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RESEARCH PRODUCT

How Have Intravitreal Anti-VEGF and Dexamethasone Implant Been Used in Italy? A Multiregional, Population-Based Study in the Years 2010–2016

Michele ReibaldiRosa GiniAntonio LongoCarlo RapisardaTeresio AvitabileSalvatore CillinoAdele Emanuela De FrancescoMassimiliano CopettiGianni VirgiliEliana MirabelliGiulia ScondottoSebastiano Pollina AddarioAndrea FontanaPasquale CananziYlenia IngrasciottaJanet SultanaValentina IentileClaudia La CaveraPatricia Ibanez ToroGiovambattista De SarroMaria VadalàOlivia LeoniGianluca TrifiròMaria Rosalia PuzoCostantino John Trombetta

subject

MaleVascular Endothelial Growth Factor A0301 basic medicineintravitrealAngiogenesis Inhibitorsalgorithm.0302 clinical medicineMedicineSummary of Product Characteristicsmedia_commonAged 80 and overDrug ImplantsvalidationLaser CoagulationRGeneral MedicineMiddle AgedItalyanti-VEGF030220 oncology & carcinogenesisMedicineFemaleclinical dataoriginal articleResearch Articlemedicine.drugDrugmedicine.medical_specialtyArticle Subjectmedia_common.quotation_subjectMEDLINEdexamethasonePharmacyMacular EdemaGeneral Biochemistry Genetics and Molecular BiologyInsurance Claim Review03 medical and health sciencesRanibizumabInternal medicineHumansDosingDexamethasoneAgedDiabetic RetinopathyGeneral Immunology and MicrobiologySettore MED/30 - Malattie Apparato Visivobusiness.industryclaims database030104 developmental biologydrug utilisationMacular Edema; Ranibizumab; Laser CoagulationImplantRanibizumabbusiness

description

Purpose. To describe intravitreal anti-VEGF drug and dexamethasone use in four Italian regions. Methods. Four regional claims databases were used to measure drug prevalence, compare dosing intervals to those recommended in the summary of product characteristics (SPC), and identify switchers. Bilateral treatment and diabetic macular edema (DME) coding algorithms were validated, linking claims with a sample of prospectively collected ophthalmological data. Results. Overall, 41,836 patients received ≥1 study drug in 2010–2016 (4.8 per 10,000 persons). In 2016, anti-VEGF drug use ranged from 0.8 (Basilicata) to 5.7 (Lombardy) per 10,000 persons while intravitreal dexamethasone use ranged from 0.2 (Basilicata) to 1.4 (Lombardy) per 10,000 persons. Overall, 40,815 persons were incident users of study drugs. Among incident users with ≥1 year of follow-up (N = 30,745), 16.0% (N = 4,890) had only one pharmacy claim, especially for ranibizumab (60.9%). Switching occurred in 8.0% of users with ≥2 pharmacy claims (N = 33,637). The algorithms had an accuracy of 83.8 (95% CI: 79.7–87.3) concerning bilateral treatment and 72.3% (95% CI: 67.5–76.8) for DME. Conclusion. Study drug use increased over time in Lombardy, Basilicata, Calabria, and Sicily, despite a large heterogeneity in prevalence of use across regions. Drug treatment appeared to be partly in line with SPC, suggesting that improvement in clinical practice may be needed to maximize drug benefits.

https://doi.org/10.1155/2020/7582763