Founders Thoughts on Emerging Reimbursement Pathways
We’ve been seeing some exciting progress to consolidating the evidence through commercialisation route in the UK and Europe in the last couple of months, so I thought I’d send a quick note around. Especially as the UK NHS 10 Year Plan is soon to be released, that will have a significant impact on long-term market access strategies and shorter-term commercial activities (although as we know, national policy does not always equal local decision making). These are my thoughts only based on my experience and inferences and should only be interpreted as such.
What I had been seeing as a direction of travel (and been involved in) for the more direct reimbursement of med tech has been materialising in the UK and Europe. This is a significant shift towards reimbursement based on evidence for med tech, in particular via HTA body recommendations (such as NICE in the UK). The progress in the UK reflects what’s also happening (and happened) across Europe, in the Netherlands, Germany, France, Belgium, Switzerland, the Nordics and others - both in rhetoric and practice.
Specifically, the new UK government’s Industrial Strategy describes an evidenced, rules based, pathway for the reimbursement of med tech which should be outlined in the 10 Year Plan (expect publication next month). I recently held a workshop (under Chatham House Rule) on directly linking evidence to reimbursement with system stakeholders across the NHS (local and central), NICE, industry and investors which will meet again post-publication, which was well received with widespread support and follow-up activities planned. If you would like to be involved and are not already, let me know.
This follows senior policymakers and officials within HTA bodies and in government increasingly discussing and committing to a more direct relationship between evidence and reimbursement. For example, in the UK, the rules-based pathway consultation last year (as referenced in the Industrial Strategy) that built on the launch of the NICE Early Value Assessment and more recently wider updates and consolidation to NICE med tech assessments. Further strengthening this narrative was the CEO of NICE, Sam Roberts, comments in the Health Service Journal that med tech should be reimbursed the same way that medicines are, and that NICE is ready to lead the way in determining which and at what cost - directly linking evidence to reimbursement. In Europe, we have seen programmes such as DiGA in Germany, ZIN in the Netherlands, mHealth in Belgium, and PECAN in France amongst others reflect similar principles. Some of these have had successes, and other have faced more challenges, which is natural in an evolving landscape.
I believe we are likely to see more national price negotiation and reimbursement of health tech, both directly and indirectly via an approved list for providers (and regional bodies such as Integrated Care Boards and insurance providers) in the UK and Europe in the long-run, with initial pilots commencing next financial year.
This is in part to address the lack of reimbursement for evidenced technologies (and also the ad hoc paying for low or none evidenced technologies), against appropriate thresholds and bring closer parity to that of medicines reimbursement pathways in most major European jurisdictions.
This won’t be an instant fix, and local procurement and purchasing decisions will remain significant (i.e the majority of existing commercial arrangements) especially in the short to medium term, but it reflects a notable shift in med tech reimbursement approaches in the longer term. This should directly affect health tech commercial and market access strategies – linking evidence generation to commercial outcomes, with a focus on the shorter-term development, commercialisation, and scaling needs (i.e. directly with payers) while simultaneously generating further evidence (including for HTA assessments) with potential new/national reimbursement routes (direct or indirect) and/or price negotiations.
If you have any questions or want to chat through the impact this may have please do reach out. I will be sending a further note post 10 Year Plan publication and as we know more concrete plans and programmes.