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LEGAL-EASE
Supreme Court Ruling on Patent Case Gives Teva Pharmaceuticals More Time to Market Copaxone for MS Without Generic Drug Competition

ARTICLE IN BRIEF

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Attorney William Jay, center, representing Teva Pharmaceuticals, leaving the Supreme Court in October 2014 after closing arguments in the case of Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc.

MS specialists discuss the Supreme Court ruling allowing Teva more time to sell its version of glatiramer acetate before competing generic versions are introduced and what the ramifications are for prices of available multiple sclerosis drugs.

Patients, physicians, and health insurers hoping for a break on the high-price of multiple sclerosis (MS) drugs probably won't get relief from a US Supreme Court ruling that will leave more time for Teva Phamaceutical Industries to sell its blockbuster version of the injectable drug glatiramer acetate (Copaxone) before competing generic versions are introduced.

The high court, in a 7–2 decision on Jan. 20, sent a patent protection case back to the US Court of Appeals for the Federal Circuit for more review, saying that the lower court had not taken a correct approach in a 2013 ruling that invalidated a Teva patent on glatiramer acetate that was set to expire in September 2015. In that earlier ruling in 2013, the Federal Circuit had reversed a ruling by a New York trial judge in 2011 that had upheld the validity of a Teva patent on the drug and barred generic-drug challengers including Novartis AG's Sandoz unit and Mylan Inc. from entering the market until the patent expired. The Federal Circuit had ruled that the Teva patent was invalid. The added round of litigation in the patent dispute will buy Teva at least a bit more time to switch as many MS patients as it can to a new formulation of their drug, whcih replaces daily 20-mg injections with three 40 mg injections a week.

Teva has been promoting the 40 mg formulation of glatiramer acetate in anticipation that it would soon be facing generic competition. At least two pharmaceutical teams, Mylan/Natco and Momenta/Sandez, have made moves to seek approval from the US Food and Drug Administration for generic versions of the drug.

HIGH-PRICE DRUGS

The court case, while turning on legalities, served to draw attention to the over-arching issue of the high cost of treating MS and the absence of any generic medications that might provide some less expensive treatment options.

“For neurologists and our patients with MS, it's very disappointing that we don't have a single generic on the market, even though some of these drugs are 20 years old, and the prices have risen exponentially over the past five years,” said neurologist Annette Langer-Gould, MD, PhD, a partner physician and research scientist at Southern California Kaiser Permanente.

“It's a very bizarre market,” she said. “Every time a new MS drug comes out, all of the prices of the other medicines jump.”

According to a 2013 survey by Healthline, the retail cost for a month's supply for the disease-modifying MS drugs then on the market ranged from about $4,757 for teriflunomide (Aubagio) to $6,000 for Copaxone — or about $57,000 to $72,000 a year. The cost to most MS patients is far short of that because their health insurance picks up much of the cost of prescriptions, and some patients also get help with out-of-pocket costs by taking advantage of drug-sponsored patient assistance programs. Health plans also negotiate varying prices with drug manufacturers.

Gregory Barkley, MD, the clinical vice chair for the department of neurology at Henry Ford Hospital in Detroit, said Copaxone is a good example of how the prices of MS drugs keep rising at a steady clip for no explicable reason.

“Over the nearly two decades it has been on the market, in the face of competition from one competitor after another, the price of Copaxone has steadily marched upward,” Dr. Barkley told Neurology Today. “Now Copaxone is facing generic competition, so Teva has ramped up the rate of price increases, with a 9.9 percent increase in September 2014, and another 9.9 percent increase in January 2015 for the 20-mg dose that has been on the market all this time.”

Dr. Barkley was quick to add that Teva was no different than other drug manufacturers when it comes to pricing. Teva, which is also a leading manufacturer of generic drugs, did not respond to a Neurology Today request to answer questions related to the pricing and marketing of Copaxone.

A CALL FOR MORE COMPARATIVE STUDIES

Experts interviewed by Neurology Today said that price isn't the only confounding factor in the MS drug arena.

Dr. Langer-Gould said there is a paucity of research on head-to-head comparisons of MS drugs, which means that most drugs cannot truly distinguish themselves from the competition. But she said companies can bring new products to market without demonstrating superiority to drugs already available and still charge more than for any other drug on the market.

“The prices are not tied to how good these products are,” said Dr. Langer-Gould. “If anything, the evidence is mounting that the drugs are not as helpful in preventing long-term disability as we had hoped.”

A cost-effectiveness study published in Neurology in 2011 looked at 844 MS patients diagnosed with early-stage MS and analyzed how they fared on their drugs over a 10-year period. The research team, based at the University of Rochester, looked at factors such as medication use, doctor visits, and hospitalizations and concluded that the cost of using disease-modifying MS drugs (as compared to drugs that treated symptoms) was more than eight times higher than what would be considered “reasonable” from a cost-effectiveness perspective.

Another problem is that it's not easy to predict which MS patients will go on to develop severe complications of the disease, so there is a sense that it's best to cover the bases for everyone, even if that comes at tremendous expense.

“The problem is that MS is quite variable, with about one-third of the people doing relatively well after 20 years, one-third with moderate disability, and one-third with severe disability or even death in the same time frame,” Dr. Barkley said.

WHAT PATIENTS WANT

David E. Jones, MD, an assistant professor of neurology at University of Virginia, said “the economics of MS drugs almost defy logic,” so that “while we assume that generics are going to be so much cheaper, I'm not sure that will be true.”

Dr. Jones said demand for certain MS drugs — no matter their price tags — is fueled in part by direct-to-consumer advertising, which sometimes takes the shape of a patient education night over dinner at a local restaurant.

“I have a fair amount of patients who come in knowing what drug they want to be on because they've heard good things about it,” said Dr. Jones, who is associate director of clinical operations of the James Q. Miller MS Clinic at the University of Virginia and chair of the AAN MS Section. “It can be hard to dissuade a patient who has almost decided on, or against, a certain drug before their clinic visit.” He cautions his patients that “a lot of MS research has been funded by the drug industry.”

Dr. Jones, who said he had done promotional speaking for drug companies but stopped it when he went to the University of Virginia three years ago, said the neurology community talks a lot about the high cost of MS drugs, but hasn't done much to try to change that, probably in part because many MS researchers rely on industry to fund their work. He said that much more research funding from the government and other sources would be needed to fill the void if drug companies were to be less involved.

Dr. Langer-Gould said MS researchers could learn something from the HIV/AIDS community, where activist patients and researchers joined forces to help get truly promising drugs to market. Absent some change in business as usual, she said, the marketplace of MS drugs is going to be driven by factors other than what drugs are most effective.

In the case of Teva's glatiramer acetate, Dr. Langer-Gould has patients coming in requesting to switch to the new three-days-a-week regimen — in large part because requiring fewer injections sounds like a desirable alternative. Dr. Langer-Gould said the effectiveness of the treatment should be the deciding factor, and she thinks that daily dosing with 20 mg of Copaxone is a better way to go.

Timothy Coetzee, PhD, chief of advocacy and services and research officer for the National Multiple Sclerosis Society, said that while he could not comment on the Teva court case, “the Society advocates for increased treatment options for people with all forms of MS.

“Having approved generics has the potential to increase individuals' access to MS therapies and provides the MS community with more options,” Dr. Coetzee said. “We believe that it is only a matter of time before a generic therapy will be approved for the treatment of MS.”

He added, however, that “one thing that needs to be remembered when evaluating any treatment for MS, including a generic, is that no one size fits all. The generic MS therapy will help some people with MS and not others, and we need to ensure that the option for the right treatment for the right individual remains on the table.”

EXPERTS: ON THE SUPREME COURT RULING ON TEVA

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DR. ANNETTE LANGER-GOULD: “For neurologists and our patients with MS, its very disappointing that we dont have a single generic on the market, even though some of these drugs are 20 years old, and the prices have risen exponentially over the past five years.”

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DR. TIMOTHY COETZEE: “Having approved generics has the potential to increase individuals access to MS therapies and provides the MS community with more options. We believe that it is only a matter of time before a generic therapy will be approved for the treatment of MS.”

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DR. GREGORY BARKLEY: “Over the nearly two decades it has been on the market, in face of competition from one competitor after another, the price of Copaxone has steadily marched upward. Now Copaxone is facing generic competition, so Teva has ramped up the rate of price increases, with a 9.9 percent increase in September 2014, and another 9.9 percent increase in January 2015 for the 20-mg dose that has been on the market all this time.”

LINK UP FOR MORE INFORMATION:

•. Supreme Court ruling: Teva Pharmaceuticals USA Inc., et al vs. Sandoz, Inc. et al: http://bit.ly/scotus-teva
    •. Noyes K, Bajorska A, Chappel A, et al. Cost-effectiveness of disease-modifying therapy for multiple sclerosis: A population-based study http://www.neurology.org/content/77/4/355.abstract. Neurology 2011; 77(4): 355–363.
      •. Neurology Today archive on cost of MS drugs: http://bit.ly/MScosts-NT