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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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Methods and processes for HTA and recommendations by the Danish Healthcare Quality Institute

The Danish Healthcare Quality Institute (DHQI) is a national body established in 2025 by the Danish Regions to strengthen quality and prioritization in the healthcare system. A central task of DHQI is to assess treatment methods (i.e., health technologies, procedures, diagnostics, rehabilitation, prevention, and organizational models), with the aim of optimizing resource use, freeing up staff capacity, and discontinuing interventions that do not provide sufficient value to patients.

In April 2026, DHQI released its first Method and Process Guide for Health Technology Assessment (HTA). The guide describes the processes and methodological approaches used to produce both HTA and commented HTA. It also defines the role of the DHQI Council as the decision-making body responsible for issuing HTA-based recommendations to the regions on national prioritization and implementation of treatment methods. It clarifies the distinction between HTA as a knowledge product and the Council’s recommendations as a separate decision output.

The document clearly distinguishes between two products:

  • HTA, which is a knowledge product developed as an original analysis within DHQI using its defined methodology.
  • Commented HTA refers to a product in which DHQI reviews and assesses an existing international HTA (such as Norway, Sweden, and Finland) to evaluate their applicability in a Danish setting. 

The process follows a staged structure with defined responsibilities: 

  • In the proposal phase, topics are identified and selected. While the process differs slightly between HTA and commented HTA, in both cases, the DHQI Council appoints an expert committee and recommends initiation.
  • In the assessment phase, DHQI’s project group and expert committee develop protocols and carry out the HTA or commented HTA. The HTA methodology is based on structured frameworks such as PICO/PIROT and covers clinical effectiveness, safety, patient perspectives, organizational aspects, and health economic evaluation.
  • In the decision phase, the DHQI Council issues recommendations or advisory statements. For HTA, this may include recommendations on adoption, continued use, or phase-out of interventions. For commented HTA, recommendations may be issued if the evidence is transferable; otherwise, the Council may provide an advisory statement; the Council may also request additional analyses, such as de novo health economic or budget impact analysis adapted to Danish conditions. Final recommendations and supporting documents are shared with the regions and other relevant stakeholders (e.g., municipalities or professional societies).
  • In the implementation phase, responsibility lies with the regions, which are expected to follow the recommendations unless there are justified reasons not to.

The full details in Danish can be found 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.