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+30 YEARS' GLOBAL EXPERIENCE ACROSS MULTIPLE INDICATIONS1-4

 

CHRONIC MIGRAINE

BOTOX® (botulinum toxin type A) is indicated for the prophylaxis of headaches in adults with chronic migraine (headaches on at least 15 days per month of which at least 8 days are with migraine).5

Guidelines recommend BOTOX® as a treatment option in the management of chronic migraine6,7

NICE RECOMMENDS BOTOX® AS AN OPTION FOR THE PROPHYLAXIS OF
HEADACHES IN ADULTS WITH CHRONIC MIGRAINE6†

Adapted from NICE TA2606

NICE guidance:6

  • 1.1 Botulinum toxin type A is recommended as an option for the prophylaxis of headaches in adults with chronic migraine (defined as headaches on at least 15 days per month of which at least 8 days are with migraine):
    • that has not responded to at least three prior pharmacological prophylaxis therapies and
    • whose condition is appropriately managed for medication overuse
  • 1.2 Treatment with botulinum toxin type A that is recommended according to 1.1 should be stopped in people whose condition:
    • is not adequately responding to treatment (defined as less than a 30% reduction in headache days per month after two treatment cycles) or
    • has changed to episodic migraine (defined as fewer than 15 headache days per month) for three consecutive months
  • 1.3 People currently receiving botulinum toxin type A that is not recommended according to 1.1 and 1.2 should have the option to continue treatment until they and their clinician consider it appropriate to stop.

THE SMC RECOMMENDS BOTOX® AS AN OPTION FOR THE PROPHYLAXIS OF
HEADACHES IN ADULTS WITH CHRONIC MIGRAINE7

Adapted from SMC Medicines Advice 692/117


CG: clinical guideline; CM: chronic migraine; NICE: National Institute for Health and Care Excellence; SMC: Scottish Medicine Consortium; TAG: technology appraisal guidance.

 

© NICE [2012] Botulinum toxin type A for the prevention of headaches in adults with chronic migraine. Available from nice.org.uk. All rights reserved. Subject to Notice of rights

NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.

 

References

  1. AbbVie Data on file. Approval Dates for BOTOX® in UK. UK-BTX-230044. April 2023
  2. Allergan. Data on file. INT/0423/2016
  3. Aurora S K, Winner P et al. Onabotulinum toxin A for treatment of chronic migraine: pooled analyses of the 56-week PREEMPT clinical program. Headache. 2011;51(9):1358-1373
  4. Blumenfeld A M, Stark R J et al. Long-term study of the efficacy and safety of Onabotulinum toxin A for the prevention of chronic migraine: COMPEL study. J Headache Pain. 2018;19(1):13
  5. BOTOX® Summary of Product Characteristics. Available from: https://www.medicines.org.uk/emc/product/859/smpc. Accessed April 2024
  6. National Institute for Health and Care Excellence (NICE). TA260: Botulinum toxin type A for the prevention of headaches in adults with chronic migraine. Available at: www.nice.org.uk. Accessed April 2024
  7. Scottish Medicines Consortium (SMC) Medicines advice: botulinum toxin A (Botox). SMC 692/11. Available at: www.scottishmedicines.org.uk. Accessed April 2024 

 

 

References

  1. AbbVie Data on file. Approval Dates for BOTOX® in UK. UK-BTX-230044. April 2023
  2. Allergan. Data on file. INT/0423/2016
  3. Aurora S K, Winner P et al. Onabotulinum toxin A for treatment of chronic migraine: pooled analyses of the 56-week PREEMPT clinical program. Headache. 2011;51(9):1358-1373
  4. Blumenfeld A M, Stark R J et al. Long-term study of the efficacy and safety of Onabotulinum toxin A for the prevention of chronic migraine: COMPEL study. J Headache Pain. 2018;19(1):13
  5. BOTOX® Summary of Product Characteristics. Available from: https://www.medicines.org.uk /emc/product/859/smpc. Accessed April 2024
  6. National Institute for Health and Care Excellence (NICE). TA260: Botulinum toxin type A for the prevention of headaches in adults with chronic migraine. Available at: www.nice.org.uk. Accessed April 2024
  7. Scottish Medicines Consortium (SMC) Medicines advice: botulinum toxin A (Botox). SMC 692/11. Available at: www.scottishmedicines.org.uk. Accessed April 2024 

 

Please refer to the BOTOX® Summary of Product Characteristics for further information on adverse events, contraindications and special warnings and precautions for use.

 

 

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk

Adverse events should also be reported to AbbVie on [email protected] 

 

Date of preparation: April 2024. UK-BCM-240042.