In September, our Founder and CEO Nick Lansman talked to The Journal of mHealth about Why HealthTech Should Receive the Same “Automatic” Treatment in Funding and Uptake as Medicines.
“In April, MHRA and NICE announced a new joint pathway to expedite patient access to medicines by streamlining licensing and value assessment. This pathway synchronises NICE technology appraisal decisions with MHRA regulatory decisions. In practice, this means companies register early PharmaScan which is the national horizon scanning database and confirm at NICE topic selection stage that they can meet coordinated timelines, then submit to both bodies, resulting in a 3-6 month reduction in waiting times for NHS patient access.
While welcome news, this streamlined process does not extend to medical technologies. The disparity is not deliberate but creates challenges for healthtech companies who have to navigate a slower and more fragmented route to market compared to their pharmaceutical counterparts.
The pathway offers clear benefits to pharmaceutical companies. For example, NICE publishing its technology appraisal guidance at the same time as MHRA marketing authorisation closes the gap between a medicine being licensed and it actually being funded and available on the NHS. Timelines become far more predictable too, as the priority scheduling from NICE and coordinated milestones give companies a clear, agreed structure to plan clinical, regulatory and commercial activity around. Furthermore, commercial benefits arrive sooner, as earlier entry into the NHS means a longer period before the Voluntary Scheme for Branded Medicines Pricing Access and Growth refund starts to apply. More broadly, this pathway will incentivise large global pharmaceutical companies to sell into the NHS, in turn speeding up NHS adoption of new medicines over time…”
Read the full article here.