High-Cost Drug Evaluation: Dutch Institute Reduces Assessment Times for Expensive Medications

In High-Cost Drug Evaluation, the Dutch Healthcare Institute Zorginstituut Nederland, announced that the average duration for assessing expensive hospital drugs from the sluise list decreased by 27 days in 2025 relative to the preceding year, positioning this evaluation phase as roughly one-third of the complete period from European Medicines Agency (EMA) registration through to the conclusion of price negotiations. This development coincides with a reduction in assessment times for pharmacy-dispensed medications, which averaged 92 days in 2025 compared to 110 days in 2024. These advancements highlight the institute’s success in refining its processes to expedite reviews while upholding standards of care.

Strong 2025 Performance

The Zorginstituut achieved an average assessment time of 144 days for expensive sluice drugs in 2025, marking a 27-day improvement, with nearly a third of the 33 sluice drugs processed within 120 days. This progress results from initiatives such as augmenting the number of assessors and refining the examination of pre-dossiers that pharmaceutical companies submit before lodging a formal reimbursement request, which helps preempt issues with incomplete data. Between the beginning of 2023 and the end of 2025, the institute evaluated 170 new medications and expanded indications, of which 34 percent were orphan drugs for rare diseases, with approximately 90 percent, equating to 52 such drugs, classified as providing proven effective care, and half of these necessitating price negotiations. Consequently, these metrics illustrate a commitment to efficient yet meticulous evaluations that facilitate timely decisions on drug inclusion. The results reflect ongoing improvements in High-Cost Drug Evaluation.

Enhanced Pre-Dossier Process

Assessments for admission to the basic benefits package initiate solely after the manufacturer submits the definitive reimbursement dossier to the Zorginstituut, distinguishing this from the EMA registration that grants European market access and often accounts for the prolonged timelines noted by industry stakeholders. Pharmaceutical firms are advised to file a pre-dossier in advance of the full application, enabling the institute to detect deficiencies and thereby diminish the potential for delays arising from absent or insufficient information. By expanding the assessor workforce and conducting a thorough review of the pre-dossier workflow toward the close of 2024, the Zorginstituut has enhanced operational efficiency without sacrificing the thoroughness required to verify the value of new therapies.

Prioritizing Patient Value

The reported efficiencies indicate that drugs demonstrating a fair balance between health gains for patients and society can proceed directly to inclusion in the basic benefits package upon a positive recommendation from the Zorginstituut, eliminating the necessity for price negotiations with the Ministry of Health, Welfare and Sport (VWS) when the proposed price is deemed reasonable. This framework supports accelerated patient access to valuable innovations while exercising selectivity, as noted by chairman Mark Janssen, who remarked that the data show effective care at a reasonable price can be made available quickly, with priority given to medicines offering clear added value rather than pursuing availability of all new agents that may provide limited health or quality-of-life improvements. In the context of health economics and outcomes research (HEOR), these developments encourage pharmaceutical entities to engage proactively with pre-dossier submissions and pursue pricing aligned with demonstrated benefits, fostering more sustainable approaches to High-Cost Drug Evaluation that prioritize both innovation and resource stewardship.