Restrictions for reimbursement of interferon-free direct-acting antiviral drugs for HCV infection in Europe

Abstract

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.

Is hepatitis C virus elimination possible among people living with HIV and what will it take to achieve it?

“…Despite the availability of generic and low‐cost DAAs in some resource limited settings, costs of DAA therapy in the vast majority of countries remains a barrier to widespread scale‐up of HCV treatment . Greater market transparency and price negotiations are required . Broad access to HCV treatment without restrictions: Modelling studies indicate that restricting treatment for those with more advanced fibrosis and/or by drug use status, as is occurring in many settings , will likely have limited impact on preventing transmission among PWID populations , the vast majority who are younger with less advanced disease. In settings where HCV epidemics are predominantly PWID‐driven, broad access to HCV treatment regardless of disease stage is therefore required for HCV elimination.…”

Territory‐wide population‐based study of chronic hepatitis C infection and implications for hepatitis elimination in Hong Kong

“…Because of the high list price of DAAs, our current reimbursement criteria are limited to patients with advanced liver diseases. Such restrictions for reimbursement are also commonly found in many high to moderate‐income countries which do not have access to generic DAAs . Therefore, a comprehensive population‐based epidemiological data are urgently needed to clarify the scope of the problem.…”

Hep‐CORE: a cross‐sectional study of the viral hepatitis policy environment reported by patient groups in 25 European countries in 2016 and 2017

“…NSPs can contribute substantially to reducing transmission of blood‐borne viruses among PWID , yet less than one‐third of study countries were reported to have NSPs available in all parts of their countries in 2017. The presence of injecting drug use‐related restrictions on access to DAAs for the treatment of HCV in several study countries is also a matter of concern, and other research has similarly documented such restrictions . European and global experts concur that injecting drug use does not constitute a valid reason for withholding treatment – indeed, global HCV elimination strategies depend on the reductions in transmission that are expected to occur when large numbers of chronically HCV‐infected people who currently inject drugs are cured with DAAs .…”