NHS England and NICE launched a consultation on an integrated, rules-based MedTech pathway

On May 23, 2024, NHS England and the National Institute for Health and Care Excellence (NICE) launched a joint consultation on their proposed rules-based, integrated, and predictable pathway for the evaluation, funding, and commissioning of MedTech in the NHS.

The intention is that the pathway will apply across the entire lifecycle from promising early-stage technologies to groups of new, innovative products ready for a NICE assessment of clinical and cost-effectiveness, as well as existing technologies in widespread use where there is scope to drive greater value. By establishing the pathway, NHS England and NICE seek to improve patient outcomes, provide greater certainty for MedTech innovators and suppliers, and drive better value for money for taxpayers and the NHS.

The five key elements of the proposed pathway are the following:

• Pre-authorization: This phase covers activities before a product is approved for sale on the market. It includes manufacturer idea creation and proposition development, as well as horizon scanning and demand signaling. A more coordinated approach is needed for data collection to improve horizon scanning for MedTech. Building on how the NHS Innovation Service has developed the Innovation record, there is ongoing work across organizations to agree on the baseline level of information needed for horizon scanning. Early engagement will be essential to the pathway, providing an opportunity to share advice as well as signposting technologies through the pathway where they are most likely to benefit from a NICE assessment;
• Authorization: This is about everything related to obtaining the necessary authorization to take a product to market. It includes the process leading to registration with the Medicines and Healthcare products Regulatory Agency (MHRA), following the appropriate assessment and certification processes;
• Evaluation and guidance: This is about determining whether a technology is clinically and cost-effective in the use of NHS resources, ultimately aiming for NICE evaluation and recommendation for use in the NHS. NICE is currently updating its approach to topic selection and prioritization. NICE plans to establish a centralized prioritization board that will make topic selection decisions for all NICE programs. Topic selection will be integrated with the horizon scanning and demand signaling activity of the pre-authorization phase. To decide on priority topics, NICE has developed a set of eligibility and decision-making criteria, which will be considered by the prioritization board. NICE has introduced several different routes to assess the clinical benefit of technology after topic selection, which spans the lifecycle of technology development: early value assessment (EVA), multi-technology guidance (MTG), and late-stage assessment (LSA). There are clear, rules-based eligibility criteria for each;
• Commercial and commissioning: This covers how products are commissioned after being recommended by NICE. A consistent set of ‘rules’ will be applied to suitable funding streams, whether they are held nationally or by integrated care boards (ICBs), based on a range of potential funding sources to deliver access and adoption. For example, established funding programs may be linked to a recommendation in EVA guidance to provide support while evidence is generated;
• Scaled adoption: This is about increasing widespread adoption and patient access to MedTech. It includes workforce considerations, pathway changes, and realizing the benefits of MedTech. The pathway will provide a consistent and predictable route for commissioners to adopt new technologies to improve care and clinical pathways based on a NICE recommendation.

Anyone, including industry, is welcome to give feedback on the proposed pathway. The deadline for submitting comments is August 15, 2024.

See the full details here.

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