HTA and Reimbursement Timelines in the Republic of Ireland

OBJECTIVES: The aim of this study was to evaluate trends in timelines to reimbursement for medicines that have been evaluated by the National Centre for Pharmacoeconomics (NCPE) in Ireland, and help pharmaceutical companies identify possibilities of shortening the market access (MA) timeline.

METHODS: A retrospective data analysis from the NCPE website was conducted. 290 rapid reviews (RRs) and 108 full health technology assessments (HTAs) between 2017 and 2021 were identified, and appraisal outcomes, reimbursement status and dates were extracted. Timelines for each step were calculated as the average number of calendar days.

RESULTS: Where reimbursement was achieved after RR, regardless of the RR outcome, it took average 39 days for a medicine to complete RR and another 272 days to gain reimbursement. The timeline between RR submission and reimbursement decreased from 335 days in 2017, to 300 days in 2020 and 256 days in 2021. Where reimbursement was achieved after a full HTA, it took 33 days for NCPE to complete RR, 107 days for preliminary assessment, 66 days for re-assessment after company’s comments, and 19 days for finalising the appraisal; it took 119 days for a company to prepare for the submission, 31 days for comments, and 11 days for factual check; and it took 88 days for a company and NCPE to schedule a pre-submission consultation meeting, and 384 days for the HSE for negotiation and approval of reimbursement. The timeline between RR submission to reimbursement increased from 848 days in 2018 to 998 days in 2019 but decreased to 873 days in 2020 and 701 days in 2021.

CONCLUSIONS: The NCPE’s two-step assessment process provides an opportunity to maximise efficiency and minimise MA timeline. Where a full HTA is unavoidable, companies could accelerate work on submission preparation, commenting and factual checks to shorten the MA timeline.