Clinical evidence requirements for determining coverage with basic health insurance for medical technologies 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.

Medical technologies should meet the following eligibility criteria in order to be evaluated for coverage with basic health insurance in the Netherlands:

• Determination for basic insurance coverage is assessed based on necessity, effectiveness, cost-effectiveness, and feasibility;
• Medical technology that complies with the state of science and practice criteria is reimbursed under the basic health insurance package; 
• Sufficient and appropriate evidence of the clinical benefit, i.e., does the intervention work for the claimed indication;
• Sufficient and appropriate evidence of the cost-effectiveness of the medical technology;
• The intervention of interest should lead to added value for the patient compared to the current standard of care in the Netherlands.

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.