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.