Treatment Patterns in Castrate Resistant Prostate Cancer Patients With Bone Metastases in a Medicare Population

Bayer1,163 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,163

Conditions

Prostate Cancer

Interventions

Radium-223 dichloride (Xofigo, BAY88-8223)DRUG

Therapies used to treat prostate cancer and more specifically castrate resistant prostate cancer inclusively Xofigo (Radium-223 dichloride, BAY88-8223)

Eligibility

Sex: MALEMin age: 55 YearsMax age: 88 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Louisville, Kentucky, United States

Outcomes

Primary Outcomes

Overall survival of mCRPC patients

mCRPC: Metastatic castrate-resistant prostate cancer

Time frame: Up to 24 months

Number of skeletal related events (SREs) of the mCRPC patients

Time frame: Up to 30 months

Type of skeletal related events (SREs) of the mCRPC patients

Time frame: Up to 30 months

Number of patients with mCRPC with bone metastases

Time frame: Up to 24 months

Type of treatments associated with mCRPC

Treatments could include chemotherapy or bone radiation

Time frame: Up to 24 months

Duration for each treatment identified

Time frame: Up to 30 months

Distribution of providers by treatment

Distribution of treatments for mCRPC patients will be tracked by the type of provider (oncologist, versus urologist, versus radiation oncologist, etc)

Time frame: Up to 30 months

Clinical and demographic characteristics of the mCRPC patients

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

Time frame: Up to 12 months

Treatment patterns of mCRPC patients with bone metastases

Time frame: Up to 30 months

Data from ClinicalTrials.gov

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Secondary Outcomes

All-cause healthcare resource utilization for mCRPC patients

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

Time frame: Up to 30 months

mCRPC-specific healthcare resource utilization for mCRPC patients

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

Time frame: Up to 30 months

All-cause healthcare costs for mCRPC patients

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)

Time frame: Up to 30 months

mCRPC-specific healthcare costs for mCRPC patients

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.

Time frame: Up to 30 months