France will provide access to hepatitis C treatment with
direct-acting antivirals to everyone diagnosed with hepatitis C from September
2016, and will begin to provide treatment to everyone with stage 2 fibrosis
immediately, health minister Marisol Touraine announced last week.
Treatment will also be made available immediately for anyone
with hepatitis C waiting for a liver transplant or experiencing a recurrence of
hepatitis C infection after a liver transplant, regardless of the stage of
post-transplant fibrosis.
Immediate access to hepatitis C treatment will also be
granted to groups at high risk of transmitting hepatitis C: prisoners, migrants,
pregnant women and people who inject drugs. The French Society for Hepatology
has criticised the lack of immediate access for people who acquired hepatitis C
through transfusion or contaminated blood products prior to the introduction of
screening in 1992.
Until now, treatment for hepatitis C using direct-acting
antivirals has been restricted to people with stages F3 (advanced liver damage)
or F4 fibrosis (cirrhosis). Approximately 30,000 people in France have received
treatment with interferon-free combinations, of whom around 90% have been cured
of hepatitis C.
Guidance on how to provide treatment for people with stages
F0 and F1 fibrosis will be drawn up by the French national authority for health
(Haute Autorité de Santé, or HAS) by September 2016.
Up to 230,000 people in France with hepatitis C could be
treated for hepatitis C under the new rules, the French health ministry has
said, but Marisol Touraine said that the prices paid by the French health
system for direct-acting antivirals must be renegotiated. The current cost of treatment
is around 41,000 euros, and the budget for hepatitis C treatment had been
capped at 700 million euros, with Gilead required to pay an unspecified rebate
on the cost of sofosbuvir if expenditure rose above this level.
The financial arrangements that will permit universal access
are still unclear: the announcement comes ahead of any firm agreement on price
reduction.The announcement on universal access will place pressure on companies with already-licensed products to cut deals with the government ahead of the European marketing approval of Merck's Zepatier later this year.
“The time has come for France to renegotiate the price,” Marisol Touraine said in a press statement. She pointed out that the extension of indications for prescribing of drugs has expanded, increasing the size of the market, and competitor products are becoming available. “It is high time that the sense of responsibility prevails. In their own interest, laboratories must play the game.”
The Comité économique des produits de santé (CEPS) will now
pursue a price renegotiation, taking into account recent price agreements in
other countries.
The French health minister noted that other European countries had been able to use the French price negotiations to achieve favourable deals for high-volume prescribing. In Spain and Portugal prices of 13,000 euros are believed to have been achieved in confidential deals, in which governments pay nothing for patients who are not cured and the cost of treatment is the same regardless of duration. Funding will also be made available to assist associations and voluntary organisations in providing rapid testing for hepatitis C.