New assessment method for medicines and the use of non-published data in the Danish Medicines Council
The Danish Regions have decided that as of October 2020, the Danish Medicines Council is to use the QALY measure for assessment of new medicinal products, and that with immediate effect the Danish Medicines Council will be able to include non-published data in its assessment of the medicines' effect.
At a supervisory board meeting on 21 November 2019, the Danish Regions have adopted seven changes to the assessment methods of the Danish Medicines Council. The changes are a result of an external evaluation back in May 2019 of the Danish Medicines Council's assessments.
Among other things, the changes entail that as of October 2020, the Danish Medicines Council is to use the QALY measure for its assessment of whether to recommend new hospital medicines as the standard treatment. This measure is already being used in England, Norway and Sweden, and it will increase the processing time from 12 weeks to 16 weeks. The Organization of Danish Medical Societies, Danish Patients and the Danish Association of the Pharmaceutical Industry will be given the opportunity to provide input on the new measure as an expert monitoring group. Subsequently, the draft QALY measure manual will be going out for consultation to the relevant interested parties.
Moreover, the changes entail that with immediate effect the Danish Medicines Council can include relevant non-published data in its assessment of the effect of the medicines. The Medicines Council must establish its own criteria regarding the use of these data. Another change entails that in future the Medicines Council must keep records of the time it takes from the receipt of the preliminary application to the receipt of the final application from the pharmaceutical companies, and that in future the Medicines Council must also prepare several therapeutic instructions in fields where there are several medicines to choose from.
You can read more about the changes here
You can read more about the evaluation of the Danish Medicines Council and the subsequent process in our previous newsletters:
"Evaluering af Medicinrådet - hvad bibringer fremtiden?" (in Danish)