OBJECTIVES:

The Danish Medical Council (DMC) assesses hospital drugs and publishes recommendations on use. The objective was to describe the DMC evaluations and decisions made since its inception and to investigate grounds for negative recommendations.

METHODS:

All 178 decisions available on the DMC website on 1st June 2022 were reviewed. Data extracted included product and indication specifics, date of preliminary application and decision, DMC subject committee, decision outcome and case processing time. Further information was collected about the grounds of non-recommendation of products which were coded as four categories for analysis: unacceptable side effects, unacceptably high price, uncertainty in the health economic evaluation, and worse clinical effect than current treatment.

RESULTS:

Of all assessed drugs, 51% were recommended, 17% partially recommended and 32% were not recommended. Of the decisions, only 8 were assessed according to the updated 2021 DMC guidelines (4 applications included cost-effectiveness analyses and 4 cost-minimisation analyses). Most (98%) of the remaining applications underwent a health professional assessment (focusing on the value of the drug) and all decisions but one reassessment included an economic analysis (cost analysis and budget impact analysis). The majority (54%) of all 178 evaluated drugs were oncology treatments. The average reported processing time for all decisions was around 112 days, with no statistically significant difference based on their outcome. The average reported time was 139 days for the 8 products assessed according to the new 2021 guidelines. Regarding non-recommended drugs (57 decisions), 72% of the decisions mentioned unacceptably high prices. 32% applicant drugs were deemed worse than the current standard of care, while uncertainty and unacceptable side effects were discussed in 28% and 12% of rejections respectively.

CONCLUSIONS:

The DMC process takes into account multiple dimensions of value in its assessment, with the health benefit of medicines and their price being key criteria for obtaining a recommendation.