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Using evidence to promote fast track adoption

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, 5 th December 2013. A brief history of NICE. Aims of MTEP. Section 2.1 The aims of the Programme are:

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Using evidence to promote fast track adoption

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  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. A brief history of NICE

  3. 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.

  4. 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

  5. Medical Technologies Evaluation Programme (MTEP) bespoke design (1) Campbell B, Campbell M. Appl Health Econ Health Policy 2012; 10 (5): 295-297

  6. Medical Technologies Evaluation Programme (MTEP) bespoke design (2)

  7. 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

  8. 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

  9. MTEP overview – selection and routing Informal+supportive MTEP Process Guide 10 wks

  10. Eligibility and selection criteria Plausible promise Ineligible or not-selected topics are returned to the sponsor with a summary of the Committee’s considerations

  11. Routing Clinical Guidelines • 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. • Single product • Innovative devices and diagnostics (early stage evidence) • More benefit/same cost OR same benefit/less cost. • 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. Diagnostics Guidance Medical Technologies Guidance Technology Appraisals Guidance Interventional Procedures 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. • 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.

  12. From regulatory assessment to evaluation of value propositionLow-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

  13. 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

  14. 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 ? • It depends on the claims • If there’s currently limited evidence on my product, what further studies should be carried out before or while engaging with NICE ? • It depends on the claims

  15. 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

  16. 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)

  17. Cost modelling – cost consequences analysis

  18. Some common pitfalls and potential solutions

  19. 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.

  20. 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

  21. 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

  22. Thanks for listeningwww.nice.org.uk/mtNotify a technology:medtech@nice.org.uk

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