The Zorginstituut Nederland (Dutch National Health Care Institute) has introduced a significant reform in the pharmacoeconomic evaluations Nederland framework. The changes are outlined in a concept report detailing adjustments to structure and content for pharmaceuticals under reimbursement consideration. Effective from September 1, 2025, the core innovation is a revised main report format. It now features an executive summary and two structured appendices. One appendix focuses on the registration holder’s methods and results. The second catalogues discussion points systematically classified by relevance and impact.
Under the new model, the main report will present only a concise summary. Detailed methodological and outcome information will now reside in the appendices. Appendix A encapsulates the registration holder’s (generally the pharmaceutical company’s) analysis. It defines core components such as Population, Intervention, Comparator, Outcomes, Time horizon, and Setting (PICOTS). It also includes model structure and validation, cost assumptions, health outcomes like QALYs (quality-adjusted life years), and key base case results. This framing ensures accessibility to a wider professional audience.
Appendix B organizes significant discussion points identified by reviewers in the registration holder’s analysis. These issues are classified as ‘major’ or ‘minor’. Major issues could compromise model validity, like misrepresenting the Dutch treatment population. Minor issues involve less critical aspects, such as minor demographic variations. This distinction guides applicants on which methodological shortcomings require remediation to avert negative reimbursement recommendations.
This structured, transparent method serves several vital purposes. It clarifies the criteria for methodological rigor and decision-making. This makes the evaluation process more straightforward for stakeholders, including pharmaceutical sponsors, clinicians, and policymakers. By highlighting methodological flaws and emphasizing sensitivity and scenario analyses, Zorginstituut seeks to foster consistency and robustness in pharmacoeconomic evaluations. These evaluations support General Reimbursement System (GVS) decisions and specialist drug reviews.
Aligning with Global Standards in Health Technology Assessment
The new approach mirrors ongoing trends in health technology assessment (HTA) internationally. The demand for transparency, replicability, and structured critique mechanisms is increasingly prominent. Similar structured HTA reporting methods are seen in agencies like the UK’s NICE and Canada’s CDA. However, the Dutch model stands out by deliberately separating summary, methods, and discussion points. This showcases rigor and accessibility.
The newly structured report will likely impact pharmaceutical market access and the pricing and reimbursement landscape in the Netherlands. Sponsors must prepare for a more rigorous, transparent, and dialogue-driven evidentiary review. Strengths and weaknesses of economic models will be explicitly catalogued and need proactive addressing. This transition is expected to enhance submission quality, promote alignment with Dutch clinical practice, and mitigate ambiguities in economic evidence interpretation.
Moreover, the process fosters better stakeholder engagement. It offers all parties—including clinicians and payers—a clear, structured insight into methods and critiques. This refinement aligns with global trends towards evidence-based, value-driven health care access decisions. It may further spur methodological innovation, such as customizing cost-effectiveness models or employing advanced uncertainty analyses.
In summary, the transition initiated by Zorginstituut Nederland reflects national policy goals and broader international movements in health technology assessment. This model is anticipated to enhance decision-making consistency, spur methodological innovation, and build greater engagement and trust among key stakeholders. For comprehensive insights into the new evaluation format, you can explore the full details in the original report by Zorginstituut Nederland here.
