You are here:

Archived: botulinum toxin type a (Botox)

Advice

following a full submission

botulinum toxin type A (Botox®) is not recommended for use within NHS Scotland.

Indication under review: 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).

In pooled analysis of two phase III studies, botulinum toxin type A was superior to placebo for the primary endpoint, headache days. However, there were weaknesses in the clinical data that limit the ability to assess its likely clinical effectiveness in the target treatment population.

Overall the manufacturer did not present a sufficiently robust clinical and economic analysis to gain acceptance by SMC. 

The licence holder has indicated their intention to resubmit.
 

Drug Details

Drug Name: botulinum toxin type a (Botox)
SMC Drug ID: 692/11
Manufacturer: Allergan Ltd
Indication: 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)
BNF Category:
Sub Category: 4.9 Drugs used in Parkinsonism and related disorders
Submission Type: Full submission
Status: Not Recommended
Date Advice Published: 10 April 2011

Current Advice

Resubmission 13 February 2017

Archived Advice

Resubmission 8 April 2013

Back