Annual indirect cost savings in patients with episodic or chronic migraine: post-hoc analyses from multiple galcanezumab clinical trials

Abstract

Aim

This post-hoc analysis estimated annual indirect cost savings with galcanezumab (GMB) treatment in patients with episodic migraine (EM) or chronic migraine (CM).

Methods

Data from 4 randomized, Phase 3, double-blind (DB), placebo (PBO)-controlled studies of GMB were analyzed: EVOLVE-1 and EVOLVE-2 (EM, 6-months DB), REGAIN (CM, 3-months DB), and CONQUER (previous failure of 2–4 migraine preventive medication categories, 3-months DB). Indirect costs were calculated at baseline and Month 3 using the first 2 items in Migraine Disability Assessment (MIDAS): (A + B)/60*country specific annual wage (A = days of missed work/school; B = days of reduced productivity at work/school; assuming 60 working days in 3 months). All costs were annualized and expressed in international dollars (Int$) in 2018. ANCOVA models estimated the indirect cost savings as a change from baseline. Secondary analyses determined cost savings by employment and responder status.

Results

Patients (>80% females) from EVOLVE-1 and −2 (n = 1,201; mean age 41.9 years), REGAIN (n = 759; mean age 41.3 years), and CONQUER (n = 453; mean age ∼46.0 years) were analyzed. GMB showed significant indirect cost savings for EM (Int$6256, p < .0001) and CM (Int$7129, p = .0002), with substantial savings for patients with previous failure of 2–4 migraine preventive medication categories (EM: Int$5664, p = .0030; CM: Int$5181, p = .1300). Compared with PBO, GMB showed significantly greater indirect cost savings for EM (p = .0156) and patients with previous failure of 2–4 migraine preventive medication categories (p = .0340). Employed patients with CM (p = .0018) and with previous failure of 2–4 migraine preventive medication categories (p < .0001) had significant cost savings after GMB treatment. GMB showed significant indirect cost savings in patients with a reduction in migraine headache days.

Conclusion

GMB treatment resulted in annual indirect cost savings in patients with EM, CM, and with previous failure of 2–4 migraine preventive medication categories, with similar observations in the sensitivity analyses.

Keywords:

• Chronic migraine
• episodic migraine
• employment
• indirect cost
• migraine headache days
• post-hoc

JEL CLASSIFICATION CODE:

• I00
• I
• I12
• I1
• I19

Transparency

Declaration of funding

This study was funded by Eli Lilly and Company.

Declaration of financial/other relationships

JHF, ATH, WY, RMN, and KS are employees and stockholders at Eli Lilly and Company.

RB is a former employee of Eli Lilly and Company.

JT is an employee of Neurosciences Clinic, Banner University Medical Center. He is a former employee of Xenoscience Inc. (affiliation during the research and manuscript writing). Independent Contractor (Including Contracted Research), Speaking, Teaching, and Advisory Boards 2021 – Eli Lilly and Company; Speaking – SK Life Sciences, Lundbeck, Eli Lilly and Company, AbbVie.

XM is an employee of TechData Service Company and is under contract with Eli Lilly and Company.

RBL: Consulting – AbbVie (Allergan), Amgen, Biohaven, Dr. Reddy’s Laboratories (Promius), ElectroCore, Eli Lilly and Company, eNeura Therapeutics, GlaxoSmithKline, Merck, Novartis, Teva, Vector, and Vedanta Research; Membership on Advisory Committees or Review Panels - American Academy of Neurology, American Headache Society, Biovision, Dr. Reddy’s (Promius), Equinox, Grifols, Headache, Lundbeck (Alder), Pernix, and Pfizer; Stocks – Biohaven, CtrlM; Board Membership – Cephalgia, Neurology; Received Royalties – Informa (Other Activities), Wolff's Headache, 8th edition (Oxford University Press, 2009) (Other Activities); Others – Migraine Research Foundation, National Headache Foundation, National Institute of Neurological Disorders and Stroke, National Institute on Aging, and National Institutes of Health.

A reviewer on this manuscript has disclosed that they have received honoraria from Allergan, Novartis, Lilly and Teva Pharmaceuticals for their work as a consultant and speaker. Peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.

Author contributions

Conception of work: JHF. Design of the work: JHF. Acquisition of data: JT, RB, WY, XM. Data Analysis: WY, XM. Data interpretation: JT, JHF, ATH, RMN, RB, KS, RBL. Manuscript writing and critical revision: JT, JHF, ATH, RMN, WY, RB, KS, RBL. Final approval: JT, JHF, ATH, RMN, WY, RB, XM, KS, RBL.

Acknowledgements

None reported.

Data availability statement

Lilly provides access to all individual participant data collected during the trial, after anonymization, with the exception of pharmacokinetic or genetic data. Data are available to request 6 months after the indication studied has been approved in the US and EU and after primary publication acceptance, whichever is later. No expiration date of data requests is currently set once data are made available. Access is provided after a proposal has been approved by an independent review committee identified for this purpose and after receipt of a signed data sharing agreement. Data and documents, including the study protocol, statistical analysis plan, clinical study report, blank or annotated case report forms, will be provided in a secure data sharing environment. For details on submitting a request, see the instructions provided at www.vivli.org.

Previous presentations

The data were presented as a poster at the 63^rd Annual Meeting American Headache Society (P-78: https://headachejournal.onlinelibrary.wiley.com/doi/10.1111/head.14130).