Key points are not available for this paper at this time.
Background: We previously showed biosimilar-promoting policies like tendering (i.e., inviting bids from potential suppliers) and prescribing quotas (i.e., mandating switching to or new prescriptions of biosimilar products) are key drivers for biosimilar market penetration.1 Whether these policies reduce expenditures on anti-TNF products is unknown. Objectives: To compare differences in anti-TNF product expenditures among countries with and without biosimilar-promoting policies. Methods: Quarterly IQVIA MIDAS sales data from 2012-2021 for anti-TNF products in 13 countries were used. We used a narrative approach to examine policy impact. We identified information on five key biosimilar policies for each country (tendering, prescribing quota, price-link constraining the price of biosimilars to the price of their originator, automatic substitution at the pharmacy, and co-payment schemes). We then paired countries on product, setting (retail/hospital) and all-but-one biosimilar policy (country 1 has a given policy while country 2 does not, all other policies being comparable). We examined relative expenditure reduction after biosimilar launch between comparators in a pair. To calculate relative expenditure reduction, we used the price of the originator in the year prior to biosimilar launch as the but-for-biosimilar price of each product, and calculated the but-for-biosimilar expenditure by multiplying 2021 total sales volumes of both the originator and the biosimilars by the but-for-biosimilar price. Expenditure reductions after biosimilar launch were the difference between the actual expenditure in 2021 and the but-for-biosimilar expenditure. Relative expenditure reductions in % were summarized by product, setting, and country. Results: The magnitude of expenditure reduction differed greatly across product, setting, and country (Figure 1). The change may be negatively correlated with the pre-launch price of the originator for infliximab and adalimumab, and this is less apparent for etanercept. Table 1 presents the pairings and the corresponding relative expenditure reductions in each comparator. There was only one pair for prescribing quotas (i.e., Belgium with quotas; France without quotas; hospital setting; infliximab), which showed the comparator with quotas had lesser expenditure reduction compared to the comparator without. In three price-link policy comparisons, in which biosimilars were priced at -20% of their originator, two showed lesser reductions for the comparator with the policy. Comparators with tendering policies generally showed greater expenditure reductions compared to those with absent tendering (four of six comparisons). Of these four, all were tenders in the retail setting. Conversely, tendering in the hospital setting did not achieve greater expenditure reductions. A greater concentration of tendering (regional vs local, or national vs regional) did not show greater reductions. Conclusion: Procurement of biosimilars through tendering may potentially help bring down spending on expensive anti-TNFs in the retail outpatient setting whereas price-links with small price reductions do not appear to help. The impact of prescribing quotas needs to be further elucidated. Policy packages specific to the hospital setting need to be further explored to identify key drivers of expenditure reduction. REFERENCES: 1 Zhang W, Guh D, Sun, HY, Tam ACT, Bansback N, Hollis A, Grootendorst P, Anis AH. Policy drivers for market penetration of anti-TNF biosimilars: multi-country comparisons. Non-Presented Abstract at the 2023 Annual European Congress of Rheumatology (EULAR); 2023, May 31-June 3; Milan, Italy. Table 1. Comparisons of relative expenditure change in anti-TNF products based on 2021 sales volume and sales-weighted price of biosimilars and their originator by country and setting. Acknowledgements: We acknowledge the funding support the Canadian Institutes of Health Research Project Grant (PJT-178132) and the National Research Foundation of Korea (NRF) (NRF-2021R1A6A1A03038899). Disclosure of Interests: Alexander Tam 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. The consultation work was conducted between 2018 and 2020, and did not overlap with the present study., Jasleen Badesha: None declared, Daphne Guh: None declared, Nick Bansback: None declared, Aidan Hollis: None declared, Paul Grootendorst Expert reports on behalf of both of branded and generic drug companies. None were specifically related to drugs/devices for use in rheumatology, Sanofi co-sponsored (along with a public organization) a post doctoral fellowship that I supervised., Sang-Cheol Bae: None declared, Aslam Anis 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., Wei Zhang Grant support from Pfizer, Tilray, bioMérieux Canada.
Tam et al. (Sat,) studied this question.