Valutazione economica del trattamento con impianto intravitreale biodegradabile di desametasone di pazienti affetti da edema maculare secondario a occlusione della vena retinica, in Italia
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Economic evaluation with dexamethasone biodegradable intravitreal implant for the treatment of patients with macular edema following retinal vein occlusion in Italy
Macular edema (ME) secondary to retinal vein occlusion (RVO) is an important cause of vision loss resulting in substantial morbidity in terms of reduced health-related quality of life and functioning. Until recently, no approved pharmacological treatment options were available.
The present analysis is an economic evaluation of an innovative, new treatment specifically approved for this indication (ME secondary to RVO), from the perspective of the Italian national healthcare system.
Two clinical trials (GENEVA 008 and 009) were conducted to evaluate the safety and efficacy of the biodegradable dexamethasone intravitreal implant compared with sham in patients with ME due to RVO. Outcomes demonstrated that the treatment can significantly both reduce the risk of vision loss and improve the speed and incidence of visual improvement.
For this analysis a previous study conducted for NICE was adapted to the Italian context. Based on the clinical results supplemented by expert opinion, a Markov model was developed for cost-utility analysis, running from 65 to 100 years (or death) and including six health states, defined in terms of best corrected visual acuity (BCVA). Utility was assessed as a function of BCVA. In the present analysis, unit costs are referred to the Italian healthcare system.
In the base case, the cost per quality-adjusted life-year (QALY) resulted equal to €31,148. An extensive sensitivity analysis showed that results remained below €45,000.
This analysis results suggest that dexamethasone intravitreal implant is cost-effective when compared with observation, in patients with ME following RVO.
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