Abstract 1553P
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.
Resources from the same session
1199P - Developing and systematically validating homologous recombination repair gene detection method based on next-generation sequencing
Presenter: Yi Sun
Session: Poster session 10
1200P - Investigation of multiphoton microscopy as an innovative tool for intraoperative section-free histologic investigations in just a few minutes
Presenter: Martí Homs Soler
Session: Poster session 10
1201P - Novel deep learning model and validation of whole slide images in lung cancer diagnosis
Presenter: Alhassan Ahmed
Session: Poster session 10
Resources:
Abstract
1202P - A deep learning approach using routine pathology images to guide precision medicine in metastatic CRC
Presenter: Chaitanya Parmar
Session: Poster session 10
1203P - Analytical evaluation of whole genome sequencing for acute myeloid leukemia
Presenter: Guidantonio Malagoli Tagliazucchi
Session: Poster session 10
1204P - Real-world utility of whole genome sequencing for patients with cancer: Evaluation of a regional implementation of the 100,000 genomes project
Presenter: Helen Robbins
Session: Poster session 10
1205P - A retrospective machine learning-based analysis of nationwide cancer CGP data across cancer types to identify features associated with recommendation of mutation-based therapy
Presenter: Hiroaki Ikushima
Session: Poster session 10
1478P - Dual single-nucleotide polymorphism biomarker combination to select opioid for cancer pain management
Presenter: Yoshihiko Fujita
Session: Poster session 10
1479P - Use of rescue opioids and pain control after ketamine initiation in refractory cancer pain: A multicentric observational study
Presenter: Pablo Gallardo Melo
Session: Poster session 10
1480P - Long term therapy with denosumab and zoledronic acid: A comparative real-world retrospective observational study on skeletal-related events and pain in patients with metastatic breast cancer
Presenter: Giacomo Massa
Session: Poster session 10