MS Patient, Ph.D.: Pros and Cons of the First Generic DMT
The Copaxone patent expired on May 24, which could lead to cost-based DMT choice
This Memorial Day weekend marked not only the unofficial start of summer but also a possible change in the way MS patients consider their treatment choices. Copaxone (glatiramer acetate), the number one worldwide disease-modifying therapy (DMT) for relapsing MS, went off patent on May 24, 2014. This would be the first time MS patients in the U.S. have a generic DMT option, a reflection on how only recently DMTs for MS have existed and the fact that most DMTs are biologics.
Biologics are treated differently as far as generics are concerned. Because generic glatiramer acetate is only an approximation of the patented drug Copaxone, due to the complexity of drug production through biological means, the drug falls under a different regulatory pathway called a biosimilar. These differences generally necessitate clinical trials to show that the biosimilar generic drug is equally as safe and efficacious as the patented drug.
Teva, the company that makes Copaxone, is arguing that the trials are crucial before the biosimilar DMTs are used, which they hope will delay generic competitors as much as possible and reduce their losses. The company estimates that every additional month of market exclusivity means an additional $78 million in sales.
It's unlikely that you will be able to actually purchase generic glatiramer acetate beginning May 25, although one company has already done a clinical trial with their generic biosimilar DMT. In the meantime, Teva is trying to shift its patients to a new formulation that is given every other day. This is intentionally timed, and if they succeed, the generic glatiramer acetate might not stand a chance. I mean, who doesn't want less frequent injections? But some argue that patients can have an impact; it's not worth the benefit of fewer injections if that wouldn't allow Copaxone to directly compete with generic glatiramer acetate for price (see “Teva's Copaxone: Perspectives From a Patient and Investor,” “Voices for Change: How You Can Impact MS Drug Pricing,” and “Taking Copaxone? Expect a Call in the Coming Weeks”).
The generic option sounds attractive. The big winners, aside from the manufacturers of the generics, are the insurance companies. Some patients might benefit as well, if their insurance company will now cover a generic DMT for MS if it wasn't doing so before, or if it lowers the copay for the DMT. Paradoxically, these same patients might also lose the most if Teva’s decreased revenues and margins affect the Copaxone patient assistance program. Additionally, Teva loses with the availability of generic glatiramer acetate, and maybe the clinicians too if they are restricted by what they can prescribe or what will be covered by the insurance companies. Which ultimately means that MS patients could be the losers, since they would have to consider not just the safety, effectiveness, and convenience, but also the cost of the DMT.
One company, Momenta, is taking a new approach by trying to take the guesswork out of biologic drugs; by identifying the exact components of the drug they are in essence making a traditional generic rather than a biosimilar generic. This would potentially override the need for new and expensive clinical trials, which might make the difference between a generic that is priced competitively with Copaxone and one that will be considerably cheaper.
Will this bring down prices of other drugs as well? The opposite situation arose in 2010: Gilenya was introduced at a higher price point than other drugs, documented by an MS blogger, and all the other drugs raised their prices in the following 4 years to match Gilenya’s. It's unclear how a (cheaper) generic drug will affect prices for other DMTs.
I'm curious to see how this emerging healthcare economics scenario plays out in real time. It will be interesting to see if a generic does become available, how it will be priced, and what that will do to the prices of other DMTs. But what I'm most concerned about is how the insurance companies will handle the availability of a much cheaper DMT. Will they allow only generic glatiramer acetate as part of their preferred drug list? Or will the insurance companies insist that you first try the generic as part of a “step therapy” program, before using any other DMT?
Here is where clinicians might be able to assert their opinions about a drug and circumvent this problem by looking at what the patient really needs and prescribe according to that. But I'm not sure how this dynamic between insurance companies, manufacturers, and physicians will play out, nor how many patients will be affected by DMT availability and affordability in the months or years until the prices settle. At this point, the similar efficacy of first-line DMTs allows the choice to be based on personal preference. It’s a choice I fear may disappear if patients are affected by the cost of the drugs.