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Transcript of NICE Scientific advice & Diagnostics assessment programme September 23, 2014 How to generate...
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NICE Scientific advice &
Diagnostics assessment programme
September 23, 2014
How to generate evidence to support value claims for diagnostics
Dr Grace Jennings and Dr Sarah Byron
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What is NICE?
•prevent, diagnose and treat disease and ill health in most effective ways
•reduce inequalities and variation
•ensure quality and value for money for the NHS
An independent institute that identifies how to:
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Accountabilityfor
reasonableness
Accountabilityfor
reasonableness
NICE’s Procedural Principles
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A NICE Process
Decision Committee
Public Consultation
Decision
StakeholderPerspectives
Evidence submissions
Independent review
Input from topic experts
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DIFFICULT CHOICES FORDECISION MAKERS
HTA
Scarce resourcesScarce resources
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Product Market
Evidence-based way of guiding the efficient allocation of health care resources
Health Technology Assessment (HTA)
Evidence
Policy-making
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Benefits of engaging with NICE
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How NICE makes decisions
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Two key questions asked by NICE
• How well does the technology work compared to established practice in the National Health Service (NHS)?
• How much does this course of action cost compared to established practice in the NHS?
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Decision-making at NICE
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Value Proposition
Impact on health system
resources
Impact on health system
resources
Incremental benefit for patients
Incremental benefit for patients
Value varies depending on your perspective
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Perspective
NICE takes the perspective of the National Health Service (NHS) and
Personal Social Services (PSS)
Understand the perspective of your decision maker and know what question they want to answer
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Defining the clinical question: Components
• Population• Intervention• Comparator• Outcomes
PICO
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Population Usually the patients indicated in the marketing authorisation
Intervention Technology to be appraised
Comparators Established practice in the NHS
Outcomes Outcomes which have an impact on: - survival - health related quality of life (HRQoL)
Putting your case together
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Navigating NICE
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Product developers may be interested in ensuring their clinical development studies and other plans generate the evidence which is relevant to NICE
Why seek scientific advice?
IIncrease the likelihood that clinical trials and other research ncrease the likelihood that clinical trials and other research activities undertaken meet NICE evidence requirementsactivities undertaken meet NICE evidence requirements
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Typical issues raised for advice
Clinical Trial Programme• Study population• Comparators• Acceptability of endpoints, surrogate endpoints • Trial design• Appropriateness of health-related quality of life and other Patient
Reported Outcomes• Positioning in the clinical pathway
Economic Evaluation• Plans for using specific economic models• Sources of data , observational studies, analyses
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Additional issues raised in previous diagnostics advice projects
• Study design• Diagnostic cohort design, case-control study, cluster randomisation trial• Sensitivity and specificity• Diagnostic accuracy• Stratification by risk factor• Clinician blinding
• Outcomes relevant to NICE• Role of new diagnostic in existing treatment pathway• Assessment of cost-effectiveness• Model structure and input assumptions
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Key stages of advice processes
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Advice for developers of screening tests
• Screening not part of NICE remit• Screening and diagnostic tests often similar• Diagnostic test may be used as screening test in treatment pathway
• National Screening Centre• Part of Public Health England
• Areas of screening needs explored• Models developed by external academic group• New initiative – advice from NICE Scientific Advice in conjunction
with NSC for screening tests
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Questions?
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Medical Technologies
EvaluationProgramme
(MTEP)
DiagnosticsAssessment Programme
(DAP)
Technology Appraisals
(TA)
Programmes at NICE
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Topic SelectionSTEP 1
The Company submits a notification form to Medical Technologies Evaluation Programme that details:
•Product description• Patient population• Current management and comparator(s)• Claimed patient benefit • Claimed healthcare system benefit• Claimed sustainability benefit • Costs• Patient safety
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Notifying a product to NICE
STEP 2.
NICE produces a briefing note for MTAC which decides whether the technology is suitable for the evaluation at NICE
STEP 3.
If selected, MTAC routes the technology to the appropriate Programme.
Process takes ~10 weeks
Questions about the process and eligibility? Contact MTEP:
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MTEP vs DAP
DAP and MTEP encourage further research into promising technologies
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• Specialist programme to undertake complex assessments of diagnostic technologies
• Decision making by independent Diagnostics Advisory Committee
• Assessment of single or multiple technologies
• No formal manufacturer submission required
• Systematic review of evidence and modelling to estimate outcome benefits and cost effectiveness is undertaken as part of the assessment
Diagnostics Assessment Programme
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Overview of assessment process
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Two key questions asked by NICE
• How well does the technology work compared to established practice in the National Health Service (NHS)?
• How much does this course of action cost compared to established practice in the NHS?
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Scoping Single technology notified and referred to DAP
DAP technical lead •Diagnostic pathway•Care pathway•Alternative technologies•Relevant population(s) •Costs•Outcomes •Potential equality issues •Potential implementation barriers
Scoping workshop
Registered stakeholders
ASG meeting
Specialist Committee membersStanding DAC member
Draft scope
Revised scope
Final scope
Assessment of single or multiple technologies
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1. How is the condition
managed in the NHS?
3. What does my product deliver?
2. Where does my product fit in the care pathway?
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Understanding benefits: diagnostics
False negative?
False positive?
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•The treatment pathway or the range of pathways must be understood for the value of the diagnostic to be assessed
•Test side effects should be included
Patient benefits rarely arise from the diagnostic directly – they come mainly from treatments informed by the
diagnostic
Understanding benefits: diagnostics
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Assessment
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Regulator
• Product safety: laboratory testing with clinical trial data for devices with greatest risk
• Evidence of efficacy: does the device meet its intended purpose? (not necessarily from comparative studies)
HTA•Evidence on clinical effectiveness (compared to established practice): trials, evidence synthesis
•Evidence on cost effectiveness: trials, modelling
•Evidence on relative safety/adverse events
What data do you need?
Trueman P et al 2011
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• The ideal evidence would be a good quality ‘end-to-end’ study – follows patients from testing, through treatment, to final outcomes• Typically not available for diagnostics • Search for data on test accuracy, direct outcomes from the test,
indirect health outcomes from the test result, and costs• Identified evidence can then be combined through a linked
evidence approach
Diagnosticaccuracy
Impact onoutcomes
Impact on treatmentdecisions
Evidence considerations
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Evidence hierarchy
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Study design
• Outcomes: patient focussed outcomes are particularly important, as opposed to intermediate or surrogate outcomes
• e.g. a reduction in tumour size will be given less weight than evidence about clinical benefit such as improved survival or quality of life
• Size: Studies with larger numbers of patients will usually be preferred as estimates of benefits and harms will be more accurate
• Duration: Studies should have sufficient follow up to capture final outcomes where possible
• e.g. very important for prognostic tests
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Diagnostic tests: Outcomes data
IIdeally comparative ‘end-to-end’ clinical studies including the test and subsequent treatments should be conducted
Test side effects should be included
Identify studies on the effectiveness of those subsequent treatments
Use a systematic approach to identifying relevant studies
Not possible
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Diagnostic tests: Outcomes data
• Measurements of test accuracy are necessary:
Condition as determined by “Gold Standard”
Condition positive
Condition negative
Test outcome
Test outcome positive
True Positive
False Positive
PPV
Test outcome negative
False negative
True Negative
NPV
Sensitivity Specificity
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Diagnostic tests: Outcomes data
Cut off points
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Example:SonoVue (sulphur hexafluoride microbubbles)Contrast agent for contrast-enhanced ultrasound imaging of the liver
Characterising incidentally detected
focal liver lesions
Detection of potential liver metastases
Characterising focal liver lesions
(cirrhosis)
No end-to-end studies available
High quality accuracy data – SonoVue vs CT and MRI
Relevant evidence on care pathway and outcomes
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Characterising incidentally detected
focal liver lesions
Detection of potential liver metastases
Characterising focal liver lesions
(cirrhosis)
Cost effective
Adoption recommendation
Slightly less cost effective than CT and MRI
Adoption recommendations
where CT and MRI not
appropriate+
Research recommendations
to explore potential broader
applicability
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Decision making
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Recommendations
• Adoption recommendations
• Research recommendations
• Not recommended
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Guidance development
• Decision making in presence of uncertainty• Public consultation can change decision making• Clarity in recommendations on indicationo Rule-in / rule-out / diagnosis / monitoringo SettingSupported by evidence, minimise risk of indication creep and
inappropriate use of tests that may lead to misdiagnosis Cost-effective use of NHS resources
• ‘Committee considerations’ describe uncertainties and rationale behind decision-making.
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Diagnostic Guidance (DG5)
SonoVue (sulphur hexafluoride microbubbles) – contrast agent for contrast-enhanced ultrasound imaging of the liver
Contrast-enhanced ultrasound with SonoVue is recommended for
characterising incidentally detected focal liver lesions in adults in whom an
unenhanced ultrasound scan is inconclusive. An unenhanced ultrasound
scan in which a focal liver lesion is detected, but not characterised, is
defined as inconclusive.
Examples of recommendations
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Recommendations
• Adoption recommendations
• Implementation support
• Health Technologies Adoption Programme
• Research recommendations
• NICE research commissioning
• Not recommended
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Technology Appraisal Programme
Diagnostics Assessment Programme
Appraisals of new and existing medicines and treatments
Specialist programme to undertake complex assessments of diagnostic technologies
Topics from department of health Topics from manufacturers or clinical sponsors
Assesses single or multiple technologies
Assesses single or multiple technologies
STA - Manufacturer submission
MTA – Manufacturer submission and evidence gathered by academic group
No formal manufacturer submission
Structured information requestEvidence gathered by academic group
Evidence assessed by independent external group
Evidence assessed by independent external group
STA – 35 weeksMTA – 62 weeks
62 weeks
NICE: Companion diagnostics
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NICE: Companion diagnostics
• Alternative technologies• Timing is an important factoro Appraisal programme coordinates publication of guidance with market
authorisation of drug o CDx may be developed simultaneously with drugo CDx can come to market years after drug approval or may already be
availableo Rapid development of CDx and supporting technologies
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• In January 2013, NICE published update to methods guide• Costs of CDx testing incorporated into evaluation of clinical and
cost effectiveness
• Sensitivity analysis to assess impact of CDx cost on cost effectiveness of pharmaceutical
• Diagnostic accuracy can be examined and incorporated in cost effectiveness analysis
• Potential issues of alternative CDx can be highlighted in guidance without assessment of evidence
Technology Appraisals: Companion diagnostics
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Example of CDx in TA programme
• TA 208 Trastuzumab for HER2-positive metastatic gastric cancer• MA included testing with fluorescence in situ hybridisation (FISH) then revised to include silver
in situ hybridisation (SISH)• Timing of MA meant that only FISH was included in NICE appraisal
• Trial used parallel testing strategy• Sequential testing strategy in manufacturer’s model
• Only ICH2 positive received FISH test• ERG scenario analyses for both sequential and parallel testing strategies
• Sequential ICER £66,982 per QALY• Parallel ICER £71,637 per QALY due to increased incremental costs
• Committee concluded that sequential testing was most appropriate for people with metastatic gastric cancer
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Example of CDx in DAP programme
• EGFR-TK mutation testing in adults with locally advanced or metastatic non-small-cell lung cancer
• Evidenceo Two tests used in clinical trialso Three tests had accuracy data o Linked to clinical trial data
o Remaining tests had no trial or accuracy data
o Included a survey of labs providing EGFR-TK testing o test characteristics and costs
o Data from an EGFR-TK national external quality assurance scheme study
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EGFR testing - Recommendations• 5 tests recommended but insufficient evidence to make
recommendations for others
• Key issues:
• Test validation
• Competent execution
• Participation in external quality assurance scheme
• Research recommendation
• Studies comparing different EGFR-TK mutation methods that link to patient outcomes
• Many assumptions in assessment
Diagnostics guidance (http://www.nice.org.uk/dg9)
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Ways of assessing alternative CDx:
• Only assess CDx used in clinical trial • include general commentary on use of alternative CDx tests • Where appropriate, undertake sensitivity analysis on
diagnostic accuracy and cost to understand the importance of CDx in relation to patient outcome benefits and cost effectiveness
Technology Appraisal programme
• Assess each alternative CDx / treatment package separately • Separate clinical and cost effectiveness analyses Diagnostics Assessment programme
Summary
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Health Technology Adoption Programme (HTAP)Main objectives:
•Increase the uptake of NICE recommended technologies
•Establish an agreed approach for NICE to develop effective partnerships with Academic Health Science Networks (AHSN) •To support the expansion of the Medical Technologies Industry in the UK by providing adoption advice to suppliers
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Two approaches to adoption in the NHS:
57
• Site demonstrator projects for commonly used technologies
• Adoption projects for more complex, less commonly used technologies
Produce adoption support packs to accompany guidance produced in MTEP, DAP, TA and Quality Standards (QS).
Please contact Jae Long ([email protected]), Assistant Project Manager for HTAP, for further details.
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Key contacts
• NICE Scientific Advice• Richard Chivers ([email protected])• http://www.nice.org.uk/about/What-we-do/Scientific-advice• NICE/Medilinks seminar http://www.medilinkem.com/events/events-calendar/2014/10/21/nice-medtech-workshop
• NICE DAP• Sarah Byron ([email protected])• http://www.nice.org.uk/About/What-we-do/Our-Programmes/NICE-guidance/NICE-diagnostics-guidance
• NICE Medical Technologies Evaluation Programme• Lee Dobson ([email protected])• http://www.nice.org.uk/About/What-we-do/Our-Programmes/NICE-guidance/NICE-medical-technologies-evaluation-
programme • Health Technologies Adoption Programme
• Jae Long ([email protected])• http://www.nice.org.uk/About/What-we-do/Into-practice/Health-Technologies-Adoption-Programme
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Any questions?