Novartis Pharmaceuticals Corporation, East Hanover, NJ.
KMK Consulting, East Hanover, NJ.
J Manag Care Spec Pharm. 2021 Jan;27(1):27-36. doi: 10.18553/jmcp.2020.19433. Epub 2020 Oct 12.
Costs associated with biologic switching and discontinuation can be high in chronic inflammatory diseases. Inappropriate use of medications may have cost implications for both payers and patients. Understanding of biologic utilization and switching rates is lacking among patients with ankylosing spondylitis (AS).
To compare direct costs of treatment switchers, nonswitchers, and discontinuers among patients with AS who newly initiated a biologic.
Patients aged ≥ 18 years with an AS diagnosis and ≥ 1 pharmacy claim for an FDA-approved subcutaneous biologic for AS between January 1, 2016, and December 31, 2016 (identification period) were identified from the Truven Health MarketScan Databases. At the time of biologic initiation (index date), eligible patients were continuously enrolled with medical and pharmacy claims for ≥ 1 year before (baseline period) and ≥ 1 year after the index date (follow-up period). Patients with AS were categorized into 3 mutually exclusive groups of nonswitchers (patients who remained on their index biologic), switchers (patients who had a prescription for a biologic therapy other than their index biologic), and discontinuers (patients who had gaps in prescription claims [> 120 days]) based on their biologic utilization pattern during the 1-year follow-up period. Health care costs (inflated to year 2017 costs) during follow-up were described across the 3 groups separately and by disease. Adjusted health care resource utilization and costs during 1-year follow-up were estimated, controlling for age, sex, fulltime work status, and Charlson Comorbidity Index (Deyo's modification) during the baseline period.
A total of 791 patients with AS who were newly initiating a biologic were categorized as switchers (15.4%), nonswitchers (53.1%), and discontinuers (31.5%). Switchers and discontinuers had higher all-cause health care utilization than nonswitchers during the 1-year follow-up period. Switchers had higher mean total health care costs than nonswitchers ($71,280 vs. $66,573) due to increased medical ($13,897 vs. $12,043) and pharmacy costs ($57,384 vs. $54,530). Discontinuers had the lowest total health care costs ($41,179) but had the highest medical costs ($19,079). Adjusted analyses for covariates confirmed similar trends as the unadjusted analysis, where discontinuers had significantly lower total health care and pharmacy costs but had higher medical costs (with increased emergency department and outpatient visits) than nonswitchers (all < 0.001). Switchers had increased outpatient visits and costs versus nonswitchers in the adjusted analysis ( < 0.001); small sample sizes in the switcher group may have limited the ability to detect significant trends in the adjusted analysis.
Biologic switching resulted in higher total health care costs than remaining on the same biologic in patients with AS. These findings highlight the clinical and economic impact of discontinuing or switching biologic therapies in patients with AS, which may inform treatment and/or formulary decision making.
This study was sponsored by Novartis Pharmaceuticals (East Hanover, NJ). Yi, Dai, and Park are employed by Novartis. Piao was an employee of KMK Consulting, supporting Novartis at the time of this study; Zheng is an employee of KMK Consulting and works as a consultant for Novartis. Portions of this work were presented at the 2019 AMCP Managed Care and Specialty Pharmacy Annual Meeting; March 25-28, 2019; San Diego, CA; and AMCP Nexus 2019; October 29-November 1, 2019; National Harbor, MD.
在慢性炎症性疾病中,与生物制剂转换和停药相关的成本可能很高。药物的不当使用可能会对支付方和患者都产生成本影响。在强直性脊柱炎(AS)患者中,对生物制剂的使用和转换率了解不足。
比较新开始使用生物制剂的 AS 患者中治疗转换者、非转换者和停药者的直接治疗成本。
从 Truven Health MarketScan 数据库中确定了 2016 年 1 月 1 日至 2016 年 12 月 31 日(识别期)期间年龄≥18 岁且至少有 1 次 FDA 批准的用于 AS 的皮下生物制剂的药房索赔的患者。在开始使用生物制剂时(索引日期),符合条件的患者在索引日期前≥1 年(基线期)和索引日期后≥1 年(随访期)持续接受医疗和药房索赔。根据他们在 1 年随访期间的生物制剂使用模式,将 AS 患者分为 3 个互斥组:非转换者(仍使用其索引生物制剂的患者)、转换者(处方其他生物制剂治疗的患者)和停药者(处方索赔有间隙[>120 天]的患者)。分别和按疾病描述了随访期间的 3 组的医疗保健费用(膨胀至 2017 年的费用)。在控制基线期的年龄、性别、全职工作状态和 Charlson 合并症指数(Deyo 改良)的情况下,估计了 1 年随访期间的调整后的医疗资源利用和成本。
共有 791 名新开始使用生物制剂的 AS 患者被归类为转换者(15.4%)、非转换者(53.1%)和停药者(31.5%)。在 1 年随访期间,转换者和停药者的全因医疗保健利用率均高于非转换者。由于医疗费用(13897 美元比 12043 美元)和药房费用(57384 美元比 54530 美元)增加,转换者的平均总医疗保健费用高于非转换者(71280 美元比 66573 美元)。停药者的总医疗保健费用最低(41179 美元),但医疗费用最高(19079 美元)。对协变量的调整分析证实了与未调整分析相似的趋势,停药者的总医疗保健和药房成本明显低于非转换者,但急诊室和门诊就诊次数增加(均<0.001)。与非转换者相比,转换者在调整分析中门诊就诊次数和费用增加(<0.001);转换者组的样本量较小可能限制了在调整分析中检测到显著趋势的能力。
与继续使用相同的生物制剂相比,AS 患者的生物制剂转换导致总医疗保健费用增加。这些发现突出了在 AS 患者中停止或转换生物制剂治疗的临床和经济影响,这可能为治疗和/或配方决策提供信息。
这项研究由诺华制药(新泽西州东 Hanover)赞助。易、戴和朴受雇于诺华制药。朴曾是 KMK 咨询公司的员工,在本研究期间支持诺华制药;郑是 KMK 咨询公司的员工,是诺华制药的顾问。这项工作的部分内容在 2019 年 AMCP 管理式医疗和专科药房年会;2019 年 3 月 25-28 日;圣地亚哥,加利福尼亚州;和 AMCP Nexus 2019;2019 年 10 月 29 日-11 月 1 日;马里兰州国家港。