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Generic First Approach in MS


MS specialists Darin Okuda, MD and Thomas Leist, MD discuss the viability of a generic-first treatment approach in MS.

Neil Minkoff, MD: Does a generic-first approach work in this disease state? I’m going to be slightly more provocative and mention that we don’t do it in cancer. The flip side is that in cancer, we have NCCN [National Comprehensive Cancer Network] Guidelines and ASCO [American Society of Clinical Oncology] guidelines that help nonprofessionals, like me and Dr Lopes, understand the rule of generic first vs nongeneric first, a pathway, and so on that we can depend on. Does generic first actually make sense in this disease state? What other resources or tools could we use to try to get away from our natural inclination to start small and work big?

Thomas Leist, MD: To give an analogy, MS [multiple sclerosis] is not a carousel. You cannot step up, go once around, and then end up at the same place. If the patient has injury, the patient will have enduring injury. If you think about the disease, you want to prevent injury. Obviously, switching at the time of the next injury is almost a counterproposition of best management. I have a certain trepidation with the fact that we will probably have representatives of any of the oral classes that are going to be generics over the next 3 years. It will be relatively difficult for patients to move to, for example, an anti-CD20 therapy without having to step through 1 or 2 of the oral or injectable therapies that are going to be generic. That would obviously be a bit of a back-to-the-future move. It will be necessary for patients to have access to the different classes of medication. Dr Okuda and I may slightly differ. For example, when we look at anti-CD20, whether there are significant differences between the different products, a bigger issue is when people move from 1 product to the other 1, whether they develop resistance or antibodies or things like this that we haven’t tested because we haven’t had this cross-exposure of patients.

As [Nancy] Ross said, we also need to keep in mind when all of a sudden our patients are exposed to $1500 or $1600 co-pays. That happened when dalfampridine went generic, the “most-liked” medication by pharmacy plan. That’s the walking pill, not the treatment pill. I say that tongue in cheek, “the most-liked medication.” I can go to HealthWarehouse.com and order the medication from a specialty pharmacy at a fraction of what it costs at CVS or any of the major pharmacy chains. I don’t understand why the generic fumaric acid esters are now at a price point of $3500 while the price point that’s encountered by patients is in the range of $15,000 to $16,000. There’s a place where the payers have to lean on either captive or contracted specialty pharmacies to ensure that the patient doesn’t encounter significant co-pays in this medication class.

When patients come to me and say this medication has gotten really expensive, I ask, “What do you mean?” They say, “I’m now paying $100 per month in co-pay.” They’re not talking about the $15,000 or $16,000. It’s very significant. Even these relatively low co-pays are already burdens on patients. Many of the patients are on multiple medications and see multiple practitioners, so their pharmacy and medication budget is already maxed out before they start. We really need to understand that.

It’s very important not to step away from this most effective medication available first line, even in a transition to a genericized marketplace in multiple sclerosis. That’s where I have a little fear. I also have a little fear about what that means for future innovation in the MS marketspace because we’re not meeting every patient’s needs at this point. I understand the frustrations that we haven’t gotten to a point where we can fully agree on the right approach, also because MS is so varied in the presentation of patients. We haven’t reached a point where we can categorize patients as neatly as our oncologic colleagues, where a biopsy result sometimes puts a patient in a neat box for a treatment. We don’t have that.

Darin Okuda, MD: When you have someone who’s Black or African American, you know their disease course is on a different trajectory from others’. Generic Copaxone won’t work well in that situation. I hope Tom is in agreement with that. If someone who’s White has an exceptionally high number of lesions within the spinal cord, you know that a generic DMF [dimethyl fumarate] is probably not ideal for that individual. If you know you’re going to be fighting with compliance issues, it’s great to start with something more effective. In those situations, a generic approach doesn’t work. Will things be different when we have generic fingolimod or generic teriflunomide? We’re still struggling with that issue of at least having the option of using a high-efficacy treatment. Even if it’s something like generic rituximab, I’ll take it, rather than having to go through the motions of failing this therapy that leads to a waste of resources and everyone’s time, having to bring them in and do pretesting and then all these different things. That’s really important.

Getting back to Nancy’s comment, it would be nice if payers did adopt a generic approach but then transferred some of those savings on to patients. Other companies don’t entice people to go on their sexy new drug because of co-pay assistance. It’s because people just don’t have money. That’s the big issue. It’s especially relevant during times of COVID-19. When a patient tells me, “Look, I can’t have that blood test done, because if I do, I won’t eat for 7 days,” the value and meaning of $18 or $23 per month for patients is heartbreaking. It’s not that companies are enticing them to do it. They’re put in a hole. It’s like, “Wait, I wasn’t paying for Tecfidera from January through September of last year, and then I get hosed with this $180-per-month bill for a generic agent that’s never really been tested to the same degree as brand-name Tecfidera.” I don’t think patients look at that as a value play. It would be nice if payers could come to the table to allow for some degree of help on that side.

Transcript edited for clarity.

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