背景:临床和经济评论研究所(ICER)已经在美国医疗保健中发挥了明显的作用。然而,目前尚不清楚美国商业健康计划在其特殊药物承保决策中使用ICER价值评估的程度.目的:评估ICER报告的成本效果比(CERs)与覆盖范围限制性之间的关系。此外,检查计划在其承保政策中引用ICER的频率,并调查在ICER评估后的12个月内,健康计划调整其药物承保标准的频率。方法:我们分析了塔夫茨医学中心专业药物证据和覆盖范围数据库,其中包括17个美国大型商业健康计划发布的特殊药物承保决定。对于ICER评估的药物,我们以获得的每质量调整生命年成本(QALY)的形式记录了ICER的估计CER。首先,我们使用多变量逻辑回归来检验ICER报告的CER与计划覆盖范围限制性之间的关联,当控制其他可能影响决策的因素时。接下来,我们检查了计划在2017-2020年发布的覆盖决策中引用ICER评估的频率。最后,我们检查了计划是否添加或删除了承保限制(例如,患者亚组限制或分步治疗方案)在ICER评估后的12个月内。结果:与CER低于$100,000/QALY的药物相比,计划更严格地涵盖CER较高(较差)的药物:如果每个QALY$100,000-$175,000,则比值比(OR)=4.48;如果每个QALY$175,000-$500,000,则OR=2.00;如果每个QALY$500,000或更高,则OR=2.10(均P<计划在2017年占覆盖政策的0.8%(5/622),2018年占0.6%(5/833),2019年占1.7%(19/1,139),2020年占2.4%(33/1,406)。对于CER低于$175,000/QALY的药物,计划调整了37%的病例覆盖率:20%的病例增加了限制,取消了15%的限制,并添加了一个限制,但在2%中删除了另一个限制。对于CER为175,000美元或以上的药物,计划在29%的情况下改变了覆盖标准:21%的情况下增加了限制,取消了5%的限制,并增加了一个限制,但在4%中删除了另一个限制。结论:我们发现,当控制其他因素时,健康计划的特殊药物承保决定与ICER的估计CER相关。不经常引用ICER价值评估的计划。我们没有观察到与CER低于175,000美元的药物相比,CER为175,000美元或更多的药物的计划更经常缩小覆盖范围的趋势。披露:这项研究得到了一个资助者财团的支持:安进,Genen-tech,Janssen制药公司,Otsuka,GSK。
BACKGROUND: The Institute for Clinical and Economic Review (ICER) has emerged in a visible role in US health care. However, it is unclear to what extent US commercial health plans use ICER value assessments in their specialty drug coverage decisions. OBJECTIVE: To evaluate the relationship between ICER\'s reported cost-effectiveness ratios (CERs) and coverage restrictiveness. Also, to examine the frequency with which plans have cited ICER in their coverage policies and to investigate how frequently health plans adjusted their drug coverage criteria in the 12 months after ICER\'s assessments. METHODS: We analyzed the Tufts Medical Center Specialty Drug Evidence and Coverage Database, which includes specialty drug coverage decisions issued by 17 large US commercial health plans. For ICER-assessed drugs, we recorded ICER\'s estimated CERs in the form of cost per quality-adjusted life-year (QALY) gained. First, we used multivariate logistic regression to examine the association between ICER\'s reported CERs and plan coverage restrictiveness, when controlling for other factors that were likely to affect decision-making. Next, we examined how often plans cited ICER\'s assessments in coverage decisions issued in years 2017-2020. Lastly, we examined whether plans added or removed coverage restrictions (eg, patient subgroup restrictions or step therapy protocols) in the 12 months following ICER\'s assessment. RESULTS: Plans tended to cover drugs with higher (less favorable) CERs more restrictively than drugs with CERs less than $100,000 per QALY: odds ratio (OR) = 4.48 if $100,000-$175,000 per QALY; OR = 2.00 if $175,000-$500,000 per QALY; and OR = 2.10 if $500,000 or more per QALY (all P < 0.01). Plans cited ICER in 0.8% (5/622) of coverage policies in 2017, 0.6% (5/833) in 2018, 1.7% (19/1,139) in 2019, and 2.4% (33/1,406) in 2020. For drugs with CERs less than $175,000 per QALY, plans adjusted coverage in 37% of cases: added restrictions in 20%, removed restrictions in 15%, and added one restriction but removed another in 2%. For drugs with CERs of $175,000 or more, plans changed coverage criteria in 29% of cases: added restrictions in 21%, removed restrictions in 5%, and added one restriction but removed another in 4%. CONCLUSIONS: We found that when controlling for other factors, health plans\' specialty drug coverage decisions were associated with ICER\'s estimated CERs. Plans infrequently cited ICER value assessments. We did not observe a trend for plans more often narrowing coverage criteria for drugs with CERs $175,000 or more compared with drugs with CERs less than $175,000. DISCLOSURES: This research study was supported by a consortium of funders: Amgen, Genen-tech, Janssen Pharmaceuticals, Otsuka, and GSK.