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Step 3 (optional) - Independent review of evidence gathered in Step 1 and 2 and issuance of a nationally-respected 'Guidance', 'Guideline' or 'Implementation Plan' addressed to the NHS

NICE - Evaluation Pathway Programme

As of 2011, there are various support mechanisms for manufacturers in cases where a strong body of evidence has been gathered but idiosyncratic barriers (eg cultural barriers, reluctance to change, and integration within legacy care delivery pathways) are hindering the adoption of the innovative medical device by the NHS. Those mechanisms can be grouped under two main categories, as follows:

  • Health Technology Assessment (HTA) programmes. From an industry perspective, all those HTA programmes can help expand the availability of a given innovative device across the country. Indeed, HTA programmes independently review the body of evidence for a new medical device (ie results from clinical investigations and health economics studies). This independent review is then published as a ‘Guidance’ or ‘Guideline’ and addressed to the NHS community. Currently, a number of HTA programmes exist (eg NIHR HTA[1], NICE Technology Appraisal). Those programmes overlap and NICE identified a number of pitfalls that could be solved with a unifying Evaluation Pathway Programme.
  • Implementation programmes can help manufacturers in cases of innovative medical devices failing to be adopted by the NHS despite the existence of a positive independent review by an HTA programme. The remit of Implementation programmes such as those carried out by the NHS Technology Adoption Centre[2] (NTAC) is to intervene in such cases where there is reluctance from clinicians to adopt the new medical device specifically due to changes that would be brought about to the pre-existing care pathway. NTAC can work with a number of pilot NHS Trusts to uncover the range of implementations barriers and eventually publish national ‘How to Why to Guides’ addressed to clinicians and facilitating the future procurement and implementation of the innovative medical device.

Building from its experience, NICE recognised in 2008/09 several pitfalls of the evaluation landscape for innovative medical devices (including those used for diagnostics):

  • Some medical devices do need bespoke evaluation methods and processes which imposes complexity on HTA programmes.
  • The small capacity for identifying and selecting topics to be fed into existing HTA programmes limits the number of beneficial products that can be recommended to the NHS.
  • Even after positive recommendations, there are general concerns about the lack of widespread and quick adoption of beneficial products in the NHS. Implementation programmes have started to play a beneficial role in this area, which needs to be scaled up.

In the beginning of 2010, NICE launched the Evaluation Pathway Programme that establishes a new evaluation pathway to drive the adoption and diffusion of innovative medical technologies more quickly throughout the NHS. The products that will be considered as candidate are mostly innovative medical devices and diagnostics with demonstrable therapeutic gain and/or the ability to drive significant efficiencies. In other words, products that will not be considered as candidates are devices and diagnostics requiring price-based procurement decisions or non-innovative ‘me-too’ products trying to enter established markets.

A first draft of the Evaluation Pathway Programme was presented by NICE, in October 2009 (Figure 9).

evaluation pathway programme

Figure 9 The Evaluation Pathway Programme, as designed by NICE[3] (2009).

Mike Wallace, Association of British Healthcare Industries (ABHI) commented in November 2009 on the Evaluation Pathway: ‘This is an exciting development for everyone involved in the medical technologies industry. Having a clear pathway to identify and evaluate promising innovative medical technologies is good for patients, the NHS and manufacturers. I encourage the industry to contribute to the Evaluation Pathway Programme for Medical Technologies when the process gets underway next year.’[4]

From 18 June to 10 September 2010, the Evaluation Pathway Programme ran a consultation on its process and methods guides. The two guide documents are open to consultation and can be found online[5].

More recently, a process map was produced by NICE (see Figure 10), describing the current state of the MTAC single evaluation pathway.

process map

Figure 10 Process map for the MTAC single evaluation pathway programme
(© NICE, 2010). Modified by HTM KTN to fit document.

Medical Technologies Advisory Committee (MTAC)

Preeminent role of MTAC after 2010

The Medical Technologies Advisory Committee is the authoritative body that will be implementing and managing the Evaluation Pathway Programme.

In the long run, the NHS adoption of products that embed radically new technologies will be only possible in cases where an MTAC approval has been provided. Therefore, manufacturers are recommended to learn more about MTAC processes and methods through reading the method and process guides, available online[6].

  • Single point of entry

The MTAC was created in late 2009 to become the single point of entry of the Evaluation Pathway Programme for innovative medical technologies, including mainly medical devices and diagnostics. There are two possible entries that can be fed into the MTAC evaluation pathway:

  • Manufacturers-led entries:

Manufacturers can notify MTAC of their products for evaluation. Application is done through completion of a filled in notification form available online. The MTAC is to route selected products to appropriate evaluation procedures, whether carried out by NICE or other organisations. Technologies likely to be selected into the Evaluation Pathway Programme are those which offer a step change in management, resulting in significant advantages to patients and /or to the healthcare system.

  • Department of Health-led entries:

MTAC can also produce its own guidance on appropriate products.

Single exit point

The Evaluation Pathway Programme will also have a single exit point. Indeed, guidance and evidence on all products going through the pathway will be published on the NHS Evidence web portal.

To notify a product to the Evaluation Pathway email This email address is being protected from spambots. You need JavaScript enabled to view it. or visit: