OBJECTIVES: In January 2017, Medicinrådet (The Danish Medicines Council) was established alongside a new appraisal process for the public reimbursement of new hospital drugs (NHDs) in Denmark. Medicinrådet‘s new appraisal process comprises a clinical value assessment for each NHD (with six levels of incremental clinical benefit), plus an economic value assessment. These assessments, together with subsequent price negotiations, inform Medicinrådet’s final reimbursement recommendation, which is implemented by the regional authorities/hospitals. We sought to analyse Medicinrådet’s appraisal process for NHDs and its recommendations to date, and to compare these with the equivalent recommendations of other European HTA bodies.

METHODS: Publicly-available appraisals conducted by HAS (France), G-BA (Germany), TLV and the Novel Therapies Committee (Sweden), and NICE (UK) were analysed from the relevant websites (to 01/04/2018).

RESULTS: Medicinrådet published recommendations for 13 NHDs (most commonly for oncology indications [38%]). Medicinrådet’s clinical value assessments were aligned with those of the HAS and G‑BA in 63% and 70% of cases, respectively. The majority of NHDs (85%) received a positive reimbursement recommendation from Medicinrådet. Only 2 NHDs (15%) were not recommended, with the decision not to recommend based primarily on cost. Medicinrådet’s final recommendations were aligned with those of the TLV/NT Committee and NICE in 80% and 71% of cases, respectively. On average, Medicinrådet took 15.7 weeks to publish its recommendation after manufacturers’ final application; however, manufacturers rarely applied for reimbursement at the earliest opportunity (CHMP opinion) leading to delays in access from the point of regulatory approval.

CONCLUSIONS: The new appraisal process offers national public reimbursement recommendations for new NHDs. Most outcomes to date have been positive, relatively rapid, and broadly aligned with those seen in other European countries. Manufacturers should take advantage of the opportunity to apply for reimbursement immediately after CHMP positive opinion to achieve earlier market access for NHDs in Denmark.