OBJECTIVES: The National Centre for Pharmacoeconomics (NCPE) conducts the health technology assessment (HTA) for all drugs seeking reimbursement in Ireland. All new drugs are subjected to a rapid review (RR). Following this, drugs which are high cost or predicted to have a significant budget impact are then subjected to undertake a full HTA. The objective of this paper is to quantify each stage of the timeline from marketing authorisation (MA) to completion of HTA and explore the association between features of submissions (including orphan and cancer status) and the time to complete RRs and HTAs.

METHODS: All RRs and HTAs submitted to the NCPE (RR commissioned 2021 to 2022 inclusive) were included in the dataset. A number of dates and features (cancer medicine and orphan status) of each submission were also listed for the purpose of analysis. Descriptive statistics (median, interquartile range) were calculated for overall timeline and each stage in the process. Timelines were compared for cancer, orphan and other medicines with Kolmogorov–Smirnov tests used to assess differences.

RESULTS: The median time from MA to submission of RR was 95 days. 29% (42/145) of RRs were submitted within 30 days of MA being granted. Median time to complete the RR was 30 days. Only 41% (60/145) of RRs completed were recommended for HTA. Median time from HTA commissioning to submission was 212 days. Median time taken to complete full HTA was 275 days.

CONCLUSIONS: This work identifies which stages of the process make a substantial contribution to the HTA timeline. The efficiency of the two-step process is highlighted, as it is successful at preventing unnecessary HTAs being carried out when a RR is sufficient to make a reimbursement recommendation.