The U.K.'s cost-effectiveness watchdog has changed its mind about Gilenya. The National Institute for Health and Clinical Excellence at first rejected the Novartis ($NVS) multiple sclerosis pill, in spite of an upfront discount offer. But thanks to some new data from the Swiss drugmaker, NICE has now decided to recommend the drug.
That's a good thing for Novartis, which expects great things from Gilenya, the world's first oral therapy for MS. NICE's initial rejection was a blow to those hopes, especially since the agency didn't see clear superiority to existing treatment. NICE's decisions not only determine what drugs are paid for by the British National Health Service, but influence adoption in other countries as well.
But Novartis sliced and diced its Gilenya data and found some persuasive evidence. The drugmaker presented data that showed Gilenya's benefits in patients with stubborn disease, with continued relapses in spite of treatment with injectable beta interferon drugs. Based on that data, NICE decided Gilenya would be cost-effective for this group of patients at the previously proposed discount.
The amount of that discount hasn't been disclosed, but the list price is about £1,470 ($2,300) for 28 capsules, or £19,000 (about $30,000) per year, Reuters says.
Meanwhile, EU regulators have put off releasing a new review of Gilenya's safety that was prompted by heart problems and deaths in patients who recently started therapy. The FDA is also looking at the case reports. Novartis told Dow Jones it's working with the agencies on their reviews and "remains committed to engaging with the EMA, other health authorities and the MS community with the goal of ensuring that appropriate patients will have access to Gilenya."