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NICE Technology Appraisals

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Title: NICE Technology Appraisals


1
NICE Technology Appraisals
Meet the engine room
  • The NICE Appraisals Team

2
Meet the team
  • Introduction to the team
  • The appraisal process
  • Whats new in the process
  • Hints, tips and challenges

3
Things should be made as simple as possible but
not simpler!
Albert Einstein
4
The drug itself has no side effects but the
number of health economists needed to prove its
value may cause dizziness and nausea
5
Technology Appraisals The process
Ruth Frankish Information Specialist
6
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

7
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

8
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

9
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

10
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

11
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

12
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

13
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

14
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

15
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

16
Technology AppraisalsWhats New?
Kathleen Dalby Nina Pinwill Technology
Appraisal Project Managers
17
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

18
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
19
Whats New?
  • Defining features
  • Consultation
  • Transparency
  • Time

20
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

21
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

22
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

23
Any questions?
24
Technology AppraisalsHints,Tips and Challenges
Dr Dogan Fidan Health Technology Analyst
25
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

26
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

27
Effectiveness Data
  • Appropriate comparators
  • Should be current practice
  • Unlicensed comparators should be avoided
  • Appropriate patient groups
  • Definition of the eligible group
  • Subgroup analysis

28
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

29
Effectiveness Challenges
  • Alternatives to RCTs
  • Validating surrogate markers
  • Improving Quality of Life assessments
  • Limits to observational studies

30
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

31
Cost-effectiveness Challenges
  • Methodological difficulties with economic reviews
  • Quality assessment of economic evaluations
  • Handling uncertainty

32
Other Challenges
  • Timing of the appraisal
  • Unpublished evidence
  • Confidentiality vs. transparency
  • plus.

33
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