News from the Danish Medicines Council - reassessments must be made according to the QALY measure as of 1 June 2022
The Danish Medicines Council has just announced that come 1 June 2022, the Council will make reassessments according to the new assessment methods comprising the QALY measure. This will apply for all recommendations - regardless of when they were made.
The Medicines Council started using the new assessment models on 1 January 2021. These models include the use of the QALY measure, involving the systematic use of quality of life data in the assessment of a medicinal product's worth for the patients. QALY refers to quality-adjusted life years, and it is standardized measure combining the patients' quality of life and length of life into a single number.
The new assessment models - and thus the QALY measure - are used for applications requesting assessment of a medicinal product filed as of 1 January 2021.
Starting 1 June 2022, recommendations must also be reassessed according to the new assessment models regardless of when the original recommendation was made.
If a reassessment of a recommendation made under the former method is requested after 1 June 2022, applicant must file a new application, which still has to follow the new methods, including the QALY measure.