The U.K.'s cost-effectiveness analysts aren't sure Sanofi's ($SNY) new multiple sclerosis pill is worth the price--even at a discount. In a new review, the National Institute for Health and Care Excellence (NICE) found information on Aubagio wanting, and so it asked the French drugmaker's Genzyme unit for more.
In draft guidance, NICE said it still has questions about Aubagio (teriflunomide) and its effectiveness. "That is why we have requested more details from the manufacturer; we want to ensure that we have as much information as possible to make an informed final recommendation," the agency's CEO, Sir Andrew Dillon, said in a statement.
Sanofi has offered a discount off Aubagio's £13,529-per-year list price (about $21,600). The discount is undisclosed, but NICE noted that it would be a simple price break applied to invoices or at the point of purchase. Other patient access schemes are more complicated; sometimes they are volume discounts, and sometimes they include performance guarantees.
Aubagio is one of two new MS drugs that Sanofi is counting on for sales growth. The other, Lemtrada, just won approval in the EU yesterday. Sanofi says it's planning to launch both drugs in the near future in Europe; Aubagio is already on the market in the U.S., but Lemtrada isn't yet approved by the FDA.
Aubagio is up for reimbursement in the U.K. as a first-line treatment in combination with beta interferons, such as Merck Serono's Rebif and Bayer's Betaseron, and Teva Pharmaceutical Industries' ($TEVA) Copaxone (glatiramer acetate). Among the analyses NICE wants are comparisons among various drug combinations. For example, NICE wants Genzyme to compare the combination of Aubagio, Rebif and Novartis' ($NVS) Gilenya with Rebif and Gilenya. It also wants to see numbers on Aubagio, Rebif and Copaxone versus Rebif and Copaxone.
If NICE finally rules against Aubagio, that could throw a wrench into Sanofi's marketing plans. The drug then wouldn't be routinely available to patients on Britain's National Health Service. Other countries also keep a close watch on NICE's deliberations, which means a rejection from NICE can have a ripple effect, particularly to other countries that lack the U.K.'s extensive regulatory infrastructure.
- read the NICE statement
- get more from Reuters
Special Reports: Top Pharma Companies by 2012 Revenues - Sanofi | Top 20 Orphan Drugs by 2018 - Rebif - Copaxone