Treatment Patterns, Mortality, Healthcare Resource Utilization, and Costs in Patients With Prostate Cancer With Bone Metastases: A Retrospective Database Analysis .
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 565
- 主要终点
- Total costs of healthcare
研究概览
简要总结
This study will evaluate treatment patterns, mortality, healthcare resource utilization, and costs in patients with prostate cancer with bone metastases (primary objectives). Additionally, this study will evaluate opioid/analgesic use among lines of therapy in this patient population (secondary objective). The study is descriptive in nature and is meant to provide a greater understanding of the patterns of therapy observed in real-world clinical practice (in the absence of clear guideline recommendations with regards to treatment sequencing), to contribute to a greater understanding of the major cost drivers (thus better-informing payers), and to examine real-world mortality in such patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subjects with at least one claim with a primary diagnosis of prostate cancer (International Classification of Diseases(ICD) Clinical Modification (CM)185.xx )and any of the below on same day or after the prostate cancer claim:
- •At least one inpatient claim with a primary or secondary diagnosis indicating bone metastases (ICD 9 CM 198.5 or Healthcare Common Procedure Coding System (HCPCS) code for a treatment indicative of bone metastases OR
- •At least two outpatient claims with a primary or secondary diagnosis indicating bone metastases (ICD 9 CM 198.5 or HCPCS code for a treatment indicative of bone metastases, with a minimum of 30 days between claims.
排除标准
- •Subjects with a diagnosis of a cancer other than prostate cancer - defined as the presence of one inpatient or two outpatient claims with a primary or secondary diagnosis of malignant neoplasms (ICD-9-CM 140.xx-171.xx, 174.xx-184.xx,186.xx-195.xx,200.xx-209.3x, 230.xx-239.xx) - in the 12-month pre-index period.
- •Subjects with any claim for a primary or secondary diagnosis indicating bone metastases (ICD-9-CM 198.5) or any treatment indicative of bone metastases in the 12-month pre-index period.
- •Patients who had a SRE in the 12-month pre-index period.
- •Subjects without continuous enrollment for at least 12 months before the index date.
- •Subjects without continuous eligibility for at least 6 months after the index date.
- •Subjects that are female.
- •Subjects that have negative costs.
- •Subjects that are less than 45 years of age on the index date.
研究组 & 干预措施
Treatment patterns, healthcare resource utilization and costs
Part 1 - Assessment of treatment patterns, healthcare resource utilization and costs. The study cohort will include all patients with prostate cancer with incident bone metastases during the index period (1 June 2013 to 1 July 2014) based on a large database encompassing a broad sample of the commercially insured U.S. population. The first date of bone metastases diagnosis or first date of treatment indicative of bone metastases (whichever occurs first) will be designated as the index date. All patients must have no diagnosis of other cancers, no diagnosis of bone metastases or a claim for a treatment indicative of bone metastases, and no skeletal-related events (SREs) in the 12-month pre-index period. Additionally, all subjects must be continuously enrolled for at least 12 months before and at least 6 months after the index date.
干预措施: Xofigo (Radium 223 dichloride,BAY88-8223) (Drug)
Mortality
Part 2 - Assessment of mortality. The study cohort will include all patients with prostate cancer with incident bone metastases during the index period (1 June 2013 to 1 July 2014) based on a large database encompassing a broad sample of the commercially insured U.S. population. The first date of bone metastases diagnosis or first date of treatment indicative of bone metastases (whichever occurs first) will be designated as the index date. All patients must have no diagnosis of other cancers, no diagnosis of bone metastases or a claim for a treatment indicative of bone metastases, and no SREs in the 12-month pre-index period. Additionally, all subjects must be continuously enrolled for at least 12 months before the index date. Unlike in Part 1, there will be no required minimum follow-up time after the index date (in order to assess mortality).
干预措施: Xofigo (Radium 223 dichloride,BAY88-8223) (Drug)
结局指标
主要结局
Total costs of healthcare
时间窗: Upto 6 month post index period
Distribution of treatment types among lines of therapy
时间窗: Up to 6 months
Possible Treatment Types: Sipuleucel-T, Abiraterone, Enzalutamide, Docetaxel, Cabazitaxel, Radium-223, Anti-Androgens, All other chemotherapy(oral and injectables), Radiation therapy
Number of inpatient visits per patient
时间窗: Upto 6 month post index period
Length of hospital stay (days) among those with an inpatient visit
时间窗: Upto 6 month post index period
Time to treatment (days)
时间窗: Up to 6 months
Duration of treatment (days)
时间窗: Up to 6 months
Number of physician office visits per patient
时间窗: Upto 6 month post index period
Pharmacy costs of healthcare
时间窗: Upto 6 month post index period
Mortality rate
时间窗: Up to 6 months
Number of patients on each drug or drug combination
时间窗: Up to 6 months
Drug: Sipuleucel-T, Abiraterone, Enzalutamide, Docetaxel, Cabazitaxel, Radium-223, Anti-Androgens, All other chemotherapy(oral and injectables), Radiation therapy
Number of emergency room (ER) visits per patient
时间窗: Upto 6 month post index period
Number of claims per patient
时间窗: Upto 6 month post index period
Number of medication prescriptions per patient
时间窗: Upto 6 month post index period
Number of patients by provider type
时间窗: Upto 6 month post index period
Number of outpatient visits per patient
时间窗: Upto 6 month post index period
Medical costs of healthcare
时间窗: Upto 6 month post index period
Per-patient-per-month (PPPM)) costs of healthcare
时间窗: Upto 6 month post index period
次要结局
- Opioid/analgesic use among lines of therapy(Y/N)(Up to 6 months)