MILAN, Mar 10 (APM) - The Italian medicines agency AIFA is on the brink of excluding Gilead's HCV drugs Sovaldi and Harvoni from reimbursement as the possibility of an agreement for prices in a new contract fades, according to several press reports in Italy.

News agency Adnkronos reported on Thursday afternoon that at a negotiation session at the beginning of the week, the regulator had reiterated its demands for a price of no more than 4,000 euros per treatment for Sovaldi (sofosbuvir) and 4,400 euros for Harvoni (sofosbuvir+ledipasvir).

It described the situation as "fragile", saying the ball is now firmly in Gilead's court. "If there are no developments in the next 10 days, the anti-hepatitis drugs could become non-reimbursable," the news agency wrote.

On Wednesday, AIFA published new criteria for who can be treated with direct acting antivirals, opening up treatment to all patients for whom they are indicated (APMMA 52169). Italy aims to treat 80,000 patients a year for three years, with special funding to be provided. But it can only do so if the price per treatment is low enough.

Adnkronos said AIFA believes that Gilead has made good profits from sales in Italy and the time has come for a more "ethical approach" which takes into account the plan to provide treatment to everyone who needs it.

AIFA's director general, Mario Melazzini has made clear that, as a last resort, Italy would apply for an obligatory licence to make its own HCV drugs (APMMA 51864). A military pharma facility in Florence could be used to make the generic direct-acting antivirals, Adnkronos said.

La Repubblica is even more convinced that AIFA is headed towards exclusion of Gilead's drugs from reimbursement. "After days of talks, the director of the drugs agency Mario Melazzini has decided to put the two products in Class C, which means not reimbursable, and to negotiate with the company for a third drug which is about to come onto the market and which can treat all genotypes of the infection," the paper wrote on Thursday.

The third drug mentioned by La Repubblica is Epclusa (sofosbuvir+velpatasvir), which has still not been approved for reimbursement in Italy and can be used to treat all genotypes.

La Repubblica said that the medicines agency's hard line on new reimbursement prices for Sovaldi and Harvoni has undermined the relationship with Gilead, which is looking to maintain its leadership in the Italian HCV drugs market. According to the paper, negotiations were halted at one point to allow the U.S. company's global chief, who had flown to Rome for the occasion, to take part.

Melazzini is said to have refused to budge, arguing that the health of patients is as important as financial considerations. "That's why, in the end, Harvoni and Sovaldi are destined for Class C [the non-reimbursed category]," the paper wrote.

AIFA published the La Repubblica article on its website.

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