The Danish Medicines Council to use new assessment method for medicines and the use of non-published data will be allowed
Following a board meeting yesterday, the Danish Regions plan to change of the way the Danish Medicines Council assesses medicines and to allow the use of non-published data in the medicine assessments. The changes will not be implemented until the relevant interested parties have had opportunity to comment on them.
Firstly, the changes entail that in future, the Danish Medicines Council will have to assess medicines according to the so-called QALY measure, which calculates the effect of the medicine against its price. The Danish Regions hope to increase the transparency of the decisions of the Medicines Council with the new method. However, using QALY will increase the processing time from 12 to 16 weeks, as the QALY method is more complicated than the previously used assessment of the added clinical value.
Secondly, with the changes the Medicines Council will be able to use non-published data in their medicine assessments in future. It will therefore also be possible to include non-published data in the Medicines Council's assessment of orphan drugs.
The reason for the change
In May 2019, the Danish Medicines Council was evaluated concluding that the council fulfilled its purpose and respected the principles set out by the board of the Danish Regions and the Danish Parliament. However, the report also found that was room for improvement in several areas.
Following up on the evaluation, the board of the Danish Regions identified five focus areas for the Medicines Council going forward: 1) The case review time limits should be changed; 2) new treatment guidelines should be prioritized; 3) more transparent case review times; 4) the use of non-published data in the assessment of orphan drugs; and 5) the pros and cons of changing the assessment of the effect of medicines from added clinical value to Quality-adjusted life year (QALY).
The relevant interested parties were then given the opportunity to comment on these focus areas, and during yesterday's meeting the board discussed said comments resulting in the Danish Regions' proposal to change the medicines assessment and allow the use of non-published data. The Danish Regions do not mention the other three focus areas specifically, but point out that it is important to prioritize the new treatment guidelines.
Plesner will follow the future developments in the Medicines Council closely and we will provide updates regularly.
Read Plesner's previous newsletter on the evaluation of the Danish Medicines Council here (in Danish).Read the report "Evaluering af Medicinrådet" here (in Danish).