The French Government has negotiated a steep discount from Gilead Sciences for its hepatitis C virus (HCV) therapy Sovaldi, setting the retail price of the drug at the lowest in Europe.
The Economic Committee for Health Products (CEPS) has agreed a price of €13,667 per 28-tablet pack of Sovaldi (sofosbuvir), around €5,000 lower than the initial list price, as well as rebates on the drug's cost in cases of treatment failure.
France has 200,000 cases of HCV infection, according to data from the Ministry of Health, and the discount takes into account the number of patients that will be treated with the drug and "projected sales volumes" for Sovaldi.
Health Minister Marisol Touraine said that - given the high price and clear medical benefits with Sovaldi - the French health insurance system will pick up the tab for 100% of the price of the drug, with no patient co-pay, to help make it affordable for citizens with HCV infection.
Sovaldi's price has been a source of considerable contention and debate since its launch at the end of last, with its ticket price - around $84,000 per course in the US - helping it rack up a record $8.5bn in sales in the first nine months of the year from being used in a little under 120,000 patients. France's negotiation means that a typical 12-week course of the drug will now cost around €41,000 ($51,000).
The cost of the drug has led to questions being raised in the US Senate, with a number of state Medicaid programmes have started to implement controls on prescribing of the drug, and been debated in the European Parliament, with the European Commission (EC) having to clarify for MEPs that it has no tools in hand to affect pricing of new drugs directly.
Commissioner Connie Hedegaard suggested a few weeks ago that the only actions the Commission can take are indirect, such as sharing pricing and reimbursement information between member states.
France's agreement brings the temporary use authorisation (ATU) for Sovaldi to an end, although that process now kicks off for Gilead's follow-up therapy Harvoni (sofosbuvir plus ledipasvir), which has just been approved in the EU.
The drug has a list price of €16,000 per 28-tablet pack, and negotiations are already taking place with the French government aiming for a lower price, according to a Reuters report.
Touraine also said the successful negotiations provide an opportunity for other EU member states to "mobilise" their efforts to make Sovaldi available at an affordable price for HCV patients.
Furthermore, France's proposed 2015 Social Security Finance Bill includes specific provisions to make pharma companies reimburse the health system when their medicines exceed an agreed cost and volume.