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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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White Paper: Evidence Requirements for Interventional Procedures Program at NICE in the United Kingdom

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White Paper: Evidence requirements for Med Tech Early Value Assessment at NICE in the United Kingdom

Get insights from MTRC White Papers to explore the analysis of five HTAs of digital and diagnostic technologies and strategic recommendations for evidence generation strategy in the UK

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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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NICE implemented a new HealthTech program in England

On July 14, 2025, NICE published a HealthTech program manual that outlines the processes and methods NICE will use to evaluate health technologies and interventional procedures. 

A new HealthTech program will produce two types of guidance:

  • HealthTech guidance will replace Medical Technologies guidance and Diagnostics guidance. The HealthTech (often used interchangeably with “MedTech”) guidance will cover non-medicine technologies, such as diagnostics, medical devices, and digital technologies, including AI. The program will make recommendations based on the assessment of the clinical and cost-effectiveness. 
  • Interventional Procedures guidance (IPG) scope will remain as it is, covering procedures that involve making an incision, puncture, or entry into a body cavity or using ionizing, electromagnetic, or acoustic energy. Recommendations are made based on assessing the efficacy and safety of new, significantly modified, or established procedures. Although some interventional procedures can involve implanting or using a health technology, the guidance and recommendations are about the procedure.

NICE will utilize a life-cycle approach to assessment and recommendations in the HealthTech program: 

For early use

  • For HealthTech guidance, this approach considers HealthTech products that could address a national NHS unmet need. It rapidly assesses products early in the lifecycle (but that have appropriate regulatory approval for use in the UK) or that have limited use in the NHS and need further evidence to support wider use. Technologies considered for early use can be conditionally recommended for use while further evidence is generated during the evidence generation period. This enables early access to promising new technologies for patients. Conditional recommendations are for a fixed period of time, and the technologies will be reassessed for routine use based on the evidence generated;
  • For IPG, new or significantly modified procedures can be conditionally recommended for use while more evidence is generated to check if they are safe and efficacious.

For routine use

  • For HealthTech guidance, the approach considers HealthTech products that address a national NHS need and may be suitable for routine, widespread use in the NHS. Recommendations are based on assessment of clinical and cost effectiveness, or cost comparison;
  • For IPG, a recommendation is made that the procedure can be used if there is enough evidence on the safety and efficacy of the procedure for healthcare professionals to consider it an option.

For existing use

  • This approach considers HealthTech products that are already in established use within the NHS to inform commissioning and procurement decisions. The process is outlined in the late stage assessment (LSA) manual.

Four types of recommendations can be made:

  • Can be used (meaning routine NHS use);
  • Can be used during the evidence generation period (conditional recommendation);
  • More research is needed (limited to research settings);
  • Should not be used (due to lack of safety, efficacy, or cost-effectiveness).

See the full details here.

This news is just one of about 300 market access news collected by our team in the premium subscription service Market Access Monitor 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, three-month, no-obligation trial.