OBJECTIVES: Health technology assessment (HTA) plays an ever-increasing role in reimbursement decisions for novel oncology drugs. This study aims to assess the timelines between market authorisation (MA), the start of patient access and assessment by the Dutch HTA agency (ZIN). As a secondary outcome, the association between orphan status and conditional approval on time until ZIN report will be assessed.

METHODS: We included new active substances that obtained EMA MA between 01-01-2000 and 1-10-2017, had an oncology indication and belonged to the L01 (antineoplastic) ATC category. Timing of HTA recommendation was defined as the release date of the ZIN report and patient access was defined as the start of product sales, with data provided by FarmInform. We used t-tests and linear regression for statistical analysis.

RESULTS: We included 36 products, of which 13 products (36%) had an initial orphan status and 7 products (19%) were conditionally approved. The mean time from MA until HTA was 559 days (median = 244) and the mean time from first patient access until HTA was 261 days (median = 129). Mean time from MA until patient access was 352 days (median = 104). Orphan status was significantly associated with earlier HTA recommendation after both MA (302 vs. 704 days, p=