England, and Central and Eastern Europe, have the most restrictions on who can be treated
England, Malta, Slovakia, Hungary and Croatia have the tightest restrictions on who can receive direct-acting antiviral treatment for hepatitis C, while France, Ireland, Portugal, Germany, Poland and the Netherlands are the least restrictive, research presented today at the International Liver Congress in Amsterdam shows.
The study, carried out by researchers from every European Union country, looked at access arrangements in the European Economic Area (which covers the European Union, Switzerland, Norway and Iceland).
The researchers looked at national policies between November 2016 and February 2017 to check which patients were eligible to receive treatment with direct-acting antiviral combinations recommended in EASL’s 2016 hepatitis C treatment guidelines (all those products currently licensed in the European Union, plus the combinations of sofosbuvir and daclatasvir, and sofosbuvir and simeprevir).
The study found that Slovakia and Croatia restrict reimbursement for DAAs to people with F4 fibrosis – cirrhosis of the liver – while the Czech Republic, Greece, Italy, Latvia and Romania restrict access to people with F3 fibrosis and above.
England and Northern Ireland have different restrictions for different genotypes of hepatitis C. Whereas in Scotland, everyone with fibrosis of F2 stage or above is eligible for treatment, people with hepatitis C in England and Northern Ireland face restrictions, according to genotype as well as stage of fibrosis. Direct-acting antiviral treatment is not available for people with genotypes 2 or 3 who have F3 fibrosis or less, except in cases where people cannot tolerate interferon. Even in cases of interferon intolerance, only one drug combination is currently reimbursed (sofosbuvir and ribavirin for genotype 2, and sofosbuvir and daclatasvir for genotype 3).
In contrast, treatment is available for everyone with genotypes 1 or 4 in England and Northern Ireland. (See this useful tool developed by the Hepatitis C Trust to check eligibility for treatment in the United Kingdom by genotype and disease stage.)
For reimbursement purposes, England, Scotland, Wales and Northern Ireland are separate entities, each having its own decision-making process for health spending.
Reimbursement for different drug combinations varied by country too. The most common DAAs reimbursed were ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin (97%) and sofosbuvir/ledipasvir ± ribavirin (88%).
The researchers also looked at whether restrictions were placed on access to treatment regarding drug and alcohol use, HIV coinfection or by prescriber type.
Drug and alcohol restrictions are common in Central Europe. Bulgaria, Croatia, Hungary, Poland and Slovakia place restrictions on access to hepatitis C for active users of drugs or alcohol, as does Cyprus.
No country prevents people with HIV and hepatitis C coinfection from receiving DAA treatment, and coinfected people are prioritised for treatment in Belgium, Croatia, the Czech Republic, Greece, Malta and Slovakia.
Prescription of direct-acting antivirals is restricted to liver specialists in almost every European country except England, where general practitioners may prescribe these medicines in some circumstances.
“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. Retsrictions are the consequence of current drug prices, calling for revised strategies to make these strategies available to all in need,” said Professor Francesco Negro of the University Hospital of Geneva, a member of the governing board of the European Association of the Study of the Liver (EASL).
By Keith Alcorn
Marshall A et al. Restrictions for reimbursement of interferon-free direct-acting antiviral therapies for HCV infection in Europe. International Liver Congress, Amsterdam, abstract LBP-505, 2017.