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Abstract
Background: Frequent migraine with four or more headache days per month is a common, disabling neurovascular disease. From a US societal perspective, this analysis models the clinical efficacy and estimates the value-based price (VBP) for erenumab, a fully human monoclonal antibody that inhibits the calcitonin gene-related peptide receptor.
Methods: A Markov health state transition model was developed to estimate the incremental costs, quality-adjusted life-years (QALYs), and value-based price range for erenumab in migraine prevention. The model comprises “on preventive treatment”, “off preventive treatment”, and “death” health states across a 10-year time horizon. The evaluation compared erenumab to no preventive treatment in episodic and chronic migraine patients that have failed at least one preventive therapy. Therapeutic benefits are based on estimated changes in monthly migraine days (MMD) from erenumab pivotal clinical trials and a network meta-analysis of migraine studies. Utilities were estimated using previously published mapping algorithms. A VBP analysis was performed to identify maximum erenumab annual prices at willingness-to-pay (WTP) thresholds of $100,000–$200,000 per QALY. Estimates of VBP under different scenarios such as choice of different comparators, assumptions around inclusion of placebo effect, and exclusion of work productivity losses were also generated.
Results: Erenumab resulted in incremental QALYs of 0.185 vs supportive care (SC) and estimated cost offsets due to reduced MMD of $8,482 over 10 years, with an average duration of treatment of 2.01 years. The estimated VBP at WTP thresholds of $100,000–$200,000 for erenumab compared to SC ranged from $14,238–$23,998. VBP estimates including the placebo effect and excluding work productivity ranged from $7,445–$13,809; increasing to $12,151–$18,589 with onabotulinumtoxinA as a comparator in chronic migraine.
Conclusion: Erenumab is predicted to reduce migraine-related direct and indirect costs, and increase QALYs compared to SC.
JEL classification codes:
Transparency
Declaration of funding
The study was funded by Amgen Inc.
Declaration of financial/other relationships
RBL has received research grants from NIH, the Migraine Research Foundation, and the National Headache foundation, and has received consulting fees from the American Academy of Neurology, Alder, Allergan, American Headache Society, Amgen, Avanir, Biohaven, Biovision, Boston Scientific, Dr. Reddy’s, Electrocore, Eli Lilly, eNeura Therapeutics, GlaxoSmithKline, Merck, Pernix, Pfizer, Supernus, Teva, Trigemina, Vector, and Vedanta. RBL serves on the editorial board of Neurology, as an Associate Editor of Cephalalgia, and as a senior advisor to Headache. RBL receives royalties from Wolff’s Headache and Other Head Pain, 8th Edition (Oxford Press University, 2009), Wiley, and Informa, and holds stock in eNeura and Biohaven. DD has received consulting fees from Allergan, Amgen, Alder, Pfizer, Colucid, eNeura, Eli Lilly, Autonomic Technologies, Supernus, Tonix, Novartis, Teva, Zosano, Insys, GBS/Nocira, Acorda, Biohaven, Nocira, Ipsen, and Promius. DD receives royalties from Oxford University Press and Cambridge University Press, and holds stock in Nocira, Epien, King-Devick, Migraine Buddy, and Mobile Health (Second Opinion). ST has received research grants (no personal compensation) from Alder, Allergan, Amgen, ATI, Dr. Reddy’s, ElectroCore, eNeura, Scion Neurostim, Teva, and Zosano. ST serves as a consultant or on Advisory Boards, Scientific Advisory Boards, or Trial Steering Committees for Acorda, Alder, Allergan, Amgen, ATI, Cefaly, Charleston Laboratories, DeepBench, Dr. Reddy’s, ElectroCore, Eli Lilly, eNeura, GLG, Guidepoint Global, Impax, Neurolief, Pfizer, Scion Neurostim, Slingshot Insights, Supernus, Teva, and Zosano. ST sits on the board of the American Headache Society, receives royalties from Springer, and holds stock in ATI. ST is an employee of Dartmouth Hitchcock Medical Center and receives a salary for editorship from the American Headache Society. AB has received research grants from the National Institute of Health Research, Public Health England, the National Institute of Health (US), and the Department of Health (UK), and has received consulting fees from Amgen, GlaxoSmithKline, RTI, and TeamDRG. SP has received consulting fees from Amgen. AJH was an employee of BresMed Health Solutions, who have received consulting fees from Amgen, when the study was conducted. JKP is an employee of Amgen. SS, GV, and NS are employees of Amgen and hold stock. Peer reviewers on this manuscript have received an honorarium from JME for their review work, but have no other relevant financial relationships to disclose.
Acknowledgments
We are grateful to Gertruud Haitsma, Saswat Panda, and Dr. Mark Connolly for their technical and editorial contributions to this work.