The NICE Diagnostics Assessment
Programme
UK Genetic Testing Network Conference:
Transformation – Changes to Improve Patient Care
November 2012, London
Nick Crabb
Associate Director, Diagnostics Assessment Programme, NICE
Overview
• Introduction to NICE
• Medical technologies programmes
– Medical Technologies Evaluation Programme
(MTEP)
– Diagnostics Assessment Programme (DAP)
• Guidance recommendations
• Evidence considerations
• Companion diagnostics
• Support for implementation
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.
It was established in 1999 as a Special Health Authority
and in 2005 it was expanded to include the functions of
Health Development Agency.
In 2013 NICE will be re-established as a non
departmental public body and will expand to incorporate
social care.
Medical technologies programmes
• Programmes established in 2010 driven by notification
of technologies by manufacturers / sponsors
• Two new programmes representing major increase in
capacity for medtech evaluation
• Programmes aim to improve the timeliness and
consistency of adoption of technologies with the
potential to:
– Improve patient outcomes
– Reduce costs
– Provide system benefits (e.g. facilitate service
redesign)
The two programmes
• Medical Technologies Evaluation Programme (MTEP) and
the Medical Technologies Advisory Committee (MTAC)
– Undertakes topic selection and routing for all medtech
products, including diagnostics
– Produces guidance on topics routed to itself
– Supported by an infrastructure of independent external
assessment centres
Note: Some diagnostic technologies are assessed within MTEP
• Diagnostics Assessment Programme (DAP) and the
Diagnostics Advisory Committee (DAC)
– Specialist programme for complex assessments of diagnostic
technologies
– Appropriate topics routed to DAP by MTAC
– Supported by an infrastructure of independent external
assessment groups
Assessment of diagnostic technologies
within the MTEP
• Programme methodology includes the evaluation of clinical
effectiveness and cost consequences – but not cost effectiveness
(no evaluation of patient outcome benefits)
• 38 week process from topic selection to guidance publication
• Assessments limited to the specific technology notified to the
programme by the sponsor
• Evidence submission by the sponsor, including economic model to
support the case for adoption
• Applicable to diagnostics technologies offering both:
– Equivalent or superior clinical performance compared to current
practice
– Potential for cost savings or no net increase to NHS costs
• Dependence on the evidence submission means that sponsors will
normally need to be commercial sponsors (manufacturers or
distributors)
Diagnostics Assessment Programme (DAP)
• Specialist programme to undertake complex assessments of
diagnostic technologies
• Diagnostics advisory committee structure includes standing members
and specialist members to ensure deep expertise on each topic
• Assessments include cost effectiveness analysis (requires the
evaluation of outcome benefits – QALYs)
• Assessments may involve single or multiple related diagnostic
technologies (scope may be expanded beyond the notified technology
that was selected and routed by MTAC)
• 62 week process from topic selection to guidance publication
• Manufacturers encouraged to provide relevant information through a
structured evidence request but no formal submission is required
• Modelling to estimate outcome benefits and cost effectiveness is
undertaken as part of the assessment
• Sponsors may be commercial sponsors or senior members of the
clinical community
Characteristics of topics for the DAP
• Cost effectiveness analysis needed to provide a
meaningful assessment
– Expensive new technology with the potential to
significantly improve patient outcomes
• Care pathway(s) not well understood requiring access
to highly specialist clinical expertise
• Significant advantages of assessing multiple
technologies
Guidance recommendations
• The NICE guidance from the DAP or MTEP may
include:
– Adoption recommendations
– Research recommendations
• Research recommendations expected to be important
for DAP and MTEP
• The programmes include capacity for research
commissioning to:
– Clearly capture the key research questions resulting
from evidence gaps
– Facilitate the efficient generation of research data
Evidence considerations - DAP
• DAP methodology includes cost effectiveness analysis
• Patient outcome benefits – length and quality of life, are estimated
(in comparison to current standard clinical care – the comparator)
– Measured in quality adjusted life years (QALY)
• Costs throughout the care pathway are also determined in
comparison to costs for the comparator
• Cost effectiveness calculated – cost (£) per QALY
• This requires evidence throughout the care pathway
Diagnostic
accuracy
Impact on
treatment
decisions
Impact on
outcomes
Generating the patient outcome estimates
• End to end clinical studies that follow patients from diagnosis
through care to outcomes
– Typically not available for diagnostics
– In some cases may be the only way to demonstrate the value
of a diagnostic
• Linked evidence modelling
– In some cases there may be existing evidence for parts of the
care pathway that can be used to develop models for
estimating outcome benefits and cost effectiveness
– In some cases it may also be possible to use existing models
(directly or with modification)
– It may be possible to link to the existing evidence from
diagnostic accuracy data (robust diagnostic accuracy data
is probably the minimum evidence needed)
Companion diagnostics (CDx)
• CDx are used to identify sub-populations of patients where
treatment is likely to be more effective
• Increasingly, licensed indications for pharmaceuticals require the
use of CDx
• The health technology assessment (HTA) of CDx may be simpler
than for diagnostics generally
–
–
Health outcomes from treatment informed by the CDx are available
from the clinical trials of the treatment
Less dependence on modelling approaches to estimate the patient
outcome benefits
• European regulation of CDx does not require that the diagnostic
used in clinical trials be used in clinical practice
• There may be several proprietary or “in-house” tests that could be
considered as consistent with the licensed indications even though
the diagnostic accuracy of the various options and potential impact
on the patient population for treatment may not be understood
CDx in NICE Technology Appraisals (TA)
• Pharmaceuticals, including those dependent on the use of CDx are
evaluated in the NICE TA programme
• Updated methods guide developed in 2012 (publication expected
Q4 2012/13) includes consideration of companion diagnostics:
–
–
–
–
–
Within a TA the CDx used in the pivotal clinical trials is likely to be
considered
Cost effectiveness determination accounts for the cost of the drug and
CDx (with the sensitivity analysis including a scenario where the CDx
costs are excluded)
The guidance may include commentary on the companion diagnostic
used in the pivotal trials
The guidance may include consideration of the potential impact of
using alternative tests
The appraisal is unlikely to evaluate alternative CDx options
CDx in the NICE DAP
• Diagnostic technologies for use as CDx products may be notified to
NICE by sponsors (manufacturers or senior members of the clinical
community)
• Where appropriate these may be selected for evaluation
• The DAP process allows for the various CDx options (e.g. other
proprietary and “in-house” tests) to be included in the assessment
• The assessment may include separate cost effectiveness
determinations for each pharmaceutical / CDx combination
• Current DAP CDx topics:
– Epidermal growth factor receptor tyrosine kinase (EGFR-TK)
mutation testing in adults with locally advanced or metastatic
non-small-cell lung cancer
– KRAS mutation testing in adults with metastatic colorectal
cancer
Support for implementation
• NICE implementation support activities
– NICE is committed to bespoke and innovative implementation
products to support medical technologies and diagnostics
guidance - so far, these have included audit criteria, podcasts,
webinars, technical/usability reports and costing tools
– Promotion of guidance through regional implementation
consultants
• NHS technology adoption centre (NTAC)
– Increased focus on technologies approved by NICE
• New activities from the NHS Innovation Health and
Wealth report including establishment of NICE
implementation collaborative
Further information
• Please visit
http://www.nice.org.uk/aboutnice/whatwedo/aboutdiagnosticsasses
sment/diagnosticsassessmentprogramme.jsp for:
– Further background to the DAP
– Published diagnostics guidance (6 topics completed to date)
and supporting documents
– Information on DAP assessments in development
– Programme manual detailing DAP processes and methodology