6533b82bfe1ef96bd128d653
RESEARCH PRODUCT
Restrictions for reimbursement of interferon-free direct-acting antiviral drugs for HCV infection in Europe
Alison D. MarshallEvan B. CunninghamStine NielsenAlessio AghemoHannu AlhoMarkus BackmundPhilip BruggmannOlav DalgardCarole Seguin-devauxRobert FlisiakGraham R. FosterLiana GheorgheDavid GoldbergIoannis GoulisMatthew HickmanPatrick HoffmannLigita JancorienėPeter JarcuskaMartin KåbergLeontios G. KostrikisMihály MakaraMatti MaimetsRui Tato MarinhoMojca MatičičSuzanne NorrisSigurður ÓLafssonAnne ØVrehusJean-michel PawlotskyJames PocockGeert RobaeysCarlos RonceroMarieta SimonovaJan SperlMichele TaitIeva TolmaneStefan TomaselliMarc Van Der ValkAdriana VinceGregory J. DoreJeffrey V. LazarusJason GrebelyInternational Network On Hepatitis In Substance Users (Inhsu)Alison D. MarshallEvan B. CunninghamStine NielsenAlessio AghemoHannu AlhoMarkus BackmundPhilip BruggmannOlav DalgardCarole Seguin-devauxRobert FlisiakGraham R. FosterLiana GheorgheDavid GoldbergIoannis GoulisMatthew HickmanPatrick HoffmannLigita JancorienėPeter JarcuskaMartin KåbergLeondios G. KostrikisMihály MakaraMatti MaimetsRui Tato MarinhoMojca MatičičSuzanne NorrisSigurður ÓLafssonAnne ØVrehusJean-michel PawlotskyJames PocockGeert RobaeysCarlos RonceroMarieta SimonovaJan SperlMichele TaitIeva TolmaneStefan TomaselliMarc Van Der ValkAdriana VinceGregory J. DoreJeffrey V. LazarusJason GrebelyInternational Network On Hepatitis In Substance Users (Inhsu)subject
hepatitis C virusHIV Infectionschemistry.chemical_compound0302 clinical medicineAntiviral Agents/economicsHIV-HCV co-infection030212 general & internal medicineReimbursementliver fibrosismedia_commonDasabuvirCoinfectionHealth PolicyGastroenterologyHepatitis C3. Good healthEuropeHepatitis C Chronic/complicationsInsurance Health Reimbursement030211 gastroenterology & hepatologySwitzerlandmedicine.drugmedicine.medical_specialtyHIV Infections/complicationsAntiviral AgentsDrug Costs03 medical and health scienceshepatitis C treatmentmedicineHumansmedia_common.cataloged_instanceEuropean UnionEuropean unionPWIDIntensive care medicineHepatitisdirect-acting antiviralHepatologybusiness.industryHepatitis C Chronicalcohol usemedicine.diseasereimbursementVirologyOmbitasvirchemistryParitaprevirRitonavirbusinesstreatment restrictionsdescription
All-oral direct-acting antiviral drugs (DAAs) for hepatitis C virus, which have response rates of 95% or more, represent a major clinical advance. However, the high list price of DAAs has led many governments to restrict their reimbursement. We reviewed the availability of, and national criteria for, interferon-free DAA reimbursement among countries in the European Union and European Economic Area, and Switzerland. Reimbursement documentation was reviewed between Nov 18, 2016, and Aug 1, 2017. Primary outcomes were fibrosis stage, drug or alcohol use, prescriber type, and HIV co-infection restrictions. Among the 35 European countries and jurisdictions included, the most commonly reimbursed DAA was ombitasvir, paritaprevir, and ritonavir, with dasabuvir, and with or without ribavirin (33 [94%] countries and jurisdictions). 16 (46%) countries and jurisdictions required patients to have fibrosis at stage F2 or higher, 29 (83%) had no listed restrictions based on drug or alcohol use, 33 (94%) required a specialist prescriber, and 34 (97%) had no additional restrictions for people co-infected with HIV and hepatitis C virus. These findings have implications for meeting WHO targets, with evidence of some countries not following the 2016 hepatitis C virus treatment guidelines by the European Association for the Study of Liver. 3 2 125 133
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2018-02-01 | The Lancet Gastroenterology & Hepatology |