NICE: evaluating innovative devices and diagnostics

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NICE evaluating innovative devices and
diagnostics

• Mirella Marlow
• Associate Director
• National Institute for Health and Clinical
  Excellence
• World Leaders in Medical Innovations, 30th April
  2009

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NICEs current role devices

• Technology Appraisals Guidance, eg
• Drug eluting stents
• ICDs
• Interventional Procedures Guidance, eg
• Direct skeletal fixation of limb or digit
  prostheses using intraosseous transcutaneous
  implants
• Transcatheter aortic valve implantation for
  aortic stenosis
• Suburethral synthetic sling insertion for SUI in
  men
• Clinical Guidelines as technologies are
  established and appear in the pathway of care

3
NICEs current role diagnostics

• Technology Appraisals Guidance, eg
• Liquid-based cytology
• Myocardial perfusion scintigraphy
• Interventional Procedures Guidance, eg
• Catheterless oesophageal pH monitoring
• Lumbar infusion test for the investigation of
  normal pressure hydrocephalus
• Falloposcopy with coaxial catheter
• Clinical Guidelines, eg
• Preoperative tests
• Intrapartum care (includes fetal monitoring)

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Pros and cons
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Kennedy study of valuing innovation

• Commissioned by NICE, January 2009
• How to ensure innovation is properly taken into
  account when establishing value?
• Should some forms of value be considered more
  important than others?
• How should innovation in health technologies be
  defined?
• What is the relationship between innovation and
  value?
• Format evidence review, submissions and
  workshops

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The Challenge

• For new clinical technologies, we will simplify
  the way in which they pass from development into
  wider use by creating a single evaluation
  pathway, and will develop ways to benchmark and
  monitor their successful uptake
• Lord Darzi

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Vision need

• NHS organisations good decisions using product
  data and local clinical expertise, but
• For some new products, with particular
  features, a national evaluation will help the NHS
  recognise and take advantage of therapeutic gain
  and/or improvements in the efficient use of
  resources more quickly

8
Vision objective

• To enable the NHS to deliver better care with
  greater efficiency
• To create a partnership with the medtech industry
  that is effective, evidence-based and
  value-driven

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Vision solution

• Common evaluation pathway (devices and
  diagnostics)
• Developers and horizon scanners put forward
  products with required characteristics, to one
  point of contact
• Products routed to one of several evaluation
  processes
• Allows different forms of evidence to be
  accommodated with appropriate outputs
• Accompanying implementation signal reflects state
  of evidence (DH)
• Pathway outputs and evidence base on NHS Evidence

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Pathway elements
Selection and routing
Identification
Further research
Evaluation
Dissemination
Implementation signal
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Pathway access possible criteria

• CE Marking for the specified indication
• No equivalent product available in the UK
• Offers measurable additional therapeutic benefit
• Offers a measurable improvement in the efficient
  application of resources
• Supported by an evidence base or value
  proposition of a nature and extent that will
  allow a credible evaluation

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Pathway candidate technologies

• Innovative devices and diagnostics
• with demonstrable therapeutic gain
• and/or the ability to drive significant
  efficiencies
• but not
• devices and diagnostics requiring price-based
  procurement decisions
• me-too products in established markets
• pharmaceuticals alone

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Pathway
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Outputs, evidence types and implementation
signals

• Pathway project will map
• Outputs required by NHS
• Evidence types and levels required by evaluating
  bodies
• Implementation signals DH

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Device and diagnostic evaluation routes and
outputs
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Device and diagnostic evaluation routes and
outputs
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Device and diagnostic evaluation routes and
outputs
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Device and diagnostic evaluation routes and
outputs
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Device and diagnostic evaluation routes and
outputs
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Device and diagnostic evaluation routes and
outputs
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Summary

• Intended to work for patients, the NHS and
  industry
• Industry-driven topic selection, but with the
  opportunity for notifications by others
• Evaluation methods created to meet the need for
  advice, rather than being driven exclusively by
  the availability of evidence (new methods and
  processes required)
• An incentive for innovators to develop good
  quality evidence
• Clear product differentiation
• Implementation signals appropriate to the level
  of evidence

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NHS Evidence new today!
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NHS Evidence

• http//www.evidence.nhs.uk/