Gilenya isn't worth the price, NICE says

The U.K.'s cost-effectiveness watchdog has crashed Gilenya's party. The Novartis ($NVS) multiple sclerosis drug got a thumbs down from the National Institute for Health and Clinical Excellence, which is something of a standard-bearer for drug reimbursements. Novartis was disgusted by the decision, and patient groups immediately began planning their protests.

The explanation leaned heavily on efficacy data. "Unfortunately our independent committee wasn't given sufficient evidence to show that Gilenya could reduce relapses considerably better than the other treatments currently being used," NICE's Carole Longson said in a statement. "Based on the available clinical evidence and economic analysis, our independent committee concluded that Gilenya would not be a good use of resources."

NICE logged several criticisms of the Gilenya data, including a complaint that the Swiss drugmaker didn't compare the new pill with beta interferons besides Avonex, not to mention Biogen Idec's Tysabri. But no doubt the bar wouldn't have been set so high if Gilenya had a less-hefty price tag; at 19,000 pounds ($30,000) in the U.K., it's cheaper than in U.S., but still not cheap. In the cost-effectiveness balance, a big weight on the cost side has to be offset by more impressive data on the efficacy side.

That's why Novartis balked at NICE's suggestion to compare Gilenya with "best supportive care," i.e., no active treatment; at costs that low, treatment doesn't have to be super-effective to be worth the price. "It will be very difficult for any new therapy to demonstrate cost-effectiveness against best supportive care," the drugmaker said in a statement. The only drugs likely to win that match-up would be symptom-management treatments, rather than meds aimed at stalling progress of the disease, Novartis said.

Novartis plans to fight NICE's decision, and it will have help from the MS Society in the U.K., which pronounced itself disappointed with the recommendation (or lack thereof). If public outcry isn't enough to sway NICE--and it often isn't--the drugmaker could offer a patient-access scheme, a.k.a. discount program, to lighten up the cost side of the equation. Or maybe Novartis has some other data in its files to put forward. Whatever the appeal strategy, NICE will be playing its familiar bad-guy role in U.K. media. 

- find NICE's draft guidance
- get the statement from the MS Society
- read the story from Reuters
- see the Dow Jones coverage
- check out the Daily Mail story