How Netherlands HTA works
Zorginstituut Nederland (the National Health Care Institute) advises the Minister of Health, Welfare and Sport (VWS) on what belongs in the basic health insurance package. The Minister takes the reimbursement decision. The route depends on where the medicine is used.
Outpatient medicines are reimbursed only once they are included in the Medicine Reimbursement System (GVS). The GVS has three lists. List 1A holds interchangeable medicines, clustered and subject to a reimbursement limit, so the patient pays any excess above it. List 1B holds medicines that are not interchangeable, with no reimbursement limit. List 2 adds conditions to a 1A or 1B listing, for example restricting use to specific patients. The statutory period from acceptance of the application to the decision is 90 days, and the clock can be stopped when further information is requested.
Hospital medicines normally enter the package without a prior assessment. The lock procedure (sluis) allows the Minister to hold back a new, very expensive medicine until it has been assessed and a price has been agreed. Zorginstituut advises on candidates, informed by the Horizon Scan for Medicinal Products. A medicine qualifies if its new indications are expected to cost 20 million euros a year or more nationally, or if one indication costs 10 million euros or more a year at 50,000 euros or more per patient per year. Only the cost of the medicine itself counts.[1]
Zorginstituut is advised by the Scientific Advisory Board (WAR), through its Medicinal Products Committee, on clinical and cost-effectiveness questions, and by the Insured Package Advisory Committee (ACP) on societal considerations.
Zorginstituut assesses therapeutic value; a new List 1B medicine with added value also needs a pharmacoeconomic evaluation and budget impact analysis. Statutory period: 90 days.
Minister decides on inclusion in List 1A or 1B, with any List 2 conditionsThe Minister can place a medicine in the lock at 20 million euros or more a year, or 10 million euros or more for one indication at 50,000 euros or more per patient a year. Zorginstituut assesses the four package criteria.
Minister can hold pricing discussions; release once price and appropriate use are agreedFrom assessment to price agreement
For GVS listing, Zorginstituut first assesses therapeutic value against standard treatment in the Netherlands, weighing favourable and unfavourable effects most heavily. Costs play no role at that stage. For a new List 1B medicine with a claimed added therapeutic value, the dossier must also contain a pharmacoeconomic evaluation and a budget impact analysis. An exemption from the pharmacoeconomic evaluation can be requested where expected costs stay at or below 10 million euros a year over the first three years.
In the lock procedure, the company submits a complete dossier once the medicine is placed in the lock. Zorginstituut assesses it against the four package criteria: necessity, effectiveness, cost-effectiveness and feasibility. A positive advice states whether a price reduction is needed and what appropriate use looks like. The Minister can then hold pricing discussions with the company, and the medicine is released once it is judged worth its price and appropriate use has been agreed. Many of these financial arrangements contain confidential discounts.
Economic evaluation and reference values
Zorginstituut's 2024 guideline for economic evaluations in healthcare sets the reference case:[2]
- Perspective: societal, with other perspectives as scenarios
- Analysis: cost-utility analysis, with QALYs from the EQ-5D-5L valued with the Dutch tariff (EQ-5D-Y for children aged 8 to 12)
- Comparator: standard or usual Dutch practice, plus the most cost-effective option where that differs
- Time horizon: lifetime for model-based evaluations
- Discounting: 3% for costs and 1.5% for effects
- Costs: methods and reference prices from the costing manual module; healthcare costs in life-years gained are included; productivity losses valued with the friction cost method; informal care valued at replacement cost
- Uncertainty: results based on the probabilistic analysis, with deterministic and scenario analyses and value of information analysis for models
Zorginstituut interprets the incremental cost-effectiveness ratio against reference values that rise with disease burden, measured by proportional shortfall. They are reference points, not cut-offs, and an ICER above them is not by itself a reason to refuse reimbursement.[3]
| Disease burden (proportional shortfall) | Reference value |
|---|---|
| 0.1 to 0.4 | Up to 20,000 euros per QALY |
| 0.41 to 0.7 | Up to 50,000 euros per QALY |
| 0.71 to 1.0 | Up to 80,000 euros per QALY |
Because the disease burden estimate sets the reference value, it deserves the same care as the ICER. See health economic modelling.
| Expected remaining QALYs without the disease (same age and sex) | 20.0 |
| Expected remaining QALYs with the disease, on standard treatment | 7.0 |
| QALYs lost to the disease | 20.0 − 7.0 = 13.0 |
| Proportional shortfall | 13.0 / 20.0 = 0.65 |
| Disease burden band | 0.41 to 0.7 |
| Reference value | Up to 50,000 euros per QALY |
An ICER of 42,000 euros per QALY would sit within the reference value for this burden band.
Figures are invented for illustration. Reference values are reference points, not cut-offs, and Zorginstituut weighs them with the other package criteria.
Conditional inclusion
For orphan medicines and medicines with conditional or exceptional EMA approval, where there is an unmet medical need and the evidence is not yet sufficient, Zorginstituut runs a conditional inclusion route (voorwaardelijke toelating). The company applies with an independent research institution, the professional group and patient organisations, and the research must be able to answer the package question within the term, usually up to seven years. Inclusion also requires a price arrangement with VWS. The company bears the research costs, a supporting registry is required, and a final assessment dossier is due no later than six months before the term ends.
How the EU JCA interacts with Dutch assessments
The EU-wide phase-in dates are set out in our HTA requirements comparison. Member States must give due consideration to published joint clinical assessment reports and must not request at national level evidence already submitted at Union level. The reports contain no value judgement on added clinical value.
Zorginstituut states that it takes the JCA into account when drafting its assessment reports, while the conclusion on added therapeutic value, the pharmacoeconomic report, the budget impact analysis and the advice to the Minister remain national. The Dutch comparator and patient population therefore need to be mapped against the JCA PICOs early. Our EU JCA dossier work is planned that way.[4, 5]
What we deliver
- Early evidence planning against Dutch standard treatment and the likely JCA PICOs
- GVS dossiers, including the case for List 1B and any List 2 conditions
- Lock procedure dossiers addressing the four package criteria
- Cost-utility models to the 2024 guideline, or adaptation of global models to the Dutch reference case and costing manual
- Disease burden calculations by proportional shortfall
- Budget impact analyses and exemption requests
- Indirect treatment comparisons and network meta-analyses
- Evidence to inform pricing discussions and appropriate-use agreements
What assessors look for
- A comparator that reflects actual Dutch practice, not only the trial control arm
- A transparent, defensible disease burden estimate, since it moves the reference value
- Full societal costs, including productivity losses by the friction cost method and medical costs in life-years gained
- Probabilistic results and value of information analysis, not a deterministic ICER alone
- A budget impact analysis consistent with the patient numbers in the clinical dossier
Why Evidaxia
We bring HTA experience from the assessor's side, including technical lead work at NICE, together with EU JCA dossier work covering PICO scoping, indirect comparisons and network meta-analyses, and global model adaptation. That EU-level work is built to feed national processes such as Zorginstituut assessments, and we bring it to Dutch submissions alongside your local market access team.
References
- Zorginstituut Nederland. Lock procedure for expensive medicinal products [Internet]. Diemen: Zorginstituut Nederland; [date unknown] [cited 2026 Oct]. Available from: https://english.zorginstituutnederland.nl/about-us/working-methods-and-procedures/lock-procedure-for-expensive-medicinal-products
- Zorginstituut Nederland. Guideline for economic evaluations in healthcare [Internet]. Diemen: Zorginstituut Nederland; 2024 [cited 2026 Oct]. Available from: https://english.zorginstituutnederland.nl/documents/2024/01/16/guideline-for-economic-evaluations-in-healthcare
- Zorginstituut Nederland. Cost-effectiveness in practice [Internet]. Diemen: Zorginstituut Nederland; 2015 [cited 2026 Oct]. Available from: https://English.zorginstituutnederland.nl/binaries/zinl-eng/documenten/reports/2015/06/16/cost-effectiveness-in-practice/Cost-effectiveness+in+practice.pdf
- Zorginstituut Nederland. FAQ on the EU HTA Regulation [Internet]. Diemen: Zorginstituut Nederland; [date unknown] [cited 2026 Oct]. Available from: https://zorginstituutnederland.nl/binaries/zinl/documenten/publicatie/2024/06/12/veelgestelde-vragen-eu-htar/FAQ+over+de+EU+HTAR.pdf
- Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU. Official Journal of the European Union. 2021 Dec 22;L458:1-32. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32021R2282
Sources reviewed October 2026. Methods and procedures change; check the latest agency guidance before submission.