by Francois Boissier

PARIS, Nov 4 (APM) - Gilead’s head in France has admitted the price of its hepatitis C drug Sovaldi (sofosbuvir) is “not acceptable” under its current temporary authorisation in France and hinted the price was likely to fall as competition arrived.

Present in the audience at a symposium at the Ministry of Health on Monday, Gilead France president Michel Joly pleaded for a “change in way of thinking” that needs to integrate within price-setting the fact that the drug leads to a cure, which is different from the treatment of a chronic disease.

However, he apparently took a step towards relaxing the position of his pharmaceutical company, by stating that the current prices are “not acceptable” and that it is “not possible to plan treatments at that price”. Sovaldi is currently priced at 56,000 euros per course by Gilead, under a temporary authorisation (ATU) for certain patients in France.

Joly was reacting to comments from French associations involved in hepatitis C (HCV) management, who organised the event to raise concerns over the prices of new drugs to treat the disease. They say it is leading to selective prescribing and will endanger the health insurance system.

Regarding the ongoing pricing and reimbursement negotiations for Sovaldi, Joly said they were “very active” and he hoped they will conclude soon.

Meanwhile, he also said price cuts could come from “competition,” with the arrival of other HCV drugs, and from “treatment duration” that is likely to be shortened.

A survey of current treatment costs of drugs under ATU, at prices set by the pharmaceutical companies, revealed: the sofosbuvir+ribavirin combination costs 56,000 euros; sofosbuvir+pegylated interferon+ribavirin 59,000 euros; Janssen’s Olysio (simeprevir+ pegylated interferon+ribavirin) 38,000 euros; sofosbuvir+simeprevir 91,000 euros; and Bristol-Myers Squibb’s Daklinza (sofosbuvir+daclatasvir) 91,500 euros or 147,000 euros depending on treatment duration.

The associations underlined that ATU requests for two HCV treatments were currently delayed: for Gilead’s Harvoni (sofosbuvir+ledipasvir) and AbbVie’s triple therapy. France’s drugs regulator ANSM has said it is in favour of these ATUs, but it seems the block comes from the Department of Social Security (DSS), the symposium heard.

The official reason is that an ATU is awarded where there is “no appropriate therapeutic alternative”. Since several new HCV drugs are already available, there would be alternatives. However, professor Daniel Dhumeaux, who met DSS director Thomas Fatome told the symposium he had argued that the “alternatives are not quite appropriate for some patients”.

Decisions on these ATU requests should be delivered shortly, an association member said, since the marketing authorisations for these products should be obtained soon. If an ATU has not been authorised before such time, it will not be made available during the pricing negotiation period and consequently the relevant companies will not be able to sell their product during that time.

Meanwhile, the associations repeated their request for a compulsory licence for Gilead’s Sovaldi a system that would allow producing and marketing this drug at lower cost. (APMMA 39720)

Olivier Maguet of Médecins du Monde said the price of Sovaldi given the large number of patients to treat, represents a “danger” for the French social security system - a “legacy of the national Council of Resistance” and “one of the fundamental bricks in our republican base”.

It is necessary to “exert our citizenship right” and “resist” a “process that is not financially sustainable,” he said. Whereas social security holds as a principle the fact that all diseases should be treated, the obligation to restrict access to these new HCV drugs owing to price means that France is “confronted with the same problems as a developing country”.

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