Guideline for economic evaluations in healthcare
An economic evaluation provides insight into the relationship between the effectiveness of a treatment and the costs that must be incurred to achieve this effect. This is called 'cost-effectiveness', and is a criterion that helps make choices in healthcare. In order to keep healthcare affordable and accessible for everyone, it is important that a good balance is made between the effects and costs of new interventions in healthcare. The guideline helps with this. We published a revised guideline in January 2024.
In-depth modules for the guideline
The guideline includes 3 in-depth modules, explaining certain topics in more detail:
- The costing manual focuses on the identification, measurement and valuation of costs used in economic evaluations.
- The in-depth module 'QALY and quality-of-life measurements' focusses on measuring health-related quality of life and the various instruments that can be used for this. This document is only available in Dutch.
- The in-depth module 'Uncertainty and Value of Information analyses' focuses on uncertainty, probabilistic analysis and Value of Information analyses. This document is only available in Dutch.
Scope of the guideline
The guideline forms the starting point for conducting economic evaluations of healthcare interventions. This may concern medicines, but also surgical procedures, medical devices or other types of interventions. It is important that economic evaluations are carried out in an unambiguous manner, so that a comparison between different interventions is possible.
Exemption from a pharmacoeconomic evaluation
In individual cases, the National Health Care Institute can grant an exemption from the obligation for an extensive pharmacoeconomic evaluation as part of the reimbursement dossier. This mainly concerns an application for inclusion on list 1B in the GVS or an extension of the additional conditions.
The National Health Care Institute carries out a pharmacoeconomic assessment of extramural medicines, if in 1 of the first 3 years after market introduction:
- the total costs (macro costs) are € 10 million or more per year; or
- the total costs (macro costs) are between €1 million and €10 million per year, with costs per patient per year of €50,000 or more.
If these 2 criteria are not met, a pharmacoeconomic exemption may be granted. The registration holder must submit a written request to the National Health Care Institute, with an accompanying letter and an extensive budget impact analysis, and including all relevant literature.
It is recommended to submit the application for exemption 2 months prior to the desired date of the preliminary consultation. The National Health Care Institute can only schedule a preliminary consultation if there is clarity about the necessity of a pharmacoeconomic analysis. If the exemption is rejected, a pharmacoeconomic evaluation must still be added to the preliminary dossier.