PCSK-9 Inhibitors for the Control of Hypercholesterolemia: Eligibility for Treatment, Prescription Appropriateness and Outcomes, in a Real-World Clinical Setting
Author(s)
Perrone V1, Iacolare B2, Dovizio M2, Andretta M3, Bacca M4, Barbieri A5, Bartolini F6, Cavaliere A7, Chinellato A8, Ciaccia A9, Cillo MR10, Costantini A11, Dell'Orco S12, Ferrante F13, Gentile S14, Grego S15, Lavalle A14, Maccio S15, Mancini D4, Moscogiuri R16, Mosele E17, Pagliaro R18, Pastorello M19, Procacci C20, Re D21, Santoleri F11, Ubertazzo L22, Vercellone A23, Degli Esposti L2
1CliCon S.r.l. Società Benefit Health, Economics & Outcomes Research, Bologna, BO, Italy, 2CliCon S.r.l. Società Benefit Health, Economics & Outcomes Research, Bologna, Italy, 3Azienda ULSS 8 Berica, Vicenza, Italy, 4ASL Brindisi, Brindisi, Italy, 5ASL Vercelli, Vercelli, Italy, 6USL Umbria 2, Terni, Italy, 7ASL Viterbo, Viterbo, Italy, 8Azienda ULSS 3 Serenissima, Mestre (VE), Italy, 9Servizio Farmaceutico Territoriale ASL Foggia, Foggia, Italy, 10ASL Salerno, Salerno, Italy, 11ASL Pescara, Pescara, Italy, 12ASL Roma 6, Albano Laziale, Italy, 13ASL Frosinone, Frosinone, Italy, 14Direzione Generale per la Salute Regione Molise, Campobasso, Italy, 15ASL 3 Genovese, Genova, Italy, 16ASL Taranto, Taranto, Italy, 17UOC Assistenza Farmaceutica Territoriale Azienda ULSS 7 Pedemontana, Bassano del Grappa (VI), Italy, 18ASL Roma 5, Tivoli, Italy, 19ASP Palermo, Palermo, Italy, 20Dipartimento Farmaceutico ASL BAT, Trani, Italy, 21ASL Teramo, Roseto degli Abruzzi, Italy, 22U.O.C. Farmacia Territoriale, ASL Roma 4, Civitavecchia (RM), Italy, 23ASL Napoli 3 SUD, Torre del Greco, Italy
Presentation Documents
OBJECTIVES: A real-world data analysis was conducted in Italy to estimate among dyslipidemic patients those potentially eligible for proprotein convertase subtilisin/kexin type 9 inhibitors (iPCSK9), to assess prescription appropriateness and treatment-related outcomes in a normal clinical practice setting.
METHODS: This retrospective analysis was performed on administrative databases of geographically distributed healthcare entities covering about 3 million health-assisted individuals. Patients with at least one LDL measurement since 2015 were included. The time of the first LDL measurement was the index-date. In the 12 months before index-date, lipid-lowering therapy prescription was investigated. Patients were defined adherent with a proportion of days covered (PDC) ≥80%. The achievement of LDL-target was defined considering LDL-index value and thresholds indicated by guidelines. The distance-to-target (DTT) was recorded. Patients potentially eligible for iPCSK9 treatment were identified, and among them the presence of at least one iPCSK9 prescription was assessed throughout the available period.
RESULTS: 899,505 patients with at least one LDL determination were included: 160,811 (17.9%) were under statin treatment, of which 23,919 (14.9%) under high-potency statins; 1,906 (8.0%) patients received combination of high-potency statins with ezetimibe, and 1,252 (63.9%) resulted adherent to treatment. Besides, 982 (78.4%) patients failed reaching LDL-target, thus resulting potentially eligible for iPCSK9. Among them, 900 (91.6%) were not treated with iPCSK9 (under-treatment). DTT in the 6 months prior to iPCSK9 treatment initiation was 75.4 mg/dL and 7.2 mg/dL in the 6 following months. Furthermore, 93.9% of the patients did not reach the LDL-target in the 6 months prior to treatment, and this percentage decreased to 47.2% in the 6 months after treatment.
CONCLUSIONS: This real-world analysis conducted in an Italian clinical practice setting allowed an estimation of patients potentially eligible for treatment with iPCSK9, to evaluate prescription appropriateness and outcomes associated with treatment.
Conference/Value in Health Info
Value in Health, Volume 25, Issue 12S (December 2022)
Code
HSD16
Disease
SDC: Cardiovascular Disorders (including MI, Stroke, Circulatory), STA: Drugs