The application of Health Technology Assessment in the field of biologics: an evaluation of etanercept for treating Rheumatoid Arthritis

Background: Biologic drugs are used in patients with Rheumatoid Arthritis (RA) with inadequate response to non-biologic diseasemodifying anti-rheumatic drugs (DMARDs). Etanercept is an anti- Tumor Necrosis Factor (TNF) a and it is one of the first biologics which has been approved. Objectives: Because of the availability of several biologics, this HTA was aimed at studying the current impact of etanercept use in Italy. Methods: In order to assess the burden of the disease and the competitors an extensive literature search was done: papers dealing with RA prevalence, incidence, mortality, disability and treatments effectiveness and safety were selected. A cost-effectiveness analysis was performed from the National Health Service viewpoint to evaluate benefits of choosing etanercept in comparison to DMARDs and other anti-TNF a on the base of the Italian Study Group on Early Arthritis data. A comprehensive analysis of tools and services to be promoted was done to evaluate organizational aspects of managing RA. Results: Literature review showed that RA prevalence in Italy ranges from 0.33% to 0.46% with an incidence of 0.98‰ being these estimates close to the international ones. RA is an important cause of Years Lived with Disability and determines an increase risk for death and losing work. Experimental studies have shown etanercept as well as other biologics to be effective; anyhow etanercept showed lower discontinuation rates due to adverse events. The cost-effectiveness analysis demonstrated that etanercept costs more than DMARDs but allows gaining more benefits being the best option, with regard to other anti-TNF a commonly used, in many scenarios considered. Anyway, in order to get better outcomes from available treatments, a multidisciplinary team should be involved for early disease detection and patients empowerment in the view of chronic care model. Implications: This HTA demonstrated that etanercept is worth to be utilized in comparison to other anti-TNF a.