43095 ABPI Brief NICE guide by AndyMcNally

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									                       Media briefing
                                Information about the pharmaceutical industry
                                   supplied by the Association of the British
                                           Pharmaceutical Industry


A guide to how NICE works
HOW DOES THE NICE APPRAISAL PROCESS WORK?
              STAGE 1                               STAGE 2                                STAGE 3
       NICE is instructed by DoH               NICE sets timetable and                 Start of appraisal.
        and/or Welsh Assembly                 commissions Assessment                Companies, healthcare
                                         L




                                                                              L
         Government on what                      Report and asks for                 professionals, patient
         medicines/treatments/                evidence to be submitted.             groups, other interested
         therapies to assess.                                                       parties submit evidence.




                STAGE 6                              STAGE 5                              STAGE 4
      Final Appraisal Determination             ACD is released for                NICE’s Evaluation Report is
          (FAD) is considered by                  consultation to all              considered by its Appraisal
                                  L




                                                                          L




                                                                                                               L
      Appraisal Committee, released            interested parties and              Committee. From this, the
         to interested parties and            posted on NICE website                 Appraisal Consultation
        posted on website, having                 with deadline for                  Determination (ACD) is
       taken account of comments.                    comments.                             produced.



              STAGE 7                                STAGE 8                             STAGE 9
              EITHER                                  EITHER                              EITHER
            FAD accepted.                     Original decision upheld.               Decision accepted.
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                                         L




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            Guidance                               Guidance                              Guidance
            published.                             published.                            published.


              STAGE 7                                 STAGE 8                             STAGE 9
                   OR                                     OR                                  OR
      Appeal made by one/more                 Appeal upheld. Appraisal               Further appeal made.
                                                                              L
                                         L
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      interested parties within 10           Committee then reconsiders
          days (in confidence).              original decision and issues
      Appeal Board hears appeal                 new FAD. If new ACD
          and makes decision.                produced, back to Stage 5.


                                                    STAGE 10
                                      Appeal hearing considers nature of appeal.
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                                             Guidance published.

NICE appraisals should take about a year to complete from start to finish, but
may in practice take longer.
WHAT IS SELECTED FOR APPRAISAL                                         USEFUL
BY NICE?                                                               CONTACTS
Technologies are selected for appraisal by NICE by the Department
of Health and the Welsh Assembly Government based on one or              ABPI Press
more criteria:                                                           Office:
     Does it relate to a Government health priority area?                Richard Ley,
     Would it address a condition associated with significant            020 7747 1410
     disability, morbidity or mortality?                                 fax,
     Would it have the potential significantly to improve patients’      020 7747 1414
     or carers’ quality of life, or reduce avoidable morbidity or        e-mail,
     premature mortality?                                                rley@abpi.org.uk
     Would it have a significant impact on NHS or other societal
     resources or, if used more selectively, enable resources to be      ABPI Scotland:
     freed up for use elsewhere in the NHS?                              Yvonne White,
     Will NICE be able to add value by issuing guidance?                 0131 247 3689
NOTE: NICE does not operate in Scotland. The Scottish                    fax,
equivalent body, the Scottish Medicines Consortium (SMC) and             0131 225 4865
the Health Technology Board for Scotland (HTBS), operate in              e-mail,
different ways.                                                          ywhite@abpi.org.uk

  WHAT IS NICE’s APPRAISAL
  COMMITTEE?
  Submissions from manufacturers and others, and NICE’s
  evaluation of them, are considered by an Appraisal Committee
  (see Stage 4 in diagram). This advisory committee is
  composed of independent experts, including healthcare
  professionals, health service managers, health economists
  and patient-focused representatives. Other experts will be
  appointed on an ad hoc basis.


           WHO IS ON NICE’s APPEAL
           BOARD?
           If an appeal is made, the chairman of NICE nominates an
           appeal panel comprising:
                3 non-executive Board members of NICE
                2 independent members taken from a list, drawn up
                                                                                              June 2003




                by the NICE Board in consultation with its Partners’
                Council, and comprising individuals with knowledge
                and experience of the relevant industry and of
                patient/consumer affairs.
           Appeals will normally be heard within 28 days of the        Produced by
           request.
                                                                                              ref.MedBrief014A




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