Background

The adoption of oncology biosimilars has been slow in the USA, which may be attributed in part to stakeholder perceptions and lack of operational guidance that supports favorable access to biosimilars.

Objective

Our objective was to understand the real-world implementation experiences with oncology biosimilars of US payers and healthcare professionals (HCPs) as their experience with biosimilars has evolved.

Methods

In-depth qualitative interviews with payers (n = 20) and HCPs (n = 17 physicians, n = 3 practice managers) were conducted. Payers included managed care organizations (MCOs), integrated delivery networks, and pharmacy benefit managers (PBMs). Physicians were affiliated with a healthcare network or were community based, specialized in hematology/oncology, and had prescribed oncology biosimilars. Audio transcripts of the interviews were coded using MaxQDA software to enable descriptive analysis of the qualitative data.

Results

Over 80.0% of physicians perceived the efficacy and safety of biosimilars to be highly comparable to that of originators. Up to 87.5% of physicians reported using biosimilars in > 50% of their treatment-naïve patients and were comfortable using biosimilars in all approved indications. To encourage utilization, 75.0% of MCOs/PBMs preferred biosimilars over originators in treatment-naïve patients and implementation via step therapy. Physician involvement in choosing biosimilars was minimal, which was largely dependent on practice protocols or insurance preferences. The major factor influencing payers’ coverage decisions and biosimilar adoption was potential cost savings.

Conclusions

US payers and physicians who have experience with biosimilars have favorable views of oncology biosimilars, particularly for treatment-naïve patients. A framework for integrating biosimilars into oncology practice is developing, primarily driven by insurance coverage, contracting, and cost benefits.

中文翻译：

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美国对肿瘤单克隆抗体生物仿制药的不断发展的认知、利用和实际实施经验：付款人和医生的观点

背景

美国采用肿瘤生物类似药的速度很慢，这可能部分归因于利益相关者的看法和缺乏支持有利获得生物类似药的操作指导。

客观的

我们的目标是了解美国付款人和医疗保健专业人员 (HCP) 使用肿瘤生物仿制药的实际实施经验，因为他们在生物仿制药方面的经验不断发展。

方法

对付款人（ n  = 20）和 HCP（n  = 17 名医生，n  = 3 名实践经理）进行了深入的定性访谈。付款人包括管理式医疗组织 (MCO)、综合交付网络和药房福利经理 (PBM)。医师隶属于医疗保健网络或以社区为基础，专门从事血液学/肿瘤学，并开具了肿瘤学生物仿制药的处方。使用 MaxQDA 软件对采访的音频记录进行编码，以便对定性数据进行描述性分析。

结果

超过 80.0% 的医生认为生物仿制药的疗效和安全性与原研药具有高度可比性。高达 87.5% 的医生报告说，在其 50% 以上的初治患者中使用生物仿制药，并且在所有批准的适应症中使用生物仿制药感到舒适。为了鼓励使用，75.0% 的 MCO/PBM 在初治患者和通过分步治疗实施的患者中更喜欢生物仿制药而不是原研药。医生参与选择生物仿制药的程度很小，这在很大程度上取决于实践方案或保险偏好。影响付款人的承保决定和生物仿制药采用的主要因素是潜在的成本节约。

结论

拥有生物仿制药经验的美国付款人和医生对肿瘤生物仿制药持积极态度，特别是对于未接受过治疗的患者。将生物仿制药整合到肿瘤学实践中的框架正在开发中，主要由保险范围、合同和成本效益驱动。