Once again, U.K. cost-effectiveness gatekeepers have shut out Gilenya. The Novartis ($NVS) multiple sclerosis pill still isn't a good value for money, the National Institute for Health and Clinical Excellence has determined, even with new evidence submitted by the company--and a patient-access scheme that lowered the cost.
Nevertheless, Novartis believes that it's making progress toward getting Gilenya onto the National Health Service list, Pharmafocus reports. For one thing, NICE conceded that Biogen Idec's ($BIIB) injectable Avonex is a direct competitor to Gilenya, when the agency previously said Avonex wasn't widely used in the U.K. That's key because an important Gilenya study pitted the oral drug against Avonex and showed Gilenya to be superior at staving off relapses.
The cost of Gilenya is considerable: about £19,000 a year, or $30,000. That compares with £9,061 for Avonex and £9,088 or £12,068 for Merck Serono's Rebif, depending upon the dose. Novartis won't offer details on its cost concessions, but in any case, they weren't enough. "While Novartis submitted evidence that shows [Gilenya] can reduce relapses," NICE chief Andrew Dillon said, "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."
The agency's decision isn't final yet. Novartis has some time to either submit new data or revise its access scheme. Patient advocacy groups are also lobbying for Gilenya's acceptance. NICE's final guidance is due in April. Novartis "remains committed to engaging with NICE with the goal of ensuring that appropriate patients will have access to Gilenya," the company told Bloomberg.
- see the statement from NICE
- read the story from InPharm
- check out Bloomberg's piece