ARTICLE SUMMARY:
NHS and NICE propose an integrated, rules-based medical technology pathway. Excerpted from Pathways’ Picks May 29: Rethinking Medtech Pathways in the EU, UK, and New Zealand.
UK agencies circulated plans last week for what they say will be a more coordinated, streamlined commercial path to the NHS for devices. NHS England and the UK National Institute for Health and Care Excellence (NICE) published the proposal to revamp medtech market access procedures starting before a device gains regulatory approval and extending into procedures for funding, commissioning of technologies in NHS hospitals, and scaling adoption of medtech tools. The agencies’ plans emphasize early engagement between innovators and the NHS and sending clear signals on data scanning needs and healthcare system priorities. The proposal is also intended to clarify and expand the path for routine NHS commissioning of devices that gain positive NICE recommendations. NICE and NHS are building on existing programs including the Innovative Devices Access Pathway (which also includes participation by the UK regulator MHRA) and NICE’s Early Value Assessment program. Public comments on the pathway proposal are due August 15.