Prostate Cancer
Conditions
Keywords
Castrated resistant prostate cancer, Patients with bone metastases
Brief summary
The goal of the study is to provide a detailed description of treatments for CRPC (Castrate Resistant Prostate Cancer) patients with bone metastases and the resource utilization and costs associated with that diagnosis and subsequent treatments.
Interventions
DRUGRadium-223 dichloride (Xofigo, BAY88-8223)
Therapies used to treat prostate cancer and more specifically castrate resistant prostate cancer inclusively Xofigo (Radium-223 dichloride, BAY88-8223)
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
55 Years to 88 Years
Healthy volunteers
No
Inclusion criteria
* First diagnosis for bone metastases for members diagnosed with prostate cancer found in the claims data during the identification period * Members age ≥ 55 to 89 years at index * Medicare members with medical and pharmacy coverage; and * Continuously enrolled during the pre- and post-index periods.
Exclusion criteria
* Member with diagnosis of any other cancer (excluding melanoma (ICD-9 172.x) and other metastases (ICD-9 198.x)) before the index date; and * Members age ≥ 89 years of age at index date
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression of the disease of mCRPC patients | Up to 12 months | — |
| Duration for each treatment identified | Up to 30 months | — |
| Distribution of providers by treatment | Up to 30 months | Distribution of treatments for mCRPC patients will be tracked by the type of provider (oncologist, versus urologist, versus radiation oncologist, etc) |
| Clinical and demographic characteristics of the mCRPC patients | Up to 12 months | Gender, age, geographical region and race/ethnicity, Key comorbidities will also be documented using the Deyo-Charlson Comorbidity Index (DCCI); laboratory results for Prostate-Specific Antigen (PSA) and alkaline phosphatase (ALP) testing using laboratory claims; Rx utilization including opioid use |
| Treatment patterns of mCRPC patients with bone metastases | Up to 30 months | — |
| Overall survival of mCRPC patients | Up to 24 months | mCRPC: Metastatic castrate-resistant prostate cancer |
| Number of skeletal related events (SREs) of the mCRPC patients | Up to 30 months | — |
| Type of skeletal related events (SREs) of the mCRPC patients | Up to 30 months | — |
| Number of patients with mCRPC with bone metastases | Up to 24 months | — |
| Type of treatments associated with mCRPC | Up to 24 months | Treatments could include chemotherapy or bone radiation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mCRPC-specific healthcare resource utilization for mCRPC patients | Up to 30 months | Healthcare resource utilization will be measured using all post-index medical and pharmacy claims to create counts for physician office visits, outpatient services, inpatient stay, length of inpatient stay, ancillary services and counts of pharmacy claims |
| All-cause healthcare costs for mCRPC patients | Up to 30 months | Healthcare costs will be determined using all post-index medical and pharmacy claims. The all-cause total (medical + pharmacy), medical and pharmacy costs will be computed. A family of general linear model analysis will be performed (medical, pharmacy, and total costs) |
| mCRPC-specific healthcare costs for mCRPC patients | Up to 30 months | Healthcare costs will be determined using all post-index medical and pharmacy claims where a diagnosis of mCRPC appears in any of the nine diagnosis positions. The mCRPC specific total (Medical + pharmacy), medical and pharmacy costs associated with these claims will be computed. |
| All-cause healthcare resource utilization for mCRPC patients | Up to 30 months | Using all post-index medical and pharmacy claims, compute the count of physician office visits, outpatient services, inpatient stay, length of inpatient stay, ancillary services, and count of pharmacy claims |
Countries
United States
Outcome results
None listed