Economic modeling of the use of botulinum toxin A in a homogenous patient population based on real-life clinical practice: ULIS-II (The Upper Limb International Spasticity Study); the French perspective

Mr Jérôme DINETa, Mrs Dimitra LAMBRELLIb, Dr Marc RABBANIa

a Ipsen Pharma, b Evidera Ltd

Objective : To evaluate the real life practice of the use of botulinum toxin A (BoNT-A) in post-stroke upper limb spasticity and the economic consequences of fair comparisons of the dosing between either abobotulinumtoxinA (Dysport®) or onabotulinumtoxinA (Botox®) or incobotulinumtoxinA (Xeomin®) in France.

Methods : ULIS-II is an 18-month, observational, prospective study, conducted in 84 centers in 22 countries. France was the major contributor with 14 centers. Of 456 adults with post-stroke upper limb spasticity presenting for treatment with BoNT-A, 193 patients with the same injected limb segments “upper arm and lower arm” were analyzed for the dose injected for one cycle of BoNT-A. Treatment and concomitant interventions were in accordance with routine local clinical practice. Sample size, mean (SD)/median dose (min-max) in Unit for each BoNT-A and annual cost per patient were calculated using the median dose administered and considering no vial sharing. An injection interval of 12 weeks was simulated for all BoNT-A treatments and the France listed public price was used to ascertain annual cost.

Results : For the abobotulinumtoxinA group (N=141) a mean (SD)/median (min-max)dose of 665 U (280)/500 U (150-1500) was injected, for the onabotulinumtoxinA group (N=37) a mean (SD)/median dose of 183 U (99)/200 U (50-500) was injected and for incobotulinumtoxinA (N=15), a mean (SD)/median dose of 235 U (108)/200 U (100-440) was injected. Based on a BoNT-A injection interval of 12 weeks, the annual cost per patient in France would be 1 123 € for abobotulinumtoxinA, 1 784 € for onabotulinumtoxinA and 1 784 € for incobotulinumtoxinA (based on median doses).

Conclusions : Considering the real life practice of BoNT-A injections and the comparison of treatment groups treated for the same limb segment, this analysis suggests that the use of abobotulinumtoxinA would result potentially in a reduction in the healthcare cost for the treatment of spasticity (-37%) and that more patients could be treated with abobotulinumtoxinA with a given budget.

Keywords : Health-economic study; spasticity; botulinum toxin; Dysport; Botox; Xeomin