Identification of patients with metastatic castration-sensitive or metastatic castration-resistant prostate cancer using administrative health claims and laboratory data

Abstract

Objective

To develop algorithms to identify metastatic castration-sensitive prostate cancer (mCSPC) patients and castration-resistant prostate cancer (mCRPC) patients, using health claims data and laboratory test results.

Methods

A targeted literature review summarized mCSPC and mCRPC patient selection criteria previously used in real-world retrospective studies. Novel algorithms to identify mCSPC and mCRPC were developed based on diagnosis codes indicating hormone sensitivity/resistance, prostate-specific antigen (PSA) test results, and claims for castration and mCRPC-specific treatments. These algorithms were applied to claims data from Optum Clinformatics Extended DataMart (Date of Death) Databases (commercial insurance/Medicare Advantage [COM/MA]; 01 January 2014–31 July 2019) and Medicare Fee-for-Service (Medicare-FFS; 01 January 2014–31 December 2017).

Results

Previous real-world studies identified mCSPC primarily based on metastasis diagnosis codes, and mCRPC based on mCRPC-specific drugs. Using the current study’s algorithms, 7034 COM/MA and 19,981 Medicare-FFS patients were identified as having mCSPC, and 2578 COM/MA and 11,554 Medicare-FFS as having mCRPC. Most mCSPC patients were identified based on evidence of being hormone/castration-naive. Patients were identified as having mCRPC most commonly based on rising PSA (COM/MA), or at the metastasis diagnosis date if it occurred after castration (Medicare-FFS). Among patients with mCSPC, 14–17% had evidence of progression to castration resistance during a median 1-year follow-up period, mostly based on use of mCRPC-specific drugs.

Conclusions

Comprehensive algorithms based on claims and laboratory data were developed to identify and distinguish patients with mCSPC and mCRPC. This will facilitate appropriate identification of mCSPC and mCRPC patients based on health claims data and better understanding of patient unmet needs in real-world settings.

Keywords:

• Metastatic castration-sensitive prostate cancer (mCSPC)
• metastatic castration-resistant prostate cancer (mCRPC)
• hormone resistance
• hormone sensitivity
• real-world data
• administrative health insurance claims data
• laboratory data

Transparency

Declaration of Funding

Financial support for this research was provided by Janssen Scientific Affairs, LLC. The study sponsor was involved in several aspects of the research, including the study design, the interpretation of data, the writing of the manuscript, and the decision to submit the manuscript for publication.

Declaration of interest

SF has received consulting fees from Astellas, Pfizer, Sanofi, Bayer, Myovant, Merck, Astra Zeneca, Clovis, and Janssen Scientific Affairs, LLC. CR has received consulting fees from Janssen Scientific Affairs, LLC. XK and DMD are employees of Janssen Scientific Affairs, LLC and stockholders of Johnson & Johnson. MHL, HR, FK, and PL are employees of Analysis Group, Inc., a consulting company that has provided paid consulting services to Janssen Scientific Affairs, LLC. PF is an employee of Janssen Pharmaceuticals, Inc. and stockholder of Johnson & Johnson. AP, ZP, and SK are employees of Avalere Health, a consulting company that has provided paid consulting services to Janssen Scientific Affairs, LLC. Peer reviewers on this manuscript have received an honorarium from CMRO for their review work. One of these reviewers has disclosed they have been an advisor or speaker for Astra Zeneca, Astellas, Janssen, Bayer, Pfizer, and Sanofi. The remaining reviewers have no other relevant financial relationships or otherwise to disclose.

Author contributions

SF, XK, PF, DMD, and CR contributed to study conception and design, and data analysis and interpretation. MHL, HR, FK, and PL contributed to study conception and design, collection and assembly of data, and data analysis and interpretation. AP, ZP, and SK contributed to study conception and design, collection and assembly of data, and data analysis and interpretation. All authors reviewed and approved the final content of this manuscript.

Acknowledgements

Medical writing support was provided by a professional medical writer, Christine Tam, an employee of Analysis Group, Inc.

Previous presentation

Part of the material based on the COM/MA database in this manuscript was presented at the Academy of Managed Care Pharmacy (AMCP) Nexus 2019 held from 29 October to 1 November 2019 in National Harbor, MD and the American Society of Clinical Oncology (ASCO) Annual Meeting held virtually from 29 to 31 May 2020.

Notes

i Clinformatics is a registered trademark of Optum located at Eden Prairie, MN, USA.

ii National Comprehensive Cancer Network is a registered trademark located at Plymouth Meeting, PA, USA.