Treatment of Macular Edema: What'S New? Evidence from an Hta Study Comparing Ranibizumab and Dexamethasone Implant

Diabetic Macular Edema (DME) is a leading cause of vision loss and blindness. The aim of the study is the evaluation of the benefits concerning the introduction of an additional alternative technology, Dexamethasone intravitreal implant (DEX), in comparison with the present scenario consisting of the repeated administration of intravitreal injections of Ranibizumab. They differ for the number of injections and adverse events (AEs) occurring after each therapeutic cycle. An HTA was conducted within 3 Italian Departments of Ophthalmology, in Lombardy Region. Qualitative and quantitative data were collected using specific validated questionnaires and self-reported interviews, applying a MCDA approach and considering 7 dimensions resulting from the EUnetHTA Core Model. At the 36 month time point of the base-case scenario for market penetration, the introduction of DEX could lead to i) significant economic savings to the Regional Health Service (-15%), even considering the AEs impacts (14.82% severe AEs for Ranibizumab vs 27.46% mild and moderate AEs for DEX); ii) an optimization of the operating theatre’s time, with fewer minutes spent delivering an entire treatment cycle (-27%); iii) a perception of improved staff workflow organization (+209%); iv) a decrease of social expenditure, in terms of productivity loss, with both transportation and waiting time’s reduced (-69%); v)an improvement on equity aspects, considering in particular advantages in caregivers’ quality of life (233%), since new treatment requires fewer injections. The Resultssuggest that DEX could be considered an advantageous technological alternative to adopt within the DME target population. It acquired a higher score than the comparator (0.579 vs 0.472, considering the final normalized weight derived from the MCDA approach). Economic, organizational and equity savings could be reinvested within the same therapeutic area, i) improving patient access and adherence to therapy, ii) treating a wider population, iii) reducing waiting lists.