News from the Danish Medicines Council - reassessments must be made according to the QALY measure as of 1 June 2022

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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. 

You can read the Medicines Council's announcement (in Danish) regarding reassessments under the new assessment models/the QALY measure here

Read the Danish Medicines Council's previous announcement on the approval of the new QALY measure here (in Danish)

Read Plesner's previous insight on the implementation of the QALY measure here 

Read Plesner's previous insight on the QALY measure here