FROM EARLY ACCESS TO REIMBURSEMENT: A RETROSPECTIVE ANALYSIS OF TIMELINES IN IRELAND
Author(s)
Shauna Corless, MSc Health Economics1, Amy Louise Wall, MSc Health Economics1, Miguel Sancho Curiel, MSc Health Economics2, Karen McNamara, MB BCh BAO, MPH Dip Med law3.
1AstraZeneca Ireland, Dublin 15, Ireland, 2Alexion AstraZeneca Rare Disease, Dublin Ireland, Ireland, 3AstraZeneca Ireland, Dublin, Ireland.
1AstraZeneca Ireland, Dublin 15, Ireland, 2Alexion AstraZeneca Rare Disease, Dublin Ireland, Ireland, 3AstraZeneca Ireland, Dublin, Ireland.
OBJECTIVES: This research aimed to descriptively assess whether reimbursement timelines differ by the provision status of a company-funded Expanded Access Programme (EAP), without adjustment for potential confounding factors.
METHODS: Kieran et al. (2024) identified medicines which had active EAPs in place for solid tumour indications in Ireland as at April 2023. These formed the basis of this analysis and the selection of the July 2021 to December 2024 window for Health Technology Assessment (HTA) completions. This date range was used to extract data from the National Centre for Pharmacoeconomics (NCPE) and the Health Service Executive (HSE) Drugs Group (DG), identifying a comparator cohort of medicines for which it was assumed an EAP was not in place. Eligibility was restricted to medicines that had completed a full HTA and were subsequently discussed by the HSE DG. Time intervals were measured between key milestones; specifically, from HTA outcome to reimbursement and from DG decision to reimbursement.
RESULTS: Applying the eligibility criteria, a total of 24 medicines were included in the analysis, comprising 8 medicines with an EAP and 16 without an EAP. While the median time from Drugs Group decision to reimbursement was 2.5 months for medicines with an EAP and 2 months for medicines without an EAP, the median time from HTA outcome to reimbursement was 11 months in both groups.
CONCLUSIONS: In this descriptive analysis, reimbursement timelines appeared broadly similar for medicines with and without an EAP. These findings suggest that, within this sample, the presence of an EAP was not associated with a clear change in reimbursement timelines. However, the results should be interpreted cautiously, as the analysis was descriptive only, included a small sample, and did not adjust for potentially important confounding factors.
METHODS: Kieran et al. (2024) identified medicines which had active EAPs in place for solid tumour indications in Ireland as at April 2023. These formed the basis of this analysis and the selection of the July 2021 to December 2024 window for Health Technology Assessment (HTA) completions. This date range was used to extract data from the National Centre for Pharmacoeconomics (NCPE) and the Health Service Executive (HSE) Drugs Group (DG), identifying a comparator cohort of medicines for which it was assumed an EAP was not in place. Eligibility was restricted to medicines that had completed a full HTA and were subsequently discussed by the HSE DG. Time intervals were measured between key milestones; specifically, from HTA outcome to reimbursement and from DG decision to reimbursement.
RESULTS: Applying the eligibility criteria, a total of 24 medicines were included in the analysis, comprising 8 medicines with an EAP and 16 without an EAP. While the median time from Drugs Group decision to reimbursement was 2.5 months for medicines with an EAP and 2 months for medicines without an EAP, the median time from HTA outcome to reimbursement was 11 months in both groups.
CONCLUSIONS: In this descriptive analysis, reimbursement timelines appeared broadly similar for medicines with and without an EAP. These findings suggest that, within this sample, the presence of an EAP was not associated with a clear change in reimbursement timelines. However, the results should be interpreted cautiously, as the analysis was descriptive only, included a small sample, and did not adjust for potentially important confounding factors.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HTA273
Topic
Economic Evaluation, Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
Oncology