Cost per care of the first year of direct antiviral agents in the Liguria Region: a multicenter analysis

References

• StanawayJDFlaxmanADNaghaviMThe global burden of viral hepatitis from 1990 to 2013: findings from the Global Burden of Disease Study 2013Lancet2016388100491081108827394647
   PubMed Web of Science ®Google Scholar
• GowerEEstesCBlachSRazavi-ShearerKRazaviHGlobal epidemiology and genotype distribution of the hepatitis C virus infectionJ Hepatol201461Suppl 1S45S5725086286
   PubMed Web of Science ®Google Scholar
• SacchiniDCraxìLRefoloPWEF Study GroupEthical assessment of hepatitis C virus treatment: the lesson from first generation protease inhibitorsDig Liver Dis201547535135525534233
   PubMedGoogle Scholar
• DavisGLRodrigueJRTreatment of chronic hepatitis C in active drug usersN Engl J Med2001345321521711463020
   PubMed Web of Science ®Google Scholar
• PetruzzielloACoppolaNDiodatoAMAge and gender distribution of hepatitis C virus genotypes in the metropolitan area of NaplesIntervirology201356320621223594735
   PubMed Web of Science ®Google Scholar
• HillAMSaleemJHeathKASimmonsBEffects of Sustained Virological Response (SVR) on the risk of liver transplant, hepatocellular carcinoma, death and re-infection: meta-analysis of 129 studies in 23,309 patients with Hepatitis C infectionHepatology20146055A
   Web of Science ®Google Scholar
• van der MeerAJVeldtBJFeldJJAssociation between sustained virological response and all-cause mortality among patients with chronic hepatitis C and advanced hepatic fibrosisJAMA2012308242584259323268517
   PubMed Web of Science ®Google Scholar
• AfdhalNZeuzemSKwoPLedipasvir and sofosbuvir for untreated HCV genotype 1 infectionN Engl J Med2014370201889189824725239
   PubMed Web of Science ®Google Scholar
• AfdhalNReddyRNelsonDRLedipasvir and sofosbuvir for previously treated HCV genotype 1 infectionN Engl J Med2014370161483149324725238
   PubMed Web of Science ®Google Scholar
• SulkowskiMSGardinerDFRodriguez-TorresMAI444040 Study GroupDaclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infectionN Engl J Med20143701521122124428467
   PubMed Web of Science ®Google Scholar
• WylesDLRuanePSulkowskiMDaclatasvir plus sofosbuvir for HCV in patients coinfected with HIV-1N Engl J Med2015373871477226196502
   PubMed Web of Science ®Google Scholar
• NelsonCooperJNLalezariJPAll-oral 12-week treatment with daclatasvir plus sofosbuvir in patients with hepatitis C virus genotype 3 infection: ALLY-3 phase 3 studyHepatology20156141127113525614962
   PubMed Web of Science ®Google Scholar
• HézodeCAsselahTReddyKROmbitasvir plus paritaprevir plus ritonavir with or without ribavirin in treatment-naive and treatment-experienced patients with genotype 4 chronic hepatitis C virus infection (PEARL-I): a randomised, open-label trialLancet201538599862502250925837829
   PubMed Web of Science ®Google Scholar
• FerenciPBernsteinDLalezariJABT-450/r-ombitasvir and dasabuvir with or without ribavirin for HCVN Engl J Med2014370211983199224795200
   PubMed Web of Science ®Google Scholar
• FeldJJKowdleyKVCoakleyETreatment of HCV with ABT-450/rombitasvir and dasabuvir with ribavirinN Engl J Med2014370171594160324720703
   PubMed Web of Science ®Google Scholar
• ZeuzemSJacobsonIMBaykalTRetreatment of HCV with ABT-450/rombitasvir and dasabuvir with ribavirinN Engl J Med2014370171604161424720679
   PubMed Web of Science ®Google Scholar
• WylesDSulkowskiMSEronJJTURQUOISE-I: 94% SVR12 in HCV/HIV-1. Coinfected patients treated with ABT- 450/r/ombitasvir dasabuvir and ribavirin65th Annual meeting of the American Association for the Study of Liver DiseasesNov 7–112014Boston, MA, US
   Google Scholar
• LawitzESulkowskiMSGhalibRSimeprevir plus sofosbuvir, with or without ribavirin, to treat chronic infection with hepatitis C virus genotype 1 in non-responders to pegylated interferon and ribavirin and treatment-naïve patients: the COSMOS randomised studyLancet201438499561756176525078309
   PubMed Web of Science ®Google Scholar
• CenderelloGArtioliSViscoliCBudget impact analysis of sofosbuvir-based regimens for the treatment of HIV/HCV-coinfected patients in northern Italy: a multicenter regional simulationClinicoecon Outcomes Res20158152126770065
   PubMed Web of Science ®Google Scholar
• GaragiolaEFerrarioLCroceDHCV novel therapeutic regimens in Wonderland: a budget impact analysis in the Lombardy RegionDig Liver Dis201648101200120727474199
   PubMedGoogle Scholar
• FraccaroPDentoneCFenoglioDGiacominiMMulticentre clinical trials’ data management: a hybrid solution to exploit the strengths of electronic data capture and electronic health records systemsInform Health Soc Care201338431332923957714
   PubMed Web of Science ®Google Scholar
• FraccaroPPupellaVGazzarataRThe Ligurian Human Immunodeficiency Virus Clinical Network: a web tool to manage patients with human immunodeficiency virus in primary care and multicenter clinical trialsMed 2 0201322e525075240
   PubMedGoogle Scholar
• MinervaDEpatiteCIl farmaco c’è ma costa troppo Available from: http://espresso.repubblica.it/visioni/scienze/2015/02/27/news/quel-farmaco-costa-troppo-1.201536Accessed June 27, 2015
   Google Scholar
• salute.regione.emilia-romagna.it [homepage on the internet]Documenti. Trattamento epatite c (Documents. HCV treatment) Available from: http://www.salute.regione.emilia-romagna.it/documentiAccessed November 29, 2016
   Google Scholar
• Regione Emilia Romagna Direzione Generale Sanità e Politiche Sociali. Documento di indirizzo per la definizione delle strategie terapeutiche da applicare sul breve termine per “Nuovi antivirali diretti nella terapia dell’epatite C cronica” aggiornamento 14 Maggio 2015 Available from: http://salute.regione.emilia-romagna.it/documentazi-one/ptr/ptr/archivio/PTR_229_maggio_2015.pdfAccessed October 26, 2016
   Google Scholar
• Regione Emilia Romagna Direzione Generale Sanità e Politiche Sociali. Documento di indirizzo per la definizione delle strategie terapeutiche da applicare sul breve termine per “Nuovi antivirali diretti nella terapia dell’epatite C cronica” aggiornamento 16 Luglio 2015 Available from: http://salute.regione.emilia-romagna.it/documentazione/ptr/ptr/archivio/229_nuovi-antivirali-epatiteC-luglio-2015Accessed October 26, 2016
   Google Scholar
• Regione Emilia Romagna Direzione Generale Sanità e Politiche Sociali. Documento di indirizzo per la definizione delle strategie terapeutiche da applicare sul breve termine per “Nuovi antivirali diretti nella terapia dell’epatite C cronica” aggiornamento Dicembre 2015 Available from: http://salute.regione.emilia-romagna.it/documentazione/ptr/ptr/archivio/229_nuovi-antivirali-epatiteC-dicembre-2015Accessed October 26, 2016
   Google Scholar
• Official Italian Gazette. General Series n 283-05/12/2014DETER-MINA 12 novembre 2014. Regime di rimborsabilità e prezzo del medicinale per uso umano “Sovaldi (sofosbuvir)” [Price and reimbursement process of drug for human use named “Sovaldi” (sofosbuvir)]. (Determina 1353/2014).
   Google Scholar
• Data on file. Regione LiguriaDeliberazione della Giunta Regionale n. 957 del 30/07/2013 con oggetto “Remunerazione delle prestazioni di assistenza specialistica ambulatoriale. Adeguamento delle tariffe al D.M. 18 ottobre 2012
   Google Scholar
• Data on file. Regione LiguriaGara farmaci 2014 Lotto Gara 2014 1095 SUB A Ribavirina TEVA 200 mg
   Google Scholar
• Data on file. Regione Liguria. Gara Farmaci 2014 Lotto Gara 2A NeoRecormon.
   Google Scholar
• Ministero del Lavoro, della Salute e delle Politiche SocialiClassificazione Diagnosis Related Groups versione 14 Available from: http://www.salute.gov.it/imgs/C_17_pubblicazioni_1094_allegato.pdfAccessed October 26, 2016
   Google Scholar
• Official Italian Gazette. General Series n 109-13/05/2015 DETER-MINA 8 maggio 2015Regime di rimborsabilità e prezzo del medicinale per uso umano “Harvoni (ledipasvir/sofosbuvir)” [Price and reimbursement process of drug for human use named “Harvoni”(ledipasvir/sofosbuvir)]. (Determina 544/2015)
   Google Scholar
• IoannouGNBesteLAChangMFEffectiveness of Sofosbuvir, Ledipasvir/Sofosbuvir, or Paritaprevir/Ritonavir/Ombitasvir and Dasabuvir Regimens for Treatment of Patients With Hepatitis C in the Veterans Affairs National Health Care SystemGastroenterology2016151345747127267053
   PubMed Web of Science ®Google Scholar
• IngilizPChristensenSKimhoferTSofosbuvir and ledipasvir for 8 weeks for the treatment of chronic hepatitis C virus (HCV) Infection in HCV-monoinfected and HIV-HCV-coinfected individuals: results from the German hepatitis C cohort (GECCO-01)Clin Infect Dis201663101320132427535952
   PubMed Web of Science ®Google Scholar
• HézodeCFontaineHDorivalCCUPIC Study GroupTriple therapy intreatment experienced patients with HCV-cirrhosis in a multicentre cohort of the French Early Access Programme (ANRS CO20-CUPIC) – NCT01514890J Hepatol201359343444123669289
   PubMed Web of Science ®Google Scholar
• StahmeyerJTRossolSBertFOutcomes and costs of treating hepatitis C patients in the era of first generation protease inhibitors – Results from the PAN StudyPLoS One2016117e015997627467772
   PubMed Web of Science ®Google Scholar
• LashinAHShaheenYAMetwallyMAEl-FekyHMHegabMFAbbasSMIncidence and predictors of hematological side effects in chronic HCV Egyptian patientstreated with PEGylated interferon and ribavirinIndian J Gastroenterol201332531632323715642
   PubMedGoogle Scholar
• FeldJJMorenoCTrinhRSustained virologic response of 100% in HCVgenotype 1b patients with cirrhosis receiving ombitasvir/paritaprevir/r and dasabuvir for 12 weeksJ Hepatol201664230130726476290
   PubMed Web of Science ®Google Scholar
• BichoupanKMartel-LaferriereVSachsDCosts of telaprevir-based triple therapy for hepatitis C: $189,000 per sustained virological responseHepatology20146041187119525065814
   PubMed Web of Science ®Google Scholar
• MaanRvan TilborgMDeterdingKSafety and effectiveness of direct-acting antiviral agents for treatment of patients with chronic hepatitis C virus infection and cirrhosisClin Gastroenterol Hepatol201614121821183027404965
   PubMed Web of Science ®Google Scholar
• PolilliECentoVRestelliUConsequences of inaccurate hepatitis C virus genotyping on the costs of prescription of direct antiviral agents in an Italian districtClinicoecon Outcomes Res2016846747327695353
   PubMedGoogle Scholar
• GaneEKowdleyKVPoundDEfficacy of sofosbuvir, velpatasvir, and GS-9857 in patients with hepatitis C virus genotype 2, 3, 4, or 6 infections in an open-label, phase 2 trialGastroenterology2016151590290927486033
   PubMed Web of Science ®Google Scholar
• PerroneVSangiorgiDBudaSDegli EspostiLDiseases progression and healthcare resource consumption in patients affected by hepatitis C virus in real practice settingClinicoecon Outcomes Res2016859159727789966
   PubMed Web of Science ®Google Scholar
• Regione Emilia Romagna Direzione Generale Sanità e Politiche Sociali. Documento di indirizzo per la definizione delle strategie terapeutiche da applicare sul breve termine per “Nuovi antivirali diretti nella terapia dell’epatite C cronica” aggiornamento Settembre 2016 Available from: http://salute.regione.emilia-romagna.it/documentazione/ptr/elaborati/229-epatite-c-cronica-settembre-2016Accessed October 26, 2016
   Google Scholar
• De CompardiPKolevaDMangiaAMotterliniNGarattiniLAnalisi costo minimizzazione della terapia di durata 12 o 24 settimane di peginteferferone alfa 2b e di ribavirina nell’infezione da da virus dell’epatite. C. Quaderni di Farmacoeconomia. Numero 10 Ottobre 2009 Available from: http://www.quadernidifarmacoeconomia.com/component/content/article/118-archivio-qf-preview/611-qf10.htmlAccessed October 26, 2016
   Google Scholar
• RavasioRSacchiPMaiocchiLCosto efficacia di peginteferone α2a+ribavirina verso peginterferone α2b+ribavirina nel trattamento dell’epatite cronica di tipo C in pazienti non pretrattati. [Cost-effectiveness of peginterferon α-2a plus ribavirin versus peginterferon α-2b plus ribavirin as initial therapy for patients with Chronic Hepatitis C]Pharmacoeconomics Ital-Res-Articles200573207
   Google Scholar
• ShepherdJBrodinHFCaveCBWaughNRPriceAGabbayJClinical- and cost-effectiveness of pegylated interferon alfa in the treatment of chronic hepatitis C: a systematic review and economic evaluationInt J Technol Assess Health Care2005211475415736514
   PubMed Web of Science ®Google Scholar
• FriedMWShiffmanMLReddyKRPeginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infectionN Engl J Med20023471397598212324553
   PubMed Web of Science ®Google Scholar
• MannsMPMcHutchisonJGGordonSCPeginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trialLancet2001358928695896511583749
   PubMed Web of Science ®Google Scholar
• HadziyannisSJSetteHJrMorganTRPEGASYS International Study GroupPeginterferon-alpha2a andribavirin combination therapy in chronic hepatitis C: a randomized study of treatment duration and ribavirin doseAnn Intern Med2004140534635514996676
   PubMed Web of Science ®Google Scholar