生物类似物的引入旨在与高价生物治疗竞争，但它们的采用速度比预期慢，并且效率收益有限。我们旨在研究与商业计划在美国（US）中相对于其参考产品覆盖生物类似物的因素。我们在Tufts Medical Center Specialty Drug Evidence and Coverage数据库中确定了19种商业化可用生物类似物的1,181个覆盖决策，相应地对应了7种参考产品和28种适应症。我们还利用Tufts Medical Center Cost-Effectiveness Analysis Registry的成本效益证据，以及Merative™ Micromedex® RED BOOK®的列表价格。我们根据是否健康计划覆盖该产品以及如果覆盖，支付者治疗行的与生物类似物及其参考产品之间的差异，将覆盖限制性总结为二元变量。我们使用多元逻辑回归来检查覆盖限制性和多个可能的覆盖驱动因素之间的关联。与参考产品相比，健康计划在229个（19.4％）决策中限制生物类似物的覆盖范围或阶梯疗法限制。计划更有可能限制儿童人口（比值比[OR] 11.558，95％置信区间[CI] 3.906-34.203）的生物类似物覆盖，那些美国患病率超过1,000,000（OR 2.067，95％CI 1.060-4.029）的疾病，并且如果该计划没有与三家主要药店利益管理人之一签订合同（OR 1.683，95％CI 1.129-2.507）。与参考产品相比，如果生物类似物指示用于癌症治疗（OR 0.019，95％CI 0.008-0.041），如果产品是第一个生物类似物（OR 0.225，95％CI 0.118-0.429），如果生物类似物有两个竞争对手（包括参考产品；OR 0.060，95％CI 0.006-0.586），如果生物类似物可以每位患者带来每年超过15,000美元的列表价格节省（OR 0.171，95％CI 0.057-0.514），如果生物类似物的参考产品受到计划的限制（OR 0.065，95％CI 0.038-0.109），或者如果成本效益度量不可用（OR 0.066，95％CI 0.023-0.186），则计划不太可能对生物类似物适应症对采取限制措斀ǜ 我们的研究提供了商业计划在美国相对于它们的参考产品覆盖生物类似物的相关因素的新见解。癌症治疗、儿童人口和参考产品的覆盖限制是与生物类似物覆盖决策相关的一些最重要因素。 ©2023. 作者（S）已著作权所有。

Biosimilars have been introduced with the goal of competing with high-priced biologic therapies, yet their adoption has been slower than expected and resulted in limited efficiency gains. We aimed to explore factors associated with biosimilar coverage relative to their reference products by commercial plans in the United States (US).We identified 1181 coverage decisions for 19 commercially available biosimilars, corresponding to 7 reference products and 28 indications from the Tufts Medical Center Specialty Drug Evidence and Coverage database. We also drew on the Tufts Medical Center Cost-Effectiveness Analysis Registry for cost-effectiveness evidence, and the Merative™ Micromedex® RED BOOK® for list prices. We summarized the coverage restrictiveness as a binary variable based on whether the product is covered by the health plan, and if covered, the difference of payers' line of therapy between the biosimilar and its reference product. We used a multivariate logistic regression to examine the association between coverage restrictiveness and a number of potential drivers of coverage.Compared with reference products, health plans imposed coverage exclusions or step therapy restrictions on biosimilars in 229 (19.4%) decisions. Plans were more likely to restrict biosimilar coverage for the pediatric population (odds ratio [OR] 11.558, 95% confidence interval [CI] 3.906-34.203), in diseases with US prevalence higher than 1,000,000 (OR 2.067, 95% CI 1.060-4.029), and if the plan did not contract with one of the three major pharmacy benefit managers (OR 1.683, 95% CI 1.129-2.507). Compared with the reference product, plans were less likely to impose restrictions on the biosimilar-indication pairs if the biosimilar was indicated for cancer treatments (OR 0.019, 95% CI 0.008-0.041), if the product was the first biosimilar (OR 0.225, 95% CI 0.118-0.429), if the biosimilar had two competitors (reference product included; OR 0.060, 95% CI 0.006-0.586), if the biosimilar could generate annual list price savings of more than $15,000 per patient (OR 0.171, 95% CI 0.057-0.514), if the biosimilar's reference product was restricted by the plan (OR 0.065, 95% CI 0.038-0.109), or if a cost-effectiveness measure was not available (OR 0.066, 95% CI 0.023-0.186).Our study offered novel insights on the factors associated with biosimilar coverage by commercial health plans in the US relative to their reference products. Cancer treatment, pediatric population, and coverage restriction of the reference products are some of the most significant factors that are associated with biosimilar coverage decisions.© 2023. The Author(s).