Margaretos Nikoletta M, Patel Anisha M, Panzer Ari D, Lai Rachel C, Whiteley Jennifer, Chambers James D
Center for the Evaluation of Value and Risk in Health, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, USA.
Genentech, Inc, South San Francisco, CA, USA.
J Med Econ. 2021 Jan-Dec;24(1):1143-1148. doi: 10.1080/13696998.2021.1982225.
US commercial health plans have been found to vary in how they cover specialty drugs indicated for a range of diseases. In this study, we examined patients' access to hemophilia A (HemA) treatments across a set of large commercial health plans.
To examine variation in health plans' coverage policies for HemA treatments.
We reviewed HemA treatment coverage policies (current as of August 2019) issued by 17 commercial health plans primarily using the Tufts Medical Center Specialty Drug Evidence and Coverage Database. We categorized policies as: (coverage consistent with the FDA label); (conditions on coverage beyond the FDA label); (coverage for a broader patient population than the FDA label); and (conditions on coverage beyond the FDA label in one way, but coverage was broader than the FDA label in another).
We identified 296 coverage policies for 26 HemA treatments, including 15 short half-life factor VIII (FVIII) products, five extended half-life FVIII products, three bypassing agents, two desmopressin products, and emicizumab. We classified 36% of policies as 50% as , 7% as , and 7% as . Plans applied conditions on coverage with different frequencies: two did not apply conditions in any policies; ten applied conditions in ≥50%; four applied conditions in <40%. One plan did not publish coverage policies for any HemA products. Conditions on coverage most often related to bleeding frequency (36%), although specific requirements varied. Plans applied step therapy protocols in 17% of policies.
How health plans covered HemA treatments varied. Plans added conditions on coverage beyond the FDA label roughly half the time. Conditions most often related to bleeding frequency. Variable coverage affects patients' access to treatment, and potentially has clinical implications on disease management and disease progression.
美国商业健康保险计划在如何覆盖一系列疾病的专科药物方面存在差异。在本研究中，我们调查了一组大型商业健康保险计划中患者获得甲型血友病（HemA）治疗的情况。
研究健康保险计划对HemA治疗的覆盖政策差异。
我们主要使用塔夫茨医疗中心专科药物证据与覆盖数据库，审查了17家商业健康保险计划发布的HemA治疗覆盖政策（截至2019年8月）。我们将政策分类为：（与FDA标签一致的覆盖范围）；（超出FDA标签的覆盖条件）；（比FDA标签更广泛的患者群体覆盖范围）；以及（在一个方面超出FDA标签的覆盖条件，但在另一个方面覆盖范围比FDA标签更广泛）。
我们确定了26种HemA治疗的296项覆盖政策，包括15种短效因子VIII（FVIII）产品、5种长效FVIII产品、3种旁路药物、2种去氨加压素产品和艾美赛珠单抗。我们将36%的政策分类为，50%为，7%为，7%为。各计划对覆盖范围适用条件的频率不同：两家计划在任何政策中均未适用条件；十家计划在≥50%的政策中适用条件；四家计划在<40%的政策中适用条件。一家计划未发布任何HemA产品的覆盖政策。覆盖条件最常与出血频率相关（36%），尽管具体要求各不相同。各计划在17%的政策中应用了阶梯治疗方案。
健康保险计划对HemA治疗的覆盖方式各不相同。各计划约有一半时间会在FDA标签之外增加覆盖条件。条件最常与出血频率相关。覆盖范围的差异会影响患者获得治疗的机会，并可能对疾病管理和疾病进展产生临床影响。
