Evaluation of the clinical and economic value of sofosbuvir/velpatasvir (SOF/VEL) in patients with chronic hepatitis C in Spain during the last 5 years

Direct-acting antivirals for the treatment of hepatitis C virus (HCV) represented a paradigm shift. In 2017, sofosbuvir/velpatasvir (SOF/VEL-Epclusa®) was approved, which showed a high cure rate in all patient, contributing to HCV elimination. The analysis aimed to quantify the clinical and economic value of SOF/VEL in HCV chronic patients since its approval in Spain. An economic evaluation was elaborated adapting a Markov model that simulated the lifetime disease progression in of all HCV chronic patients treated with SOF/VEL (30,488 patients) since its launch (5-years), compared to previous therapies. Patients entered the model and were distributed between the fibrosis states (F0-to-F4) in treated and untreated. All patients (100%) were treated with SOF/VEL regardless of their fibrosis, and 49% with previous therapies in ≥F2. The average sustained viral response (SVR) rates 98.9% SOF/VEL versus 61.0% previous therapies. All parameters for the analysis were obtained from real-life data and literature. Only direct healthcare costs associated with disease management were included. The SOF/VEL value was measured as the number of hepatic complications avoided and their associated cost, and hepatic mortality compared to previous therapies. National Health System perspective and a 3% discount rate was applied. SOF/VEL decreased the number of liver complications, avoiding 92% decompensated cirrhosis, 80% hepatocellular carcinomas, and 87% liver transplants, as well as 85% liver-related mortality. Their cost associated was reduced, amounting to savings of 197 M€. SOF/VEL adds relevant value to the HCV treatment, reducing the clinical and economic disease burden and contributing to HCV elimination in Spain. Los antivirales de acción directa para el tratamiento del virus de la hepatitis C (VHC) representaron un cambio de paradigma. En 2017 se aprobó sofosbuvir/velpatasvir (SOF/VEL-Epclusa®), con elevadas tasas de curación en todos los pacientes, contribuyendo a la eliminación VHC. El objetivo fue evaluar el valor clínico y económico de SOF/VEL en pacientes crónicos desde su aprobación en España. Se adaptó un modelo de Markov que simulaba la progresión de la enfermedad durante toda la vida de pacientes crónicos tratados con SOF/VEL (30.488 pacientes) desde su lanzamiento (5 años), versus terapias previas. Los pacientes entraron al modelo distribuidos entre los estados de fibrosis (F0-F4) en tratados y no tratados. Todos los pacientes fueron tratados con SOF/VEL independientemente de su fibrosis, y el 49% con terapias previas (≥ F2). La respuesta viral sostenida promedio: 98,9% SOF/VEL versus 61,0% terapias previas. Los parámetros para el análisis se obtuvieron de datos reales y literatura. Solo se incluyeron costes sanitarios directos asociados al manejo de la enfermedad. El valor SOF/VEL se midió como el número de complicaciones hepáticas evitadas y su coste, y la mortalidad hepática versus terapias previas. Se aplicó la perspectiva del Sistema Nacional de Salud y una tasa de descuento (3%). SOF/VEL disminuyó las complicaciones hepáticas, evitando el 92% cirrosis descompensadas, el 80% hepatocarcinomas y el 87% trasplantes hepáticos, así como el 85% la mortalidad hepática; generando ahorros de 197 millones de euros. SOF/VEL añade un valor relevante al tratamiento del VHC, reduciendo la carga clínica y económica de la enfermedad y contribuyendo a la eliminación VHC en España.