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
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).