What does the new integrated rules-based med-tech pathway mean?

NHS England and NICE have published a consultation document which sets out proposals to move towards a more rules-based, integrated, and predictable pathway for the evaluation, funding, and commissioning of medical technology (MedTech) in the NHS. This can be found here.  This public engagement is open until midnight on Thursday 15 August 2024.

A disparity has long existed between medicine and medical technology in terms of national recommendation and reimbursement schemes. Addressing this imbalance requires a nuanced approach that acknowledges the unique challenges posed by medical technologies. Initiatives such as the Early Value Assessment (EVA) process and Late-Stage Assessment (LSA) process are attempting to address some of these issues. This consultation is the next step in the process.

NHS England and NICE, in conjunction with DHSC, have worked together to develop a proposed pathway that brings together the entire MedTech lifecycle – from early-stage technologies where additional evidence generation is needed, to groups of new, cutting-edge technologies ready for a NICE assessment of clinical and cost effectiveness, to existing technologies already in use in the NHS to drive greater value. The consultation does not define value, but mentions value for the taxpayer and the NHS, and one of the consultation questions is around how industry engagement can inform a shared understanding of the value of MedTech.

The consultation sets out two key elements to the proposed pathway.

1. Firstly, it outlines the ‘rules’ and principles on which NICE and NHS England will work in partnership to evaluate, commission and fund MedTech. 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.
2. Secondly, the proposals outline how the NHS will support the routine commissioning of technologies determined to be clinically and cost effective by NICE in the NHS.

In general the consultation is committing to both policy initiatives and supporting initially a small number of Med-Tech products. The policy initiatives include improved horizon scanning processes for MedTech, better use of NICE’s processes, streamlined demand signaling, and additional commercial flexibility embedded across processes. The expectation around MedTech is NICE to assess 5 innovative MedTech products a year through its multi-tech guidance, with a cost-effectiveness threshold of around £20,000 per QALY, and a budget impact of up to £10 million a year. There is no national reimbursement, but a commitment to either support the effective use of nationally held, ringfenced funds to scale the adoption and rollout of well-evidenced, beneficial MedTech, or where MedTech falls within an ICB-commissioned pathway and has been recommended by NICE, the pathway will support trusts and ICBs in making decisions about what to commission and fund by providing guidance.

Analysis from Newmarket Strategy

• Our view is that while this integrated rules-based med-tech pathway is undoubtably a step in the right direction for patients, the NHS and industry in addressing some of the commonly known issues, it is no panacea.
• There are five guidance principles for the pathway which seem sensible. These are broadly that the pathway should maintain NICE’s independence, the partners should use appropriate clinical and cost-effectiveness assessments using NICE’s methods, that the pathway should support the automatic identification of funding for recommended products, that the pathway should support the transformation of clinical pathways and services, and that the pathway should work to tackle ethnic and unfair biases in med-tech.
• While these principles are laudable, they are limited by the capacity and capability of NICE to assess products, and the understandable reluctance for any commitment for national funding for med-tech in a similar way to medicines. Therefore, the consultation is keen to stress that evaluation of topics will be limited in number. There is also a notable absence of Med-Tech contribution to reduce carbon emissions as a theme. This may negatively impact businesses that are investing in products that also create value by supporting NHS decarbonization.
• We also believe this is a missed opportunity to provide statutory funding for products that can reach a higher value threshold, i.e., which will save money for the NHS through their adoption. It is highly counter-productive that the NHS does not routinely adopt technologies that will increase productivity and release cash savings, and therefore we believe an additional category of statutory reimbursed cost-saving med-tech should be created
• The pathway will evolve over time, including learning lessons from current and past programmed and initiatives. NICE and NHS England will start selective and small in scale to learn from the approach and iterate as it becomes more embedded. The focus of this financial year (2024-2025) will be to engage with stakeholders throughout this consultation process, to develop and establish the fundamental mechanics of the pathway.

At Newmarket, we will be keeping a close eye on MedTech policy development as it continues, and we will continue to support our clients to effectively navigate the ever-changing UK health and life sciences landscape.

The consultation can be found at https://www.engage.england.nhs.uk/specialised-commissioning/building-an-integrated-rules-based-medtech-pathway/