by Guillaume Biétry
PARIS, Nov 21 (APM) - The head of Gilead’s French operations, Michel Joly, told APM the price granted to its oral hepatitis C drug Sovaldi (sofosbuvir) represents a “compromise that is also an equilibrium the community can sustain”.
The before-tax price selling price to hospitals for the drug, the first representative in a new generation of HCV drugs that are more effective and have fewer side effects, has been set at 41,000 euros for a 12-week course. (APMMA 40512).
Owing to the high level of the price applied or requested for Sovaldi, Gilead is the target of strong criticism around the world: governments are concerned over their ability to finance the drug and other innovations due to reach the market.
In France, the minister of social affairs, health and women’s rights Marisol Touraine has repeatedly made clear her determination to drive down the price requested by the company. Since September 2013, Gilead has marketed it at the open price of 56,000 euros for a 12-week course within the framework of its temporary autorisation (ATU).
On Thursday, the ministry said the price granted was the “lowest retail price in Europe,” adding that the drug would be reimbursed in full (100%) “in view of (its) irreplaceable and particularly costly nature”.
In his interview with APM on Thursday, Joly said this price is an “agreement that is a compromise” between the “level of innovation of the product, improved patient access to the treatment and an equilibrium the community can sustain for a while”.
He also said discussions with the authorities, particularly with the French economic committee for health products, CEPS, had been “shorter than average,” the product having been approved in Europe in January.
“The discussions were complicated. Things were tricky and the worst-case scenario was a possibility,” he said. “The worst-case would have been failing to reach an agreement, not understanding that a treatment that cures is not a chronic treatment. It took a while to get this across, but we did it,” he added.
Joly did not go into details, beyond the price, on the agreement signed with CEPS. The ministry in charge of health noted in its statement that “given the number of patients managed, further reductions linked to forecast sales volumes have been obtained. A performance contract conditions the payment of rebates in case of treatment failure,” he added.
According to the law, Gilead will need to reimburse, in the form of rebates to health insurance, the difference between the price applied until now and price finally determined multiplied by the number of patients having benefitted from the drug in the indications in its ATU.
Questioned by APM, Joly said 14,000 patients will have been treated by the end 2014 within the framework of the ATU, particularly in combination with the other new generation HCV drugs, Johnson & Johnson’s Olysio (simeprevir) and Bristol-Myers Squibb’s Daklinza (daclatasvir). “They have just about all been cured,” he said, although he did not want to disclose Sovaldi's turnover in France.
“The issue is not just about Sovaldi, it is about the cost of the market as a whole. It is also about anticipating the arrival of innovation,” he added.
The arrival of new HCV drugs and their impact on public finances is a cause for concern for the French government that wants to set up a new mechanism to regulate the expenditure specific to these products, within the framework of the proposed social security budget bill (PLFSS) for 2015.
In his interview with APM, Joly referred to the temporary authorisation (ATU), announced on Thursday, granted to Harvoni, the successor to Sovaldi that combines sofosbuvir and ledispasvir in a single tablet, with no need for any other treatments.
The ATU price is 48,000 euros for a 12-week course, “halving the cost of the treatments currently available,” for a drug that has recorded a “success rate of over 85% in three months,” Joly emphasised. It will also be possible to use the treatment for eight weeks in patients with HCV genotype 1 who are treatment-naïve and free of cirrhosis, at a cost of 32,000 euros.
Harvoni, which was approved on Tuesday (APMMA 40487), should be made available to patients in January within the framework of its ATU, Joly said.
“The future is Harvoni, and not Sovaldi,” he stated. “The eight-week course population - that is the future population. The further we go, the less cirrhosis there will be. Consequently, costs will fall,” he added, pointing out that Gilead is working on shortening treatment durations for its products under development.
Questioned over the relevance of granting a temporary authorisation to Harvoni, as alternatives exist, he said the aim of the health authorities is to reinforce access to treatments on the market and provide doctors with a wider choice.
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