Качественная клиническая практика (Apr 2019)
Pharmacoeconomic analysis of botulinum toxins as treatment for treatment of adult upper limb spasticity
Abstract
Actuality. A major problem for rehabilitating patients after a stroke, other major cerebrovascular events or trauma (such as traumatic brain injury (TBI)) is increased muscle tone (spasticity) which in turn causes impairments of mobility and formation of pathological postures (which are oft en painful). In cases when it affects upper limb, the decrease in employment ability, capacity for self-service and overall quality of life of the patient becomes exceptionally pronounced. Botulinum toxin type A preparations (BTA) are first-line drug therapy for this type of disorder. Data indicating that different BTA-based drugs have differences in terms of compensation period (period during which the patient does not require re-administration of botulinum toxin) has become available. The pharmacoeconomic effect of this property within context of treating upper limb spasticity in the Russian healthcare system has not yet been investigated. Given the importance of compensation period both for patient well-being and for the burden upon the healthcare system, performing this pharmacoeconomic analysis represents significant interest. Aim. To assess the respective pharmacoeconomic performances of different botulinum toxin preparations as treatments for upper limb spasticity, specifi cally onabotulinumtoxin А (Botox®), incobotulinumtoxin А (Xeomin®), abobotulinumtoxin А (Dysport®) as well as Relatox®, a Russian botulinum toxin. Methodology. The analysis was performed from the perspective of Russian healthcare system in context of government guarantee program for provision of free medical aid. A Markov model was constructed to carry out this analysis. The following forms of analysis were performed based on modeling results: cost-effectiveness analysis, budget impact analysis, and several sensitivity analyses to assess model’s robustness to a number of assumptions as well as price fluctuations. Model accounted for differences between botulinum toxins in terms of compensation period in context of upper limb spasticity, as well as probability of treatment discontinuation for all causes which included severe adverse events and all other possible discontinuation circumstances. Analysis accounted for direct medical costs associated with botulinum toxin administration. The opportunity to optimize Botox use through utilization of diff erently sized vials was accounted for. Modelling horizon was set at one year (due to the way patient treatment discontinuation obtained from literature sources). This modeling horizon was sufficient to account for the disease’s burden upon the healthcare system. The number of patients in each simulated group for cost-effectiveness analysis was set at 1 000 patients, the number of patients for budget impact analysis was estimated based on epidemiological data for Moscow city. Result. The costs per 1 000 within the scope of one year were lowest for abobotulinumtoxin А (Dysport®) and amounted to 58 947 570 rubles. Other drugs had total costs amounting to 94 954 468 rub., 92 049 480 rub, and 97 143 620 rub for onabotulinumtoxin А (Botox®), incobotulinumtoxin А (Xeomin®) and Relatox® respectively. During cost-effectiveness analysis Dysport demonstrated lowest cost-effectiveness ratio and thus is pharmacoeconomically superior. Cost-effectiveness ratio were 316 752 rub for Dysport, 641 584 rub., 619 028 rub., 656 376 rub. for Botox, Xeomin and Relatox respectively. The Dysport superiority within cost-effectiveness amounted to 48.8 %. During budget impact analysis, Dysport as the drug with superior CEA results was compared to Xeomin. Analysis indicated that moving 25 % of patients from Xeomin to Dysport results in 11.7 % reduction of budget burden (which amounts to more than 23 million rubles when epidemiological data for Moscow city is used). Several sensitivity analysis were carried out and confirmed model robustness to price fluctuations of drugs involved up to 25 % as well as alterations of a number of underlying assumptions related to treatment discontinuation curve parameters and Botox dosing regimens. Conclusion. These results indicate that Dysport has pharmacoeconomic advantages when used for treatment of adult upper limb spasticity resulting from stroke and traumatic brain injury within the context of the Russian healthcare system.
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