Abstract’
Introduction/aims
There are disparities in the availability of systemic anticancer therapies (SACTs) globally. We set out to investigate the cost and reimbursement of SACTs in the United Kingdom (UK) and the Republic of Ireland (ROI) in conjunction with efficacy and licensing authority decisions in the United States (US) and the European Union (EU).
Methods
We sought data pertaining to licensing in the EU, reimbursement in ROI/UK and cost/efficacy of SACTs licensed by the Food and Drug Administration (FDA) between January 2015 and May 2021. Independent samples t tests, chi-square test and Pearson’s correlation were used for statistical analysis.
Results
We identified that the majority of FDA-approved regimens are licensed by the European Medicines Agency (EMA) (n = 91, 67.9%). However, only a minority of these are currently reimbursed in the UK (n = 60, 45%) or the ROI (n = 28, 21%) as of the 1st of May 2021. In addition, only a minority of regimens have demonstrated a statistically significant OS benefit (n = 54, 40%). There was no association between cost of regimens and either the presence (t = 0.846, p = 0.40) or duration of OS benefit (t = − 0.84, p = 0.64).
Conclusions
Our study highlights that many licensed systemic anticancer treatments are not currently reimbursed in ROI/UK. The high cost of these medicines is independent of the presence of an OS benefit. Collaboration between regulatory agencies, governments and industry partners is needed to ensure health expenditure is directed towards the most effective treatments.
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Change history
29 April 2022
The author family name has been change to O'Reilly to correct the citation online.
Abbreviations
- ADC:
-
Antibody-drug conjugates
- BRAF:
-
B-Raf proto-oncogene
- CDF:
-
Cancer Drugs Fund
- EMA:
-
European Medicines Agency
- DOH:
-
Department of Health
- FDA:
-
Food and Drug Association
- GDP:
-
Gross domestic product
- HSE:
-
Health Service Executive
- ICI:
-
Immune checkpoint inhibitors
- IPHA:
-
Irish Pharmaceutical Healthcare Association
- NCPE:
-
National Centre for Pharmacoeconomics
- NHS:
-
National Health Service
- NICE:
-
National Institute for Clinical Excellence
- ORR:
-
Overall response rate
- OS:
-
Overall survival
- pCR:
-
Pathological complete response
- PFS:
-
Progression-free survival
- QOL:
-
Quality of life
- R&D:
-
Research and development
- RCT:
-
Randomised controlled trials
- ROI:
-
Republic of Ireland
- SACT:
-
Systemic anticancer treatment
- TKI:
-
Tyrosine kinase inhibitor
- UK:
-
United Kingdom
- US:
-
United States
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As per our local ethical guidelines, ethical approval was not required for this study.
Conflict of interest
DOR has received educational grants from Pfizer and Servier. RB has received educational grants from Pfizer, Astellas and Jannsen. He is co-founder of Portable Medical Technology. SOR has received consultant fees from Astrazeneca, travel expenses from Astrazeneca, Pfizer, Novartis, Roche and honoraria from Novartis, Roche, Pfizer. DCC has received consultant fees from Genmab, MSD; research funding from Pfizer; travel expenses from Roche, MSD, Genmab; and honoraria from Amgen, Pfizer, Roche, MSD. RC has received an unrestricted educational grant from Pfizer. SN is a former employee of MSD and has received honoraria from Pfizer and meeting registration expenses from Pfizer, MSD and Roche.
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O’Reilly, D., McLaughlin, R., Ronayne, C. et al. Cost and public reimbursement of cancer medicines in the UK and the Republic of Ireland. Ir J Med Sci 192, 541–548 (2023). https://doi.org/10.1007/s11845-022-02990-3
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DOI: https://doi.org/10.1007/s11845-022-02990-3