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加拿大强制性非医学转换生物制剂治疗风湿性疾病和炎症性肠病的潜在成本影响。

Potential Cost Implications of Mandatory Non-Medical Switching Policies for Biologics for Rheumatic Conditions and Inflammatory Bowel Disease in Canada.

机构信息

Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada.

Women's College Hospital, Toronto, Ontario, Canada.

出版信息

Clin Pharmacol Ther. 2021 Mar;109(3):739-745. doi: 10.1002/cpt.2042. Epub 2020 Oct 3.

DOI:10.1002/cpt.2042
PMID:32909249
Abstract

In 2018, TNFα inhibitors were the highest cost drug class for Canadian public drug programs. In 2019, two Canadian provinces announced mandatory nonmedical switching policies in an attempt to reduce their costs by increasing biosimilar uptake. The national impact of similar policies across Canada is unknown. We conducted a cross-sectional analysis of monthly publicly funded prescription claims for infliximab, etanercept, and adalimumab between June 2015 and December 2019. We reported the market share of biosimilars for infliximab and etanercept in 2019 for each province and estimated the cost savings that public payers could have realized in 2019 if mandatory switching policies had been implemented across Canada, including a sensitivity analysis, which assumed that governments receive a 25% rebate on all biologics. Provincial drug programs spent CAD $991.84 million on infliximab, etanercept, and adalimumab in 2019, and, when biosimilars were available, they constituted only 15.5% of national utilization of these drugs. In British Columbia, the implementation of a mandatory switching policy for patients with rheumatic conditions increased the biosimilar market share of infliximab and etanercept by 299% (from 19.7% to 78.5%). If applied nationwide to all three biologics for all indications, we estimate such policies could lead to annual savings of between CAD $179.71 million and CAD $425.64 million nationally. The overall market share of biosimilars remains low in all provinces where mandatory switching policies have not been introduced. The cost implications of successfully increasing biosimilar uptake would be substantial, particularly as more biosimilars reach the Canadian market.

摘要

2018 年,TNFα 抑制剂是加拿大公共药物计划中成本最高的药物类别。2019 年,加拿大的两个省份宣布实施强制性非医疗转换政策,试图通过增加生物类似药的使用来降低成本。加拿大全国范围内类似政策的影响尚不清楚。我们对 2015 年 6 月至 2019 年 12 月期间每月的英夫利昔单抗、依那西普和阿达木单抗的公共资助处方药索赔进行了横断面分析。我们报告了 2019 年每个省份英夫利昔单抗和依那西普生物类似药的市场份额,并估计如果在加拿大全国范围内实施强制性转换政策,公共支付者在 2019 年本可以节省多少成本,包括一项敏感性分析,该分析假设政府对所有生物制剂都有 25%的回扣。2019 年,各省的药物计划在英夫利昔单抗、依那西普和阿达木单抗上花费了 9.9184 亿加元,而当生物类似药可用时,它们仅占这些药物全国使用率的 15.5%。在不列颠哥伦比亚省,对患有风湿性疾病的患者实施强制性转换政策,使英夫利昔单抗和依那西普的生物类似药市场份额增加了 299%(从 19.7%增加到 78.5%)。如果在全国范围内对所有三种生物制剂的所有适应症实施这些政策,我们估计这些政策每年可节省 1.7971 亿至 4.2564 亿加元。在尚未引入强制性转换政策的所有省份,生物类似药的整体市场份额仍然较低。成功增加生物类似药的使用量将带来巨大的成本影响,特别是随着更多的生物类似药进入加拿大市场。

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