Cost‐effectiveness analysis of ledipasvir/sofosbuvir in patients with chronic hepatitis C: Treatment of patients with absence or mild fibrosis compared to patients with advanced fibrosis

Abstract

To evaluate the cost-effectiveness of ledipasvir/sofosbuvir (LDV/SOF) in treatment-naïve patients with chronic hepatitis C (CHC) genotype 1 (GT1) in the absence or mild fibrosis (F0-F1) versus advanced fibrosis (F2-F4), from the perspective of the Spanish Health System. A Markov model was developed to simulate disease progression, estimating costs and outcomes [life years gained (LYG) and quality-adjusted life years (QALY)] derived from starting with LDV/SOF in patients with F0-F1 compared with F2-F4. Therapy duration was 8 weeks in noncirrhotic patients with viral load <6 million IU/mL and 12 weeks in the remaining patients. Sustained virologic response rates were obtained from real-world cohort studies. Transition probabilities, utilities and direct costs were obtained from the literature. A 3% annual discount rate was applied to costs and outcomes. Sensitivity analyses were performed. LDV/SOF in F0-F1 patients was a dominant strategy, being more effective (19.85 LYG and 19.80 QALY) than beginning treatment in F2-F4 patients (18.63 LYG and 16.25 QALY), generating savings of €9228 per patient (€3661 due to disease management and monitoring). In a cohort of 1000 patients, LDV/SOF in F0-F1 patients decreased the number of cases of decompensated cirrhosis (93%), hepatocellular carcinoma (97%) and liver-related deaths (95%) and prevented 6 liver transplants compared to initiating LDV/SOF in F2-F4 patients. In CHC treatment-naïve GT1 patients, starting treatment with LDV/SOF in patients with F0-F1 compared to those with F2-F4 increases effectiveness by 1.22 LYG and 3.55 QALY gained and reduces disease burden and it is associated with cost savings.

Direct medical costs associated with the extrahepatic manifestations of hepatitis C infection in Europe

“…Cost‐effectiveness analyses (CEA) seek to place the costs associated with a DAA in context with its long‐term value to the health system. While several models assessing the cost‐effectiveness of DAAs in HCV in European countries have been published, these have focused exclusively on the costs associated with hepatic manifestations of the disease. To our knowledge, no CEA has incorporated the cost savings attributable to the decreased clinical burden of EHMs after DAA treatment.…”

“…There are a large number of studies that document the significant morbidity and mortality benefit of achieving SVR in HCV patients at all stages of fibrosis . Thus, early treatment with DAAs can prevent a substantial portion of direct medical costs related to downstream hepatic HCV complications . Treatment of at‐risk populations with DAAs has also been projected to reduce viral transmission …”

“…4 Thus, early treatment with DAAs can prevent a substantial portion of direct medical costs related to downstream hepatic HCV complications. [12][13][14][15][16][17][18] Treatment of at-risk populations with DAAs has also been projected to reduce viral transmission. 19,20 Achieving SVR can also lessen the clinical burden of EHMs.…”

“…There is some evidence that the impact of SVR on EHMs can vary by genotype, 25 a level of granularity that was not accounted for in our analysis. Estimation of total reduction in annual costs associated with extrahepatic manifestation of HCV infection, assuming that all treated patients are cured Given the increased acquisition cost of DAAs relative to older, less effective regimens for HCV, many health systems have in the past questioned whether DAAs provided adequate value for money.Cost-effectiveness analyses (CEA) seek to place the costs associated with a DAA in context with its long-term value to the health system.While several models assessing the cost-effectiveness of DAAs in HCV in European countries have been published,[12][13][14][15] these have focused exclusively on the costs associated with hepatic manifestations of the disease. To our knowledge, no CEA has incorporated the cost savings attributable to the decreased clinical burden of EHMs after DAA treatment.…”

Significant Improvement in Diagnosis of Hepatitis C Virus Infection by a One-Step Strategy in a Central Laboratory: an Optimal Tool for Hepatitis C Elimination?

“…and provide more benefits when the disease is treated in its initial stages (5,6). These outstanding improvements in therapeutic tools have driven the proposal of strategies to eradicate the HCV infection.…”