Novartis will pay out-of-pocket costs for non-Medicare patients who use Gilenya! PLUS:  Novartis will also help patients navigate testing and monitoring recommended by the FDA, paying as much as $600 per patient for that expense.
BASEL, Switzerland—On Sept. 22, Novartis announced that the U.S. Food and Drug Administration (FDA) had approved the oral multiple sclerosis (MS) treatment Gilenya (fingolimod 0.5 mg daily dosage) as a first-line treatment for relapsing forms of multiple sclerosis—the most common forms of the disease—and as the first oral treatment for this indication. But as big as that news is, what's been making waves since early October is news of Novartis' ambitious co-payment plans to help ensure Gilenya's market penetration and success.

As Bloomberg and others reported on and after Oct. 4, Novartis will pay out-of-pocket costs for non-Medicare patients who use the company's multiple sclerosis pill Gilenya, and Novartis will also help patients navigate testing and monitoring recommended by the FDA, paying as much as $600 per patient for that expense.

Eric Althoff, a spokesman for Novartis, has said that Gilenya will be priced wholesale at about $48,000 annually, or roughly $4,000 a month.

Injectable treatments such as Avonex, Rebif and Copaxone, on the other hand, cost between $2,800 and $3,200 a month for most patients. The $800 co-pay, of course, will bring Gilenya down the upper end of that range. Novartis's co-pay plan isn't based on income or medical history, according to Darlene Jody, head of Novartis's MS medical unit.

"It's a pretty aggressive approach," said Ira Loss, an analyst with Washington Analysis, in the Bloomberg article. "It seems like an enhancement of what was required. Maybe Novartis decided to build on that and make it a patient-friendly program. My hat's off to them."

In the end, the sting of that co-pay plan may be eased by sales. Andrew Weiss, an analyst at Bank Vontobel AG in Zurich, predicts sales of Gilenya could reach $3 billion a year.

Business information and analysis firm Datamonitor predicts that Gilenya could easily become the leading treatment in MS, ending the decade-long dominance of interferon betas and Copaxone.

"In July 2010, Gilenya lost out in the race to become the world's first oral disease-modifying [therapy] after Merck Serono's Movectro (oral cladribine) won Russian approval," says Trung Huynh, healthcare analyst at Datamonitor. "However, supported by robust clinical trial data, the once-daily pill will enter the lucrative U.S. market as the first oral therapy to treat relapse remitting MS, offering patients a highly welcomed alternative to injections."

"Datamonitor expects widespread use as a first-line therapy, given the high efficacy, convenience and less invasive administration, and forecast Gilenya to capture seven major market sales of $2.4 billion in 2019," Huynh adds. "With the forthcoming arrivals of more oral and efficacious therapies driving market growth these are exciting times ahead for the development and treatment of MS."

Labels: Rebif