NICE: role and value ‘ Selling sickness’ conference Meindert Boysen Programme Director
<ul><li>The National Institute for Health and Clinical Excellence (NICE) is the independent organisation responsible for p...
“ Probably not, but it’s worth a bloody good try.”  Frank Dobson, Health Secretary, who established NICE in 1999, when ask...
Nasty truth about NICE: It's the body that rations NHS drugs. But this leading cancer specialist says its decisions are de...
A short history of NICE QOF Public health Interventional Procedures Clinical guidelines Quality standards NHS Evidence acc...
This is what we do NICE and NHS Evidence Evidence – guidance – shared learning
This is how we add value Independence, objectivity and transparency.
Over 700,000 visitors a month
HTA in the UK
HTA in Europe
Interface regulation & payers
What is NICE guidance? <ul><li>We produce guidance in three areas of health: </li></ul><ul><li>Public health  – guidance o...
Core principles of all NICE guidance <ul><li>Based on the best evidence available </li></ul><ul><li>Expert input </li></ul...
NICE decision process Appraisal Consultation Guidance Update  decision Evidence review
NICE advisory bodies
Appraisal Committees <ul><li>Members </li></ul><ul><li>Statisticians </li></ul><ul><li>GPs </li></ul><ul><li>Lay members <...
Assessment and appraisal ASSESSMENT APPRAISAL REVIEW OF EVIDENCE UNPUBLISHED EVIDENCE? PUBLISHED EVIDENCE HEALTHCARE PROFE...
Multiple / Single Technology Appraisals <ul><li>Evidence base by academic group / manufacturer </li></ul><ul><li>Review by...
Methods - Reference Case
Fixed Budget & Opportunity Cost
The  Q uality  A djusted  L ife  Y ear Health-related quality of life Length of life (years) 0 1 QALYs gained Current trea...
Establishing value: cost effectiveness  Probability of rejection Cost per QALY (£’000) 10 20 30 40 50 0 1 x x Rituximab fo...
Why appraise cost effectiveness?
NICE technology appraisals 83% of our recommendations are positive Decision Recommendations Yes 245 (67%) Optimised 61 (16...
NICE cancer technology appraisals 74% of our recommendations are positive Decision Recommendations Yes 64 (71%) Optimised ...
 
Uptake of Varenicline
Anakinra for rheumatoid arthritis
‘ How to’ implement guidance
The NICE Field Team <ul><li>Seven consultants based in the field - the ‘local face’ of NICE </li></ul><ul><li>Providing pe...
<ul><li>There have been concerns that NICE is subject to inappropriate influence… </li></ul>
The Triumph of NICE “ NICE may prove to be one of Britain’s greatest cultural assets along with Shakespeare, Newtonian phy...
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Meindert Boysen Selling Sickness 2010

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  • What is NICE ? The National Institute for Health and Clinical Excellence (NICE) is the independent organisation responsible for providing national guidance on the promotion of good health and the prevention and treatment of ill health. NICE is an arms length body that supports the running of the NHS. It is funded by the Department of Health but its guidance is developed independently of the Department.
  • NICE, together with NHS Evidence: Provides the best clinical and non-clinical evidence and best practice. Can help the NHS and other organisations to ensure not only that the money they spend improves health for their communities but also, just as importantly, that they do not spend money on ineffective care. Sets the standards for high quality healthcare. Provides ‘evidence at your fingertips’ on the NICE website and through the NHS Evidence search site. Provides implementation tools to help you use NICE guidance on our website.
  • NICE can improve the quality and productivity of clinical practice, public health and social care. Our guidance promotes better outcomes for patients and effective use of NHS resources. It can provide new knowledge for NHS professionals and patients, and it can help manufacturers access the NHS market.
  • What does NICE do? We produce guidance in three areas of health: Public health – guidance on the promotion of good health and the prevention of ill health – for those working in the NHS, local authorities and the wider public and voluntary sector. Health technologies – guidance on the use of new and existing medicines, treatments, procedures and medical technologies and diagnostics, within the NHS. Clinical practice – guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS. NB. You may want to mention here that our work programmes have expanded to include new areas in addition to producing guidance (to be covered later in your presentation). Where does NICE guidance apply? NICE produces guidance on health technologies and on clinical practice for the NHS in England, Wales and Northern Ireland. Our guidance on interventional procedures, which states whether interventional procedures are safe and work well enough for use in the NHS, covers England, Wales, Scotland and Northern Ireland. NICE guidance on public health covers England only. Other guidance for the NHS in Scotland is developed by NHS Quality Improvement Scotland (technology appraisals) and the Scottish Intercollegiate Guidelines Network (SIGN). The Department of Health, Social Services and Public Safety (DHSSPS) provide advice on implementation of NICE guidance in NI. For technology appraisals – there is a Department of Health direction to NHS to make funding available within 3 months unless advised otherwise For clinical guidelines – NHS has to take into account any DH directions to NHS (for example, when NICE published its guidance on fertility, the Secretary State issued a statement to say that the NHS should provide one cycle of IVF within a year and work towards implementing the full three cycles recommended by NICE in due course. Local government and NHS organisations are expected to take account of NICE public health guidance in taking action to achieve the targets set out in the 2004 White Paper ‘Choosing Health’ and the development of local area agreements Note – if you’re asked about the status of our guidance (ie is it mandatory?) you could answer with the following: Health professionals expected to take NICE guidance into account when deciding what treatments to give people. However, NICE guidance does not replace their knowledge and skills; it is still up to health professionals to make decisions about a particular patient in consultation with the patient and/or their guardian or carer when appropriate.
  • 1 Centre Director 1 Programme Director 5 Associate Directors Project management and Committee liaison 1 Programme Manager 7 Project Managers &amp; 2 assistant PMs 6 Administrators 1 Centre coordinator Technical Staff 20+ health technology analysts/ technical leads 8 technical advisors 4 Appraisal Committees 2 in London (A, B) and 2 in Manchester (C, D) 3 ‘new’ Chairs
  • Purpose of reference case – in past great variability across submissions. There ref case allows greater consistency but retains some flexibility. Note: evidence for an appraisal comes from the following groups: Independent academic HTA group Manufacturers / sponsors Patient / carer groups Professional groups Clinical specialists and patient experts The Reference Case specifies the methods considered to be the most appropriate for the Appraisal Committee’s purpose Submissions should include an analysis of results generated using reference case methods Additional analyses in which the aspects of methods differ from the Reference Case are not precluded but these should not replace the Reference Case
  • There have been 377 recommendations within 190 appraisals published since the beginning of 2000. 6 recommendations were withdrawn because: *the regulator revoked the marketing authorisation due to safety concerns (3 occasions) *the product was no longer produced by the manufacturer (one occasion) * a nationally funded program for a technology rendered the guidance obsolete (on 2 occasions)
  • One of the key objectives within the NICE Implementation Strategy is to provide practical generic implementation tools to support the implementation of NICE guidance into practice. One of the ways we aim to achieve this objective is to develop a series of ‘how to’ guides to aid implementing NICE guidance at a local level. The guide How to put NICE guidance into practice provides an implementation model to help NHS organisations comply with the Department of Health’s ‘Standards for better health’ and meet the expectations of the Healthcare Commission. In 2007 we launched the guide How to change practice: understand, identify and overcome the barriers to change which aims to improve patient care by providing practical advice on how to encourage healthcare professionals and managers to change practice in line with the latest guidance. Last year we have developed a “How to” guide to implementation that aims to support Local Authorities with the implementation of NICE guidance. This guide is for chief executives, their senior officers and others within local authorities who lead on different aspects of health and wellbeing.
  • Transcript of "Meindert Boysen Selling Sickness 2010"

    1. 1. NICE: role and value ‘ Selling sickness’ conference Meindert Boysen Programme Director
    2. 2. <ul><li>The National Institute for Health and Clinical Excellence (NICE) is the independent organisation responsible for providing national guidance on the promotion of good health and the prevention and treatment of ill health. </li></ul>What is NICE?
    3. 3. “ Probably not, but it’s worth a bloody good try.” Frank Dobson, Health Secretary, who established NICE in 1999, when asked whether he thought it would work.
    4. 4. Nasty truth about NICE: It's the body that rations NHS drugs. But this leading cancer specialist says its decisions are deeply flawed
    5. 5. A short history of NICE QOF Public health Interventional Procedures Clinical guidelines Quality standards NHS Evidence accreditation decisions Medical devices Diagnostics Publications
    6. 6. This is what we do NICE and NHS Evidence Evidence – guidance – shared learning
    7. 7. This is how we add value Independence, objectivity and transparency.
    8. 8. Over 700,000 visitors a month
    9. 9. HTA in the UK
    10. 10. HTA in Europe
    11. 11. Interface regulation & payers
    12. 12. What is NICE guidance? <ul><li>We produce guidance in three areas of health: </li></ul><ul><li>Public health – guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector. </li></ul><ul><li>Health technologies – guidance on the use of new and existing medicines, treatments, procedures and medical technologies and diagnostics within the NHS. </li></ul><ul><li>Clinical practice – guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS. </li></ul>
    13. 13. Core principles of all NICE guidance <ul><li>Based on the best evidence available </li></ul><ul><li>Expert input </li></ul><ul><li>Patient and carer involvement </li></ul><ul><li>Independent advisory committees </li></ul><ul><li>Genuine consultation </li></ul><ul><li>Regular review </li></ul><ul><li>Open and transparent process </li></ul>
    14. 14. NICE decision process Appraisal Consultation Guidance Update decision Evidence review
    15. 15. NICE advisory bodies
    16. 16. Appraisal Committees <ul><li>Members </li></ul><ul><li>Statisticians </li></ul><ul><li>GPs </li></ul><ul><li>Lay members </li></ul><ul><li>Public health physicians </li></ul><ul><li>Health economists </li></ul><ul><li>Clinical pharmacists </li></ul><ul><li>Nurses </li></ul><ul><li>Surgeons </li></ul><ul><li>Consultant physicians </li></ul><ul><li>NHS management </li></ul><ul><li>Clinical pharmacologists </li></ul><ul><li>Psychiatrist </li></ul><ul><li>PAM </li></ul><ul><li>Paediatrician </li></ul><ul><li>People from the pharmaceutical and medical devices industry </li></ul>2 in London 2 in Manchester
    17. 17. Assessment and appraisal ASSESSMENT APPRAISAL REVIEW OF EVIDENCE UNPUBLISHED EVIDENCE? PUBLISHED EVIDENCE HEALTHCARE PROFESSIONAL GROUPS CLINICAL EXPERTS HEALTH SERVICE PATIENT GROUPS POLICY MAKING
    18. 18. Multiple / Single Technology Appraisals <ul><li>Evidence base by academic group / manufacturer </li></ul><ul><li>Review by academic group </li></ul><ul><li>Clarification </li></ul><ul><li>Consultation on evidence base and decision </li></ul><ul><li>Committee meeting in public with representation from stakeholders </li></ul><ul><li>Appeal </li></ul>
    19. 19. Methods - Reference Case
    20. 20. Fixed Budget & Opportunity Cost
    21. 21. The Q uality A djusted L ife Y ear Health-related quality of life Length of life (years) 0 1 QALYs gained Current treatment New treatment Initial QALY loss due to side effects
    22. 22. Establishing value: cost effectiveness Probability of rejection Cost per QALY (£’000) 10 20 30 40 50 0 1 x x Rituximab for follicular lymphoma Imatinib for chronic myeloid leukaemia (blast phase) x Trastuzumab for early stage HER-2 positive breast cancer
    23. 23. Why appraise cost effectiveness?
    24. 24. NICE technology appraisals 83% of our recommendations are positive Decision Recommendations Yes 245 (67%) Optimised 61 (16%) Only in research 22 (6%) No 40 (11%) Breakdown of all decisions contained in Technology Appraisals 1–190 (January 2000 to June 2010 ) Note: 6 withdrawn recommendations and 5 non-submissions are not included
    25. 25. NICE cancer technology appraisals 74% of our recommendations are positive Decision Recommendations Yes 64 (71%) Optimised 3 (3%) Only in research 6 (6%) No 18 (20%) Breakdown of 95 decisions contained in cancer Technology Appraisals published between January 2000 to June 2010 Note: 5 non-submissions are not included
    26. 27. Uptake of Varenicline
    27. 28. Anakinra for rheumatoid arthritis
    28. 29. ‘ How to’ implement guidance
    29. 30. The NICE Field Team <ul><li>Seven consultants based in the field - the ‘local face’ of NICE </li></ul><ul><li>Providing people implementing NICE guidance with updates, advice and support for your local strategies for implementation </li></ul>Gill Mathews Annie Coppel Chris Connell Stephen Judge Steve Sparks Deborah Bent Jane Moore
    30. 31. <ul><li>There have been concerns that NICE is subject to inappropriate influence… </li></ul>
    31. 32. The Triumph of NICE “ NICE may prove to be one of Britain’s greatest cultural assets along with Shakespeare, Newtonian physics, The Beatles, Harry Potter and the Teletubbies” Richard Smith, Editor. British Medical Journal 2004

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