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Siege is a state of mind
Anne-Toni RodgersCorporate Affairs Director
National Institute for Clinical Excellence (NICE)
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Internationally .

• Aging populations
• Changes to the patterns of disease treatments
  available
• Increasing public demands expectations
  (consumerisation)
• Burgeoning knowledge base
• Tensions between
• equity and choice
• efficiency and quality
• demand and resource

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Quality Framework
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Work programmes

• Technology Appraisals
• (60 published, 41 in progress)
• Clinical Guidelines
• (11 published, 50 in progress)
• Interventional Procedures
• (in progress 100 inherited, so far 10 new
  topics/month)
• Cancer Service Guidance
• Confidential Enquiries
• Borderline substances
• Screening

02 May 2003
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Topic Selection

• Potential to improve health
• Link with Government priorities
• Help reduce variations in clinical practice.
• Impact on NHS resources
• Will NICE guidance add value
• Link between NICE work programmes

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NICE Guidance (NICE position)

• Guidance represents the view of the Institute,
  which was arrived at after a careful
  consideration of the available evidence.
• Health professionals are expected to take it
  fully into account when exercising their clinical
  judgement, it does not however override their
  individual responsibility to make appropriate
  decisions in the circumstances of the individual
  patient, in consultation with the patient and/or
  guardian or carer.

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NHS responsibility

• Consideration of all NICE guidance be clear of
  action vs clinical governance
• Department of Health directions to NHS for
  technology appraisals
• Funding should be available with in 3 months -
  unless advised otherwise
• Specific implementation and research policies

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Technology Appraisals

• Pharmaceuticals

• Devices
• Diagnostics
• Procedures
• Health promotion

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Regulators vs. NICE

• Regulators
• Safety
• Efficacy

• Reimbursement

• NICE
• Effectiveness
• Efficiency
• Transparency

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Developing NICE guidance

• Independent advisory committees
• Involve all stakeholders (Patients/ carers,
  health care professionals, and manufacturers)
• Expert contributions
• Inclusive evidence base
• Multiple perspectives

• Transparent processes decision making
• Genuine and public consultation
• Regular review
• Effective dissemination

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Evidence for NICE
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What matters to NICE?
Need
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636 million
Review of completed technology appraisals
(02.05.03)
Includes reviews (figures in brackets no. of
individual topics)
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Total Dementia Drugs Primary Care
Guidance Issued
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Appraisal Process
Guidance Issued direct to NHS, patients public
Published on NICE web site
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Manufacturer Involvement

• Processes methodology
• Topic Identification (DH, Welsh Assembly)
• Members of Independent Advisory Committee
• Developing scopes

• Consultation
• Submitting evidence
• Appeals
• Communication / Dissemination
• Reviewing the guidance

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Frame of Reference for Independent Advisory
Committee

• broad clinical priorities for the NHS
• degree of clinical need of patients with the
  condition
• broad balance of benefits and costs
• guidance on resources likely to be available
• effective use of available resources
• encouraging innovation

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Efficacy vs. Effectiveness

• Effectiveness
• pragmatic trials
• few exclusions
• comparator current (best UK) practice
• outcomes patient-focused, down-stream resources
• the real life effect

• Efficacy
• explanatory trials
• highly selected populations
• comparator usually placebo
• outcomes clinical, morbidity, mortality, adverse
  effects
• what it says on the packet

Licensing
GAP
Appraisal
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Effectiveness Challenge (1)

• RCTs dont usually represent real word
• Most RCTs vary one parameter over a short time
  horizon
• in technology appraisals we require several
  parameters to vary over a long time horizon
• estimates of overall effectiveness may have to be
  drawn from different trials
• models are required when parameter estimates are
  not available
• Seek patient translations of outcome data /
  surrogate endpoints

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Effectiveness Challenge (2)

• Understand the differences between efficacy and
  effectiveness
• Decrease the time lag between efficacy and
  effectiveness studies
• Enhance the similarities to ease transition
  between the two
• Close the efficacy effectiveness gap

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Closing the Gap Practicalities

• Design pragmatic trials
• Measure patient-centred end points
• Follow up all people in the study
• Collect resource data
• Plan for country specific analysis in multicentre
  studies
• Make all data available

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Information evidence

• recommend that the Government should take steps
  to ensure the submission of all relevant clinical
  information to NICE (condition of ABPI
  membership or legislation)
• Health Select Committee 2002

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Information evidence

• recommend that NICE should consider options for
  improving its evidence base in respect of patient
  experience and quality of life.
• Include possibility of working with governments,
  at national and EU level, and the pharmaceutical
  industry to promote the routine inclusion of
  condition-specific quality of life measures into
  controlled clinical trials carried out prior to
  licensing by the pharmaceutical industry.
• Health Select Committee 2002

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Getting real with modelling
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So What Can We Do?

• We use decision modelling
• The modeller uses assumptions to estimate event
  probabilities and extend the analysis into
  unknown territory

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Cost () per QALY
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Clinical cost effectiveness

• recommend that NICE consider wider societal
  costs advantages of particular treatments
• In particular wider costs benefits to the
  public purse of reduced benefit dependency
  improved ability to work for patients and their
  carers.
• in tandem, NICE should work to strengthen cost
  effectiveness evidence base by encouraging
  pharmaceutical companies to collect this type of
  data routinely
• Health Select Committee 2002

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Playing Politics..

• Industry solution NICE should not review a
  product until its been on the market for at least
  2 years
• Helps NICE with its decision making prevents
  NICE blight

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XXX Drugs Monthly Sales
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Data from York University 2002
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Timing

• recommend that for all new technologies, NICEs
  work programme is arranged to facilitate
  publication of guidance at the time of launch
• Health Select Committee 2002

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Siege is a state of mind.
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Being frank
Siege mentality ..puts you under Siege
Lord of the Rings
See it from our point of view
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Being frank

• What challenges us.
• Demand vs resource
• Effectiveness vs efficiency
• Assessment vs appraisal
• International stage local decision making
• Independence not negotiable
• Transparency
• What is demanded of us we demand from our
  stakeholders

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Siege is a state of mind..

• See it from our point of view yourself
• If thats how it looks thats how it is
• Envisage the future and plan for it

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The future..

• Organisations like NICE are here to stay - Start
  closing the gap now
• Design pragmatic trials
• Measure patient-centred end points
• Follow up all people in the study
• Collect resource data
• Plan for country specific analysis in multicentre
  studies
• Make data available

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• See it from our point of view yourself!
• If thats how it looks thats how it is
• Envisage the future and plan for it NOW
• Glass is used in windows for a reason
  (www.nice.org.uk)
• Enjoy evolving real partnerships bring
  respect and results

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