1 Analysis Group, Boston, Massachusetts.
2 Novartis Pharmaceuticals, East Hanover, New Jersey.
J Manag Care Spec Pharm. 2019 Feb;25(2):246-259. doi: 10.18553/jmcp.2019.25.2.246.
The U.S. health care system's transition to a value-based reimbursement model holds important implications for medical innovation, care delivery, and value-based assessments of therapeutic interventions. This transition has been especially noteworthy in oncology, with substantial ongoing changes to payer reimbursement and the provider landscape, as well as the introduction of value frameworks to guide drug treatment decision making. The implications of these changes for provider assessments of drug value and evidence needs remain unclear.
To understand provider perspectives on drug value assessment and the utility of existing oncology value frameworks by identifying (a) key value-based trends in the evolving oncology landscape, (b) provider definitions of drug value, (c) the role of existing value frameworks in provider decision making, and (d) future provider evidence needs for making value-based treatment decisions.
We conducted a literature review to identify existing oncology value frameworks and definitions of drug treatment value in oncology. Using a structured discussion guide informed by this literature review, we conducted 12 telephone-based in-depth interviews in November and December 2017 with U.S. oncology providers involved in organizational drug treatment and formulary decision making within their practices. Responses to interview questions were analyzed and reported as averages and percentages across participants.
Of 293 publications identified by keyword searches, 35 relevant articles were identified. Among these, the literature review identified no common definition for providers to assess drug value. Interview research participants described large ongoing changes in the oncology provider landscape, with economic pressures from payers as the foremost leading factor. Although 5 value frameworks were found in the literature, interviews found that in practice few providers consider these value frameworks to be key influences when evaluating treatment or formulary decisions. Furthermore, while 83% of participants' organizations employed some form of internal clinical pathways, only the minority (25%) with pathways integrated in their electronic medical record (EMR) systems saw these pathways as significantly affecting clinicians' drug treatment decision making. To aid the ongoing shift from volume-based to value-based care, we found that, rather than value frameworks, providers are looking for patient-level tools to make more appropriate drug decisions.
Payer reimbursement pressures are leading to radical changes in the oncology provider landscape, and there is a need for improved guidance for providers in assessing drug value. In particular, this study identifies the need for a timely and multifaceted summary of information required to assess the value of alternative treatment options for a given patient. Manufacturers also need to make significant strides to help generate and improve the dissemination of evidence to support the value of their therapies.
Funding for this work was provided by Novartis Pharmaceuticals. The study sponsor was involved in study design, data interpretation, and data review. All authors contributed to the development of the manuscript and maintained control over the final content. Sasane, Howe, Wong, and Zacker were employees of Novartis at the time of this study. Frois, Jarvis, and Grice are or have been employed by Analysis Group, which received a grant from Novartis for this research. At the time of this study, Analysis Group received funding from multiple manufacturers with oncology products in their portfolio during this time period, including, but not limited to, Astellas and Genentech.
美国医疗保健系统向基于价值的报销模式的转变对医学创新、医疗服务提供和治疗干预措施的基于价值的评估具有重要意义。在肿瘤学领域,这种转变尤其显著,支付者的报销和提供者格局发生了重大变化,同时也引入了价值框架来指导药物治疗决策。这些变化对提供者评估药物价值和证据需求的影响仍不清楚。
通过确定(a)肿瘤学领域不断发展的关键价值趋势,(b)提供者对药物价值的定义,(c)现有价值框架在提供者决策中的作用,以及(d)提供者在基于价值的治疗决策中进行未来证据需求,了解提供者对药物价值评估和现有肿瘤学价值框架的看法。
我们进行了文献综述,以确定现有的肿瘤学价值框架和肿瘤学中药物治疗价值的定义。我们使用了基于文献综述的结构化讨论指南,于 2017 年 11 月和 12 月对美国肿瘤学提供者进行了 12 次电话深入访谈,这些提供者参与了他们实践中的组织药物治疗和处方决策。对访谈问题的回答进行了分析,并以参与者的平均值和百分比进行了报告。
通过关键词搜索,共确定了 293 篇相关文献,其中有 35 篇相关文章。在这些文章中,文献综述没有发现提供者评估药物价值的共同定义。访谈研究参与者描述了肿瘤学提供者格局的巨大变化,支付者的经济压力是首要的推动因素。虽然文献中发现了 5 种价值框架,但访谈发现,在实践中,很少有提供者认为这些价值框架是评估治疗或处方决策的关键影响因素。此外,虽然 83%的参与者的组织采用了某种形式的内部临床路径,但只有少数(25%)将路径集成到电子病历(EMR)系统中的组织认为这些路径对临床医生的药物治疗决策有显著影响。为了帮助从基于数量的医疗保健向基于价值的医疗保健转变,我们发现,提供者正在寻找患者层面的工具来做出更合适的药物决策,而不是价值框架。
支付者报销压力正在导致肿瘤学提供者格局发生根本性变化,因此需要为提供者评估药物价值提供更好的指导。特别是,这项研究确定了需要及时、多方面地总结评估特定患者替代治疗方案价值所需的信息。制造商也需要做出重大努力,帮助生成和改善证据的传播,以支持其治疗方法的价值。
这项工作的资金由诺华制药公司提供。研究赞助商参与了研究设计、数据解释和数据审查。所有作者都为手稿的制定做出了贡献,并保持对最终内容的控制。Sasane、Howe、Wong 和 Zacker 在这项研究期间是诺华制药公司的员工。Frois、Jarvis 和 Grice 曾受雇于 Analysis Group,该公司曾因这项研究从诺华制药公司获得过一笔赠款。在这项研究期间,Analysis Group 收到了多家拥有肿瘤学产品的制造商的资金,包括但不限于 Astellas 和 Genentech。