1PRIME Education, Fort Lauderdale, Florida.
2Academy of Managed Care Pharmacy, Alexandria, Virginia.
J Manag Care Spec Pharm. 2019 Aug;25(8):904-912. doi: 10.18553/jmcp.2019.18412. Epub 2019 Apr 22.
The Biologics Price Competition and Innovation Act (BPCIA) of 2009, which included pathways for FDA approval of biosimilar products, was designed to promote more affordable, expanded patient access to biologic therapies. Achieving these BPCIA goals depends on overcoming formidable barriers to biosimilar adoption. Managed care and specialty pharmacy professionals are uniquely qualified to inform initiatives to address these barriers.
To assess perceptions regarding strategies for overcoming barriers to biosimilar adoption among managed care and specialty pharmacy professionals by conducting a survey study.
Invitations to complete the online survey were emailed by the Academy of Managed Care Pharmacy (AMCP) to members and customers and to contacts sourced from a commercial database. In addition to questions on respondent demographics and perceptions of biosimilars, the survey listed 16 strategies for overcoming key barriers to biosimilar adoption. On a 5-point scale, participants rated their opinion on the likelihood that each strategy would have the potential to assist in achieving BPCIA goals. The survey also listed 6 barriers to biosimilar adoption. On a 5-point scale, participants rated their perceived difficulty in overcoming each barrier. The survey concluded with an open-text item that asked participants to list 3 additional strategies for overcoming biosimilar adoption barriers. Response frequencies were calculated to describe participants' ratings of the strategies and barriers. Statistical analyses were conducted to assess whether the ratings differed among respondents grouped by work organization. For the open-text item, we conducted qualitative content analyses to categorize strategies by stakeholder groups that might take primary implementation roles.
A total of 300 managed care and specialty pharmacy professionals completed the survey. There was considerable variation in the preferences, policies, and practices regarding biosimilar adoption among respondents' work organizations. Responses to several survey items reflected positive attitudes about the safety and efficacy of biosimilars; for example, 84% agreed or strongly agreed that FDA-approved biosimilars are safe and effective for patients who switch from a reference biologic. Based on pooled percentages for ratings of likely and extremely likely to overcome barriers to biosimilar adoption, the highest-rated strategies were for prescriber education about evidence from switching studies (91%) and FDA guidance on pharmacy-level substitution of reference biologics with biosimilars (90%). The lowest-rated strategies were for requiring therapeutic drug monitoring for patients who switch to biosimilars (39%) and using quotas to incentivize providers to prescribe biosimilars (40%). For the qualitative analysis, the highest numbers of respondents' suggested strategies indicated primary implementation roles of biosimilar manufacturers (40%), the federal government (26%), and managed care organizations (15%).
Reflecting the unique knowledge, perspectives, and practices of managed care and specialty pharmacy professionals, the study findings are relevant to informing and advancing initiatives for achieving BPCIA goals.
The survey study reported in this article was part of a continuing education program funded by an independent educational grant, which was awarded by Sandoz, a Novartis Division, to PRIME Education. The Academy of Managed Care Pharmacy (AMCP) received grant funding from PRIME to assist in developing the survey and writing the manuscript. The grantor had no role in the study design, execution, analysis, or reporting. Greene and Pardo are employed by PRIME. Singh and Carden are employed by AMCP. Greene, Singh, Carden, and Pardo have no other disclosures. Lichtenstein received an honorarium from PRIME for serving as faculty for the continuing education program and has been a consultant for Pfizer, Cellceutix, and Merck.
2009 年的生物仿制药价格竞争与创新法案（BPCIA）包括了 FDA 批准生物类似药的途径，旨在促进更实惠、扩大生物治疗的患者可及性。实现这些 BPCIA 目标取决于克服生物类似药采用的巨大障碍。管理式医疗和专业药房专业人员有资格为解决这些障碍的举措提供信息。
通过进行调查研究，评估管理式医疗和专业药房专业人员对克服生物类似药采用障碍的策略的看法。
通过 Academy of Managed Care Pharmacy（AMCP）向成员和客户以及从商业数据库中获取的联系人的电子邮件发送完成在线调查的邀请。除了关于受访者人口统计学和对生物类似物的看法的问题外，该调查还列出了克服生物类似物采用关键障碍的 16 种策略。参与者在 5 分制上对每种策略在帮助实现 BPCIA 目标方面的潜力进行了评价。该调查还列出了 6 个生物类似物采用障碍。参与者在 5 分制上对克服每个障碍的难度进行了评价。调查最后有一个开放文本项，要求参与者列出克服生物类似物采用障碍的另外 3 种策略。对参与者对策略和障碍的评价进行了频率计算。对按工作组织分组的受访者进行了统计分析，以评估评分是否存在差异。对于开放文本项，我们进行了定性内容分析，按可能承担主要实施角色的利益相关者群体对策略进行了分类。
共有 300 名管理式医疗和专业药房专业人员完成了调查。受访者工作组织之间在生物类似物采用方面的偏好、政策和做法存在相当大的差异。对调查项目的几个回应反映了对生物类似物的安全性和有效性的积极态度；例如，84%的人同意或强烈同意 FDA 批准的生物类似物对从参考生物制剂转换的患者是安全有效的。根据对克服生物类似物采用障碍的可能性和极有可能的评分汇总百分比，评分最高的策略是针对医生进行有关转换研究证据的教育（91%）和 FDA 关于参考生物制剂与生物类似物在药房级别替代的指导（90%）。评分最低的策略是要求患者在转换为生物类似物时进行治疗药物监测（39%）和使用配额来激励提供者开生物类似物（40%）。对于定性分析，提出的策略中，有最高数量的受访者表示生物类似物制造商（40%）、联邦政府（26%）和管理式医疗组织（15%）应承担主要实施角色。
反映了管理式医疗和专业药房专业人员的独特知识、观点和实践，研究结果与为实现 BPCIA 目标的举措提供信息和推进相关。
本文报道的调查研究是由 Sandoz（诺华制药的一个部门）资助的继续教育计划的一部分，该计划由 PRIME Education 授予 Academy of Managed Care Pharmacy（AMCP）。AMCP 从 PRIME 获得资助，以协助开发调查和撰写手稿。资助者在研究设计、执行、分析或报告方面没有任何作用。Greene 和 Pardo 受雇于 PRIME。Singh 和 Carden 受雇于 AMCP。Greene、Singh、Carden 和 Pardo 没有其他披露。Lichtenstein 因担任继续教育课程的教师和为 Pfizer、Cellceutix 和 Merck 担任顾问而获得 PRIME 的酬金。
