QALY is approved and will apply from 1 January 2021
Back in May 2020, the final implementation of the Danish Medicines Council's portended assessment model, QALY, was postponed to 1 January 2021, due to the COVID-19 situation. The Board of the Danish Regions has now approved the model.
The new QALY model will apply to applications, in which a request for assessment of a medicinal product is submitted from 1 January 2021, while the Danish Medicines Council's previous process and method will remain in effect for assessments of provisional applications submitted prior to 1 January 2021.
In its assessment of whether to recommend new hospital medicines, the Danish Medicines Council must - in addition to the QALY model - still use the Danish Parliament's seven principles for prioritising hospital medicines. In addition to that, the principles of severity and caution may also be included in the assessment.
Assessing medicines according to the QALY model is more complex and, consequently, transition to the model means that the review process will be increased from 12 weeks to 16 weeks going forward.