OBJECTIVES

: In 2017, a new health technology assessment (HTA) body (Medicinrådet (MR)) was established in Denmark, with the goal of quick and efficient HTA-review of all medicines used in the hospital sector. An assessment of the actual timeline achieved in comparison to the proposed review timeline is warranted.

METHODS

: When established, MR published a handbook outlining the time for different steps in the HTA review process from first interaction between supplier and MR to the final decision. Notably, the handbook outlined timelines for two steps in which the procedure is arguably in the hands of the MR and not the supplier. Specifically, it estimated the time between the preliminary application and the MR produced protocol, as well as the time between final application and final decision. Our analysis investigated all ongoing submissions and final decisions to compare actual timelines with the ambition.

RESULTS

: The MR handbook outlined the timelines between preliminary application and MR produced protocol (time1) to 4 weeks, and the time between final application and decision (time2) to 12 weeks. As of 30 January 2018, there are 30 ongoing procedures under review, of which 18 protocols have been produced, and additional 5 final decision have been made. The average time1 is 73.2 days, which is more than double the projected timeline. For time2 the average time is 96 days, which is about 2 weeks more than the ambition.

CONCLUSIONS

: In the first year MR has not met the timeline expectations outlined in its handbook, especially the time to produce the mandatory MR protocol is more than doubled of what was envisioned. It remains to be seen if this is a start-up time cost, or if a lengthy HTA review will in practice be the new reality for patient access to new hospital drugs in Denmark.