Assessing the value proposition and promoting the adoption of new and novel medical technologies Mark Campbell Associate Director Medical Technologies Evaluation Programme (MTEP) CE 2012: EU Medical Device Regulatory Revision Conference Birmingham, 20 September 2012
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Assessing the value proposition and promoting the adoption of new and novel medical technologies
Assessing the value proposition and promoting the adoption of new and novel medical technologies. Mark Campbell Associate Director Medical Technologies Evaluation Programme (MTEP) CE 2012: EU Medical Device Regulatory Revision Conference Birmingham, 20 September 2012. Content. - PowerPoint PPT Presentation
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Assessing the value proposition and promoting the adoption of new and novel medical technologies
Mark Campbell
Associate Director
Medical Technologies Evaluation Programme (MTEP)
CE 2012: EU Medical Device Regulatory
Revision Conference
Birmingham, 20 September 2012
Content
• General update on NICE• Development and operation of the NICE medtech
programmes• Assessing value• Published and in-development guidance
http://review2011-2012.nice.org.uk/
A short history of NICE
QOF
Public health
Interventional Procedures
Clinical guidelines
Quality standards
NHS Evidence accreditation
decisions
Medical devices
DiagnosticsPublications
NHS Chief Executive Report on Innovation - December 2011
Innovation, health and wealth:promoting uptake of NICE guidance
• Support for adoption of NICE guidance• Compliance regime and uptake metrics• End to local duplication of NICE evaluation• Support for the NICE scientific advice programme• Targeted effort to implement dementia and
oesophageal Doppler monitoring guidance• Immediate transfer of DH Innovative
Technology Adoption and Procurement Programme(iTAPP) to NICE
“...Through its medtech progammes, which use world-leading methodologies, NICE is at the forefront of helping decision-makers derive maximum value for the NHS;and we look forward to continuing to develop these with clinicians, policy-makers and industry..”
Regulation or evaluation ?Regulation Evaluation, leading to NICE
guidance
Required in order to place product on market
Not required to promote and sell product but guidance is sought by, and credible with, NHS clinicians and managers
Location-specific (UK, EU) Audience for guidance is NHS in England but very active international interest
Fundamental quality, safety and efficacy are evaluated
MTEP evaluates the value proposition (often using data from studies of safety/efficacy) including claimed benefits compared with standard care
(unless device is part of new or novel Interventional Procedure)
No assessment of resource impact Focussed on system benefits using appropriate economic methods
Medical Technologies Evaluation Programme (MTEP) bespoke design (1)
Appl Health Econ Health Policy 2012; 10 (5): 295-297
Characteristic Programme design and operational features
Different regulatory environment Can accept technologies early in life cycle
The relatively sparse evidence base for medical technologies by comparison with, for example, pharmaceuticals
All forms of evidence (published and unpublishedand with no design or quality threshold)are considered.Further evidence generation facilitated by NICE for promising technologies with guidance recommendations for further research
Medical technologies evolve at a rapid pace Short timelines. 10 weeks from notification to selection, 38 weeks from selection to guidance development
Medical technology products are usually promoted to the NHS with specific claimed benefits when used in place of or addition to standard care
The sponsor’s case for adoption drives the initial assessment and, if selected, evaluation of the product to simulate NHS decision-making. Clear and explicit value propositions are required from the sponsor before a decision is taken to evaluate
Medtech products are often claimed to be resource-releasing and more convenient.
System benefits are given equal prominence topatient benefits and sustainability benefits areidentified and actively considered.
Characteristic Programme design and operational features
The medical technology industry is large and diverse with a high rate of output of innovative products
Innovators (usually a commercial sponsor, i.e. Manufacturer or distributor) notify their products directly to NICE so that as wide a range of productss as possible can be considered.
Improving the efficiency of health services is a top policy priority
Medical Technologies Guidance specificallyexamine products which are plausibly resource releasing and the primary economic methodology used is cost-consequences analysis which gives an estimate of the saving per patient if the case for adoption is supported by the evidence
Innovative products may be slowly and/or unevenly adopted
Products which are novel but not new canbe notified and may be evaluated if there isevidence that they have plausible claimed benefitsand are not being routinely adopted.
Access to world-leading technical expertise to commission bespoke studies to answer specific questions which are relevant to the assessment clinical or cost utility
Medical Technologies Evaluation Programme (MTEP) bespoke design (2)
NICE medtech programmes (MTEP, DAP) at-a-glance
Selection and routing
Evaluation (MTG, DG or other)
Research facilitation
Scope – products to be evaluated
• Medical devices as defined in EU directives: – 93/42/EEC (concerning medical devices)– 98/79/EC (concerning in vitro diagnostic medical devices) – 90/385/EEC (concerning active implantable medical devices),
as amended
• …..including medical devices used for the purpose of diagnosis…and medical software
• Genetic tests within the scope of 98/79/EC provided they have a medical purpose
• Other products (eg tissue engineered products), on advice from DH
The case for adoption (compared with standard care)
• Replace ongoing therapy costs with one-off intervention or device
• Deliver treatment decision or care nearer to home • Reduce unnecessary surgical interventions • Enable self-care• Reduce length of stay• Enable treatment by a lower grade or less scarce type
of staff• Improve patient dignity and treatment compliance• Reduce future hospitalisation• Speed up recovery • Etc
Eligibility and selection criteria
Eligibility Selection
Timing Patient benefit
New or novel System benefit
Suitable for evaluation Disease impact
Cost considerations
Sustainability
Plausible
promise
Ineligible or not-selected topics are returned to the sponsor with a summary of the Committee’s considerations
Routing selected topics:what’s the value proposition ?
Clinical performance Better At least equivalent
Cost Higher Less overall
Patient benefits (inc preference)
Evidenced and used to adjust value
Evidenced and anecdotal – but not used to adjust value
Appropriate evaluation method
Cost effectiveness Cost consequences
Example Drug-eluting stents (TA152)
Oesophageal doppler monitoring (MTG3)
Which programme at NICE?
Cost modelling – cost consequences analysis
Cost model - examples
Acquisition costsRunning costs eg disposables or concomitant treatment
Staffing costs
System savings (eg change in setting)
Reduced costs of improved health outcomes
Improved ease of use or patient acceptability
MTG recommendationsUsually:
• Case supported (wholly, partly or not)
• Consider using in <case for adoption> <research>
• Resource consequences
NICE medical technology guidance addresses specific technologies notified to NICE by manufacturers. The ‘case for adoption’ is based on the claimed advantages of introducing the specific technology compared with current management of the condition. This ‘case’ is reviewed against the evidence submitted and expert advice. If the case for adopting the technology is supported, then the technology has been found to offer advantages to patients and the NHS. The specific recommendations on individual technologies are not intended to limit use of other relevant technologies which may offer similar advantages.
Development of further evidence
• MTEP has a research workstream as an integral part of programme
• Designed to facilitate research to address gaps in evidence which led to research recommendations in MTG or DG
• Flexible approach to research products but must be able to be completed within ~ two years
• Subject to findings and evaluation – updated guidance
Assessing value
What do decision makers need to know about new technologies?
Product value
What you need to do – constructing claims and driving value
A point-of-care diagnostic test which allows 'test and treat'
A test which confirms or excludes serious illness more quickly and/or more accurately allowing faster targeted treatment/faster discharge
A device which enables people to be more independent
A device which allows more accurate and/or more convenient monitoring (and therefore shorter or no time in hospital or fewer hospital visits)
An imaging technology which allows a reduced radiation dose and/or more accurate imaging and/or better treatment planning or monitoring
Common pitfalls and....some solutionsCommon problem Solution
Evidence doesn’t match the claim
Be clear about best possible application of product before commissioning study
Lack of clarity about the product’s position in care pathway
Talk to UK-based clinicians about how they might use the product and how it would change treatment
Unrealistic view of potential savings
Understand current treatment and availability – don’t assume a more expensive comparator is widely used
Not enough evidence to support the case for adoption
Share all possible sources of data with NICE – post-market, audit, unpublished
Getting help
General support for innovation - Technology Strategy Board/ Knowledge Transfer Networks www.innovateuk.org
Relevant evidence for health technology assessment - NICE Scientific Advicewww.nice.org.uk