Center for the Evaluation of Value and Risk in Health, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, Massachusetts, USA.
Pharmacoepidemiol Drug Saf. 2020 Oct;29(10):1307-1311. doi: 10.1002/pds.4992. Epub 2020 Mar 25.
To examine the RWE U.S. commercial health plans cite in their specialty drug coverage decisions.
We used the Tufts Medical Center Specialty Drug Evidence and Coverage Database to identify specialty drug coverage decisions (n = 7267) issued by 17 large commercial health plans. We categorized the clinical evidence plans cited in these coverage decisions (n = 5227) as randomized controlled trials (RCTs), RWE studies, and other clinical studies (studies other than RCT or RWE study). We categorized RWE studies with respect to study type, for example, case series, studies based on medical records, and so on. We compared the frequency that plans cited different categories of RWE, cited RWE for different diseases, and cited RWE for drugs on the market for different time periods.
RWE comprised 16% of cited clinical studies. Health plans cited RWE with different frequencies (5%-31% of the cited clinical evidence). Overall, plans cited RWE categorized as medical records most often (26% of cited RWE studies). Plans varied in the frequency they cited different RWE categories. Plans most frequently cited RWE for gastroenterological diseases (35% of clinical study citations) and least frequently for respiratory diseases (11% of clinical study citations). Plans cited RWE more for drugs that have long been on the market.
Health plans varied with respect to the number and types of RWE studies they cited in their specialty drug coverage decisions. Plans cited RWE more often for some diseases than others, and cited more RWE for older drugs.
考察美国商业健康计划在其专科药物覆盖决策中引用的真实世界证据。
我们使用塔夫茨医疗中心专科药物证据和覆盖数据库，确定了 17 家大型商业健康计划发布的 7267 项专科药物覆盖决策。我们将这些覆盖决策中引用的临床证据（n=5227）分为随机对照试验（RCT）、真实世界证据研究和其他临床研究（除 RCT 或真实世界证据研究外的研究）。我们按照研究类型对真实世界证据研究进行了分类，例如病例系列、基于病历的研究等。我们比较了计划引用不同类别的真实世界证据、为不同疾病引用真实世界证据以及为市场上不同时间段的药物引用真实世界证据的频率。
真实世界证据占引用临床研究的 16%。健康计划引用真实世界证据的频率不同（引用临床证据的 5%-31%）。总体而言，计划引用的真实世界证据大多归类为病历（引用的真实世界证据研究的 26%）。计划引用不同类别的真实世界证据的频率不同。计划最常引用胃肠疾病的真实世界证据（35%的临床研究引用），最不常引用呼吸疾病的真实世界证据（11%的临床研究引用）。计划引用市场上长期存在的药物的真实世界证据更多。
健康计划在其专科药物覆盖决策中引用的真实世界证据研究的数量和类型存在差异。计划对某些疾病引用的真实世界证据比其他疾病更多，对更老的药物引用的真实世界证据更多。
