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French economic committee reaches agreement on 'substantial' price cuts for Gilead HCV drugs

PARIS, Mar 31, APM - Agreement has been reached between Gilead and the French economic committee for health products (CEPS) on a "substantial" cut in the prices of Gilead's hepatitis C (HCV) drugs, the health ministry announced in a statement on Friday.
The agreement concerns Sovaldi (sofosbuvir) and Harvoni (sofosbuvir+ledipasvir), which is the biggest selling new HCV treatment. The new treatments are both more effective and more expensive than their predecessors.
Sovaldi had previously been given a pre-tax price of 41,000 euros for a 12-week course, while Harvoni had secured a price of 46,000 euros.
The ministry statement says the price of Sovaldi is to fall 30% to 28,700 euros. It does not specify the cut for Harvoni, but Gilead told APM it would cost 28,730 euros, a 37.5% drop.
"The orders will be published imminently and the new tariffs will enter into force as of April 1," the ministry said. Negotiations with Gilead had long been said not to have been progressing, and in January health minister Marisol Touraine had threatened to impose unilateral price cuts.
As with the other new HCV drugs, the agreement is accompanied by a lifting of restrictions on reimbursement according to disease stage, thereby allowing reimbursement for all patients.
"The agreement signed by Gilead and CEPS now allows universal access to all HCV treatments for all patients whatever the genotype and liver fibrosis stage,"Gilead said.
"This is a further step towards guaranteeing the sustainability of our health system and access to innovative treatments for all patients," the ministry added.

Agreement on Epclusa price

Gilead and CEPS have also agreed on a price for Epclusa (sofosbuvir+velpatasvir), a product which was approved in Europe in July 2016 but which is not yet available in France. "The price per box is the same as for Harvoni and the cost of the treatment will be cut under the agreement signed with CEPS," Gilead told APM.
In view of the high prices of the new HCV treatments, the French government had initially restricted their reimbursement to the most serious cases, before extending it to new categories of patients in June 2016.
It wanted to go further and extend reimbursement to all HCV patients, in counterpart for price cuts on the part of the pharma companies.
The first HCV treatment to secure extended reimbursement conditions was Merck & Co's Zepatier (grazoprevir+elbasvir) on the occasion of its launch early in January at a price 37.5% lower than the one in force for Harvoni at the time (APMHE 51162) (APMHE 51208).
At the end of January, AbbVie was next, with a cut of 32% in the price of its Viekirax/Exviera combination (ombitasvir+paritaprevir+ritonavir/dasabuvir) (APMHE 51547).
The price of Bristol-Myers Squibb's Daklinza (daclatasvir) will fall 32.5% as of April 1, while that of Johnson & Johnson's Olysio (simeprevir) fell 25% in November 2016. Extension of their reimbursement was published in the Official Gazette (JO) in mid-March (APMHE 52301).
"The negotiations to lower the prices of HCV treatments have just ended with the agreement reached with Gilead," the ministry says. "All these treatments are reimbursed in full by the health insurance."
In a statement, the SOS Hépatites Federation welcomed "an end to intolerable rationing" and "the beginning of a rational public health strategy". "The struggle to wipe out the epidemic is now under way: at last we have all the conditions for building a true public health strategy, although many challenges remain," it commented.
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