The Societal Impact Of Natalizumab Treatment In The Italian Relapsing-Remitting Multiple Sclerosis Clinical Practice: The Tysabri® Pharmacoeconomics (Type) Study

Abstract

Objectives: Multiple sclerosis (MS) is a chronic, immune-mediated, demyelinating disease of the central nervous system affecting more than 2 million people worldwide. MS progressively impairs patients' ability to perform independent activities of daily living, negatively affects social interactions and relationships, and reduces working capacity. Furthermore, the afore mentioned issues imply a cost to society. This study aimed to evaluate the societal impact of the treatment of MS with natalizumab in Italian clinical practice. Methods: A prospective, observational study was conducted in 25 specialized centres throughout Italy (N= 147). The direct and indirect costs, as well as the health-related quality of life of patients with MS receiving biologic treatments, were estimated, while the societal impacts were determined using a cost-utility approach. Results: Following the introduction of natalizumab, non-medical and indirect costs decreased both overall and as a proportion of the total costs, there was a reduction of 55.4{%} at baseline to 29.1{%} at one year follow up. The increased costs associated with drug treatment were nearly offset by savings from non-healthcare direct costs and increased productivity, resulting in an incremental cost of +0.5{%} between baseline and follow-up. This analysis estimated that, compared to patients at baseline, the first year of treatment with natalizumab was associated with an incremental cost of 112.70, with a concomitant increase in average EQ-5D utility score of 0.04. Conclusions: This study confirms that MS imposes a considerable burden on patients, their families and caregivers, underlining the importance of considering the societal perspective in the appraisal process. Furthermore, initiation of treatment with natalizumab in real-world Italian clinical practice delivers a noteworthy benefit in societal terms.