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Benefits and challenges of submitting to the medical technologies evaluation programme

March 25, 2015

In 2009, the National Institute for Health and Care Excellence (NICE) was tasked with establishing a system that could identify and encourage the adoption of new or novel medical devices and diagnostic technologies. After discussions with key stakeholders, NICE developed the Medical Technologies Evaluation Programme (MTEP), which is tasked with improving the experiences and outcomes of patients and/or driving efficiencies in the use of UK health-service resources. [1]

As of January 2015, MTEP has assessed and published guidance for 22 medical technologies.

Once a company has chosen to submit a product for the MTEP, a team from NICE assesses the technology’s eligibility for evaluation against the eligibility criteria. The criteria [2] are:

  • within the remit of a NICE evaluation program and not currently being evaluated
  • new or innovative technology
  • appropriate timing (e.g., technology has necessary CE marking)

If the technology is eligible for a review, the program team puts together a briefing note on the technology. This includes its costs, uses, expert and patient/carer advice, and the benefits to patients and the NHS. Based on the information provided in the briefing note, NICE’s Medical Technology Advisory Committee (MTAC) decides on the most appropriate guidance-producing program for the technology. Programs considered include:

  • technology appraisals
  • diagnostic assessment
  • clinical guidelines
  • interventional procedures
  • MTEP

Therefore, manufacturers who submit to MTEP may not always follow this path, if it is not deemed suitable for that technology program.

Once selected for MTEP appraisal, the technology must go through a 38-week-long evaluation process [2].

MTEP_chart01

The economic method utilized during appraisal is a cost-consequence analysis. This is different from the way NICE evaluates drugs, as it does not consider patient-based outcomes, such as quality-adjusted life-years (QALY) [1, 3]. Medical Technologies Guidance (MTG) is published only for products found to offer advantages to patients and the NHS.

Manufacturer perceptions and experiences

GfK conducted a review of manufacturers who had submitted products to the MTEP to gain an insight into the strengths and challenges of submitting for MTEP. We included interviews with eight manufacturing companies who had been through the MTEP process.

MTEP_chart02b

Steps for improving the process

Several recommendations came from manufacturers for advancements going forward:

  • improve triage to make sure no product will enter the appraisal process without a clear understanding that all necessary data is available and in place
  • ensure that transparent guidance exists on the acceptability of all forms of evidence [from randomized clinical trials (RCTs) to case reports] and ensure this is adhered to by MTAC and External Assessment Centres
  • provide clear guidance on the health economic data requirements, stipulating the relative importance of short-term (i.e., year 1) and long-term cost savings in the MTAC decision-making process
  • ensure all MT makes direct reference only to the branded name of the product assessed, thereby reducing the concern that competitor products will exploit a positive recommendation
  • the MTEP should provide a robust auditing system to monitor the uptake of recommended technologies within relevant hospital departments; failure to use a recommended product should require justification

Overall, submission to the MTEP was regarded as a constructive commercial strategy for a medical technology that can positively impact patient outcomes; has a clear cost per relevant consequence (from the NHS perspective); and has at least one small clinical trial completed to support the benefits.

GfK has experience with the MTEP, as well as wider medtech market access support, and is fully invested in the successful launching of new health technologies.

This article was co-authored by Julia Glover in Health and Davide Panciera in Health.

For further information, contact Joanna Entwistle at joanna.entwistle@gfk.com.

References

[1] Campbell B, Campbell M. NICE Medical Technologies Guidance: a novel and rigorous methodology to address a new health technology assessment challenge. Appl Health Econ Health Policy. 2012 Sep 1;10(5):295-7.

[2] NICE. NICE (2011) Medical Technology Evaluation Programme – Methods Guide.

[3] Green W, Hutton J. Health technology assessments in England: an analysis of the NICE Medical Technologies Evaluation Programme. Eur J Health Econ. 2014 Jun;15(5):449-52.

[4] Sprange K, Clift M. The NICE Medical Technologies Evaluation Programme (MTEP): manufacturer submission challenges. J R Soc Med. 2012 Apr;105 Suppl 1:S4-11.

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