1Cardinal Health Specialty Solutions, Columbus, Ohio.
2Division of Hematology-Medical Oncology, University of California, Los Angeles.
J Manag Care Spec Pharm. 2019 Aug;25(8):869-877. doi: 10.18553/jmcp.2019.18442. Epub 2019 Apr 4.
The treatment landscape for patients with metastatic melanoma has changed dramatically with the introduction of novel therapies, such as targeted therapies and immunotherapies, in recent years. Health care resource utilization (HCRU) and cost data are needed to further evaluate these treatments in a value-based health care system.
To examine HCRU and total cost of care among U.S. metastatic melanoma patients treated with first-line systemic therapies, including immunotherapies, targeted therapies, and chemotherapy.
A retrospective observational study was conducted using a U.S. claims database. Adults with ≥ 2 claims for melanoma and ≥ 1 claim for metastasis between January 1, 2012, and June 30, 2017, were identified. Patients had pharmacy and medical enrollment ≥ 6 months before and ≥ 3 months following first-line treatment start. Per patient per month (PPPM) HCRU and costs were calculated by first-line treatment drug class: PD-1 inhibitors, CTLA-4 inhibitors, CTLA-4 + PD-1 combination, BRAF monotherapy, BRAF + MEK combination, and chemotherapy. Adjusted odds ratios (ORs) for HCRU were estimated by logistic regressions and adjusted costs were estimated by generalized linear models using log-link with gamma distribution to control for differences in patient characteristics across groups.
Among 1,599 metastatic melanoma patients (PD-1, n = 255; CTLA-4, n = 555; CTLA-4 + PD-1, n = 88; BRAF, n = 210; BRAF + MEK, n=102; chemotherapy=389), mean age ranged from 59-68 years, and the majority were male (62%). Any hospitalization during first-line treatment was less frequent among PD-1-treated patients (25.9%) compared with 34.7%-45.5% of all other groups (all < 0.05). PPPM hospitalizations were lowest in PD-1 (0.06) compared with 0.09-0.16 across all other groups (all < 0.05), and PPPM emergency department (ED) visits were lowest in PD-1 (0.09) compared with 0.13-0.18 across all other groups (all < 0.05), except for BRAF + MEK (0.14, = 0.08). CTLA-4, CTLA-4 + PD-1, and BRAF + MEK had increased odds of hospitalization compared to PD-1 (adjusted ORs = 2.10, 2.35, 2.15, respectively; all < 0.05). Total adjusted PPPM costs were significantly lower for PD-1 ($13,059) compared with CTLA-4 ($25,583), CTLA-4 + PD-1 ($31,310), and BRAF + MEK ($21,517) and higher compared to BRAF ($8,158) and chemotherapy ($6,361).
Hospitalizations and ED visits represent important HCRU for metastatic melanoma patients and were lowest among PD-1-treated patients compared with any other systemic therapies (except for ED visits when compared with BRAF + MEK). Total monthly costs varied substantially across first-line regimens and were significantly lower in PD-1-treated patients compared with patients treated with CTLA-4, CTLA-4 + PD-1, and BRAF + MEK.
This study was funded by Merck Sharp & Dohme, a subsidiary of Merck & Co. Klink, Feinberg, and Nero are employees of Cardinal Health Specialty Solutions, which received funding from Merck to conduct this study. Chmielsowki is a consultant to Merck but received no funding for the development of this manuscript. Ahsan and Liu are employees of Merck. Chmielowski reports advisory board/speaker fees from Bristol-Myers Squibb, Merck, Genentech/Roche, Iovance Biotherapeutics, HUYA Bioscience International, Compugen, Array BioPharma, Regeneron, Biothera, Janssen, and Novartis. Ahsan has a patent (US20160008380A1) pending.
近年来,随着新型疗法(如靶向疗法和免疫疗法)的引入,转移性黑色素瘤患者的治疗格局发生了巨大变化。需要医疗保健资源利用(HCRU)和成本数据来进一步评估基于价值的医疗保健体系中的这些治疗方法。
研究接受一线系统治疗(包括免疫疗法、靶向疗法和化疗)的美国转移性黑色素瘤患者的 HCRU 和总护理成本。
使用美国索赔数据库进行回顾性观察性研究。确定了≥ 2 次黑色素瘤和≥ 1 次转移索赔且在 2012 年 1 月 1 日至 2017 年 6 月 30 日之间的成年人。患者在一线治疗开始前和开始后≥ 6 个月有药房和医疗登记。根据一线治疗药物类别计算每位患者每月(PPPM)的 HCRU 和费用:PD-1 抑制剂、CTLA-4 抑制剂、CTLA-4 + PD-1 联合治疗、BRAF 单药治疗、BRAF + MEK 联合治疗和化疗。使用逻辑回归估计 HCRU 的调整优势比(OR),并使用具有伽马分布的广义线性模型估计调整后的成本,以控制组间患者特征的差异。
在 1599 名转移性黑色素瘤患者中(PD-1,n = 255;CTLA-4,n = 555;CTLA-4 + PD-1,n = 88;BRAF,n = 210;BRAF + MEK,n=102;化疗=389),平均年龄在 59-68 岁之间,大多数为男性(62%)。与所有其他组(所有 < 0.05)相比,PD-1 治疗患者在一线治疗期间任何住院治疗的比例较低(25.9%)。PD-1 组的 PPPM 住院治疗最低(0.06),而所有其他组的 PPPM 住院治疗均为 0.09-0.16(所有 < 0.05),PD-1 组的 PPPM 急诊就诊最低(0.09),而所有其他组的 PPPM 急诊就诊均为 0.13-0.18(所有 < 0.05),除了 BRAF + MEK(0.14, = 0.08)。与 PD-1 相比,CTLA-4、CTLA-4 + PD-1 和 BRAF + MEK 具有更高的住院治疗几率(调整后的 OR 分别为 2.10、2.35 和 2.15;所有 < 0.05)。与 CTLA-4($25,583)、CTLA-4 + PD-1($31,310)和 BRAF + MEK($21,517)相比,PD-1 治疗患者的总调整后 PPPM 成本显著降低,与 BRAF($8,158)和化疗($6,361)相比则较高。
住院治疗和急诊就诊是转移性黑色素瘤患者的重要 HCRU,与任何其他系统治疗(与 BRAF + MEK 相比,急诊就诊除外)相比,PD-1 治疗患者的住院治疗和急诊就诊最低。一线方案的每月总成本差异很大,与 CTLA-4、CTLA-4 + PD-1 和 BRAF + MEK 治疗的患者相比,PD-1 治疗患者的总成本显著降低。
这项研究由默克 Sharp & Dohme 公司(默克公司的子公司)资助。Klink、Feinberg 和 Nero 是 Cardinal Health Specialty Solutions 的员工,该公司从默克获得资金进行这项研究。Chmielsowki 是默克的顾问,但在本手稿的开发过程中没有获得任何资金。Ahsan 和 Liu 是默克的员工。Chmielowski 报告说,与 Bristol-Myers Squibb、Merck、Genentech/Roche、Iovance Biotherapeutics、HUYA Bioscience International、Compugen、Array BioPharma、Regeneron、Biothera、Janssen 和诺华制药有咨询费/演讲费。Ahsan 拥有一项专利(US20160008380A1)正在申请中。