Chronic hepatitis C has long been a debilitating disease, but recent advances in direct-acting-antivirals (DAA) now allow nearly every patient to be cured. Unfortunately, the high price tag of these DAAs, often exceeding $50,000 per treatment, in combination with the high prevalence of the disease, has forced most healthcare providers, including national insurance schemes in the western world, to restrict access to DAA regimens.

A new analysis, presented at this year’s European Association for the Study of the Liver (EASL) conference in Amsterdam, now provides an extensive overview of national restrictions in Europe and indirectly highlights the two main driving forces behind the restrictions—price and prevalence.

For this international study, researchers used not only publicly available information but also directly contacted national regulatory bodies and insurance providers between 18 November 2016 and 27 March 2017, and inquired about access to multiple DAA regimens, including those marketed by Gilead and AbbVie.

DAA treatment access: restricting factors in Europe

The main restricting factor throughout Europe is the patient’s liver status. Although several Central European countries, including France and Germany, have eliminated fibrosis scores as a limiting factor based on this study, Southern European nations such as Spain, Italy, and Greece, as well as all Scandinavian countries, require either a fibrosis core of F2 or F3 for DAA reimbursement. However, unlike the US, where alcohol and drug abuse is a major limiting factor for treatment access, all Western European countries have no restrictions for patients with drug or alcohol dependence.

Another main result of the study is the limitation in prescribers. With the exemption of some regions in England, DAAs can only be prescribed by specialists throughout the EU. While general practitioners would have been reluctant to prescribe DAA regimens in the past, due to the complex treatment guidelines requiring expertise in hepatitis C treatment, new pangenotypic regimens might reduce this complexity and allow general practitioners to determine the best treatment option without consulting a specialist.

"Unlike the US, where alcohol and drug abuse is a major limiting factor for treatment access, all Western European countries have no restrictions for patients with drug or alcohol dependence."

Therefore, it will be interesting to see if these general restrictions on non-specialists will be removed during the next few years, or if they will be retained as a means of limiting the volume of prescriptions.

The study also pointed to an interesting approach used for individuals co-infected with hepatitis and human immunodeficiency virus (HIV). While this patient population has access to DAA treatment across Europe, some countries, including Iceland and Belgium, prioritize these individuals for treatment. This prioritization in some cases also includes additional screening initiatives targeting individuals known to be infected with HIV or other high-risk groups, including drug users.

In recent years, the access to DAA treatment has improved, driven by a reduced prevalence, in particular of diagnosed cases, as well as a decline in the cost of DAA regimens. GlobalData expects this trend to continue during the coming years although this progress will not be consistent throughout the EU. In particular, countries with overall low prevalence of hepatitis C and the financial abilities for broad access to DAA treatment are expected to be the first to broaden access with the goal of eliminating hepatitis C.