1553P - Access to EMA approved drugs in Europe, disparities across a border

Background

The era of precision and immuno-oncology has revolutionised treatment paradigms however access and cost has highlighted global disparities. Following authorisation by the European Medicines Agency, reimbursement processes in each country vary. On the island of Ireland, the National Institute for Health and Care Excellence (NICE) approvals are used in Northern Ireland and an independent Health Technology Assessment agency make recommendations to the Health Service Executive (HSE) in the Republic. We aimed to compare the time to reimbursement in both systems.

Methods

All systemic anti-cancer therapies for solid organ malignancies which received marketing authorisation by the EMA between 06/2018-06/2023 were included. Identified agents were cross-referenced with therapies reimbursed by the Cancer Drugs Fund and NICE (UK), and by the HSE (Ireland). The time from EMA authorisation to reimbursement in each country was compared. Clinical trial data supporting approval were reviewed, including overall survival (OS) and health related quality of life data (HRQoL).

Results

During this period, 90 treatments received marketing authorisation by the EMA, 58 were reimbursed in Ireland and 88 in the UK. Of the treatments reimbursed in both the UK and Ireland, the EMA recommended 23 of these prior to 06/2018. The median time from EMA approval to patient access was 12 months in the UK and 27.5 months in Ireland. This varied depending on the malignancy. Phase III data was available for 85% (97/114) of treatments approved by the EMA. An OS benefit was seen in 59% (65/114) of treatments. Of the remaining 41% of treatments, 30% (34/114) did not demonstrate an improvement in OS, with >50% of these pertaining to molecular targets in small patient subsets. OS data was not mature in the remaining 11%. HRQoL data are available for 91% (104/114) of treatments that received EMA authorisation, although in most cases was published after the EMA decision.

Conclusions

Reimbursement of EMA approved systemic anticancer treatments is taking more than twice as long in Ireland compared to Northern Ireland and UK processes. Estimated increases in cancer diagnoses over the next decades highlights the importance of improving the current drug reimbursement processes to allow patients timely access to novel therapies.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

O.M. Fitzpatrick: Non-Financial Interests, Personal, Other, Support to attend meeting: Pfizer, Servier, AstraZeneca. M.R. Khan: Non-Financial Interests, Personal, Other, Travel: Pfizer; Non-Financial Interests, Personal, Officer, Travel: Novartis. C.S. McNevin: Non-Financial Interests, Personal, Other, Support to attend meeting: GSK, Takeda. D.J. McMahon: Non-Financial Interests, Personal, Other, Travel: Takeda; Financial Interests, Institutional, Funding: Pfizer, Roche. G.M. O'Kane: Financial Interests, Personal, Other, Honoraria and consulting: AstraZeneca, Roche, Servier, MSD, Incyte, Eisai; Financial Interests, Institutional, Research Grant: Roche, AstraZeneca. All other authors have declared no conflicts of interest.