U.S. flag

An official website of the United States government

NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.

Clinical Review Report (Resubmission): OnabotulinumtoxinA (BOTOX): (Allergan Inc.): Indication: For the prophylaxis of headaches in adults with chronic migraine (≥ 15 days per month with headache lasting four hours a day or longer) [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2019 Nov.

Cover of Clinical Review Report (Resubmission): OnabotulinumtoxinA (BOTOX)

Clinical Review Report (Resubmission): OnabotulinumtoxinA (BOTOX): (Allergan Inc.): Indication: For the prophylaxis of headaches in adults with chronic migraine (≥ 15 days per month with headache lasting four hours a day or longer) [Internet].

Show details

References

1.
Frampton JE. OnabotulinumtoxinA (BOTOX(R)): a review of its use in the prophylaxis of headaches in adults with chronic migraine. Drugs. 2012;72(6):825–845. [PubMed: 22468643]
2.
Classification Committee of the International Headache Society. The international classification of headache disorders. 3rd ed. London (GB): International Headache Society; 2018: https://www​.ichd-3.org​/1-migraine/1-3-chronic-migraine/. Accessed January 29, 2019.
3.
Evans RW. A rational approach to the management of chronic migraine. Headache. 2013;53(1):168–176. [PubMed: 23293866]
4.
Buse DC, Manack AN, Fanning KM, et al. Chronic migraine prevalence, disability, and sociodemographic factors: results from the American Migraine Prevalence and Prevention Study. Headache. 2012;52(10):1456–1470. [PubMed: 22830411]
5.
Becker WJ, Findlay T, Moga C, Scott NA, Harstall C, Taenzer P. Guideline for primary care management of headache in adults. Can Fam Physician. 2015;61(8):670–679. [PMC free article: PMC4541429] [PubMed: 26273080]
6.
Sinclair AJ, Sturrock A, Davies B, Matharu M. Headache management: pharmacological approaches. Pract Neurol. 2015;15(6):411–423. [PMC free article: PMC4680181] [PubMed: 26141299]
7.
Ford JH, Jackson J, Milligan G, Cotton S, Ahl J, Aurora SK. A real-world analysis of migraine: a cross-sectional study of disease burden and treatment patterns. Headache. 2017;57(10):1532–1544. [PubMed: 28984356]
8.
Hepp Z, Bloudek LM, Varon SF. Systematic review of migraine prophylaxis adherence and persistence. J Manag Care Pharm. 2014;20(1):22–33.
9.
Botox(onabotulinumtoxinA for injection): Clostridium botulinum type A neurotoxin complex (900kD) sterile vacuum-dried concentrate powder for solution for injection 50, 100 and 200 Allergan units per vial [product monograph]. Markham (ON): Allergan Inc; 2018 Oct 16.
10.
AG-TOPIRAMATE (topiramate tablets): 25mg, 100mg and 200 mg tablets [product monograph]. Boucherville (QC): Angita Pharma Inc; 2018 May 22: https://pdf​.hres.ca/dpd_pm/00045484.PDF. Accessed 2019 Jan 29.
11.
AIMOVIG (erenumab injection): 70 mg in 1.0 mL (70 mg/mL) solution for subcutaneous injection [product monograph]. Dorval (QC): Novartis Pharmaceuticals Canada Inc.; 2018 Aug 1: https://pdf​.hres.ca/dpd_pm/00046673.PDF. Accessed 2019 Jan 29.
12.
Dolly JO, Aoki KR. The structure and mode of action of different botulinum toxins. Eur J Neurol. 2006;13: Suppl 4:1–9. [PubMed: 17112344]
13.
CADTH Canadian Drug Expert Committee (CDEC) final recommendation: OnabotulinumtoxinA (Allergan Inc.). Ottawa (ON): CADTH; 2014 May 28: https://cadth​.ca/sites​/default/files/cdr​/complete/SR0345_complete​_Botox-May-30-14.pdf. Accessed 2019 Jan 22.
14.
onabotulinumtoxinA for injection (Botox). CADTH Clinical review report. Ottawa (ON): CADTH; 2015: https://cadth​.ca/sites​/default/files/cdr​/clinical/SR0345_Botox​_Migraine_CL_Report_e.pdf.
15.
Cole JC, Lin P, Rupnow MF. Minimal important differences in the Migraine-Specific Quality of Life Questionnaire (MSQ) version. Cephalalgia. 2009;29(11):1180–1187. [PubMed: 19830883]
16.
Dodick DW, Turkel CC, DeGryse RE, et al. Assessing clinically meaningful treatment effects in controlled trials: chronic migraine as an example. J Pain. 2015;16(2):164–175. [PubMed: 25464159]
17.
Silberstein SD, Marmura MJ, Shaw J, Yu S. Headache prophylaxis with BoNTA: patient characteristics. Headache. 2010;50(1):63–70. [PubMed: 19549156]
18.
Tassorelli C, Diener HC, Dodick DW, et al. Guidelines of the International Headache Society for controlled trials of preventive treatment of chronic migraine in adults. Cephalalgia. 2018;38(5):815–832. [PubMed: 29504482]
19.
Calcitonin gene-related peptide (CGRP) inhibitors as preventative treatments for patients with episodic or chronic migraine: effectiveness and value. Final evidence report. Boston (MA): Institute for Clinical and Economic Review; 2018 https://icer-review​.org​/wp-content/uploads​/2017/11/ICER_Migraine​_Final_Evidence_Report_070318.pdf. Accessed 2019 Feb 8.
20.
Guidance for industry E9 statistical principles for clinical trials. Rockville (MD): U.S. Food and Drug Administration; 1998: https://www​.fda.gov/downloads​/Drugs/GuidanceComplianceRegulatoryInformation​/Guidances/UCM073137.pdf. Accessed 2019 Feb 15.
21.
Clinical study report: GMA-BTX-CM-12-545. Use of the chronic migraine impact questionnaire (acm-i) to assess patient-treatment benefit of botox® (botulinum toxin type a) in adult patients with chronic migraine - pilot study [CONFIDENTIAL internal manufacturer’s report]. Irvine (CA): Allergan; 2015 Jan 19.
22.
Clinical study report: GMA-US-NEU-0206. A multi-centre, prospective, randomized, open-label study to compare the efficacy, safety, and tolerability of Botox and topiramate for headache prophylaxis in adults with chronic migraine [CONFIDENTIAL internal manufacturer’s report]. Irvine (CA): Allergan; 2018 March 2.
23.
Clinical study report: GMA-BTX-CM-10-001. An open-label, multi-centre study of the long-term efficacy, safety and tolerability of Botox® (onabotulinumtoxina) for the prophylaxis of headaches in adult patients with chronic migraine - the COMPEL study [CONFIDENTIAL internal manufacturer’s report]. Irvine (CA): Allergan; 2016 Nov 23.
24.
Negro A, Curto M, Lionetto L, Crialesi D, Martelletti P. OnabotulinumtoxinA 155 U in medication overuse headache: a two years prospective study. Springerplus. 2015;4:826. [PMC free article: PMC4695480] [PubMed: 26753113]
25.
Negro A, Curto M, Lionetto L, Martelletti P. A two years open-label prospective study of OnabotulinumtoxinA 195 U in medication overuse headache: a real-world experience. J Headache Pain. 2015;17:1. [PMC free article: PMC4720620] [PubMed: 26792662]
26.
Natoli JL, Manack A, Dean B, et al. Global prevalence of chronic migraine: a systematic review. Cephalalgia. 2010;30(5):599–609. [PubMed: 19614702]
27.
Blumenfeld AM, Varon SF, Wilcox TK, et al. Disability, HRQoL and resource use among chronic and episodic migraineurs: results from the International Burden of Migraine Study (IBMS). Cephalalgia. 2011;31(3):301–315. [PubMed: 20813784]
28.
Blumenfeld AM, Bloudek LM, Becker WJ, et al. Patterns of use and reasons for discontinuation of prophylactic medications for episodic migraine and chronic migraine: results from the second international burden of migraine study (IBMS-II). Headache. 2013;53(4):644–655. [PubMed: 23458496]
29.
e-CPS. Ottawa (ON): Canadian Pharmacists Association; 2019: https://www​.e-therapeutics.ca/. Accessed 2019 Jan 22.
30.
Reiger L, Jensen B, Downey S. Migraine: acute and prophylaxis. Saskatoon (SK): RxFiles 2018: https://www​.rxfiles.ca. Accessed 2019 Feb 7.
31.
CDR submission: Botox (onabotulinumtoxinA), 155U to 195U administered intramuscularly [CONFIDENTIAL manufacturer’s submission]. Markham (ON): Allergan Inc; 2018 Nov 2.
32.
Blumenfeld AM, Stark RJ, Freeman MC, Orejudos A, Manack Adams A. Long-term study of the efficacy and safety of OnabotulinumtoxinA for the prevention of chronic migraine: COMPEL study. J Headache Pain. 2018;19(1):13. [PMC free article: PMC5799088] [PubMed: 29404713]
33.
Davies B, Gaul C, Martelletti P, Garcia-Monco JC, Brown S. Real-life use of onabotulinumtoxinA for symptom relief in patients with chronic migraine: REPOSE study methodology and baseline data. J Headache Pain. 2017;18(1):93. [PMC free article: PMC5587510] [PubMed: 28879545]
34.
Blumenfeld AM, Aurora SK, Laranjo K, Papapetropoulos S. Unmet clinical needs in chronic migraine: rationale for study and design of COMPEL, an open-label, multi-centre study of the long-term efficacy, safety, and tolerability of onabotulinumtoxinA for headache prophylaxis in adults with chronic migraine. BMC Neurol. 2015;15:100. [PMC free article: PMC4489131] [PubMed: 26133547]
35.
Clinical study report: MAF/AGN/NS/CM/002. A 24-month, prospective, non-interventional study to describe the long term, real-life use of Botox® for the symptomatic treatment of adults with chronic migraine, measuring healthcare resource utilization, and patient reported outcomes observed in practice [CONFIDENTIAL internal manufacturer’s report]. Westport (IE): Allergan Pharmaceuticals Ireland; 2017 Jun 22.
36.
Clinical study report: IIT 142. Calcitonin gene-related peptide (CGRP) levels in the pathogenesis of chronic migraine [CONFIDENTIAL internal manufacturer’s report]. Irvine (CA): Allergan; 2012 May 1.
37.
Cady R, Turner I, Dexter K, Beach ME, Cady R, Durham P. An exploratory study of salivary calcitonin gene-related peptide levels relative to acute interventions and preventative treatment with onabotulinumtoxinA in chronic migraine. Headache. 2014;54(2):269–277. [PubMed: 24147647]
38.
Clinical study report: A randomized, pilot study to evaluate the tolerability of onabotulinumtoxinA plus topiramate vs. onabotulinumtoxina plus placebo and long term effect of treatment on cognitive efficiency and continuation of care [CONFIDENTIAL internal manufacturer’s report]. Irvine (CA): Allergan.
39.
Bagley CL, Rendas-Baum R, Maglinte GA, et al. Validating Migraine-Specific Quality of Life Questionnaire v2.1 in episodic and chronic migraine. Headache. 2012;52(3):409–421. [PubMed: 21929662]
40.
Rendas-Baum R, Bloudek LM, Maglinte GA, Varon SF. The psychometric properties of the Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ) in chronic migraine patients. Qual Life Res. 2013;22(5):1123–1133. [PMC free article: PMC3664759] [PubMed: 22797868]
41.
Dodick DW, Silberstein S, Saper J, et al. The impact of topiramate on health-related quality of life indicators in chronic migraine. Headache. 2007;47(10):1398–1408. [PubMed: 18052949]
42.
DYNHA headache impact test. Lincoln (RI): QualityMetric 2013.
43.
Kosinski M, Bayliss MS, Bjorner JB, et al. A six-item short-form survey for measuring headache impact: the HIT-6. Qual Life Res. 2003;12(8):963–974. [PubMed: 14651415]
44.
Kawata AK, Coeytaux RR, Devellis RF, Finkel AG, Mann JD, Kahn K. Psychometric properties of the HIT-6 among patients in a headache-specialty practice. Headache. 2005;45(6):638–643. [PubMed: 15953295]
45.
Rendas-Baum R, Yang M, Varon SF, Bloudek LM, DeGryse RE, Kosinski M. Validation of the Headache Impact Test (HIT-6) in patients with chronic migraine. Health Qual Life Outcomes. 2014;12:117. [PMC free article: PMC4243819] [PubMed: 25080874]
46.
Coeytaux RR, Kaufman JS, Chao R, Mann JD, Devellis RF. Four methods of estimating the minimal important difference score were compared to establish a clinically significant change in Headache Impact Test. J Clin Epidemiol. 2006;59(4):374–380. [PubMed: 16549259]
47.
Smelt AF, Assendelft WJ, Terwee CB, Ferrari MD, Blom JW. What is a clinically relevant change on the HIT-6 questionnaire? An estimation in a primarycare population of migraine patients. Cephalalgia. 2014;34(1):29–36. [PubMed: 23843470]
48.
Patient Health Questionnaire (PHQ-9). Victoria (BC): gov.bc.ca: https://www2​.gov.bc.ca​/assets/gov/health​/practitioner-pro/bc-guidelines​/depression​_patient_health_questionnaire.pdf. Accessed 2019 Feb 14.
49.
Cohen J. A power primer. Psychol Bull. 1992;112(1):155–159. [PubMed: 19565683]
50.
Blumenfeld A, Rosa K, Evans C, et al. Psychometric evaluation of the Assessment of Chronic Migraine Impacts (ACM-I) and Assessment of Chronic Migraine Symptoms (ACM-S) (abstract). Headache. 2014;54:19.
51.
Zhang W, Bansback N, Boonen A, Young A, Singh A, Anis AH. Validity of the work productivity and activity impairment questionnaire-general health version in patients with rheumatoid arthritis. Arthritis Res Ther. 2010;12(5):R177. [PMC free article: PMC2991008] [PubMed: 20860837]
52.
Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics. 1993;4(5):353–365. [PubMed: 10146874]
53.
Louis E, Lofberg R, Reinisch W, et al. Adalimumab improves patient-reported outcomes and reduces indirect costs in patients with moderate to severe Crohn’s disease: results from the CARE trial. J Crohns Colitis. 2013;7(1):34–43. [PubMed: 22480772]
54.
EuroQol-a new facility for the measurement of health-related quality of life. Health Policy. 1990;16(3):199–208. [PubMed: 10109801]
55.
Brooks R. EuroQol: the current state of play. Health Policy. 1996;37(1):53–72. [PubMed: 10158943]
56.
Stafford MR, Hareendran A, Ng-Mak DS, Insinga RP, Xu R, Stull DE. EQ-5DTM-derived utility values for different levels of migraine severity from a UK sample of migraineurs. Health Qual Life Outcomes. 2012;10:65. [PMC free article: PMC3407525] [PubMed: 22691697]
57.
Essink-Bot ML, Krabbe PF, Bonsel GJ, Aaronson NK. An empirical comparison of four generic health status measures. The Nottingham Health Profile, the Medical Outcomes Study 36-item Short-Form Health Survey, the COOP/WONCA charts, and the EuroQol instrument. Med Care. 1997;35(5):522–537. [PubMed: 9140339]
58.
Sinnott P, Joyce V, Barnett P. Guidebook: preference measurement in economic analysis. Menlo Park (CA): Health Economics Resource Center; 2007: https://www​.herc.research​.va.gov/files/BOOK_419.pdf. Accessed 2019 Feb 8.
59.
Aurora SK, Dodick DW, Turkel CC, et al. OnabotulinumtoxinA for treatment of chronic migraine: results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 1 trial. Cephalalgia. 2010;30(7):793–803. [PubMed: 20647170]
60.
Diener HC, Dodick DW, Aurora SK, et al. OnabotulinumtoxinA for treatment of chronic migraine: results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 2 trial. Cephalalgia. 2010;30(7):804–814. [PubMed: 20647171]
61.
Silberstein SD, Dodick DW, Lindblad AS, et al. Randomized, placebo-controlled trial of propranolol added to topiramate in chronic migraine. Neurology. 2012;78(13):976–984. [PMC free article: PMC3310312] [PubMed: 22377815]
62.
Rothrock JF, Parada VA, Drinkard R, Zweifler RM, Key KF. Predictors of a negative response to topiramate therapy in patients with chronic migraine. Headache. 2005;45(7):932–935. [PubMed: 15985112]
63.
Silberstein SD, Lipton RB, Dodick DW, et al. Efficacy and safety of topiramate for the treatment of chronic migraine: a randomized, double-blind, placebo-controlled trial. Headache. 2007;47(2):170–180. [PubMed: 17300356]
64.
Bendtsen L, Sacco S, Ashina M, et al. Guideline on the use of onabotulinumtoxinA in chronic migraine: a consensus statement from the European Headache Federation. J Headache Pain. 2018;19(1):91. [PMC free article: PMC6755553] [PubMed: 30259200]
65.
Yang M, Rendas-Baum R, Varon SF, Kosinski M. Validation of the Headache Impact Test (HIT-6) across episodic and chronic migraine. Cephalalgia. 2011;31(3):357–367. [PMC free article: PMC3057423] [PubMed: 20819842]
66.
Buse D, Bigal M, Rupnow M, et al. The Migraine Interictal Burden Scale (MIBS): results of a population-based validation study (abstract). Headache. 2007;47(5):778.
67.
Seo JG, Park SP. Validation of the Patient Health Questionnaire-9 (PHQ-9) and PHQ-2 in patients with migraine. J Headache Pain. 2015;16:65. [PMC free article: PMC4501946] [PubMed: 26174509]
68.
Gillard PJ, Devine B, Varon SF, Liu L, Sullivan SD. Mapping from disease-specific measures to health-state utility values in individuals with migraine. Value Health. 2012;15(3):485–494. [PubMed: 22583459]
69.
Jhingran P, Osterhaus JT, Miller DW, Lee JT, Kirchdoerfer L. Development and validation of the Migraine-Specific Quality of Life Questionnaire. Headache. 1998;38(4):295–302. [PubMed: 9595870]
70.
Reilly Associates. Work Productivity and Activity Impairment Questionnaire: Specific Health Problem V2.0 (WPAI:SHP). http://www​.reillyassociates​.net/WPAI_SHP.html. Accessed 2019 Jan 18.
71.
Tepper S, Ashina M, Reuter U, et al. Safety and efficacy of erenumab for preventive treatment of chronic migraine: a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Neurol. 2017;16(6):425–434.
72.
Bigal ME, Edvinsson L, Rapoport AM, et al. Safety, tolerability, and efficacy of TEV-48125 for preventive treatment of chronic migraine: a multicentre, randomised, double-blind, placebo-controlled, phase 2b study. Lancet Neurol. 2015;14(11):1091–1100.
73.
Silberstein SD, Dodick DW, Bigal ME, et al. Fremanezumab for the preventive treatment of chronic migraine. N Engl J Med. 2017;377(22):2113–2122.
74.
Sandrini G, Perrotta A, Tassorelli C, et al. Botulinum toxin type-A in the prophylactic treatment of medication-overuse headache: a multi-centre, double-blind, randomized, placebo-controlled, parallel group study. J Headache Pain. 2011;12(4):427–433.
75.
Freitag FG, Diamond S, Diamond M, Urban G. Botulinum Toxin Type A in the treatment of chronic migraine without medication overuse. Headache. 2008;48(2):201–209.
76.
Mei D, Ferraro D, Zelano G, et al. Topiramate and triptans revert chronic migraine with medication overuse to episodic migraine. Clin Neuropharmacol. 2006;29(5):269–275.
77.
Diener HC, Bussone G, Van Oene JC, Lahaye M, Schwalen S, Goadsby PJ. Topiramate reduces headache days in chronic migraine: a randomized, double-blind, placebo-controlled study. Cephalalgia. 2007;27(7):814–823.
78.
Silvestrini M, Bartolini M, Coccia M, Baruffaldi R, Taffi R, Provinciali L. Topiramate in the treatment of chronic migraine. Cephalalgia. 2003;23(8):820–824.
79.
Mathew NT, Jaffri SF. A double-blind comparison of onabotulinumtoxina (BOTOX) and topiramate (TOPAMAX) for the prophylactic treatment of chronic migraine: a pilot study. Headache. 2009;49(10):1466–1478.
80.
Cady RK, Schreiber CP, Porter JA, Blumenfeld AM, Farmer KU. A multi-center double-blind pilot comparison of onabotulinumtoxinA and topiramate for the prophylactic treatment of chronic migraine. Headache. 2011;51(1):21–32.
81.
Cohen JM, Bibeau K, Galic M, et al. Reversion of patients with chronic migraine to an episodic migraine classification with fremanezumab treatment. Ann Neurol. 2018;84 (Supplement 22):S183–S184.
82.
Silberstein S, Lipton R, Dodick D, et al. Topiramate treatment of chronic migraine: a randomized, placebo-controlled trial of quality of life and other efficacy measures. Headache. 2009;49(8):1153–1162.
83.
Jansen JP, Trikalinos T, Cappelleri JC, et al. Indirect treatment comparison/network meta-analysis study questionnaire to assess relevance and credibility to inform health care decision making: an ISPOR-AMCP-NPC Good Practice Task Force report. Value Health. 2014;17(2):157–173.
84.
Jansen JP, Schmid CH, Salanti G. Directed acyclic graphs can help understand bias in indirect and mixed treatment comparisons. J Clin Epidemiol. 2012;65(7):798–807.
85.
Herd CP, Tomlinson CL, Rick C, et al. Botulinum toxins for the prevention of migraine in adults. Cochrane Database Syst Rev. 2018;6:CD011616.
Copyright © 2019 Canadian Agency for Drugs and Technologies in Health.

The copyright and other intellectual property rights in this document are owned by CADTH and its licensors. These rights are protected by the Canadian Copyright Act and other national and international laws and agreements. Users are permitted to make copies of this document for non-commercial purposes only, provided it is not modified when reproduced and appropriate credit is given to CADTH and its licensors.

Except where otherwise noted, this work is distributed under the terms of a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International licence (CC BY-NC-ND), a copy of which is available at http://creativecommons.org/licenses/by-nc-nd/4.0/

Bookshelf ID: NBK565151

Views

  • PubReader
  • Print View
  • Cite this Page
  • PDF version of this title (3.5M)

Other titles in this collection

Related information

  • PMC
    PubMed Central citations
  • PubMed
    Links to PubMed

Recent Activity

Your browsing activity is empty.

Activity recording is turned off.

Turn recording back on

See more...