OBJECTIVES: Beginning January 2021, a new HTA process in Denmark required health economic evaluations within submissions to the Danish Medicines Council (DMC) for publicly financed inpatient medicines and/or indication extensions. Any HTA submission prior to January 2021 continued to be evaluated under the old process. The transition to the new DMC HTA processes was evaluated.

METHODS: All new-process DMC submissions were evaluated to estimate durations between distinct markers along the new HTA pathway. Furthermore, monthly rates of DMC reimbursement decisions were reviewed to estimate when the transition to the new HTA process would complete.

RESULTS: As of June 2022, 74 full new HTA processes (i.e., including cost-minimization or cost-effectiveness analyses) have been initiated by manufacturers and the DMC has accepted 24 completed submission packages, averaging 255 days post initiation to completion. Of the 24, the DMC has completed reviews of 12, averaging 103 days per completed review. This equates to an average rate of 1.4 completed reviews per month since the first. Only 8 reimbursement decisions have been made based on these submissions, taking an average 41 days following the DMC’s completed review (including confidential price negotiations). Of 4 cost-minimization-based applications, 3 decisions were positive. Of 4 cost-effectiveness-based applications, 2 decisions were positive and 1 was partially positive. There were 59 old processes initiated when the transition to the new process took place, of which the monthly clearance rate of reimbursement decisions has been 3.8.

CONCLUSIONS: The transition to the new HTA process is likely to be complete in Q4 2022. However, given the rate of completion of manufacturers’ submissions and the rate of DMC reviews of completed new process submissions, it is likely to take some time before the rate of reimbursement decisions under the new HTA process is equal to that of decisions made under the old process.