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Analytical White Papers

Free analytical and research White Papers on the topic of reimbursement, HTA and evidence requirements for medical devices and IVD tests 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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MTRC has released a White Paper featuring an analysis of five HTAs and strategic recommendations for evidence generation strategy in the Netherlands

The Dutch basic health insurance system covers most medical technologies patients or hospitals use. The Dutch Healthcare Institute (ZIN) performs health technology assessments to inform decisions about the coverage status of pharmaceutical and non-pharmaceutical medical technologies. The Ministry of Health makes a final coverage decision based on the recommendations provided by the ZIN.

A decision regarding the compliance of medical technology with the current state of science and practice is based on the quality of evidence weighed together with contextual factors (for example, very serious conditions or a lack of alternatives for the patient). If there is very low-quality evidence on one or more crucial outcomes, indicating uncertainty about whether the intervention leads to clinically relevant effects on outcomes pertinent to the patient, it is generally concluded that the technology does not meet the state of science and practice. However, there are some exceptions, which may be related to contextual factors.

Two types of recommendations are available:

  • Complies with the current state of science and practice (positive);
  • Does not comply with the current state of science and practice (negative).

In this White Paper, we reviewed five cases by ZIN to present the typical evidence requirements for determining coverage with basic health insurance in the Netherlands. A review of five cases is followed by recommendations regarding evidence generation for medical technologies in the Netherlands and factors influencing the decision-making of ZIN. The analysis was performed in January 2024 and updated in December 2024.

Read more and request a White Paper here.