Uptake of biosimilars for TNF-α inhibitors adalimumab and etanercept following the best-value biological medicine initiative in Ireland

Abstract

Background There is over 10 years of clinical experience and evidence to show that biosimilar medicines can be used as safely and effectively in approved therapeutic indications as their originator biological medicines. In Ireland, biosimilar medicine uptake has been very slow, and savings to the health service will only be realised through fostering a competitive biological medicine market. Objective The objective of this study was to investigate the utilisation of biosimilars following a ‘best-value biological’ medicine initiative for adalimumab and etanercept in the Irish healthcare setting. Methods Data was extracted from the National High Tech claims database and High Tech ordering and management hub for the following drugs; adalimumab (Humira®, Amgevita®, Hulio®, Idacio®, and Imraldi®) and etanercept (Enbrel® and Benepali®). Main outcome measure: uptake of the best-value biological medicines. Results In June 2019, just over 90 patients had been initiated on, or switched to a best-value biological for adalimumab or etanercept. Over the next 12 months this increased to over 8500 patients. With the best-value biologicals accounting for approximately 50 % of market share in June 2020, the combined estimated savings and avoided costs are €22.7 million to date. The gain-share prescribing incentive has raised over €3.6 million for the specialties to invest back into patient care. Conclusion Against the background of a finite healthcare budget, this study shows that increasing use of biosimilars can create the financial savings and space to invest in new innovative therapies for the benefit of many patients.

This is a preview of subscription content, access via your institution.

Fig. 1
Fig. 2

Availability of data and material

The data that support the findings of this study are available from the HSE-PCRS but restrictions apply to the availability of these data, which were used under licence for the current study, and so are not publicly available.

Code availability

Data analyses were carried out using custom code (SAS® 9.4) and Microsoft Excel.

References

  1. 1.

    PCRS—reporting menu. https://www.sspcrs.ie/portal/annual-reporting/report/annual. Accessed 06 Aug 2020.

  2. 2.

    NMIC. NMICB December 2015—update on biosimilar medicines.pdf. http://www.stjames.ie/GPsHealthcareProfessionals/Newsletters/NMICBulletins/NMICBulletins2015/NMIC%20Bulletin%20December%202015 %20-%20Update%20on%20Biosimilar%20Medicines.pdf. Accessed 06 Aug 2020.

  3. 3.

    MMP. MMP roadmap for the prescribing of best-value biological (BVB) medicines in the Irish healthcare setting. https://www.hse.ie/eng/about/who/cspd/ncps/medicines-management/best-value-biological-medicines/mmp-roadmap-for-the-prescribing-of-best-value-biological-bvb-medicines-in-the-irish-healthcare-setting.pdf. Accessed 06 Aug 2020.

  4. 4.

    MMP. Best-value biological medicines: tumour necrosis factor-α inhibitors on the high tech drug scheme. https://www.hse.ie/eng/about/who/cspd/ncps/medicines-management/best-value-biological-medicines/mmp%20report%20bvb%20medicines%20tnf%20alpha%20 inhibitors%20may%202019.pdf. Accessed 06 Aug 2020.

  5. 5.

    MMP. Best-value biological medicines—Medicines Management Programme. HSE.ie. https://www.hse.ie/eng/about/who/cspd/ncps/medicines-management/best-value-biological-medicines/best-value-biological-medicines.html. Accessed 06 Aug 2020.

  6. 6.

    Roland M, Campbell S. Successes and failures of pay for performance in the United Kingdom. N Engl J Med. 2014;370(20):1944–9. https://doi.org/10.1056/NEJMhpr1316051.

    CAS  Article  PubMed  Google Scholar 

  7. 7.

    Walley T, Murphy M, Codd M, Johnston Z, Quirke T. Effects of a monetary incentive on primary care prescribing in Ireland: changes in prescribing patterns in one health board 1990–1995. Pharmacoepidemiol Drug Saf. 2000;9(7):591–8. https://doi.org/10.1002/pds.544.

    CAS  Article  PubMed  Google Scholar 

  8. 8.

    McCullagh L, Barry M. The pharmacoeconomic evaluation process in Ireland. Pharmacoeconomics. 2016;34(12):1267–76. https://doi.org/10.1007/s40273-016-0437-5.

    Article  PubMed  Google Scholar 

  9. 9.

    Jensen TB, Kim SC, Jimenez-Solem E, Bartels D, Christensen HR, Andersen JT. Shift from adalimumab originator to biosimilars in Denmark. JAMA Intern Med. 2020. https://doi.org/10.1001/jamainternmed.2020.0338.

    Article  PubMed  Google Scholar 

  10. 10.

    England NHS. NHS England » NHS set to save record £300 million on the NHS’s highest drug spend. https://www.england.nhs.uk/2018/11/nhs-set-to-save-record-300-million-on-the-nhss-highest-drug-spend/. Accessed 06 Aug 2020.

  11. 11.

    Moorkens E, Vulto AG, Huys I, Dylst P, Godman B, Keuerleber S, et al. Policies for biosimilar uptake in Europe: an overview. PLoS ONE. 2017;12(12):e0190147. https://doi.org/10.1371/journal.pone.0190147.

    CAS  Article  PubMed  PubMed Central  Google Scholar 

  12. 12.

    Policy recommendations for a sustainable. biosimilars market: lessons from Europe—GaBI Journal. http://gabi-journal.net/policy-recommendations-for-a-sustainable-biosimilars-market-lessons-from-europe.html. Accessed 06 Aug 2020.

  13. 13.

    Jensen TB, Bartels D, Sædder EA, Poulsen BK, Andersen SE, Christensen MM, et al. The Danish model for the quick and safe implementation of infliximab and etanercept biosimilars. Eur J Clin Pharmacol. 2020;76(1):35–40. https://doi.org/10.1007/s00228-019-02765-3.

    CAS  Article  PubMed  Google Scholar 

  14. 14.

    Jørgensen KK, Olsen IC, Goll GL, Lorentzen M, Bolstad N, Haavardsholm EA, et al. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. Lancet. 10 2017;389(10086):2304–16. https://doi.org/10.1016/S0140-6736(17)30068-5.

    Article  PubMed  Google Scholar 

  15. 15.

    Glintborg B, Loft AG, Omerovic E, Hendricks O, Linauskas A, Espesen J, et al. To switch or not to switch: results of a nationwide guideline of mandatory switching from originator to biosimilar etanercept. One-year treatment outcomes in 2061 patients with inflammatory arthritis from the DANBIO registry. Ann Rheum Dis. 2019;78(2):192–200. https://doi.org/10.1136/annrheumdis-2018-213474.

    Article  PubMed  Google Scholar 

  16. 16.

    HPRA. Guide to biosimilars for healthcare professionals. http://www.hpra.ie/homepage/about-us/publications-forms/guidance-documents/item?id=e6d50326-9782-6eee-9b55-ff00008c97d0&t=/docs/default-source/publications-forms/guidance-documents/guide-to-biosimilars-for-healthcare-professionals-v3. Accessed 06 Aug 2020.

  17. 17.

    Electronic I. S. Book (eISB). Electronic Irish statute book (eISB). http://www.irishstatutebook.ie/eli/2013/act/14/enacted/en/html. Accessed 06 Aug 2020.

  18. 18.

    Biosimilar infliximab introduction into the gastroenterology care pathway in a large acute Irish teaching hospital: a story behind the evidence—GaBI Journal. http://gabi-journal.net/biosimilar-infliximab-introduction-into-the-gastroenterology-care-pathway-in-a-large-acute-irish-teaching-hospital-a-story-behind-the-evidence.html. Accessed 06 Aug 2020.

  19. 19.

    Top developments in biosimilars during 2019—GaBI Journal. http://gabi-journal.net/top-developments-in-biosimilars-during-2019.html. Accessed 06 Aug 2020.

Download references

Acknowledgements

We would like to acknowledge the HSE-PCRS for facilitating access to the data.

Funding

No specific funding was received for this research.

Conflicts of interest

The authors declare that they have no conflict of interest.

Author information

Affiliations

Authors

Corresponding author

Correspondence to Amelia Smith.

Additional information

Publisher’s note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

Duggan, B., Smith, A. & Barry, M. Uptake of biosimilars for TNF-α inhibitors adalimumab and etanercept following the best-value biological medicine initiative in Ireland. Int J Clin Pharm (2021). https://doi.org/10.1007/s11096-021-01243-0

Download citation

Keywords

  • Biological medicines
  • Biosimilar medicines
  • Health technology management
  • TNF-α inhibitors