Treatment patterns, adverse events, and direct and indirect economic burden in a privately insured population of patients with HR+/HER2– metastatic breast cancer in the United States

ABSTRACT

Background

Real-world evidence specific to HR+/HER2– metastatic breast cancer (MBC) prior to introduction of CDK4/6 inhibitors is limited. In an effort to provide context for the introduction of new treatments, we assessed treatment patterns, adverse events, productivity loss, and direct/indirect economic burden in a privately insured population of patients with HR+/HER2– MBC.

Research design and methods

Using a retrospective cohort design, patients aged 18–64 years, selected from MarketScan databases (2007–2014), were analyzed using descriptive and multivariable methods.

Results

Among 5,563 eligible patients, endocrine therapy was the most common first-line (1L) therapy; its utilization trended downward from 63% (1L) to 23% (4L), with a simultaneous increase in chemotherapy use, 25% (1L) to 50% (4L). Two hundred and seventy-eight unique treatment regimens were used in the 1L setting. The average per patient monthly all-cause costs were $14,424. The 12-month indirect costs for short-term disability were substantially higher in MBC patients ($10,397) than in matched noncancer patients ($394).

Conclusion

The increasing use of chemotherapy as patients progressed to second and later lines and the substantial direct/indirect economic burden underscore an unmet need. The high number of 1L regimens highlights significant heterogeneity and a lack of consensus related to the management of HR+/HER2– MBC in routine practice.

KEYWORDS:

• Adverse events
• healthcare use
• healthcare costs
• metastatic breast cancer
• productivity loss
• treatment patterns

Article highlights

• Treatment landscape for HR+/HER2– metastatic breast cancer is evolving, but limited real-world data exist for this specific subpopulation.

• Our study findings show that nearly 280 unique regimens were used in the first-line setting, highlighting the extent of heterogeneity and a lack of consensus for the management of HR+/HER2– MBC in routine practice.

• In addition, our study identifies an increasing trend in the use of chemotherapy as patients progressed from first to second and later lines of therapy.

• This study finds a substantial economic burden in privately insured patients with HR+/HER2– MBC in the United States.

• To our knowledge, this is the first study to report patient out-of-pocket costs (OOP) and the indirect economic burden in patients with the HR+/HER2– subtype of MBC. The inflation-adjusted, MBC-related OOP costs in 2013 were almost twice as much as those in 2007. This finding is consistent with the reports of rising patient cost-sharing in the past several years.

Acknowledgments

The authors thank John Forbes from RTI Health Solutions, who provided assistance with editing and developing this article in accordance with the journal’s submission guidelines. The study analyses, however, were independently performed by the RTI Health Solutions’ authors as per the study protocol and analysis plan.

Author contributions

RKG, SPN, and RCP contributed to study design, data analysis, and interpretation, and drafting/revision of the manuscript; GCC, ENS, GLP, YJH, LL, KLD, and JAK contributed in study design, interpretation of results, and critical revision of the manuscript.

Availability of data and materials

The data that support the findings of this study are available from IBM (formerly Truven Health Analytics), but restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available.

Ethics approval and consent to participate

This study based on pre-existing, deidentified data from a US managed-care population that was determined not to be a human subject research by the Institutional Review Board of RTI International.

Declaration of interest

RKG, SPN, RCP, KLD, and JAK are employees of RTI Health Solutions, which received research funding from Eli Lilly and Company to perform this study. RTI Health Solutions is a unit of RTI International, an independent, nonprofit, research organization that does work for government agencies and private companies. GCC, ENS, GLP, YJH, and LL are employees of and/or shareholders in Eli Lilly and Company. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewers disclosure

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

Supplementary material

Supplemental data for this article can be accessed here.

Additional information

Funding

The study was funded in full by Eli Lilly and Company, which is conducting clinical research in advanced breast cancer. All authors representing the funding organization participated in the design of the study and interpretation of data and in writing the manuscript.