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A review of recent reimbursement data showed considerable variability in access to direct-acting antiviral therapy based on amount of liver scarring and substance use — European Association for the Study of the Liver
April 20, 2017, Amsterdam, The Netherlands: Data presented today demonstrate that there are considerable restrictions in the reimbursement of direct-acting antiviral (DAA) therapy across European countries, particularly with respect to the severity of liver fibrosis (scarring of the liver) and prescribing by specialists. The study, presented at The International Liver Congress™ 2017 in Amsterdam, The Netherlands, showed that there was evidence that some countries were not following the most recent European HCV treatment guidelines, published by the European Association for the Study of the Liver (EASL) in 2016.
“The availability of simple, tolerable DAA-based therapies for HCV with high cure rates is one of the greatest clinical advances in recent decades,” said Ms Alison Marshall, PhD candidate, Kirby Institute, UNSW Sydney, Australia, and author of the study. “While all European countries included in our study reimbursed some form of DAA treatment, there was restricted access based on fibrosis stage, substance use, and type of prescriber, meaning that some patients are encountering considerable barriers to the life-saving treatment they need. In particular, restricting DAA prescribing to specialists is a major impediment to ensuring broad access to HCV therapy. These findings have important implications for health policy makers and the delivery of health services across Europe.”
Information from online reimbursement documents for EU/EEA countries (including England, Northern Ireland, Scotland, and Wales as separate jurisdictions) and Switzerland were reviewed from November 2016 to March 2017. Primary outcomes were reimbursement restrictions based on the stage of fibrosis, drug or alcohol use, type of prescriber (e.g. specialists), and HIV-HCV co-infection.
The European countries with complete data (34/35) all reimbursed DAAs. The most common DAAs reimbursed were ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin (97%) and sofosbuvir/ledipasvir ± ribavirin (88%). For treatment naïve patients, 38% (n=13) of countries required evidence of at least moderate fibrosis (?F2) before DAAs were prescribed, nearly a quarter (24%, n=8) required at least severe fibrosis (?F3),8 over a quarter (26%, n=9) had no fibrosis stage restrictions, and 9% (n=3) had an additional requirement, such as genotype of HCV. In this study, 76% (n=26) of countries had no drug or alcohol use restriction, though almost one-fifth (n=6) had a drug or alcohol use limitation (e.g. abstinence required prior to treatment with DAAs). Overall, 94% (n=32) of countries had no additional restrictions for HIV-HCV co-infection, and in fact, 24% (n=8) of countries gave priority status to HIV-HCV co-infected people with fewer restrictions than for HCV mono-infected people. Further, 94% (n=32) of countries required specialists to prescribe DAA therapy.
“Restrictions to DAA access for Hepatitis C across Europe are widespread and conflicting with the EASL Clinical Practice Guidelines, thus preventing many patients from being treated. Restrictions are the consequence of current drug prices, calling for revised strategies to make these treatments available to all in need,” said Prof Francesco Negro, Divisions of Gastroenterology and Hepatology of Clinical Pathology, University Hospital of Geneva, Switzerland and EASL Governing Board Member.