NICE, medtech and evidence

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• NICE, medtech and evidence
• Mrs Mirella Marlow MA MBA
• Programme Director
• MediWales
• 11 December 2012

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Contents

• General information about NICE
• What do medtech products need to prove?
• How NICE works with medtech companies
• clarifying value propositions
• supporting development of evidence
• enhancing Health Technology Assessment (HTA)
  skills

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About NICE

• National Institute for Health and Clinical
  Excellence
• Established in 1999 to reduce variation in the
  availability and quality of NHS treatments and
  care
• Guidance and evidence to support the health
  service and local authorities
• Independent of government
• New responsibilities from April 2013 social
  care

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BRAND MAP HERE
2012 NICE products services
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How can innovative medtech products help? (1)
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How can innovative medtech products help? (2)
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NICE works with companies

• Pre-evaluation
• Engagement team works with companies incl. SMEs
• Changing the view of the value proposition
• Encouraging development of evidence
• Exploring pipeline, focusing on clinical utility

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How does NICE identify medical technologies for
evaluation?
Tech Appraisals guidance (TAP)
Medical technology guidance (MTEP)
Diagnostics guidance (DAP)
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NICE value proposition options
Clinical performance Better Better Non-inferior
Cost Higher Higher Less overall
Evaluation method Cost effectiveness (QALY) Cost effectiveness (QALY) Costs consequences (QIPP)
NICE guidance programme Technology Appraisals Programme (TAP) Diagnostics Assessment Programme (DAP) Medical Technologies Evaluation Programme (MTEP)
Technologies Devices Diagnostics Devices Diagnostics
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Medical technologies guidancerelevant evidence

• Sponsor submission
• Published and in-press trials
• Unpublished data
• Regulatory data
• Post-market register data, audits and
  real-life experience
• Forthcoming trial results
• Planned trials in a reasonable timeframe
• Cost model
• Expert advice clinical/patient

Must support sponsors claim
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NICEs assessment of value

• Standard clinical evidence and health economic
  techniques
• Clinical evidence systematic reviewing and
  meta-analysis, linked evidence approaches etc
• Health economics modelling, sensitivity
  analysis etc
• World class academic assessment groups and
  external assessment centres
• Regular review of technical methods with
  stakeholders
• Further development of technical methods (e.g.
  MRC funded activities)

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NICE medtech recommendations
Evidence shows sufficient certainty of benefit Product has potential to provide substantial benefits, but uncertainty about whether these are realisable in normal clinical settings Significant uncertainty, or certainty of no benefit
Case supported Adoption optimised OR Research recommended Case not supported
Use (with standard NICE implementation or deeper adoption support - NTAC) Use in subgroup OR NICE/EAC supports development of evidence Not for current use
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Collaborating for better evidence

• Pre-evaluation
• Advise companies to work with NOCRI on pipeline
  products
• Post-evaluation
• Access to research facilitation for products with
  a research-only recommendation

Pragmatic randomised controlled trial of MIST
ultrasound therapy compared to UK standard care
for the treatment of non-healing venous leg
ulcers
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Scientific advice seminars - medtech

• For developers and investors
• What is meant by value from the perspective of
  NICE?
• Know how your value proposition links to the need
  for specific evidence
• What is meant by cost effectiveness?
• Types of evidence considered by NICE
• General principles of health technology
  assessment (HTA)

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Further information

• NICE website www.nice.org.uk
• Contact the NICE medtech team
  medtech_at_nice.org.uk
• Apply to attend a NICE medtech seminar
  adviceseminars_at_nice.org.uk