Ab1591 policy drivers for market penetration of anti-tnf biosimilars: multi-country comparisons

Background Health systems across countries have used different policy measures (e.g. price discounts, tendering, mandating switches) to encourage the introduction of biosimilars but their differential impact on market penetration is unknown. Objectives To evaluate the impact of policy measures on market penetration of anti-TNF biosimilars. Methods Quarterly IQVIA MIDAS sales data from 2012-2021 for infliximab, etanercept and adalimumab in 5 countries (Canada, France, Germany, Italy and the United Kingdom (UK)) that used different policy tools were used. Biosimilar market penetration was measured by dividing the number of defined daily dose units (DDDs) of biosimilars sold by the total number of DDDs of the originator and biosimilars sold. Market penetration since the first sale date of the biosimilars was captured by product, setting (hospital vs. retail), and country. Policy impact was examined by comparing market penetration among different policy scenarios (Table 1). Results Biosimilars for all three anti-TNFs had higher volume share over time (Figure 1) in the UK than Germany, suggesting that higher prescribing quotas among new and existing patients increases the market penetration of biosimilars given comparable demand-side policies. Since some anti-TNFs are dispensed only in hospitals in some countries, the settings are somewhat different. In France, infliximab biosimilars in hospital setting had faster penetration than other anti-TNF biosimilars in retail setting, indicating that tendering works better than price-links to increase biosimilar uptake. However, infliximab biosimilars in France had slower penetration than in Italy despite the higher discount price-link but absent quotas in France. Similarly, biosimilars had higher volume share over time in UK than Italy, which also suggests that higher prescribing quotas have a greater impact than price-links. Without price-link and tendering measures, Canada had the slowest penetration. By the end of our study period, the limited rollout of mandatory switching policies (3/10 provinces) for existing patients may not be sufficient in fostering market penetration, despite widespread implementation of mandatory prescribing for new patients. Conclusion Through comparisons between and within countries, we found that higher prescribing quotas or switching for existing patients and tendering are the key policy drivers for market penetration of anti-TNF biosimilars. References [1] Vogler S, Schneider P, Zuba M, Busse R, Panteli D. Policies to Encourage the Use of Biosimilars in European Countries and Their Potential Impact on Pharmaceutical Expenditure. Frontiers in Pharmacology . 2021;12. Accessed December 15, 2022. https://www.frontiersin.org/articles/10.3389/fphar.2021.625296 [2] McClean AR, Law MR, Harrison M, Bansback N, Gomes T, Tadrous M. Uptake of biosimilar drugs in Canada: analysis of provincial policies and usage data. CMAJ . 2022;194(15):E556-E560. doi:10.1503/cmaj.211478 [3] NHS England. Commissioning Framework for Biological Medicines . NHS England; 2017. Accessed December 15, 2022. https://www.england.nhs.uk/wp-content/uploads/2017/09/biosimilar-medicines-commissioning-framework.pdf Table 1. Policy measures in study countries as of 2020 unless noted Canada France Germany Italy The UK Supply Side Price-link No –40% 1 No 1 –20% 1 No 1 Tendering No Mainly hospital level for inpatient sector 1 Hospital level for inpatient sector; sickness funds for outpatient sector 1 Regional level for inpatient sector 1 Centralized by NHS for inpatient sector 1 Demand Side Biosimilar prescribing for new patients Mandatory 2 No 1 Quotas varied by sickness funds 1 Quotas but varied 1 90% (2017/18) 3 Biosimilar prescribing or switching for existing patients Mandatory switching; varied by provinces 2 Encouraged; no quotas or targets 1 Encouraged; quotas varied by sickness funds 1 Encouraged; quotas but varied 1 80% (2017/18) 3 Figure 1. Biosimilar market penetration since first launch Acknowledgements We acknowledge the funding support the Canadian Institutes of Health Research Project Grant (PJT-178132). Disclosure of Interests Wei Zhang Grant/research support from: Pfizer, Tilray, and bioMérieux Canada for projects unrelated to the present study., Daphne Guh: None declared, Huiying Sun: None declared, Alexander Tam Consultant of: I was previously employed at a market access research company. In that capacity, I generated reports for health technology companies. Companies were: Novartis AG, Merck & Co., Pfzier Inc., Biogen Inc., Sanofi, Mylan N.V., Bristol-Myers Squibb, Jazz Pharmaceuticals, and Roche Diagnostics., Nick Bansback: None declared, Aidan Hollis: None declared, Paul Grootendorst Consultant of: I wrote expert reports on behalf of both of branded and generic drug companies. None were specifically related to drugs/devices for use in rheumatology., Grant/research support from: Sanofi co-sponsored (along with a public organization) a post- doctoral fellowship that I supervised., Aslam Anis Grant/research support from: I have previously received grants from Beijing Genomics Institute, AbbVie, Abbott Laboratories Ltd. and Sanofi-Aventis Canada Inc to conduct work unrelated to the present study.