1 Precision Health Economics, Los Angeles, California.
2 Bristol-Myers Squibb, Princeton Pike, New Jersey.
J Manag Care Spec Pharm. 2018 Jan;24(1):4-11. doi: 10.18553/jmcp.2017.17129. Epub 2017 Jul 17.
Anticitrullinated protein antibodies (ACPAs) are serological biomarkers associated with early, rapidly progressing rheumatoid arthritis (RA), including more severe disease and joint damage. ACPA testing has become a routine tool for RA diagnosis and prognosis. Furthermore, treatment efficacy has been shown to vary by ACPA-positive status. However, it is not clear if the economic burden of patients with RA varies by ACPA status.
To determine if the economic burden of RA varies by patient ACPA status.
IMS PharMetrics Plus health insurance claims and electronic medical record (EMR) data from 2010-2015 were used to identify patients with incident RA. Patients were aged ≥ 18 years, had ≥ 1 inpatient or ≥ 2 outpatient claims reporting an RA diagnosis code (ICD-9-CM code 714.0), and had an anticyclic citrullinated peptide (anti-CCP; a surrogate of ACPA) antibody test within 6 months of diagnosis. Incident patients were defined as those who had no claims with an RA diagnosis code in the 6 months before the first observed RA diagnosis. The primary outcome of interest was RA-related medical expenditures, defined as the sum of payer- and patient-paid amounts for all claims with an RA diagnosis code. Secondary outcomes included health care utilization metrics such as treatment with a disease-modifying antirheumatic drug (DMARD) and physician visits. Generalized linear regression models were used for each outcome, controlling for ACPA-positive status (defined as anti-CCP ≥ 20 AU/mL), age, sex, and Charlson Comorbidity Index score as explanatory variables.
Of 647,171 patients diagnosed with RA, 89,296 were incident cases, and 47% (n = 42,285) had an anti-CCP test. After restricting this sample to patients with a linked EMR and reported anti-CCP test result, 859 remained, with 24.7% (n = 212) being ACPA-positive. Compared with ACPA-negative patients, adjusted results showed that ACPA-positive patients were more likely to use either conventional (71.2% vs. 49.6%; P < 0.001) or biologic (20.3% vs. 11.8%; P < 0.001) DMARDs during the first year after diagnosis and had more physician visits (5.58 vs. 3.91 times per year; P < 0.001). Annual RA-associated total expenditures were $7,941 for ACPA-positive and $5,243 for ACPA-negative patients (Δ = $2,698; P = 0.002). RA-associated medical expenditures were $4,380 for ACPA-positive and $3,427 for ACPA-negative patients (Δ = $954; P = 0.168), whereas DMARD expenditures were $3,560 and $1,817, respectively (Δ = $1,743; P = 0.001).
RA-related economic burden is higher for patients who are ACPA-positive compared with those who are ACPA-negative. Providers may wish to inform patients diagnosed with ACPA-positive RA about the likely future disease and economic burden in hopes that both stakeholders can be more proactive in addressing them.
Funding for this research was contributed by Bristol-Myers Squibb. Patel and Price are employees and stockholders of Bristol-Myers Squibb. Shafrin and Tebeka are employees of Precision Health Economics, a health care consulting firm that received funding from Bristol-Myers Squibb to conduct this study. Michaud has received a grant from Pfizer and is employed by the National Data Bank for Rheumatic Diseases, which has received funds from Amgen, Bristol-Myers Squibb, Eli Lilly, Janssen, Pfizer, and Regeneron. Study concept and design were contributed by Shafrin, Price, Patel, and Michaud. Shafrin, Price, and Patel collected the data, and all authors contributed equally to data analysis. The manuscript was written by Shafrin and Tebeka and revised by Shafrin, Price, Patel, and Michaud.
抗瓜氨酸化蛋白抗体 (ACPAs) 是与早期、快速进展性类风湿关节炎 (RA) 相关的血清生物标志物,包括更严重的疾病和关节损伤。ACPA 检测已成为 RA 诊断和预后的常规工具。此外,治疗效果已被证明因 ACPA 阳性状态而异。然而,尚不清楚 RA 患者的经济负担是否因 ACPA 状态而异。
确定 RA 患者的经济负担是否因患者的 ACPA 状态而异。
使用 IMS PharMetrics Plus 健康保险索赔和电子病历 (EMR) 数据,从 2010 年至 2015 年,确定患有新发 RA 的患者。患者年龄≥18 岁,至少有一次住院或≥2 次门诊就诊记录,诊断为 RA(ICD-9-CM 编码 714.0),且在诊断后 6 个月内进行了抗环瓜氨酸肽 (抗-CCP;ACPA 的替代物) 抗体检测。新发患者定义为在首次观察到 RA 诊断前 6 个月内没有 RA 诊断代码索赔的患者。主要观察结果是 RA 相关医疗支出,定义为所有具有 RA 诊断代码的索赔中由付款人和患者支付的金额总和。次要观察结果包括治疗疾病修饰抗风湿药物 (DMARD) 和医生就诊等医疗保健利用指标。使用广义线性回归模型对每个结果进行分析,控制 ACPA 阳性状态(定义为抗-CCP≥20 AU/mL)、年龄、性别和 Charlson 合并症指数评分作为解释变量。
在诊断为 RA 的 647171 名患者中,89296 名患者为新发患者,其中 47%(n=42285)进行了抗-CCP 检测。将该样本限制为具有链接 EMR 和报告抗-CCP 检测结果的患者后,仍有 859 名患者,其中 24.7%(n=212)为 ACPA 阳性。与 ACPA 阴性患者相比,调整后的结果显示,与 ACPA 阴性患者相比,ACPA 阳性患者在诊断后第一年更有可能使用常规 (71.2% vs. 49.6%;P<0.001) 或生物 (20.3% vs. 11.8%;P<0.001) DMARD,且就诊次数更多(每年 5.58 次 vs. 3.91 次;P<0.001)。ACPA 阳性患者的年 RA 相关总支出为 7941 美元,ACPA 阴性患者为 5243 美元(Δ=2698 美元;P=0.002)。RA 相关医疗支出方面,ACPA 阳性患者为 4380 美元,ACPA 阴性患者为 3427 美元(Δ=954 美元;P=0.168),而 DMARD 支出分别为 3560 美元和 1817 美元(Δ=1743 美元;P=0.001)。
与 ACPA 阴性患者相比,ACPA 阳性患者的 RA 相关经济负担更高。医生可能希望告知诊断为 ACPA 阳性 RA 的患者可能出现的未来疾病和经济负担,希望利益相关者都能更积极地应对这些问题。
这项研究的资金由 Bristol-Myers Squibb 提供。Patel 和 Price 是 Bristol-Myers Squibb 的员工和股东。Shafrin 和 Tebeka 是 Precision Health Economics 的员工,这是一家医疗保健咨询公司,从 Bristol-Myers Squibb 获得资金进行这项研究。Michaud 收到了 Pfizer 的资助,并受雇于国家风湿病数据库,该数据库从 Amgen、Bristol-Myers Squibb、Eli Lilly、Janssen、Pfizer 和 Regeneron 获得资金。Shafrin、Price、Patel 和 Michaud 提出了研究概念和设计。Shafrin、Price 和 Patel 收集了数据,所有作者都对数据分析做出了同等贡献。手稿由 Shafrin 和 Tebeka 撰写,并由 Shafrin、Price、Patel 和 Michaud 修订。