FDA Approves Generic Gilenya for Treatment of MS

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has approved the first generic versions of Gilenya (fingolimod) for the treatment of relapsing forms of multiple sclerosis (MS). That’s welcome news for patients who have long struggled with the exorbitant cost of many MS medications.

A 30-day supply of Gilenya 0.5mg capsules currently costs about $8,130, according to Healthcare Bluebook, or about $97,560 a year.

“Approving safe and effective generics so patients have more treatment options continues to be a priority for the FDA,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “Having access to affordable treatments is important for patients with conditions that require ongoing care. The FDA has a longstanding commitment to increasing patient access to lower-cost, high-quality generic medicines.”

The FDA approved generic fingolimod applications from HEC Pharm Co. Limited, Biocon Limited and Sun Pharmaceutical Industries Limited.

Until now, Novartis held the exclusive patent rights to fingolimod, which is sold under the brand name Gilenya. Nearly 300,000 people worldwide have taken Gilenya since it was approved by the FDA in 2010, according to Novartis.

MS is a chronic and progressive disease that attacks the body’s central nervous system, causing numbness in the limbs, difficulty walking, paralysis, loss of vision, fatigue and pain. For most people with MS, there are periods of remission followed by relapses or flareups as the disease progresses. Gilenya is a widely used treatment for relapsing MS.

Generic formulations are often significantly cheaper than brand name drugs. In July, the FDA approved the first generic forms of Lyrica. Today a two-month supply of Lyrica costs about $472, while the same amount of generic pregabalin costs just $21.

Maximizing Profit

Criticism about the high cost of branded MS drugs is growing. Last month when the FDA approved a new MS medication called Vumerity, drug maker Biogen set its wholesale price at $88,000 a year. That brought a rare rebuke from the National Multiple Sclerosis Society, which released a statement that accused Biogen of price gouging.

It can take years for a new drug to get FDA approval and the pharmaceutical industry has long claimed that it needs to set prices high to recover the cost of research, clinical studies and drug development.

That claim is discounted in a recent article published in the journal Neurology, in which researchers asked four drug industry executives about the high cost of MS drugs. The executives were given anonymity to encourage them to speak freely.  

"I would say the rationales for the price increases are purely what can maximize profit," one executive said. "There's no other rationale for it.”

In setting the price for a new drug, executives said they primarily look at what their competitors are charging for similar medications. Companies fear that undercutting competitors with a lower price would undermine the attractiveness of their product.

"We can't come in at less," one of the executives said. "That would mean we're less effective, we think less of our product, so we have to go more."

The problem is unique to the United States, the only developed country that doesn’t have a universal healthcare system that regulates prices.

"And it is only in the United States, really, that you can take price increases. You can't do it in the rest of the world. In the rest of the world, prices decline with duration in the marketplace," another executive said.

Researchers say their study provides new insight into the economics behind pharmaceutical pricing.

"The frank information provided by these executives pulls back the curtain of secrecy on how drug price decisions are made," said co-author Dennis Bourdette, MD, chair of neurology at the Oregon Health & Science University School of Medicine. "We see that it is indeed the race to make more money that is driving up drug prices and nothing more."

In the meantime, MS patients like Jennifer Hochgesang struggle to make their co-payments and deductibles. She gets injections of glatiramer acetate, a generic version of Copaxone.

“It costs over $5,500 a month. When you add my migraine medication and other medications, it adds up to over $13,000 a month. I reach catastrophic level by March in my insurance and that’s the only way I can pay for it,” Hochgesang said. “It doesn’t cost that much in Europe though and it shouldn’t cost that much here.

“It seems sick to me that companies use a drug like this to profit highly from, when people can’t reasonably afford five thousand dollars a month. I believe an MS drug should be accessible to anyone. Otherwise we are only creating medicine for the rich and those able to get insurance or be on disability, leaving the rest out in the cold. That just isn’t right.”