cost-effectiveness tips

• Fit-for-purpose modelling
• A complex model is not always the best model
• Transparency
• All assumptions data sources should be clear
• A working copy of the model should be provided
• Modelling software
• Use standard packages

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Cost-effectiveness Challenges

• Methodological difficulties with economic reviews
• Quality assessment of economic evaluations
• Handling uncertainty

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Other Challenges

• Timing of the appraisal
• Unpublished evidence
• Confidentiality vs. transparency
• plus.

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Any Questions?