Novartis's multiple sclerosis pill Gilenya, one of its top new drug hopes, has again been rejected by Britain's health cost watchdog NICE, despite the offer of a price discount from the Swiss drugmaker.
The National Institute for Health and Clinical Excellence said on Thursday it still believed the medicine was not cost effective, compared with other existing treatments.
Gilenya, licensed in Europe in March, represents a significant change in multiple sclerosis (MS) treatment, since existing drugs, such as beta interferons and Elan and Biogen Idec's Tysabri, must be injected.
In bid to win over NICE after an initial rebuff in August, Novartis had offered a discount or so-called patient access scheme for Gilenya to the National Health Service (NHS).
Our independent committee has not been convinced that it is a cost effective treatment option for the NHS, even with the proposed patient access scheme, NICE Chief Executive Andrew Dillon said in a statement.
The size of the discount offered by Novartis is being kept confidential. A Novartis spokesman declined to say whether it would bring the cost of Gilenya down to that of Tysabri.
Based on current list prices, NICE said the annual cost of Gilenya was 19,196 pounds per person, compared with 14,730 for Tysabri.
The latest draft guidance from the agency is now open for comment until January 5 and final guidance is expected to be issued in April 2012.
Despite the fresh rejection, Novartis said it believed Gilenya was a highly efficacious and cost-effective treatment, adding it was committed to engaging with NICE to make sure patients in Britain got access to the medicine.
Gilenya's convenient dosing and encouraging results in clinical trials are widely expected to make it a popular alternative to current injections. The average forecast from analysts suggests annual global sales will reach $2 billion by 2015, according to Thomson Reuters Pharma.
The Novartis drug is the first MS pill of its kind, but other competitors in development include BG-12 from Biogen, Aubagio from Sanofi and laquinimod from Teva Pharmaceutical Industries.
(Reporting by Ben Hirschler)