1. Using evidence to promote fast track adoption
Mark Campbell, Associate Director
Medical Technologies Evaluation Programme
Medlilink Event: How can you work with the new NHS ?
Liverpool, 5th December 2013

2. Plus ca change, plus ca meme (MC)

3. A brief history of NICE

4. Aims of MTEP Section 2.1 The aims of the Programme are:
• to promote faster uptake of new medical technologies in the NHS
• to encourage collaborative research, in both industry and the NHS, to generate evidence on the clinical utility and/or healthcare system benefits of selected technologies.

5. NICE’s broadermedtech offer
Easy access
Single access point - MTEP
Single route of publication: NICE Evidence Services
Evidence generation
Scientific Advice Programme
Research facilitation after guidance research recommendations
Guidance
Interventional Procedures (regulatory)
Medical Technologies
Diagnostic Assessment
Technology Appraisals
Medtech Information Briefings
Health Technologies Adoption Programme
NICE’s broadermedtech offer

6. Medical Technologies Evaluation Programme (MTEP) bespoke design (1)
Characteristic
Programme design and operational features
The relatively sparse evidence base for medical technologies by comparison with, for example, pharmaceuticals
All forms of evidence (published and unpublished
and 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 to
patient benefits and sustainability benefits are
identified and actively considered.
The 8 points on this and the next slide are adapted from the editorial cited, by Bruce and Mark
Campbell B, Campbell M. Appl Health Econ Health Policy 2012; 10 (5): 6

7. Medical Technologies Evaluation Programme (MTEP) bespoke design (2)
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 products as possible can be considered.
Improving the efficiency of health services is a top policy priority
Medical Technologies Guidance specifically
examine 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 can
be notified and may be evaluated if there is
evidence that they have plausible claimed benefits
and are not being routinely adopted.
Technical considerations (safety, compatibility, procurement, maintenance, calibration, training, upgrades) can significant influence clinical utility
Access to world-leading technical expertise to commission bespoke studies to answer specific questions which are relevant to the assessment clinical or cost utility

8. 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

9. Medtech evaluation encompasses NICE’s core principles
Based on the best evidence available
Expert input
Patient and carer involvement
Independent advisory committees
Genuine consultation
Regular review
Open and transparent process

10. MTEP overview – selection and routing
Informal+supportive
Engagement
General process
Product specific considerations
Notification
Sponsor makes notification via NICE website
MTEP team assesses eligibility of product to be notified
MTEP prepares Briefing Note
Selection and routing
MTAC selects for guidance development
MTAC routes to most appropriate programme
MTEP Process Guide 10 wks

11. Eligibility and selection criteria
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

12. Routing Clinical Guidelines Technology Appraisals Guidance
Interventional Procedures Guidance
Diagnostics Guidance
Medical Technologies Guidance
A number of equivalent technologies available
The equivalents have been available in clinical practice for some time
The benefits are best evaluated in the context of a care pathway in development or already developed by NICE.
New treatments with significant impact on NHS, or policy priorities
Clinical and cost-effectiveness
Companion diagnostics suitable if an appraisal of the pharmaceutical that they are intended to enhance is appropriate
3-month funding direction.
More cost/more benefit
Complex care pathways
Recommendations on the basis of clinical utility and cost–utility analysis
‘Gold standard’ or established comparator to enable an assessment of potential benefit
Multiple or single products.
Safety and efficacy of novel procedures
New device in a novel procedure where safety and efficacy are still unknown
Comparative effectiveness and health economic considerations are not relevant at this point.
Single product
Innovative devices and diagnostics (early stage evidence)
More benefit/same cost OR same benefit/less cost.

13. From regulatory assessment to evaluation of value proposition Low-intensity pulsed ultrasound to promote fracture healing (IP Guidance Dec 2010)
1910 patients, 1 meta-analysis, 4 RCTs, 1 non-randomised comparative study, 1 case series (registry data)
Meta-analysis (13 RCTs, 563 patients with fresh and non-union fractures)
Key efficacy outcomes: reduction in healing time (confirmed by imaging)
Key safety outcomes: acute compartment syndrome, mild swelling and erythema
NICE Guidance: Safe and efficacious for normal use

14. Exogen (Medical Technologies Guidance January 2013)
Clinical evidence: 17 studies (1710 patients), 3 RCTs, 13 case series, 1 prospective comparison; 13 studies reported non-union fractures, 2 reported on delayed healing and 2 on both
Cost evidence: de novo sponsor models for non-union and delayed – latter not cost saving
No direct evidence supporting avoidance of surgery with use of Exogen, but plausible based on healing rates, supported by expert advice
Substantial QOL and return to ADL benefits, easy to self-administer
NICE Guidance: Case for adoption supported for non-union, saving of £1164 per pt through avoiding surgery

15. Frequently-asked-questions
How much evidence is needed to engage with NICE ?
It depends on the claims
What type or quality of evidence is needed to engage with NICE ?
If there’s currently limited evidence on my product, what further studies should be carried out before or while engaging with NICE ?

16. Evidence considerations – medical technologies guidance
MTEP methodology requires manufacturers to submit evidence, including an economic model
Published/unpublished/no design or quality threshold
The evidence should demonstrate:
Equivalent or superior clinical performance compared to current standard clinical care – the comparator
NHS cost savings (which may occur anywhere in the care pathway)
The evidence may be based on:
Systematic review of the clinical and economic evidence with appropriate meta-analyses
De novo cost analysis (where needed)
Clinical and technical expert advice
The submitted evidence is reviewed by an independent external assessment centre

17. Cost consequences method: medical technologies guidance
Expectation technology is therapeutically near equivalent to comparator
Costs and resource consequences of the technology as well as relevant clinical benefits
Not required: valuation of patient health status or treatment preferences
(You will probably need a health economist)

18. Cost modelling – cost consequences analysis
Cost model - examples
Acquisition costs
Running 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

19. Some common pitfalls and potential solutions
Common 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

20. MTG recommendations Usually: 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.

21. Protecting products with gaps in evidence
Notification stage: not selected for evaluation – confidential and constructive feedback
Guidance stage: MTEP research workstream
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

22. NICE Health Technologies Adoption Programme
Formerly National Technology Adoption Centre (NTAC)
Integrated into NICE May 2013 (IH&W)
Specialist adoption support for medtech/diagnostic guidance

23. Thanks for listening www. nice. org
Thanks for listening Notify a technology: