Friday, November 30, 2012
pSivida partner to lower proposed price of Iluvien in UK
The agency in charge of approving medical reimbursements in the UK has denied a pricing recommendation for Iluvien, a treatment for chronic diabetic macular edema (DME) developed by Watertown-based pSivida Corp. (Nasdaq:PSDV). As a result, pSivida’s licensee, Alimera Sciences, will negotiate a new price in anticipation of the product’s planned UK launch in the spring or early summer of 2013.
In a statement Friday, pSivida said that the UK’s National Institute for Health and Clinical Excellence (NICE) issued final draft guidance in which it said that Iluvien is not recommended for the treatment of chronic DME that hasn’t responded to other therapies. NICE concluded that the evidence provided did not show that the benefits of Iluvien justify the proposed price, according to the statement.
Paul Ashton, CEO of pSivida, downplayed the ultimate effect of the denial in an interview with Mass High Tech, saying Alimera’s proposed price - the equivalent of $8,800 - was higher that he expected would be approved for reimbursement. Alimera is now developing a Patient Access Scheme (PAS), (ways pharma companies propose to give patients access to expensive drugs) to address NICE’s cost concerns. Ashton said that he doesn’t expect the company to change the launch date as a result of the denial. PSivida stands to gain 20 percent of net profits on sales of Iluvien by Alimera under the license agreement.
“I’m not sure that it will affect our calculations, because we didn’t expect that price anyway,” he said.
Ashton said he expects Alpharetta, Ga.-based Alimera to keep the same official price for Iluvien, but to offer a discount in the UK that would bring it below about $5,500.
Iluvien has already received CE Mark approval in Europe, which will not be affected by the NICE decision, Ashton said.
Alimera has previously said it would launch Iluvien in three European countries next year; Germany expected in the first quarter, the UK in the second quarter and France in the third quarter. Alimera intends to resubmit a new drug application for Iluvien for DME in the FDA during the first quarter of 2013.
As of 1 p.m. Friday, pSivida’s stock was trading down 5 percent to $1.30.
masshightech.com |
