NHS England and the National Institute for Health and Care Excellence (NICE) are developing proposals for an integrated, rules-based medical technology (medtech) pathway.
What do the proposals involve?
As we highlighted in our earlier blog, these have been opened up for public consultation over the summer to gather views from industry, patients and healthcare providers. The techUK Life Sciences Working Group, including Mills & Reeve life sciences partner Stephanie Caird, has submitted a response representing perspectives from the medtech sector.
The evaluation framework proposals outlined two key areas:
- the ‘rules’ and principles on which NICE and NHS England will work in partnership to evaluate, commission and fund medical technologies. The proposals set out the key phases of an integrated NICE and NHS pathway for medtech devices, digital technologies and diagnostics that will apply across a product’s lifecycle.
- how the NHS will support the routine commissioning of technologies determined to be clinically and cost effective by NICE in the NHS.
The techUK response
techUK’s response is strongly supportive of a set of clear, consistent rules for innovators developing medtech solutions, and welcomes the intention to consolidate multiple access points into a single point of contact.
A number of areas of concern are identified, notably:
- The need for clarification around what digital healthcare products are included within the scope of the proposed medtech pathway.
- How prioritisation of different digital products will work, and concerns around resourcing for NICE in light of an expected increase in demand.
- Whether the proposed pathway will impact the re-tendering of products that are currently in use but have not undergone NICE evaluation.
- Whether the proposed pathway will be the only route to market, and what the future relationship will be between this pathway and existing regulations such as Digital Technology Assessment Criteria (DTAC).
- What methodology will be used to calculate cost-effectiveness, particularly for products that require significant initial expenditure but generate savings over time.
- Whether cost-effectiveness calculations will take account of savings across the entire healthcare system, including primary care and social care.
- The need for a comprehensive approach taking account of broader systemic factors, including connectivity and procurement, which will significantly impact the adoption of new technologies.
Next steps
Feedback is now being considered and reflected upon before a response and final plans for implementation from NHS England and NICE are published.
Challenges around validation and adoption within the UK healthcare system have long been an area of uncertainty for medtech innovators. This process offers welcome transparency and an opportunity to provide input in order to develop an efficient and effective pathway for bringing innovative products and services to patients.
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