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Reimbursement strategy

Market Access Strategy for Medical Devices in Europe

Strategic recommendations on the topic of market access pathways for medical devices and IVD tests

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Reimbursement summary for angioplasty of arteries of lower extremities

This post presents an extract from our reimbursement analysis for angioplasty of arteries lower extremities using plain and drug-coated balloons (DCBs) for peripheral artery disease in England, France and Germany. Plain balloon angioplasty is reimbursement via DRG solely and DCBs are reimbursement via combination of DRG and add-on reimbursement.
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Update of the NICE-wide Topic Prioritisation manual released in England

On August 25, 2026, the National Institute for Health and Care Excellence (NICE) updated the NICE-wide Topic Prioritisation manual (PMG46), which was initially published in 2024. The manual sets out the process by which new guidance topics and updates to existing NICE guidance are identified, prioritised, and routed within NICE, as well as the decision-making framework used by the NICE prioritisation board. 

The key update concerns the routing of HealthTech topics to technology appraisal as part of the new National HealthTech Access Program (NHAP), which is now clearly described in Annex A of the manual:

  • All HealthTech topics selected by the NICE prioritisation board for routine-use HealthTech guidance development, whether for new guidance or an update to existing guidance, are eligible for consideration of their suitability for NHAP guidance development using NICE's technology appraisal process.
  • The initial assessment of suitability for NHAP is conducted by a newly introduced subgroup of the NICE prioritisation board, the Health Technology Funding Decision Group (HTFG), based on three factors: 1) indicative cost impact and engagement, 2) evidence, and 3) transformation of clinical pathways and services.
  • If the HTFG determines that all assessed criteria are met, the topic is referred to the full NICE prioritisation board for a final routing decision. Formal ministerial approval from the Secretary of State is also required.

Other updates include:

  • Information on what NICE considers to be priority areas for NICE guidance and portfolio maintenance, and clarification about which topics are outside NICE's remit;
  • The introduction of flexibility in routing decisions to support the whole life-cycle approach to guidance. For example, updates can be routed to any guidance-producing programmes and combinations of more than one type of guidance;
  • Clarification of when the NICE prioritisation board will further prioritise the re-evaluation of early-use HealthTech guidance;
  • The merging of the two-stage prioritisation framework into a single-stage framework, while retaining key criteria from both stages, to streamline the topic prioritisation process.

This news is just one of about 300 market access news and updates collected by our team in the premium subscription service MTRC Access Intelligence every week from more than 80 organizations. Access our paid service to stay on top of all developments, specifically for your products in Europe (reimbursement news) and globally (HTA news). Access is organized as an online Database and email alert formats. Contact us to get a free, six-week, no-obligation trial.

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