Availability and reimbursement criteria of direct-acting antiviral drugs to treat Hepatitis C (HCV) infections vary within Europe, and restrictions regarding disease stage, alcohol or drug use, and prescriber type need to be removed in order to eliminate viral hepatitis as major public health threat by 2030. These are the main conclusions of a study co-led by the Kirby Institute (UNSW Sydney) and ISGlobal - an institution supported by the "la Caixa" Foundation – and published in The Lancet Gastroenterology and Hepatology.
Almost 70 million people are estimated to be infected with chronic HCV globally, with about 700,000 HCV-related deaths each year. Of these, about 3 million people live in Europe, where injection among drug users is the most common route of transmission.
New antiviral drugs: effective but expensive
All-oral direct-acting antiviral drugs (DAAs) to treat HCV represent one of the exciting clinical advances in recent decades: they are more tolerable than previous treatments and achieve viral cure in more than 95% of patients. However, their high list price has led many governments to restrict reimbursement based on severity of liver disease, whether the patient uses drugs or alcohol, and who prescribes the treatment.
This study aimed to review the current availability and reimbursement criteria of DAA regimens in different European countries. Data was extracted from publicly available documentation as well as from contact authors in the different countries.
The findings reveal several similarities and some differences concerning access and reimbursement restrictions for DAAs in Europe: all 35 countries and jurisdictions examined provided reimbursement for DAAs, and 94% of them required a specialist to prescribe DAAs. Disease-based restrictions were common, with nearly half of countries restricting DAAs to people with substantial liver disease. Six countries required patient abstinence from drug or alcohol use to qualify for reimbursed therapies.
Reimbursement restrictions must be eliminated
The authors point out that although these restrictions on DAA reimbursement throughout Europe are certainly linked to the high list price of DAA regimens, they are not in agreement with the 2016 European Association for the Study of Liver (EASL) recommendations, which state that all patients without contraindications to therapy should be offered treatment.
“These restrictions need to be eliminated if we want to meet the WHO target of eliminating viral hepatitis as major public health threat by 2030” says Jeffrey Lazarus, ISGlobal researcher and co-senior author of the study, “but this will require the collective efforts of researchers, health-care providers, policy-makers, the affected community, and the pharmaceutical industry”.
Broad access to DAAs requires negotiations to decrease prices, and the authors recommend greater transparency regarding this process.
Marshall AD, Cunningham EB, Nielsen S et al. Restrictions for reimbursement of interferon-free direct-acting antiviral drugs for HCV infection in Europe. Lancet Gastroenterol Hepatol. 2018 Feb;3(2):125-133. doi: 10.1016/S2468-1253(17)30284-4.
Eliminating Viral Hepatitis: the Research–Policy Nexus by Jeffrey Lazarus