Is the NHS finally developing a clear evaluation and reimbursement pathway for digital health technologies?

Today the National Institute for Health and Care Research (NIHR) in collaboration with the Office for Life Sciences (OLS) and the National Institute for Health and Care Excellence (NICE), opened a funding call to support digital health companies to generate real-world evidence for products recommended by NICE for early use in the NHS.

This is an important step in the journey to create a clear, consistent, and appropriate evaluation and reimbursement route for digital health technologies, including digital therapeutics, in the NHS.

Whilst we eagerly wait for NHS England to publish its digital therapeutic pathway policy, this funding call, the publication of NICE’s first Early Value Assessment (EVA) last year, and Big Health’s Sleepio landmark med-tech guidance (MTG), means that we can start to piece together what this pathway may look like.

It starts sketching a pathway that looks as follows:

1. It starts with identifying promising technologies that meet a national priority, such as the ones laid out in the NHS Long Term Plan, with robust and multi-dimensional entry criteria (e.g. compliance with medical device regulation, existing NHS partnership, DTAC).
2. It seeks to then evaluate the products through NICE’s EVA,
3. Products receive an evidence-generation plan and funding to support this (i.e. NIHR i4i & OLS Real World Evidence Programme) ,
4. There is a later-stage assessment once the product has met a higher evidence threshold (through NICE’s MTG for example).

Gaining clarity on the pathway, will increase confidence and add value to the whole system. It promoted a need-based approach by establishing a pathway for products that match defined national priority areas. It signals the centrality of evidence to get reimbursement. For products to receive meaningful reimbursement in the NHS they must reach a high standard of evidence, likely NICE’s med-tech guidance (MTG) or diagnostic guidance (DG).

It also demonstrates that the NHS is taking seriously the untapped utility of digital health technologies in offering value-for-money interventions that improve patient choice and experience, with well-validated clinical outcomes as assessed by NICE.  This sketched pathway also provides companies with a clear and achievable objective to aim for while providing the NHS confidence that technologies receiving reimbursement are well-evidenced and meet an identified clinical need. It seems sensible and largely, reflects the traditional pathway for pharmaceutical therapeutics.

However, most of us will note the elephant in the room – where is the money for reimbursement? This question rings particularly true in the field of digital therapeutics, as in some instances they can replace the use of a traditional therapeutic. NHS England must publish its digital therapeutics policy, and ensure that there is a long-term ringfenced, mandated, reimbursement fund for products that have achieved NICE’s high evidence threshold.

Over the coming weeks and months, we will be working with our clients to establish and make a case for such as clear, consistent, replicable reimbursement pathway for products that meet this appropriately high bar, as well as support them on their journey through evaluation and (national) reimbursement.

If you are developing an innovative digital therapeutic and would like to discuss how we can support you, including with the NIHR funding call application and delivery, please contact us at info@newmarket-strategy.com.

Isaac Ezro-Lack, Senior Manager at Newmarket Strategy