title: Real-world treatment for chronic hepatitis C infection in Germany: Analyses from drug prescription data, 2010-2015.
abstract: Direct-acting antivirals (DAAs) for hepatitis C virus (HCV) have strongly improved treatment options since 2014, but it is unclear if treatment numbers have increased. We aimed to estimate the number of treatment regimens per month from 2010-2015 and the number of patients treated and cured with DAAs since 2014, as well as the associated costs.
  
  
  
  Drug prescription data of hepatitis C virus (HCV) antivirals for patients with statutory health insurance in Germany (∼85% of population) from January 2010-December 2015 were evaluated. Standard 28-day prescriptions of pegylated interferon (PegIFN) and 1st/2nd generation DAAs were combined according to treatment guidelines and analysed. Drug costs were calculated from pharmacy sales prices. Mean treatment durations/regimen from real-world data were used to calculate drug costs/regimen and numbers of DAA-treated persons in 2014/15.
  
  
  
  From January 2010-December 2015 PegIFN/ribavirin-treatments/month decreased from ∼6500 to ∼650. Monthly HCV-prescriptions rose with the approval of 1st generation DAAs (2011), and decreased at the end of 2013. With the approval of 2nd generation DAAs, prescriptions/month increased (peak: ∼6600; March 2015), and subsequently decreased (∼4000; December 2015). In 2014, ∼7000 patients were treated with DAAs, and ∼20,100 in 2015. Treatment costs/month were stable at 12 million EUR (2010-2011), increased to ∼38 million EUR (March 2012), and peaked to 150 million EUR (March 2015). DAA-drug costs/year added up to ∼664million EUR (2014) and ∼1.3billion EUR (2015).
  
  
  
  Despite an increase in DAA prescriptions, in December 2015 less persons/month were under treatment compared to January 2010, even though access to DAAs is not limited. However, yearly treatment numbers increased from 2014-2015. Under observed conditions, ∼18,000 patients/year can be cured, making substantial reduction of the estimated 160,000 diagnosed patients realizable. Political commitment to achieve further reduce DAA-prices and increase treatment numbers is recommended.
  
  
  
  New treatment options with all-oral second generation direct-acting antivirals (DAAs) have resulted in the potential to cure chronic hepatitis C infection, but at high costs. Analyses from HCV drug prescription data of patients with statutory health insurance in Germany from 2010-2015, showed that DAAs replaced treatments with pegylated interferon and ribavirin, but accompanied by a disproportionate rise in costs. Although the monthly number of patients under treatment did not increase over time, the total number of patients yearly treated with DAAs increased from ∼7000 patients in 2014 to ∼20,100 in 2015, with a trend to shorter treatment regimens. Under observed conditions ∼18,000 patients can be cured yearly, making a substantial reduction of the estimated 160,000 diagnosed patients in Germany achievable.
authors.affiliation: Department of Infectious Disease Epidemiology, Robert Koch Institute, Berlin, Germany. Electronic address: ZimmermannR@rki.de.
authors.forename: Ruth
authors.initials: R
authors.lastname: Zimmermann
authors.affiliation: Department of Infectious Disease Epidemiology, Robert Koch Institute, Berlin, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Kollan
authors.affiliation: Centre for Infectiology, Berlin, Germany.
authors.forename: Patrick
authors.initials: P
authors.lastname: Ingiliz
authors.affiliation: Centre for HIV and Hepatogastroenterology, Duesseldorf, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Mauss
authors.affiliation: Department of Infectious Disease Epidemiology, Robert Koch Institute, Berlin, Germany; Charité University Medicine, Berlin, Germany.
authors.forename: Daniel
authors.initials: D
authors.lastname: Schmidt
authors.affiliation: Department of Infectious Disease Epidemiology, Robert Koch Institute, Berlin, Germany.
authors.forename: Viviane
authors.initials: V
authors.lastname: Bremer
mesh_terms: D000998:Antiviral Agents / Q000627:therapeutic use*; D011307:Drug Prescriptions; D017048:Health Care Costs; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D013223:Statistics as Topic; D013997:Time Factors
chemical_list: D000998:Antiviral Agents
keywords: DAAs; Direct-acting antivirals; Drug prescription data; Elimination; HCV treatment; Health insurance data; Hepatitis C; Pharmacy sales price