title: Cost-effectiveness analysis of sofosbuvir-based regimens for chronic hepatitis C.
abstract: BACKGROUND
  A new scenario of therapy for chronic hepatitis C (CHC) is being established with the approval of sofosbuvir (SOF).
  
  
  OBJECTIVE
  To estimate the cost-effectiveness of SOF-based regimens approved in the Summary of Product Characteristics (SmPC) versus the standard of care for different genotypes and patient populations (naive or pretreated).
  
  
  METHODS
  A Markov model simulating CHC progression was used to estimate disease treatment costs and effects over patients' lifetimes, from the Spanish National Public Healthcare System perspective. Different therapeutic options were analysed for genotypes 1, 2 and 3 in naive population and for genotype 2 and 3 pretreated patients, according to data obtained from clinical trials. A one-way sensitivity analysis was performed to evaluate the uncertainty of certain parameters: treatment starting age, transition probabilities, drug costs and discount rate. A probabilistic sensitivity analysis was also carried out.
  
  
  RESULTS
  For the naive population, the option SOF+pegylated-interferon-α (pIFN)+ribavirin (RBV) for 12 weeks recorded in SmPC for genotype 1 and 3 versus pIFN+RBV for 24 weeks estimated an incremental cost-effectiveness ratio (ICER) below the €40,000/quality-adjusted life-year (QALY) benchmark. For the pretreated population, SOF triple therapy reached an ICER on the threshold limit for genotype 3. Other options included in SmPC for different genotypes exceeded the accepted efficiency limit in our setting.
  
  
  CONCLUSIONS
  The options that included SOF+RBV+pIFN in a 12-week course regimen fell below the efficiency threshold considered in our setting. IFN-free regimens administered for 24 weeks reached figures over the benchmark of €40,000/QALY.
authors.affiliation: Department of Pharmacy, Complejo Hospitalario de Navarra, Pamplona, Spain.
authors.forename: Ramón
authors.initials: R
authors.lastname: San Miguel
authors.affiliation: Department of Pharmacy, Hospital Universitario Miguel Servet, Zaragoza, Spain.
authors.forename: Vicente
authors.initials: V
authors.lastname: Gimeno-Ballester
authors.affiliation: Department of Medicines for Human Use, Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain.
authors.forename: Antonio
authors.initials: A
authors.lastname: Blázquez
authors.affiliation: Clinical Management Service, Hospital Alto Deba, Mondragon, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Mar
mesh_terms: D000998:Antiviral Agents / Q000191:economics / Q000627:therapeutic use; D003362:Cost-Benefit Analysis; D018450:Disease Progression; D016527:Drug Costs; D017048:Health Care Costs / Q000706:statistics & numerical data*; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000191:economics; D006801:Humans; D008390:Markov Chains; D008875:Middle Aged; D000069474:Sofosbuvir; D013030:Spain; D014542:Uridine Monophosphate / Q000031:analogs & derivatives* / Q000191:economics / Q000627:therapeutic use
chemical_list: D000998:Antiviral Agents; D014542:Uridine Monophosphate; D000069474:Sofosbuvir
keywords: CHRONIC HEPATITIS; COST-EFFECTIVENESS; HCV