Adverse events and costs among non-metastatic castration-resistant prostate cancer patients

Abstract

Background

Limited real-world evidence exists on the economic burden of adverse events (AEs) to the healthcare system among patients with non-metastatic castration-resistant prostate cancer (nmCRPC) treated with second-generation androgen receptor antagonists (ARAs). Current data is needed to understand real-world clinical event rates among ARAs and the cost of these events.

Objectives

Describe the incidence of non-central nervous system (CNS)-related AEs and CNS-related AEs among nmCRPC patients treated in the United States with second-generation ARAs (apalutamide and enzalutamide) and evaluate healthcare resource utilization (HCRU) and costs for these patients.

Methods and study design

This was a retrospective observational cohort study using claims data from Optum Clinformatics Data Mart to identify adult males with prostate cancer, castration, no metastases, and >1 claim for apalutamide or enzalutamide. The study was conducted from January 2017 to March 2020, with a patient index identification period from January 2018 to December 2019. AEs were classified as CNS-related or non-CNS-related.

Results

Of 605 patients (156 apalutamide and 449 enzalutamide), most were ≥65 years (94%) and had ≥1 non-CNS-related AE (55%). Many had ≥1 CNS-related AE (32%). Pain (12%) and arthralgia (11%) were the most frequently reported non-CNS-related AEs. Fatigue/asthenia (14%) and dizziness (7%) were the most frequently reported CNS-related AEs. Among patients with versus without non-CNS-related AEs, 34% versus 8% had emergency room (ER) events, and 25% versus 2% had inpatient events. Among patients with versus without CNS-related AEs, 41% versus 14% had ER events, and 38% versus 4% had inpatient events. Adjusted per-patient per-year cost (in 2020 USD) differences were significant between patients with and without non-CNS-related AEs ($30,765, p = 0.0018) and between patients with and without CNS-related AEs ($40,689, p = 0.0017).

Conclusion

There is significant HCRU and cost burden among nmCRPC patients treated with ARAs developing AEs, highlighting the need for treatments with improved tolerability. Additional studies are warranted to include recently approved agents.

Keywords:

• Prostate cancer
• castration-resistant
• health expenditures
• adverse drug event
• healthcare resource utilization
• economic burden of disease

JEL Classification Codes:

• I19
• I1
• I
• I00
• I

Transparency

Declaration of financial/other relationships

SA, JY, JP, SXK, and JP are employees of and own stock in Bayer Healthcare Pharmaceuticals. SJF has a consultancy agreement with Bayer Healthcare Pharmaceuticals as well as with Janssen, Pfizer, Astellas, Merck, AstraZeneca, Sanofi, and Myovant.

Author contributions

All authors were involved in the concept and design of the study, the analysis and interpretation of the data, the drafting or critical revision for intellectual content of the manuscript, and the final approval of the manuscript for publication. All authors agree to be accountable for all aspects of the work.

Acknowledgements

The authors acknowledge Hubert Kusdono for medical writing and Jessica Beifuss and Kylie Matthews for copyediting and manuscript preparation assistance, all from Xcenda. Xcenda was contracted by Bayer to assist with the completion of this study.

Data availability

The data underlying this article will be shared on reasonable request to the corresponding author.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

Funding for this research was provided by Bayer HealthCare Pharmaceuticals.