CONCEPT: Medical devices, diagnostics and digital health technologies (DHTs) can improve patient outcomes with additional benefits for healthcare systems. However, unlike pharmaceuticals, the route to UK reimbursement for medical technologies (MedTech) is not always clear, and the roadblocks of additional economic evidence and health technology assessment can seem impassable. This concept poster will describe a practical roadmap of potential routes to market for MedTech and describe recent initiatives to accelerate access in the NHS.
BACKGROUND: NHS England and NICE have launched new initiatives to accelerate adoption of cost-saving MedTech that could reduce healthcare resource use and improve outcomes. These include: HealthTech Connect, a horizon-scanning MedTech database to foster early engagement; the NICE META tool, an online value proposition assessment tool; the Evidence Standards Framework for DHTs; and MedTech Innovation Briefings. A new funding mandate for NICE MedTech and Diagnostic Guidance has also been proposed.
RECOMMENDATIONS:
• Developers should engage early with the NHS and Academic Health Science Networks by registering with HealthTech Connect, which provides a confidential signposting service that can help with initial queries about routes for market access.
• The NICE META tool can assess a technology’s current evidence base and determine the most appropriate route for market access and if further evidence is required.
• Scientific advice should be sought when planning new studies to determine if outcomes are appropriate for MedTech decision-makers.
• Additional safety and risk assessments may be required for DHTs or implantable devices.
• Not all MedTech may be appropriate for assessment by NICE, but other routes are possible, including NHS Specialised Services or local commissioning.
CONCLUSIONS: The MedTech route to market access in the UK varies dependent on the technology. Developers should seek advice on which reimbursement pathway is the most appropriate and take advantage of new initiatives that encourage adoption by the NHS.
