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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 study found that Slovakia and Croatia restrict reimbursement for DAAs to people with stage F4 fibrosis -- or liver cirrhosis -- 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 hepatitis C virus (HCV) genotypes. Whereas in Scotland, everyone with stage F2 fibrosis 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. DAA treatment is not available for people with genotypes 2 or 3 who have F3 fibrosis or less, except in cases where they cannot tolerate interferon. Even in cases of interferon intolerance, only one drug combination is currently reimbursed (sofosbuvir and ribavirin for HCV 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 U.K. 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 based on drug and alcohol use, HIV/HCV coinfection, or 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 HCV coinfection from receiving DAA treatment, and people with coinfection are prioritized for treatment in Belgium, Croatia, the Czech Republic, Greece, Malta, and Slovakia.

Prescription of DAAs 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," said Francesco Negro of the University Hospital of Geneva, a member of the EASL governing board. "Restrictions are the consequence of current drug prices, calling for revised strategies to make these strategies available to all in need."

4/21/17

Source

AD Marshall, S Nielsen, EB Cunningham, et al. Restrictions for reimbursement of interferon-free direct-acting antiviral therapies for HCV infection in Europe. EASL International Liver Congress. Amsterdam, April 19-23, 2017. AbstractLBP-505.