title: Introduction and Utilization of High Priced HCV Medicines across Europe; Implications for the Future.
abstract: BACKGROUND
  Infection with the Hepatitis C Virus (HCV) is a widespread transmittable disease with a diagnosed prevalence of 2.0%. Fortunately, it is now curable in most patients. Sales of medicines to treat HCV infection grew 2.7% per year between 2004 and 2011, enhanced by the launch of the protease inhibitors (PIs) boceprevir (BCV) and telaprevir (TVR) in addition to ribavirin and pegylated interferon (pegIFN). Costs will continue to rise with new treatments including sofosbuvir, which now include interferon free regimens.
  
  
  OBJECTIVE
  Assess the uptake of BCV and TVR across Europe from a health authority perspective to offer future guidance on dealing with new high cost medicines.
  
  
  METHODS
  Cross-sectional descriptive study of medicines to treat HCV (pegIFN, ribavirin, BCV and TVR) among European countries from 2008 to 2013. Utilization measured in defined daily doses (DDDs)/1000 patients/quarter (DIQs) and expenditure in Euros/DDD. Health authority activities to influence treatments categorized using the 4E methodology (Education, Engineering, Economics and Enforcement).
  
  
  RESULTS
  Similar uptake of BCV and TVR among European countries and regions, ranging from 0.5 DIQ in Denmark, Netherlands and Slovenia to 1.5 DIQ in Tayside and Catalonia in 2013. However, different utilization of the new PIs vs. ribavirin indicates differences in dual vs. triple therapy, which is down to factors including physician preference and genotypes. Reimbursed prices for BCV and TVR were comparable across countries.
  
  
  CONCLUSIONS
  There was reasonable consistency in the utilization of BCV and TVR among European countries in comparison with other high priced medicines. This may reflect the social demand to limit the transmission of HCV. However, the situation is changing with new curative medicines for HCV genotype 1 (GT1) with potentially an appreciable budget impact. These concerns have resulted in different prices across countries, with their impact on budgets and patient outcomes monitored in the future to provide additional guidance.
authors: Department of Pharmaceutical Sciences, Utrecht University Utrecht, Netherlands.
authors: Winnie
authors: W
authors: de Bruijn
authors: Catalan Health Service - Servei Català de la Salut Barcelona, Spain.
authors: Cristina
authors: C
authors: Ibáñez
authors: Public Health Services Committee, Stockholm County Council Stockholm, Sweden.
authors: Pia
authors: P
authors: Frisk
authors: Health Technologies and Pharmaceuticals, Division of Health Systems and Public Health, WHO Regional Office for Europe Copenhagen, Denmark.
authors: Hanne
authors: H
authors: Bak Pedersen
authors: Turkish Medicines and Medical Devices Agency, Ministry of Health Ankara, Turkey.
authors: Ali
authors: A
authors: Alkan
authors: Independent Pharmaceutical Consultant Mellieha, Malta.
authors: Patricia
authors: P
authors: Vella Bonanno
authors: Croatian Health Insurance Fund Zagreb, Croatia.
authors: Ljiljana S
authors: LS
authors: Brkičić
authors: Department of Finance, University of Vienna Vienna, Austria.
authors: Anna
authors: A
authors: Bucsics
authors: Ministry of Health Paris, France.
authors: Guillaume
authors: G
authors: Dedet
authors: Division of Clinical Pharmacology, Department of Laboratory Medicine, Karolinska Institutet, Karolinska University Hospital Huddinge Stockholm, Sweden.
authors: Jaran
authors: J
authors: Eriksen
authors: Department of Pharmacology, Ekiti State University Ado-Ekiti, Nigeria.
authors: Joseph O
authors: JO
authors: Fadare
authors: Health Insurance Institute Ljubljana, Slovenia.
authors: Jurij
authors: J
authors: Fürst
authors: School of Medicine, The University of Notre Dame AustraliaDarlinghurst, NSW, Australia; Department of Pharmacology and Clinical Neuroscience, Umea UniversityUmea, Sweden.
authors: Gisselle
authors: G
authors: Gallego
authors: School of Pharmacy, Graduate Program in Medicines and Pharmaceutical Assistance, Federal University of Minas GeraisBelo Horizonte, Brazil; Department of Social Pharmacy, SUS Collaborating Centre - Health Technology Assessment and Excellence in Health, College of Pharmacy, Federal University of Minas GeraisBelo Horizonte, Brazil.
authors: Isabella P
authors: IP
authors: Godói
authors: School of Pharmacy, Graduate Program in Medicines and Pharmaceutical Assistance, Federal University of Minas GeraisBelo Horizonte, Brazil; Department of Social Pharmacy, SUS Collaborating Centre - Health Technology Assessment and Excellence in Health, College of Pharmacy, Federal University of Minas GeraisBelo Horizonte, Brazil.
authors: Augusto A
authors: AA
authors: Guerra Júnior
authors: Turkish Medicines and Medical Devices Agency, Ministry of Health Ankara, Turkey.
authors: Hakkı
authors: H
authors: Gürsöz
authors: Clinical Pharmacy, Rutgers State University of New JerseyPiscataway, NJ, USA; Horizon Blue Cross Blue Shield of New JerseyNewark, NJ, USA.
authors: Saira
authors: S
authors: Jan
authors: Scottish Medicines Consortium Glasgow, UK.
authors: Jan
authors: J
authors: Jones
authors: Pharmaceutical Drug Department, Azienda Sanitaria Locale of Verona Verona, Italy.
authors: Roberta
authors: R
authors: Joppi
authors: Turkish Medicines and Medical Devices Agency, Ministry of Health Ankara, Turkey.
authors: Saim
authors: S
authors: Kerman
authors: State Agency of Medicines Tartu, Estonia.
authors: Ott
authors: O
authors: Laius
authors: Ministry of Health and Child Care Harrare, Zimbabwe.
authors: Newman
authors: N
authors: Madzikwa
authors: Department of Health Services, Ministry of Health Reykjavík, Iceland.
authors: Einar
authors: E
authors: Magnússon
authors: Clinic for Infectious Diseases and Febrile Illnesses, University Medical Centre Ljubljana Ljubljana, Slovenia.
authors: Mojca
authors: M
authors: Maticic
authors: Faculty of Medicine, University of Banja LukaBanja Luka, Bosnia and Herzegovina; Ministry of Health and Social WelfareBanja Luka, Bosnia and Herzegovina.
authors: Vanda
authors: V
authors: Markovic-Pekovic
authors: Department of Clinical Pharmacology, School of Medicine, University of Botswana Gaborone, Botswana.
authors: Amos
authors: A
authors: Massele
authors: Clinical Pharmacology Unit, Department of Medicine, Lagos State University Teaching HospitalLagos, Nigeria; Department of Pharmacology and Therapeutics, Lagos State University College of MedicineLagos, Nigeria.
authors: Olayinka
authors: O
authors: Ogunleye
authors: National Centre for Pharmacoeconomics Dublin, Ireland.
authors: Aisling
authors: A
authors: O'Leary
authors: Hauptverband der Österreichischen Sozialversicherungsträger Wien, Austria.
authors: Jutta
authors: J
authors: Piessnegger
authors: IRDES Paris, France.
authors: Catherine
authors: C
authors: Sermet
authors: Department of Pharmaceutical and Pharmacological Sciences, KU Leuven Leuven, Belgium.
authors: Steven
authors: S
authors: Simoens
authors: Ministry of Health, Nelson Mandela Drive Gaborone, Botswana.
authors: Celda
authors: C
authors: Tiroyakgosi
authors: Drug Utilisation Research Unit, Faculty of Health Sciences, Nelson Mandela Metropolitan University Port Elizabeth, South Africa.
authors: Ilse
authors: I
authors: Truter
authors: Stockholms Läns Landsting, Hälso-och Sjukvårdsförvaltningen Stockholm, Sweden.
authors: Magnus
authors: M
authors: Thyberg
authors: Faculty of Management, Comenius University Bratislava, Slovakia.
authors: Kristina
authors: K
authors: Tomekova
authors: HTA Consulting Cracow, Poland.
authors: Magdalena
authors: M
authors: Wladysiuk
authors: School of Management and Business, King's College London London, UK.
authors: Sotiris
authors: S
authors: Vandoros
authors: Turkish Medicines and Medical Devices Agency, Ministry of Health Ankara, Turkey.
authors: Elif H
authors: EH
authors: Vural
authors: Catalan Health Service - Servei Català de la Salut Barcelona, Spain.
authors: Corinne
authors: C
authors: Zara
authors: Division of Clinical Pharmacology, Department of Laboratory Medicine, Karolinska Institutet, Karolinska University Hospital HuddingeStockholm, Sweden; Strathclyde Institute of Pharmacy and Biomedical Sciences, University of StrathclydeGlasgow, UK.
authors: Brian
authors: B
authors: Godman
keywords: Hepatitis C; boceprevir; cross national drug utilization study; demand-side measures; introduction new medicines; sofosbuvir; telaprevir