PharmaGossip: More on Gilenya's pricing in the US

Novartis MS Program Guides Patients to New Pill, Covers Out-of-Pocket Cost

By Michelle Fay Cortez

Oct 4, 2010 5:57 AM PT

Novartis AG will pay out-of-pocket costs for non-Medicare patients who use the company’s multiple sclerosis pill Gilenya when the drug, to be priced at $4,000 a month, goes on sale in the U.S. this week.

The Swiss drugmaker will pay as much as $800 monthly in co- payments for Gilenya, the first oral medicine for the condition, the company said in an e-mail. Novartis will also help patients navigate testing and monitoring recommended by U.S. regulators who approved Gilyena on Sept. 22, paying as much as $600 per patient for that expense.

While many drugmakers provide medicine for the poor and help people with insurance, Novartis’s plan isn’t contingent on income or medical history, said Darlene Jody, head of Novartis’s MS medical unit. Andrew Weiss, an analyst at Bank Vontobel AG in Zurich, predicts peak sales of $3 billion a year for Gilenya, which will compete with Biogen Idec Inc.’s Avonex, an injectable drug that generated $2.3 billion in sales last year.

“It’s a pretty aggressive approach,” said Ira Loss, an analyst with Washington Analysis. “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.”

Novartis fell 50 centimes, or 0.9 percent, to 55.45 Swiss francs at 2:35 p.m. in Zurich. Before today, the stock had fallen 1 percent this year.

The FDA, in approving the drug, recommended that patients treated with Gilyena be monitored for six hours after their first dose, and that an array of baseline tests be done to check their liver, eyes, blood and heart.

Disabling Disease

Loss, who regularly monitors actions of the Food and Drug Administration, said he hasn’t heard of such an extensive payout program by a drugmaker in the 30 years he’s covered the industry.

Multiple sclerosis is a chronic, often disabling disease that attacks the central nervous system, which is made up of the brain, spinal cord, and optic nerves. Symptoms may be mild, such as numbness in the limbs, or severe, such as paralysis or loss of vision, according to the National Multiple Sclerosis Society website.

The Novartis program assigns “nurse navigators” to patients enrolled independently or through their doctors, Jody said. The nurses provide logistical support, educational materials, and a hotline. The program also will offer money for co-payments and related tests and, for those without insurance who earn less than 500 percent of federal poverty levels, full coverage of treatment costs.

‘Best Support’

“We are providing what we believe is the best support to the MS community,” Novartis’s Jody said. “This group and their caregivers have a certain degree of expectation. We think it’s important that every appropriate patient has access to Gilenya.”

The Novartis program will cover costs for patients with commercial health insurance, she said. Patients enrolled in government insurance programs, such as Part D for Medicare, the U.S. health plan for the elderly and disabled, aren’t eligible to participate because of legal restrictions. That’s also true of patients who live in Massachusetts, with some restrictions for patients in Michigan, Rhode Island and Minnesota.

Less than half of the estimated 400,000 people in the U.S. with the illness are now getting therapy, said Trevor Mundel, global head of drug development for Novartis, in a telephone interview.

Side Effects

The drug may help patients who can’t use existing medications because of side effects or continued relapses, he said. New patients and those who fear the use of needles may also consider Gilenya, Mundel said.

Eric Althoff, a spokesman for Basel-based Novartis, said in a Sept. 30 e-mail that the pill will be priced wholesale at about $48,000 annually. Injectable treatments such as Avonex, Merck KGaA’s Rebif and Teva Pharmaceutical Industries Ltd.’s Copaxone cost between $2,800 and $3,200, for a standard month’s supply, according to the Web site destinationrx.com.

WellPoint Inc., an Indianapolis-based health insurer that provides pharmacy benefits for about 25 million Americans, will make the drug immediately available for its members, said Jeff White, director of drug evaluation and clinical analytics.

WellPoint, along with rivals like UnitedHealth Group Inc., of Minnetonka, Minnesota, will place Gilenya in a top price tier that typically carries the highest out-of-pocket expense until a data review determines its value for patients, officials said.

At Wellpoint, the least favorable tier of service carries a $45 a month co-pay and potentially a 20 percent co-insurance fee, with an upper limit of $250 a month, White said. A 30-day supply of a standard injected drug for multiple sclerosis is currently about $266, White said.

‘Other Than a Needle’

The drug is a welcome relief to Seth Morgan, a 56-year-old neurologist in Chevy Chase, Maryland, who practiced until symptoms from multiple sclerosis and the medicine he took to treat it led him to retire. While he suffered relapses of the disease every six months to 12 months since he was diagnosed six years ago, he hasn’t had one since starting Gilenya in one of the clinical trials, Morgan said.

“This isn’t a godsend for everyone,” Morgan said in a telephone interview. “But this drug has arrested my exacerbations, and I’m pretty much where I was three years ago,” before starting Gilenya, he said. “And I wanted something other than a needle, quite frankly.”

Patients are already calling Jeffrey Cohen, a physician at the Cleveland Clinic’s Mellen Center for Multiple Sclerosis Treatment and Research, about the drug, he said.

Cohen, who has led studies of Gilyena, said he is counseling patients who are doing well with the shots to stick with them for the moment.

“For patients on one of the available treatments, we’re advising them, even though they are tempted to change to a pill, to hold off until we get a little more information,” Cohen said. “But they are still tempted.”

To contact the reporter on this story: Michelle Fay Cortez in Minneapolis at mcortez@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net; Phil Serafino at pserafino@bloomberg.net;