PARIS, Nov 4 (APM) - Gilead’s Sovaldi (sofosbuvir) has been approved for use in France but only for part of its target population, according to Tuesday’s Official Journal (JO).

The JO said Sovaldi will be available to patients with varying stages of liver fibrosis, those who also have HIV, patients with associated lymphoma and other complications of the disease.

It can be given in hospitals and healthcare institutions and dispensed by hospital pharmacists to out-patients, the journal said.

The publication of these two orders, however, is not accompanied by the price at which the drug may be dispensed to out-patients, or by the reimbursement approval for the insured, or its price in the community. The definitive price of Sovaldi is consequently not yet known.

Health minister Marisol Touraine, speaking on the national radio station France Inter on Monday said pricing negotiations with Gilead were continuing.

In a recent interview published by le Quotidien du Médecin, the chairman of the French economic committee for health products (CEPS) Dominique Giorgi said negotiations were aimed at reducing the existing price charged by Gilead under the terms of the temporary authorisation (ATU). Until a full marketing authorisation is approved, Gilead can continue to demand this temporary price and patients will be reimbursed.

“The negotiation with Gilead is actually fairly standard,” he said. “It aims to make the displayed price fall significantly, in comparison with the existing price per box currently requested (by the company) under the ATU, namely 18,667 euros and a treatment cost of 56,000 euros for 12 weeks or 112,000 euros for 24 weeks. It also aims to obtain rebates given the very high number of patients that France manages.”

He continued: “What makes the current debate more complex is that it is necessary, at the same time, to take into account new management methods with combinations in which sofosbuvir is administered with other antivirals, such as Johnson & Johnson’s Olysio (simeprevir) or Bristol-Myers Squibb’s Daklinza (daclatasvir). And it is also necessary to anticipate the arrival, very shortly, of Gilead’s fixed combination, and some time in 2015, of AbbVie’s fixed combination.”

Given the anticipated arrival of several new HCV treatments, Giorgi said individual drug costs alone were no longer the main issue to consider.

He added: “In fact, we are already negotiating an overall treatment cost and not the cost of Sovaldi alone. On the subject of Sovaldi, the negotiation should be finalised over the coming weeks and lead to substantial savings.”

Sovaldi has been available and reimbursed in France under a group temporary authorisation (ATU de cohort) since October 2013. It is available for adults with chronic hepatitis C in advanced stages of the disease for whom there are no appropriate therapeutic alternatives, or who are on a liver transplant waiting list, or who have undergone a transplant and who present an aggressive recurrence of HCV infection.

The drug was also included in products hospital pharmacists can dispense to out-patients under this temporary authorisation at the end of October 2013.

It was approved centrally in Europe in January 2014 in a wide indication - “in combination with other drugs, for the treatment of chronic hepatitis C in adults” - but has so far only been reimbursed in the indication in its temporary authorisation.

The head of Gilead’s French arm, Michel Joly, said in an interview with the daily Le Parisien on Tuesday that “in France, Sovaldi will have been tested in 2014 in 12,000 patients under the ... ATU regimen ... This will have allowed curing 10,000 patients of a dreadful chronic viral disease. That is a first”.

Speaking on the same day at a symposium at the Ministry of Health, he also agreed that the existing price was “not acceptable”, and hinted that the cost was likely to fall as competition arrived on the market. (APMMA 40317)

The approval announced on Tuesday for use in hospitals or healthcare institutions specifies that Sovaldi is reimbursed, in combination with other drugs, in the treatment of chronic hepatitis C in adults:

:: presenting liver fibrosis stage F3 or F4;

:: presenting liver fibrosis, severe stage F2;

:: co-infected with HIV, whatever the liver fibrosis stage;

:: with systemic, symptomatic mixed cryoglobulinaemia (II & III) whatever the liver fibrosis stage;

:: and with B lymphoma associated with the HCV, whatever the liver fibrosis stage.

Approval for use in hospitals or healthcare institutions is subject to treatment initiation being discussed at a multidisciplinary meeting, at hepatitis reference centres.

The JO justifies restricting Sovaldi use to only part of its indication, by quoting a government statement that said, “in its opinion of May 14 2014, the French national authority for health (HAS) Transparency Commission specified, under its recommendations that, owing to the slow progression of the pathology, treatment of certain populations infected by the hepatitis C virus could be deferred”. (APMMA 38510)

It also cites the opinion of the HAS board that “specified that the decision to treat should be adapted to the liver fibrosis stage concerned and to certain patient characteristics”. (APMMA 38962)

“More particularly, on the subject of patients with fibrosis stage F2, the board considered it is desirable to treat, though recommending, however, that the actual fibrosis stage should be documented as well as possible before treating and treatment should have a priority level less than for more advanced fibrosis stages; consequently, it is appropriate to take into account, in these drugs’ indications for management among these patients, the observed severity of the stage 2 fibrosis,” the government added.

(Journal officiel of November 4, texts 32 & 33)

eh/aki/hlc