Efficacia, sicurezza e valutazione farmaco-economica dei farmaci biotecnologici per il trattamento dell´artrite reumatoide: revisione della letteratura e contributo casistico

Background. Rheumatoid Arthritis (RA) is a highly invalidating, chronic, progressive disease; it represents the 2% of all rheumatic diseases and it is related to very high costs for both civil society and health systems. Since many efficacious therapeutic options are now available (in particular the so-called biologic drugs) and because of the high costs related to these therapies, pharmaco-economic studies are becoming a useful tool for the optimization of health system-related budgets. Methods. Review of the literature for pharmaco-economic studies in RA. Efficacy, safety and pharmaco-economic retrospective analysis in a large monocentric cohort of patients treated with a TNF-inhibitor (first biologic line with infliximab - IFX), etanercept – ETN, or adalimumab - ADA); the database covers a follow-up of 10 years. Results. The review of the literature reported that annual direct costs for managing a patient with RA in Italy range from € 1.643 (1st stage of disease) to € 5.697 (4th stage of disease), while indirect costs range from € 2.705 to € 17.249. ADA monotherapy at the standard 40 mg every other week dose costed € 13.451/year while costs raised up to € 26.369 when the drug was administred at the dose 40 mg/week. The cost of ETN was € 13.582. In the case of combination therapy with methotrexate (MTX) the costs were € 13.637 for ADA and € 13.855 for ETN. The 3 TNF-inhibitors were highly efficacious in significantly reducing disease activity and were well tolerated (with no significant difference for the 3 molecules). Conclusion. In our experience, TNF-alfa inhibitors demonstrated to be an efficacious and safe therapeutic option, in particular in patients with moderate-to-severe disease activity. In the future, prospectic studies implementing extensive quality of life assessment (e.g. calculation of QALY) must be warranted, in order to produced detailed real-life pharmaco-economic evaluations.