Botox onabotulinumtoxinA regulatory update

The U.K.'s NICE issued a final appraisal determination (FAD) recommending the use of Botox onabotulinumtoxinA from Allergan to prevent chronic migraines in patients who have not responded to at least 3 preventative medications and whose headaches are not being caused by medication overuse. The FAD says treatment with Botox should not continue if there is less than a 30% reduction in headache days per month after 2 Botox treatments, or if the number of headache days is fewer than 15 days a month over 3 consecutive months. According to the agency, when the number of headache days is less than 15, the migraine is considering episodic and not chronic. Botox's label does not cover episodic migraines. In February, NICE asked for additional information before it could recommend the use of Botox to treat chronic migraines (see BioCentury, Feb. 20). Based on additional evidence submitted by Allergan, the committee said the most likely incremental cost-effectiveness ratio (ICER) per quality-adjusted life year (QALY) for Botox is £18,900 ($30,508). Final guidance is expected in June. ...