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Reimbursement strategy

Market Access Strategy for Medical Devices in Europe

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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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A new coverage with evidence development scheme is expected in the Netherlands

In July 2025, the Dutch Healthcare Institute (ZIN) announced the establishment of a new program, “Reimbursement within Research” (Vergoeding in Onderzoek). This scheme allows the temporary continuation of reimbursement from basic health insurance for existing care with limited evidence of effectiveness, provided that research into its effectiveness is actively conducted. The policy will apply to medical specialist care, paramedical care, and medical devices.

This new program is based on the same principles as the “Conditional Reimbursement program.”

On October 30, 2025, ZIN published the plan for implementing the program, which defines the processes, assesses feasibility, and estimates the potential risks of the “Reimbursement within Research” program for the calendar years 2025-2032. In the document, ZIN defined the selection criteria for care to be included in the program:

  • A treatment is only eligible for the program if ZIN concluded in a draft version of its assessment that the treatment does not meet the criterion of “the state of science and practice” due to insufficient evidence regarding the effectiveness of the care for the target patient group. This is necessary so that patients receive the care only at participating research centers;
  • The procedure concerns medical care (excluding medicines placed in the lock), paramedical care, or medical aids;
  • The procedure is already reimbursed from the basic health insurance for a large portion of the patient population;
  • It is a treatment that, based on the available evidence, parties (such as healthcare providers, caregivers, and patients) believe adds value to the studied target group; 
  • It concerns a treatment with a significant social impact.

According to the document, ZIN will implement the program jointly with the Dutch Organization for Health Research and Development (ZonMw). The costs of the treatment will be covered by the basic health insurance, and the associated research costs can be funded through the Appropriate Care Framework Program. The duration of the projects under the program is defined as four years, with the possibility of extension to seven years for projects that require a longer duration. 

After the research project has concluded, ZIN will assess whether the effectiveness of the care has been sufficiently demonstrated based on the study results and a systematic review of the international literature. If the assessment is positive, the treatment will remain covered within the basic health insurance; if the assessment is negative, the treatment will be removed from the basic health insurance.

The Minister of Health, Welfare, and Sport will consider the ZIN implementation plan and decide whether to initiate the “Reimbursement within Research” program.

The program's launch is planned for the fourth quarter of 2025.

The full details in Dutch can be found here and here.

This news is just one of about 300 market access news collected by our team in the subscription services "HTA Alerts" and "Reimbursement Alerts" every two weeks from more than 80 organizations. Access our paid subscription services to stay on top of all developments specifically for your products in Europe (reimbursement news) and globally (HTA news). Contact us to get a free, three-month, no-obligation trial.