by Edouard Hubert at the Pharmaceutiques’ meeting

MARSEILLE, Dec 15 (APM) - France’s drugs pricing committee has clashed with the president of Gilead France, Michel Joly, over the introduction of a new law to control drug prices, a meeting heard.

Dominique Giorgi, chairman of the French economic committee for health products (CEPS) had a tense exchange on Friday with Joly over the intrusion of a legislative measure in the pricing negotiations for Gilead’s hepatitis C drug Sovaldi (sofosbuvir).

They came face to face at a round table meeting organised at the Pharmaceutiques journal meeting in Marseille.

Sovaldi obtained its price on November 20 (APMMA 40512), 10 months after having been approved, at the end of tough negotiations.

The president of Gilead France told the meeting his concern over the risk of setting drug prices not through contractual negotiations between the company and CEPS, but through legislative means.

During the discussions between the committee and Gilead, parliament effectively approved a measure in the social security funding law (LFSS) for 2015, currently being examined by the Constitutional Council, determining a sum beyond which the companies marketing new HCV drugs (essentially Gilead’s drugs) should pay back to health insurance most of the turnover received.

The PLFSS plans this budget for the 2014 to 2016 financial years, consequently with an effect that is in part retroactive, and the amount (referred to as W) has been set at 450 million euros for 2014 and at 700 million euros for 2015.

Joly expressed concern over the fact that an identical budget system might develop for other drugs, mentioning “X, Y or Z budgets”.

In response Giorgi said: “In reality, this Article (had) weighed positively in the negotiation. It allowed securing the fairest price. What the president of Gilead France was driving at, was less the budget for 2015 and 2016, which is important and related to the epidemiology of the disease and the hospitalisation capacities in France,” than the budget for 2014, he pointed out.

“The 2014 budget was a temporary authorisation (ATU) budget … In 2014, the price had not been set, it was open. In its wisdom, the government considered that faced with a price set on an open basis, remuneration not exceeding a certain threshold was necessary,” Giorgi added.

He emphasised that the resources granted to Sovaldi had been considerably smaller in the UK and in Spain. “France sets considerable amounts on the table for the management of all the patients with this disease within the framework of the management order,” the CEPS chairman added.

Joly replied that Germany was ready to spend 1 billion euros to finance Sovaldi and Italy 1.5 billion euros.

Giorgi replied that, in the case of Italy, hepatitis C is six to seven times more prevalent than in France.

Jean-Luc Harousseau, chairman of the board of the French national authority for health (HAS), who also participated in the round table, came to the support of the CEPS chairman by emphasising that “France remains a country that is extremely attractive for innovation”. He gave the example of Roche’s cancer drug Kadcyla (trastuzumab emtansine) that is reimbursed in France but has been blocked in the UK owing to its cost.

The chairman of the French pharmaceutical industry body (LEEM) Patrick Errard, another round table participant finally assured Joly that the professional organisation was not in favour of “nationalisation” of price setting. The Article in the social security budget law for 2015 on HCV drugs, provided the Constitutional Council does not censor it, allows other pharma companies to avoid being exposed to a possible safety clause that could be triggered by strong sales of Sovaldi.

“The solution should be reached through agreement, in working with Dominique Giorgi,” Errard added, claiming that on this point, he had “fairly clear support from the (health) minister” Marisol Touraine. “We shall bury the W as soon as it is born,” he assured.

Next year, CEPS and LEEM will re-negotiate their pricing framework agreement that is due to terminate on December 31 2015.

eh/aki/hlc