OBJECTIVES : Differences in time between EMA marketing authorisation and reimbursement evaluations (i.e. “time-to-recommendation”), and the likelihood of acceptance for (orphan-)oncology drugs across European countries exist. In this study, the recommendation-making process was evaluated, from EMA approval to reimbursement recommendations in the UK, Scotland, Germany, and France for (orphan-)oncology drugs.

METHODS : (Orphan-)oncology drugs approved by EMA between January 2010 - January 2019 were selected. A database was created containing the dates of EMA approval and HTA reimbursement recommendations, and the type of recommendation (yes/restricted/no). Median time-to-recommendation was calculated per indication and country. Time-to-recommendation, type of recommendation, and the likelihood for a positive recommendation were analysed and compared using Kaplan-Meier curves.

RESULTS : In total, 94 drugs for 122 indications received marketing authorisation by EMA. Between 2010-2019 an increase of EMA approvals for oncology indications was observed, especially for orphan-oncology indications. The median time-to-recommendation was shorter for orphan-oncology indications (6 months) than oncology indications (7 months) in Germany, while the opposite was the case in France, UK and Scotland. The Scottish agency published reimbursement recommendations as first in 42% of the cases, followed by France (40%; corrected by number of recommendations per country). The Scottish agency had the lowest positive recommendation rate (67%), followed by the UK (80%). However, for 2/3 of the positive recommendations the UK agency restricted the EMA indication for reimbursement.

CONCLUSIONS : These results indicate that time needed for reimbursement recommendations of (orphan-)oncology indications differ between the EU countries. The German agency tend to make quicker recommendations on orphan-oncology indications than the other agencies. The Scottish agency seems to be first in providing reimbursement recommendations. The UK agency restricts the most EMA indications for reimbursement. Factors influencing this recommendation-making process are being studied to enhance the understanding of reimbursement trends in (orphan-)oncology products.