Annual indirect costs savings in patients with episodic or chronic migraine: a post-hoc analysis of phase 3 galcanezumab clinical trials in the United States

Abstract

Background

Galcanezumab (GMB) improved quality-of-life and reduced disability of patients with episodic (EM) and chronic migraine (CM) in Phase 3 trials.

Aim

To estimate indirect cost savings associated with GMB treatment in patients with migraine in the United States (US).

Methods

We analyzed data of patients from the US from three randomized, Phase 3, double-blind, placebo (PBO)-controlled GMB studies: EVOLVE-1 and EVOLVE-2 (EM patients), REGAIN (CM patients). Annual indirect costs were calculated using items of the Migraine Disability Assessment (MIDAS) questionnaire: lost time/productivity at work/school, household work, and leisure time. All costs were annualized and expressed in 2019 US dollars. While the main analysis considered lost time/productivity at work/school and household work as a full day, a sensitivity analysis was performed by discounting them by half. For EM, annual indirect costs savings were estimated using mixed model repeated measures analysis. For CM, ANCOVA models were used to estimate annual indirect costs savings as change from baseline.

Results

The analysis included 805 patients with EM (mean age = 41.4 years; PBO = 534; GMB = 271) and 423 patients with CM (mean age = 38.9 years; PBO = 279; GMB = 144). Compared to PBO, GMB significantly reduced annual indirect costs among patients with EM at 3 months (least square mean [95% confidence interval] work/school = $1,883.6 [603.64–3,163.65], p = .0040, household work = $628.9 [352.95–904.88], p <.0001, and leisure activity = $499.17 [42.36–955.98], p = .0323) and 6 months (work/school = $2,382.29 [1,065.48–3,699.10], p = .0004, household work = $559.45 [268.99–849.90], p = .0002, and leisure activity = $753.81 [334.35–1,173.27], p = .0004), whereas a significant difference was not observed among patients with CM. Sensitivity analysis results were similar to primary analysis results.

Conclusions

GMB treatment versus PBO resulted in significantly greater indirect cost savings in patients with EM through improved productivity at work/school, household work, and leisure days. Patients with CM receiving GMB versus PBO attained greater cost savings, although not statistically significant, through reduced lost productivity at work/school.

Plain language summary

Migraine causes missed time or reduced productivity at home and work, which further imposes an economic burden on patients, referred to as indirect costs. In this study, we evaluated the indirect cost savings in patients with episodic or chronic migraine taking either galcanezumab or placebo for treatment. We collected data using a questionnaire called the Migraine Disability Assessment (MIDAS) that was completed by patients enrolled in three clinical studies in the United States (US), namely EVOLVE-1, EVOVLE-2 (episodic migraine patients), and REGAIN (chronic migraine patients). The MIDAS questionnaire evaluated time lost/reduced productivity at work/school, household work, and leisure activity in patients with episodic or chronic migraine. Using scores of the MIDAS questionnaire and standard annual wages for the US population, we calculated indirect costs in patients. A total of 805 patients with episodic migraine and 423 patients with chronic migraine were included in this study. In galcanezumab-treated patients with episodic migraine, a significant indirect cost saving was observed through decrease in time lost/reduced productivity at work/school, household work, and leisure activity compared with patients who received placebo. In galcanezumab-treated patients with chronic migraine, indirect cost saving observed through decrease in time lost/reduced productivity at work/school were not statistically different from placebo-treated patients. The relatively lower cost savings observed in patients with chronic migraine may be due to greater disease burden compared to patients with episodic migraine. Results of this study suggest that patients with migraine receiving galcanezumab may obtain indirect cost savings.

Keywords:

• Chronic migraine
• episodic migraine
• galcanezumab
• indirect costs
• MIDAS

JEL classification codes:

• I10
• I1
• I
• I00
• I

Transparency

Declaration of financial/other relationships

OJV, WY, RB, and JH are employees and stockholders of Eli Lilly and Company. XM is an employee of TechData Services Company and performs contracted work for Eli Lilly and Company.

Author contributions

Conception of work: OJV

Design of the work: OJV and WY

Acquisition of data: WY and XM

Data Analysis: WY and XM

Data interpretation: OJV, WY, RB, XM, and JH

Manuscript writing and critical revision: OJV, WY, RB, XM, and JH

Final approval: OJV, WY, RB, XM, and JH

Acknowledgements

The authors thank Janet H Ford (Eli Lilly and Company, Indianapolis, IN) for providing input during the study design and implementation. Rahul Nikam and Keerthana Muthiah, employees of Eli Lilly Services India Pvt. Ltd., provided writing support.

Reviewer disclosures

A reviewer on this manuscript has disclosed that they have been a PI in two of the clinical trials analyzed in this manuscript (EVOLVE-2 and REGAIN). They have also received fees for training and consultancy activities from Lilly. Peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.

Previous presentations

A portion of these results was presented at the 2022 American Headache Society (AHS); June 9–12, 2022.

Additional information

Funding

This study was sponsored by Eli Lilly and Company.