The impact of lurasidone on functioning and indirect costs in adults with bipolar depression: a post-hoc analysis

Abstract

Objective

The aim of this post-hoc analysis was to assess the impact of lurasidone monotherapy on functional impairment, productivity, and associated indirect costs in patients with bipolar depression.

Methods

Data were analyzed from a 6-week randomized, double-blind (DB; NCT00868699), placebo-controlled trial of lurasidone monotherapy and a 6-month open label extension (OLE; NCT00868959) study. Patients with bipolar depression who completed the 6-week DB trial were subsequently enrolled in the OLE. Analysis of the OLE was limited to patients who either continued lurasidone (LUR-LUR) or switched from placebo to lurasidone monotherapy (PBO-LUR). The Sheehan Disability Scale (SDS), which measures functional impairment and productivity, was collected at DB baseline, DB week 6/OLE baseline, OLE month 3, and OLE month 6. Annual indirect costs were calculated based on days lost or unproductive from work/school due to symptoms. Effect sizes (ES) in functioning and days lost/unproductive were reported for the DB trial and mean changes for the OLE.

Results

A total of 485 patients were enrolled in the DB trial (lurasidone: n = 323; placebo: n = 162) and 316 were in the lurasidone monotherapy group during the OLE (LUR-LUR: n = 210; PBO-LUR: n = 106). In the DB trial, improvements in functioning (work: ES = 0.36, p = .0071; social: ES = 0.55, p < .0001; family: ES = 0.50, p < .0001) were significantly greater for lurasidone compared to placebo. Reductions in days lost (ES = 0.33, p = .0050) and unproductive (ES = 0.45, p = .0001) were significantly higher for lurasidone vs. placebo. This resulted in a greater reduction in indirect costs for lurasidone vs. placebo (least squares mean (standard error) = −$32,322 ($2,100) vs. −$20,091 ($2,838)). Improvements in functioning and productivity were sustained during the 6-month OLE for both LUR-LUR and PBO-LUR.

Conclusions

Lurasidone monotherapy for the treatment of bipolar depression significantly improved functioning and reduced indirect costs vs. placebo at week 6. Significant improvements in functioning and productivity were sustained for 6 months for both LUR-LUR and PBO-LUR.

Keywords:

• Bipolar depression
• lurasidone
• Sheehan Disability Scale
• days lost
• days unproductive
• indirect costs

JEL CLASSIFICATION CODES:

• I10
• I1
• I
• I19

Transparency

Declaration of funding

This post-hoc analysis was funded by Sunovion Pharmaceuticals Inc.

Declaration of financial/other interests

XN, CD, QF, YM, SB, and MT are employees of Sunovion. VD is an employee of IQVIA, which received funding from Sunovion to conduct this analysis.

The peer reviewers on this manuscript have received an honorarium from JME for their review work. One of the reviewers has received manuscript or speaker’s fees from Astellas, Dainippon Sumitomo Pharma, Eisai, Eli Lilly, Elsevier Japan, Janssen Pharmaceuticals, Kyowa Yakuhin, Lundbeck, Meiji Seika Pharma, Mitsubishi Tanabe Pharma, MSD, Nihon Medi-Physics, Novartis, Otsuka Pharmaceutical, Shionogi, Shire, Takeda Pharmaceutical, Tsumura, Wiley Japan, and Yoshitomi Yakuhin, and research grants from Dainippon Sumitomo Pharma, Eisai, Mochida Pharmaceutical, Meiji Seika Pharma and Shionogi. The other peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.

Author contributions

All authors were involved in the design of the post-hoc analysis, data analysis, interpretation of results, drafting and critical revision of the manuscript, and providing a final review.

Acknowledgements

We thank the participants of this study as well as the members of the Lurasidone Bipolar Disorder Study Group. We also thank Barbara Blaylock, PhD from Blaylock Health Economics LLC for providing medical writing support.

Data availability statement

This post-hoc analysis used confidential clinical trial data, which are not publicly available.

Previous presentations

An earlier version of this work was presented as a poster at the 2021 Neuroscience Education Institute Congress (Colorado Springs, CO; 4–7 November 2021) and the 2021 US Psych Congress (San Antonio, TX; 29 October–1 November).