OBJECTIVES: The National Centre for Pharmacoeconomics (NCPE) conducts the health technology assessment (HTA) of drugs for the Health Service Executive (HSE) in Ireland. Drugs are initially subject to a preliminary Rapid Review (RR). Drugs with a high cost relative to potential comparators, a net impact on the drugs budget and/or uncertainty in relation to comparative clinical and cost-effectiveness are selected for formal HTA. In recent years there have been delays in time to reimbursement for certain drugs. This work aims to examine timelines in the different stages in the reimbursement process.

METHODS: A retrospective analysis of RRs and HTAs submitted to the NCPE between 2012 and 2017 was performed. Several dates were recorded for each drug including date of first marketing authorisation, date the RR was completed, start and finish date of the HTA (including time with NCPE and time with manufacturer), and date of reimbursement. Other details such as orphan status, reimbursement scheme and therapeutic area were also recorded.

RESULTS: A total of 281 RRs were included in the analysis, comprising of 250 different drugs. The average time taken by the applicant from market authorisation to submitting a RR was 282days (median 80; SD 570 . On average the NCPE took 30 days (median 28; SD 18)to complete the RR. Of 281 RRs, 135 (48%) resulted in a recommendation for full HTA. On average the NCPE took 184 days (median 174; SD 76) to complete the review of the full HTA from date submitted, and comprised of 30% of time with company and 70% of time with NCPE.

CONCLUSIONS: This work has demonstrated that delays in the reimbursement process are multifactorial and may be attributed to different stages in the reimbursement process, including reimbursement application by the manufacturer, the HTA process and the final reimbursement decision making process.