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Cost and public reimbursement of cancer medicines in the UK and the Republic of Ireland

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Irish Journal of Medical Science (1971 -) Aims and scope Submit manuscript

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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

References

  1. Food and Drugs Association (2020) Drug approvals and databases. p. 1. Available from: https://www.fda.gov/drugs/development-approval-process-drugs/drug-approvals-and-databases

  2. Jackson K, Nahata MC (2017) Rising cost of anticancer medications in the United States. Ann Pharmacother 51(8):706–10. Available from: https://doi.org/10.1177/1060028017702406

  3. Xu K, Soucat A, Kutzin J, Brindley C (2018) Public spending on health : a closer look at global trends. Geneva. Available from: https://apps.who.int/iris/bitstream/handle/10665/276728/WHO-HIS-HGF-HF-WorkingPaper-18.3-eng.pdf?ua=1

  4. Belloni A, Morgan D (2018) Pharmaceutical expenditure and policies : past trends and future challenges. OECD (87):0–75

  5. Martinalbo J, Bowen D, Camarero J et al (2016) Early market access of cancer drugs in the EU. Ann Oncol 27(1):96–105. Available from: https://doi.org/10.1093/annonc/mdv506

  6. Johnson JR, Ning Y-M, Farrell A, Justice R, Keegan P, Pazdur R (2011) Accelerated approval of oncology products: the food and drug administration experience. J Natl Cancer Inst 103(8):636–644

    Article  PubMed  Google Scholar 

  7. Wilking N, Bucsics A, Kandolf Sekulovic L et al (2019) Achieving equal and timely access to innovative anticancer drugs in the European Union (EU): summary of a multidisciplinary CECOG-driven roundtable discussion with a focus on Eastern and South-Eastern EU countries. ESMO Open 4(6):e000550

  8. Zhang Y, Hueser HC, Hernandez I (2017) Comparing the approval and coverage decisions of new oncology drugs in the United States and other selected countries. J Manag care Spec Pharm 23(2):247–254

    CAS  PubMed  Google Scholar 

  9. Oireactas Eireann (2013) Health (pricing and supply of medical good) Act 2013. Ireland. Available from: http://www.irishstatutebook.ie/eli/2013/act/14/enacted/en/html

  10. Health D (2012) Framework agreement on the supply and pricing of medicines. Dublin 2012. Available from: https://www.hse.ie/eng/about/who/cpu/iphaagreement2016.pdf

  11. Food and Drug Administration (2020) Hematology/Oncology (Cancer) Approvals & Safety Notifications. Available from: https://www.fda.gov/drugs/resources-information-approved-drugs/hematologyoncology-cancer-approvals-safety-notifications

  12. EMA (2020) European Medicines Agency. Available from: https://www.ema.europa.eu/en

  13. Association F and D (2021) Oncology/heamatology malignancies approval notifications. p. 1. Available from: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

  14. Health Service Executive (2020) List of high tech items as of 1st October 2020. p. 1. Available from: https://www.hse.ie/eng/staff/pcrs/online-services/august-2020-high-tech-list.pdf

  15. Wilson MK, Collyar D, Chingos DT, Friedlander M, Ho TW, Karakasis K et al (2015) Outcomes and endpoints in cancer trials: bridging the divide. Lancet Oncol 16(1):e43-52

    Article  PubMed  Google Scholar 

  16. Prasad V, Mailankody S (2017) Research and development spending to bring a single cancer drug to market and revenues after approval. JAMA Intern Med 177(11):1569–75. Available from: https://doi.org/10.1001/jamainternmed.2017.3601

  17. Collier R (2009) Drug development cost estimates hard to swallow. Can Med Assoc J 180(3):279 LP – 280. Available from: http://www.cmaj.ca/content/180/3/279.abstract

  18. Ledley FD, McCoy SS, Vaughan G, Cleary EG (2020) Profitability of large pharmaceutical companies compared with other large public companies. JAMA 323(9):834–843

    Article  PubMed  PubMed Central  Google Scholar 

  19. Lozano-Blázquez A, Dickson R, Fraga-Fuentes M-D, Martínez-Martínez F, Calleja-Hernández M-Á (2015) Differences in cancer drug assessment between Spain and the United Kingdom. Eur J Cancer 51(13):1843–1852

    Article  PubMed  Google Scholar 

  20. Morrell L, Wordsworth S, Fu H et al (2017) Cancer drug funding decisions in Scotland: impact of new end-of-life, orphan and ultra-orphan processes. BMC Health Serv Res 17(1):613. Available from: https://doi.org/10.1186/s12913-017-2561-0

  21. Grover P, Babar Z-U-D, Oehmen R, Vitry A (2018) Medicines access programs to cancer medicines in Australia and New Zealand: An exploratory study. Health Policy (3):243–9.

  22. van de Vooren K, Curto A, Freemantle N, Garattini L (2015) Market-access agreements for anti-cancer drugs. J R Soc Med 108(5):166–170

    Article  PubMed  PubMed Central  Google Scholar 

  23. Vitry A, Mintzes B, Lipworth W (2016) Access to new cancer medicines in Australia: dispelling the myths and informing a public debate. J Pharm policy Pract 9:13. Available from: https://pubmed.ncbi.nlm.nih.gov/27057313

  24. Saluja R, Arciero VS, Cheng S et al (2018) Examining trends in cost and clinical benefit of novel anticancer drugs over time. J Oncol Pract 14(5):e280–e294

    Article  PubMed  Google Scholar 

  25. Chamberlain C, Collin SM, Stephens P et al (2014) Does the cancer drugs fund lead to faster uptake of cost-effective drugs? A time-trend analysis comparing England and Wales. Br J Cancer 111(9):1693–702. Available from: https://pubmed.ncbi.nlm.nih.gov/24569469

  26. McCabe C, Paul A, Fell G, Paulden M (2016) Cancer drugs fund 2.0: a missed opportunity? Pharmacoeconomics 34(7):629–33

  27. Ocana A, Amir E, Tannock IF (2016) Toward value-based pricing to boost cancer research and innovation. Cancer Res 76(11):3127 LP – 3129. Available from: http://cancerres.aacrjournals.org/content/76/11/3127.abstract

  28. Cherny NI, Sullivan R, Dafni U et al (2016) Magnitude of Clinical Benefit Scale vol 1.0 questions and answers ESMO Open 1(5) Available from: https://doi.org/10.1136/esmoopen-2016-000100

  29. Network NCC (2022) NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) with NCCN Evidence Blocks. United States. Available from: https://www.nccn.org/guidelines/guidelines-with-evidence-blocks

  30. Cortes J, Perez-García JM, Llombart-Cussac A et al (2020) Enhancing global access to cancer medicines. CA Cancer J Clin (2):105–24. Available from: https://doi.org/10.3322/caac.21597

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Correspondence to David O’Reilly.

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Ethical approval

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

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