James D. Chambers (
David D. Kim is an investigator in the Center for the Evaluation of Value and Risk in Health, Tufts Medical Center, and an assistant professor of medicine in the School of Medicine, Tufts University.
Health Aff (Millwood). 2018 Jul;37(7):1041-1047. doi: 10.1377/hlthaff.2017.1553.
We analyzed specialty drug coverage decisions issued by the largest US commercial health plans to examine variation in coverage and the consistency of those decisions with indications approved by the Food and Drug Administration (FDA). Across 3,417 decisions, 16 percent of the 302 drug-indication pairs were covered the same way by all of the health plans, and 48 percent were covered the same way by 75 percent of the plans. Specifically, 52 percent of the decisions were consistent with the FDA label, 9 percent less restrictive, 2 percent mixed (less restrictive in some ways but more restrictive in others), and 33 percent more restrictive, while 5 percent of the pairs were not covered. Health plans restricted coverage of drugs indicated for cancer less often than they did coverage of drugs indicated for other diseases. Using multivariate regression, we found that several drug-related factors were associated with less restrictive coverage, including indications for orphan diseases or pediatric populations, absence of safety warnings, time on the market, lack of alternatives, and expedited FDA review. Variations in coverage have implications for patients' access to treatment and health system costs.
我们分析了美国最大的商业健康计划发布的专科药物覆盖决策，以检查覆盖范围的变化以及这些决策与食品和药物管理局 (FDA) 批准的适应症的一致性。在 3417 项决策中，16%的 302 个药物-适应症对在所有健康计划中以相同的方式覆盖，75%的计划以相同的方式覆盖了 48%的药物-适应症对。具体来说，52%的决策与 FDA 标签一致，宽松程度降低 9%，2%混合（某些方面宽松，但其他方面严格），33%更严格，而 33%的决策更严格，同时 5%的对不涵盖。健康计划限制癌症适应症药物的覆盖范围的频率低于限制其他疾病适应症药物的覆盖范围。使用多变量回归，我们发现几个与药物相关的因素与限制较少的覆盖范围有关，包括孤儿病或儿科人群的适应症、没有安全警告、上市时间、缺乏替代品和 FDA 加快审查。覆盖范围的变化对患者获得治疗和医疗系统成本有影响。
