title: Cost-Effectiveness of Treating Hepatitis C with Sofosbuvir/Ledipasvir in Germany.
abstract: BACKGROUND
  Infections 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.
  
  
  METHODS
  We 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.
  
  
  RESULTS
  Base-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.
  
  
  CONCLUSIONS
  Our 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.
authors.affiliation: Institute for Epidemiology, Social Medicine and Health Systems Research; Hannover Medical School; Hannover; Germany.
authors.forename: Jona T
authors.initials: JT
authors.lastname: Stahmeyer
authors.affiliation: Department of Internal Medicine; Krankenhaus Nordwest; Steinbacher Hohl 2-26; Frankfurt am Main; Germany.
authors.forename: Siegbert
authors.initials: S
authors.lastname: Rossol
authors.affiliation: Institute for Epidemiology, Social Medicine and Health Systems Research; Hannover Medical School; Hannover; Germany.
authors.forename: Sebastian
authors.initials: S
authors.lastname: Liersch
authors.affiliation: Real World Strategy and Analytics; MAPI Group; 3rd Floor Beaufort House; Uxbridge, Middlesex; United Kingdom.
authors.forename: Ines
authors.initials: I
authors.lastname: Guerra
authors.affiliation: Institute for Epidemiology, Social Medicine and Health Systems Research; Hannover Medical School; Hannover; Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Krauth
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000191:economics; D001562:Benzimidazoles / Q000008:administration & dosage* / Q000191:economics; D003362:Cost-Benefit Analysis; D005449:Fluorenes / Q000008:administration & dosage* / Q000191:economics; D005838:Genotype; D005858:Germany; D016174:Hepacivirus; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000191:economics*; D006801:Humans; D008103:Liver Cirrhosis / Q000517:prevention & control; D016031:Liver Transplantation; D008390:Markov Chains; D008875:Middle Aged; D008962:Models, Theoretical; D011634:Public Health; D011788:Quality of Life; D019057:Quality-Adjusted Life Years; D012680:Sensitivity and Specificity; D000069474:Sofosbuvir / Q000008:administration & dosage* / Q000191:economics
chemical_list: D000998:Antiviral Agents; D001562:Benzimidazoles; D005449:Fluorenes; C586541:ledipasvir; D000069474:Sofosbuvir