University of North Carolina Eshelman School of Pharmacy, CB 7573 Kerr Hall, Rm. 2201, Chapel Hill, NC 27599-7573.
J Manag Care Spec Pharm. 2014 Nov;20(11):1110-20. doi: 10.18553/jmcp.2014.20.11.1110.
Introduction of biologic disease-modifying antirheumatic drugs (DMARDs) has revolutionized treatment in patients with rheumatoid arthritis (RA). However, due to substantially higher costs of biologics compared with nonbiologics, patients with less insurance generosity may have difficulty affording these agents, which may lead to potential access disparities.
To identify factors affecting treatment initiation with tumor necrosis factor (TNF)-α inhibitor biologics in patients with RA.
Health insurance claims data derived from Truven's MarketScan Commercial Claims and Encounters and Medicare Supplemental and Coordination of Benefits (2007-2010) were used to conduct a retrospective cohort study. Two separate cohorts of RA patients were identified: (1) monotherapy nonbiologic DMARD users and (2) combination therapy nonbiologic DMARD users. The primary outcome was TNF-α inhibitor initiation 12 months following an index inpatient or outpatient RA visit during 2008-2009. Predictors were measured 12 months pre-index and grouped into predisposing, enabling, or need factors based on Andersen's Behavior Model. Predisposing variables included age, sex, and geographic location; enabling variables included insurance-related factors such as capitation, payer type, and insurance generosity, which was defined using cost-sharing information from prescriptions filled by the patients in the previous year; and need variables included disease-related factors such as severity of RA, use of pain control medications, and presence of other comorbidities. Hierarchical logistic regression models were used to derive estimates of the impact of individual predictors.
Initiation of TNF-α inhibitors was observed in 10.31% of the monotherapy nonbiologic DMARD users (1,922 of 18,641) and 13.09% of combination nonbiologic DMARD users (983 of 7,508). Among monotherapy nonbiologic DMARD users, initiation with TNF-α inhibitors was associated with the predisposing factors of age (OR = 0.98, 95% CI = 0.97-0.98 for each year increase) and geographic region (Midwest vs. South OR = 0.83, 95% CI = 0.73-0.93; Northeast vs. South OR = 0.77, 95% CI = 0.64-0.92; and West vs. South OR = 0.86, 95% CI = 0.74-0.99); enabling factors of visit to rheumatologists (1 visit vs. no visit OR = 1.22, 95% CI = 1.01-1.46), health insurance type (commercial vs. Medicare supplemental OR = 0.79, 95% CI = 0.66-0.95), and drug benefit generosity (above average vs. poor OR = 1.16, 95% CI = 1.01-1.34 and most generous vs. poor OR = 1.21, 95% CI = 1.05-1.40); and need factors of RA severity (OR = 1.19, 95% CI = 1.14-1.23 for each unit increase in a claims-based RA severity index [CIRAS]), pre-index pain reliever use (steroids OR = 1.81, 95% CI = 1.62-2.02; nonselective nonsteroidal anti-inflammatory drugs [NSAID] OR = 1.17, 95% CI = 1.05-1.31; COX-2 inhibitors OR = 1.22, 95% CI = 1.05-1.41), and comorbidities (OR = 0.94, 95% CI = 0.90-0.99 for each unit increase in a comorbidity index). Treatment initiation with TNF-α inhibitors among patients with combination therapy nonbiologic DMARDs use at baseline was associated with age (OR = 0.98, 95% CI = 0.97-0.99 for each year increase) and region (Midwest vs. South OR = 0.81, 95% CI = 0.68-0.96). Stronger associations with some of the need factors were observed (CIRAS OR = 1.28, 95% CI = 1.21-1.35 for each unit increase, steroids use OR = 2.05, 95% CI = 1.73-2.42, and nonselective NSAID use OR = 1.36, 95% CI = 1.17-1.58) in these patients compared with the monotherapy nonbiologic DMARD users. However, unlike the monotherapy DMARD user group, the enabling factors of health insurance type and drug benefit generosity were not found to be associated with TNF-α inhibitor initiation among nonbiologic DMARD combination therapy users.
Potential disparities in the initiation of TNF-α inhibitors among RA patients on monotherapy DMARDs at baseline were noted among older patients, patients in certain geographic region of the United States, and patients with less generous prescription drug benefits. Although future research should examine the impact of these disparities on health outcomes, payers should be aware of the potential for undertreatment among these groups of RA patients when making formulary decisions.
生物类改善病情抗风湿药物(DMARDs)的引入彻底改变了类风湿关节炎(RA)患者的治疗方法。然而,由于生物制剂的成本明显高于非生物制剂,保险覆盖范围较小的患者可能难以负担这些药物,这可能导致潜在的治疗机会不均等。
确定影响 RA 患者使用肿瘤坏死因子(TNF)-α抑制剂生物制剂治疗的起始因素。
利用 Truven 的 MarketScan 商业索赔和医疗保险补充及福利协调(2007-2010 年)的健康保险索赔数据进行回顾性队列研究。确定了两类 RA 患者:(1)单药非生物 DMARD 使用者,(2)联合非生物 DMARD 使用者。主要结局是在 2008-2009 年期间,索引住院或门诊 RA 就诊后 12 个月内开始使用 TNF-α 抑制剂。在索引前 12 个月测量预测因子,并根据安德森行为模型将其分为倾向、使能或需求因素。倾向变量包括年龄、性别和地理位置;使能变量包括与保险相关的因素,如人头付费、支付方类型和保险覆盖范围,这是根据患者前一年的处方用药费用信息定义的;需求变量包括疾病相关因素,如 RA 严重程度、疼痛控制药物的使用以及其他合并症的存在。使用分层逻辑回归模型得出个体预测因子影响的估计值。
在单药非生物 DMARD 使用者(18641 例中的 1922 例,10.31%)和联合非生物 DMARD 使用者(7508 例中的 983 例,13.09%)中观察到 TNF-α 抑制剂的起始使用。在单药非生物 DMARD 使用者中,开始使用 TNF-α 抑制剂与以下倾向因素相关:年龄(每增加 1 岁,OR=0.98,95%CI=0.97-0.98)和地理位置(中西部地区与南部地区相比,OR=0.83,95%CI=0.73-0.93;东北部地区与南部地区相比,OR=0.77,95%CI=0.64-0.92;西部地区与南部地区相比,OR=0.86,95%CI=0.74-0.99);使能因素包括看风湿病专家(1 次就诊与无就诊相比,OR=1.22,95%CI=1.01-1.46)、保险类型(商业保险与 Medicare 补充保险相比,OR=0.79,95%CI=0.66-0.95)和药物福利覆盖范围(高于平均水平与较差相比,OR=1.16,95%CI=1.01-1.34;最慷慨与较差相比,OR=1.21,95%CI=1.05-1.40);以及需求因素包括 RA 严重程度(基于索赔的 RA 严重程度指数[CIRAS]每增加一个单位,OR=1.19,95%CI=1.14-1.23)、就诊前使用止痛剂(皮质类固醇,OR=1.81,95%CI=1.62-2.02;非选择性非甾体抗炎药[NSAID],OR=1.17,95%CI=1.05-1.31;环氧化酶-2 抑制剂,OR=1.22,95%CI=1.05-1.41)和合并症(每增加一个单位合并症指数,OR=0.94,95%CI=0.90-0.99)。在基线时使用联合非生物 DMARD 治疗的患者中,开始使用 TNF-α 抑制剂与年龄(每增加 1 岁,OR=0.98,95%CI=0.97-0.99)和地区(中西部地区与南部地区相比,OR=0.81,95%CI=0.68-0.96)相关。与单药非生物 DMARD 使用者相比,这些患者与一些需求因素的关联更强(CIRAS 每增加一个单位,OR=1.28,95%CI=1.21-1.35;皮质类固醇使用率,OR=2.05,95%CI=1.73-2.42;非选择性 NSAID 使用率,OR=1.36,95%CI=1.17-1.58)。然而,与单药 DMARD 使用者不同的是,健康保险类型和药物福利覆盖范围等使能因素与非生物 DMARD 联合治疗患者开始使用 TNF-α 抑制剂无关。
在基线时接受单药 DMARD 治疗的 RA 患者中,开始使用 TNF-α 抑制剂的机会不均等,这种差异在年龄较大的患者、美国某些地区的患者以及药物福利覆盖范围较小的患者中更为明显。尽管未来的研究应该评估这些差异对健康结果的影响,但在制定配方决策时,支付方应该意识到这些 RA 患者群体存在治疗不足的潜在风险。