The cost effectiveness of Botox in Italian patients with chronic migraine

Migraine is a primary headache which World Health Organization ranks in 19th place in the list of disabling diseases. In Europe, in 2004, the total costs for migraine were quantified by Stovner and Berg, Eur J Neurol, 12(s1) (2005) at €27 billion. The objective of this study is to provide an estimate of the incremental cost-effectiveness ratio (ICER) of the treatment of chronic migraine with Botox compared to treatment with placebo in the perspective of the Italian National Health Service and society. To do this we studied the disease progression in a cohort of 688 individuals (patients enrolled in the study PREEMPT) via the application of a Markov model. Over a period of 2 years, the total costs of the experimental arm of the model amounted to €3,274 compared with a gain of 1.34 QALYs. In contrast, the costs of the control arm amounted to €2,395 with a gain of 1.24 QALYs. It follows that the incremental costs amounted to €889 compared to an incremental gain of 0.09 QALYs in favor of the experimental arm. The relationship between costs and incremental QALYs generated an ICER of €9,407/QALY. The incremental cost-effectiveness ratio, therefore, is favorable compared to the value usually considered by NICE as a threshold limit for reimbursement which ranges between €20,000 and €40,000/QALY.