Brunetto, Maurizia R.

De Luca, Andrea

Messori, Andrea

Zignego, Anna Linda

English

Zignego, Al

Messori, A

De Luca, A

BRUNETTO, MAURIZIA ROSSANA

Archivio della Ricerca - Università di Pisa

Reducing the price of new hepatitis C drugs in the Tuscany region of Italy

Florence Research

SCREENING AND TREATMENT FOR HEPATITIS CReducing the price of new hepatitis C drugs in theTuscany region of ItalyMaurizia R Brunetto director, hepatology unit 1, Andrea De Luca director, infectious diseases unit 2,Andrea Messori head, health technology assessment unit of ESTAR3, Anna Linda Zignego director,centre for systemic manifestations of hepatitis viruses 41Hepatology Unit, Reference Centre of the Tuscany Region for Chronic Liver Disease and Cancer, University Hospital of Pisa, Pisa, Italy; 2InfectiousDiseases Unit, Azienda Ospedaliera Universitaria Senese and Department of Biotechnology, University of Siena, Siena, Italy; 3Health TechnologyAssessment (HTA) Unit, Regional Health Service, ESTAR-Tuscany Region, Florence, Italy; 4Department of Internal Medicine, Centre for SystemicManifestations of Hepatitis Viruses, University of Florence, Largo Brambilla 3, Florence, ItalyIn most European countries, regulatory agencies are engagedin approving reimbursement schemes for the new interferon-freedirect antiviral agents (DAAs) for hepatitis C.1 2 The degree ofreimbursement differs across countries and sometimes betweenregions of the same country.Owing to budget constraints, most national approvals forreimbursement have been restricted to patients with more severedisease, according to ethical and clinical considerations.2-5In May 2015, the Tuscany region of Italy proposed a regionaltendering scheme that extended reimbursement to about 20 000patients with milder disease.6 This tender will probably closeover the next month.This project has been debated among institutions, politicians,patient associations, scientific societies, and experts in the field.3Opponents (such as the Italian Medicines Agency4) argue thatthe proposal is not pharmaceutically sustainable; anothercriticism is that the effectiveness of newer DAAs relies on asurrogate endpoint with no information on long term effects;finally, trying to eradicate this disease locally has beenquestioned on theoretical grounds. Ethics has been advocatedby all stakeholders, but ethics seems to support both prioritisingpatients with severe disease and ensuring that those with milder,but potentially progressive, disease are treated. The AmericanAssociation of the Liver recently recommended treating allhepatitis C infected people except those with a life expectancyof less than 12 months due to unrelated conditions.7Patients’ associations initially argued that extended coveragein one region only would be an infringement of equity but nowrecognise that it might pave the way for other regions to follow.It is unprecedented for an effective treatment not to be used inpatients with mild disease for economic reasons. The cure rateis high in mild disease, so eradicating the disease in these caseswould save healthcare costs and prevent onward transmission.Reducing drug costs by increasing competition betweenmanufacturers could be a solution. At its first run, the Tuscantender set a maximum treatment cost per patient of about onetenth of the drug’s full price, but at the second run no such limitwill be applied.6 The results of the Tuscan tender are eagerlyawaited by scientists, clinicians, and patients.Competing interests: Although the authors have been formally involvedin the Tuscan project, the opinions presented here do not necessarilyreflect those of the Tuscany region; all the information reported hereinis publicly available.1 Matthews PC, Jeffery K, Klenerman P, et al. Screening and treatment for hepatitis C: abalanced perspective. BMJ 2015;350:h644. (24 February.)2 Etzion O, Ghany MG. A cure for the high cost of hepatitis C virus treatment. Ann InternMed 2015;162:660-1.3 Bagcchi S. Campaigners challenge patent applications for hepatitis C drug in five countries.BMJ 2015;350:h2938. (1 June.)4 Cartabellotta A. Position statement GIMBE. Efficacia e costo-efficacia del sofosbuvir neltrattamento dell’epatite C. Evidence 2015;7:e1000111.5 Pani L. Epatite C: verso un approccio terapeutico clinicamente appropriato edeconomicamente sostenibile. AIFA (ItalianMedicines Agency), 2015. www.agenziafarmaco.gov.it/it/content/epatite-c-verso-un-approccio-terapeutico-clinicamente-appropriato-ed-economicamente-sostenib.6 Toscana. Epatite C. Al via procedure negoziali per acquisto nuovi farmaci. QuotidianoSanità, 2015. www.quotidianosanita.it/toscana/articolo.php?articolo_id=28676.7 Association for the Study of Liver Diseases/Infectious Diseases Society of America.Recommendations for testing, managing and treating hepatitis C. 2015. www.hcvguidelines.org.Cite this as: BMJ 2015;350:h3363© BMJ Publishing Group Ltd 2015md3439@me.comFor personal use only: See rights and reprints http://www.bmj.com/permissions Subscribe: http://www.bmj.com/subscribeBMJ 2015;350:h3363 doi: 10.1136/bmj.h3363 (Published 24 June 2015) Page 1 of 1LettersLETTERS

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Reducing the price of new hepatitis C drugs in the Tuscany region of Italy

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