Wen Lonnie, Valderrama Adriana, Costantino Mary E, Simmons Stacey
Deputy Director, Bayer Healthcare Pharmaceuticals, Hanover, NJ.
Bayer Healthcare Pharmaceuticals during this study.
Am Health Drug Benefits. 2019 May;12(3):142-149.
Prostate cancer is the most frequently diagnosed cancer in men in the United States. There is scant real-world evidence characterizing the care utilization and clinical outcomes associated with the use of therapies currently approved by the US Food and Drug Administration (FDA) for patients with metastatic castrate-resistant prostate cancer (CRPC).
To describe the real-world treatment patterns, healthcare costs, and survival rates of patients with metastatic CRPC and bone metastases who have commercial or Medicare coverage.
This retrospective observational study was conducted using medical and pharmacy claims from the Humana research database for male patients who had Medicare or commercial coverage and were aged 55 to 89 years at the initiation of treatment for metastatic CRPC. Three inclusion criteria were used to identify appropriate patients for the 2 cohorts, including (1) a diagnosis of prostate cancer ( [] code 185.x); (2) a diagnosis of bone metastasis ( code 198.5) between 2013 and 2014; and (3) a healthcare insurance claim indicating a prescription for an FDA-approved first-line treatment for metastatic CRPC. Subsequent lines of treatment were also identified through the healthcare claims data. The 2-year survival rate was calculated and controlled for demographic and clinical characteristics, and the total costs (medical plus pharmacy) were calculated for the 6 months postindex.
A total of 1855 patients met the study inclusion criteria. Of these patients, 660 (35.6%) received at least 1 medication. The patient count by line of treatment was 660 (100%) who received first-line therapy, 380 (57.6%) who received second-line treatment, 204 (30.9%) who received third-line therapy, and 107 (16.2%) who received fourth-line therapy. The medication distribution by line of treatment (using first-, second-, third-, or fourth-line therapy for each drug) was abiraterone acetate (50.5%, 61.3%, 68.6%, 75.7%); enzalutamide (15.6%, 39.2%, 54.4%, 71.0%); sipuleucel-T (9.2%, 13.9%, 20.1%, 20.6%); radium-223 dichloride (1.7%, 2.6%, 7.4%, 13.1%); cabazitaxel (2.3%, 5.5%, 16.2%, 19.6%); and docetaxel (22.1%, 32.1%, 42.6%, 48.6%). The total monthly unadjusted healthcare costs for patients who received an FDA-approved treatment was much higher ($9435) than for patients with metastatic prostate cancer who did not receive an FDA-approved treatment ($5055), and the 2-year survival rate for patients who received an FDA-approved treatment was 57.1% (25th percentile, 250 days; 50th percentile, 541 days).
The most common first-line treatment for patients with commercial or Medicare coverage who had metastatic CRPC was abiraterone or enzalutamide. Hormone therapies used as monotherapy were the most frequently used treatment, and their concomitant administration with other treatments was the second most common treatment pattern. Additional clinical studies are needed to further elucidate the treatment sequencing for patients with metastatic CRPC.
前列腺癌是美国男性中最常被诊断出的癌症。目前几乎没有真实世界的证据来描述与美国食品药品监督管理局(FDA)批准用于转移性去势抵抗性前列腺癌(CRPC)患者的疗法相关的医疗利用情况和临床结局。
描述有商业保险或医疗保险覆盖的转移性CRPC和骨转移患者的真实世界治疗模式、医疗费用和生存率。
这项回顾性观察性研究使用了来自Humana研究数据库的医疗和药房理赔数据,针对患有医疗保险或商业保险且在开始转移性CRPC治疗时年龄为55至89岁的男性患者。使用三个纳入标准来确定两个队列的合适患者,包括:(1)前列腺癌诊断(国际疾病分类[ICD]代码185.x);(2)2013年至2014年间的骨转移诊断(ICD代码198.5);(3)医疗保险理赔表明开具了FDA批准的转移性CRPC一线治疗药物的处方。后续治疗线也通过医疗理赔数据确定。计算2年生存率并对人口统计学和临床特征进行控制,计算索引后6个月的总费用(医疗加药房)。
共有1855名患者符合研究纳入标准。在这些患者中,660名(35.6%)接受了至少一种药物治疗。按治疗线划分的患者数量为:接受一线治疗的660名(100%),接受二线治疗的380名(57.6%),接受三线治疗的204名(30.9%),接受四线治疗的107名(16.2%)。按治疗线划分的药物分布(每种药物使用一线、二线、三线或四线治疗)为:醋酸阿比特龙(50.5%、61.3%、68.6%、75.7%);恩杂鲁胺(15.6%、39.2%、54.4%、71.0%); sipuleucel-T(9.2%、13.9%、20.1%、20.6%);二氯化镭-223(1.7%、2.6%、7.4%、13.1%);卡巴他赛(2.3%、5.5%、16.2%、19.6%);多西他赛(22.1%、32.1%、42.6%、48.6%)。接受FDA批准治疗的患者每月未调整的总医疗费用(9435美元)远高于未接受FDA批准治疗的转移性前列腺癌患者(5055美元),接受FDA批准治疗的患者的2年生存率为57.1%(第25百分位数,250天;第50百分位数,541天)。
对于有商业保险或医疗保险覆盖的转移性CRPC患者,最常见的一线治疗是阿比特龙或恩杂鲁胺。激素疗法作为单一疗法是最常用的治疗方法,其与其他治疗联合使用是第二常见的治疗模式。需要进一步的临床研究来进一步阐明转移性CRPC患者的治疗顺序。