Cost-Effectiveness of Treating Hepatitis C with Sofosbuvir/Ledipasvir in Germany

Abstract

BackgroundInfections with the hepatitis C virus (HCV) are a global public health problem. Long-term consequences are the development of liver cirrhosis and hepatocellular carcinoma. Newly introduced direct acting antivirals, especially interferon-free regimens, have improved rates of sustained viral response above 90% in most patient groups and allow treating patients who were ineligible for treatment in the past. These new regimens have replaced former treatment and are recommended by current guidelines. However, there is an ongoing discussion on high pharmaceutical prices. Our aim was to assess the long-term cost-effectiveness of treating hepatitis C genotype 1 patients with sofosbuvir/ledipasvir (SOF/LDV) treatment in Germany.Material and MethodsWe used a Markov cohort model to simulate disease progression and assess cost-effectiveness. The model calculates lifetime costs and outcomes (quality-adjusted life years, QALYs) of SOF/LDV and other strategies. Patients were stratified by treatment status (treatment-naive and treatment-experienced) and absence/presence of cirrhosis. Different treatment strategies were compared to prior standard of care. Sensitivity analyses were performed to evaluate model robustness.ResultsBase-case analyses results show that in treatment-naive non-cirrhotic patients treatment with SOF/LDV dominates the prior standard of care (is more effective and less costly). In cirrhotic patients an incremental cost-effectiveness ratio (ICER) of 3,383 €/QALY was estimated. In treatment-experienced patients ICERs were 26,426 €/QALY and 1,397 €/QALY for treatment-naive and treatment-experienced patients, respectively. Robustness of results was confirmed in sensitivity analyses.ConclusionsOur analysis shows that treatment with SOF/LDV is cost-effective compared to prior standard of care in all patient groups considering international costs per QALY thresholds.

A blueprint for the primary prevention of cancer: Targeting established, modifiable risk factors

“…Like with many other new drugs, however, cost and limited access among select groups (such as those with minimal fibrosis or active substance abuse problems) have been barriers to this treatment . Expanding efforts to screen all at‐risk individuals for HCV infection and increase access to treatment define emerging opportunities for the prevention of an important cause of liver cancer in the United States …”

“…161 Expanding efforts to screen all at-risk individuals for HCV infection and increase access to treatment define emerging opportunities for the prevention of an important cause of liver cancer in the United States. 162,163 Epstein-Barr Virus EBV is the most prevalent oncogenic pathogen, with an estimated >90% of adults infected with the virus worldwide; it is usually spread through saliva and is best known as the major cause of infectious mononucleosis, although most people experience mild or no symptoms after being infected with EBV. 164 EBV is an established cause of several types of cancer, including Burkitt lymphoma, Hodgkin lymphoma, and nasopharyngeal cancers.…”

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.…”