Neil Minkoff, MD: In many of the other disease states, or in disease states where there are complicated medical regimens, whether it’s rheumatoid arthritis and the use of TNF [tumor necrosis factor] inhibitors or IL [interleukin] agents, or even building up to what’s the appropriate time to do a clot buster vs a catheterization, there are some reasonably well-defined guidelines for community physicians, emergency department doctors, and payers to refer to in order to help understand the standard of care. We keep not having something to respond to here. I’m wondering why that is and what the barriers are to creating a guideline here that doesn’t exist in other forms of medicine to help us guide those decisions, because the guidelines do help open up coverage.

Thomas Leist, MD: I may jump in over here. I challenge you a little on that particular point. If you look at it, it says if a patient has a new lesion on a traditional MRI—and we can all agree that the traditional MRIs show us only part of the disease because MS [multiple sclerosis] also affects the brain matter, which we don’t see on traditional MRIs—then we should have a discussion with this patient regarding switching medication. It’s imperfect, but we have some of these guidelines. For me, the switching of medication means another mode of action—not the favorite flavor of an interferon du jour when the patient has been on another interferon beforehand, but a true switch of medication.

We’re also very clear that there are patients with stigmas at the initial presentations that put them at very high risk. These patients will need to have higher-efficacy medications. When you look at it in aggregate, many of these things are already there. They may not have been as clearly formulated as they could be, but they’re already present. They’re also present in the value-based care initiative, for example, from the [American] Academy of Neurology. They need to be implemented. In addition, we have more data from the large databases like MSBase or the big MS consortiums that have emerged over the years, where very valid information is present. Dr Okuda, what do you think?

Darin Okuda, MD: Neil is asking for guidelines or an algorithm, which we all hate. MS is not linear. It’s not like aggressive cancer, where you have it and then you’re dead. You treat based on probabilities and who you think is going to do poorly in the future. The complicating feature is if Tom and I see a person who’s 26 years old and has moderate disease, regardless of what we give this person, they may have progressive disease at age 45. That’s the challenge. When we start to impose treatment guidelines, whether Maria then says, “I’m going to bless 1 high efficacy, we’re going to stratify things based on efficacy so that practitioners have the choice of selecting 1 high-efficacy agent, something that’s moderate, or something that falls into a traditional injectable class therapy,” then we have abuse by physicians too. I can see people using Ocrevus for no good reason at times than to use it because their reimbursement is rich on the infusion side. We’re not exactly pure as well on the clinician side.

It gets really muddy that way. It leads to a system of confusion. Maybe it’s the right approach to tier it based on efficacy, but it’s a challenge. The problem is that everyone is an expert in our field. That’s why we don’t have guidelines. Everyone thinks they’re right. Everyone thinks they do it best, and that’s why there’s no agreement.

The other thing is that, in a condition where there’s so much heterogeneity, because you can be fine for 14 years and then get hit with something really catastrophic because of some social stressor or work or relationship, and disease can come back with a vengeance, it’s complicated. The other thing we didn’t talk about is that it’s really meaningful to not just look at therapies. Look at what happens when we take people off therapy because they get hosed by their payer. In some cases, we can have severe disease recrudescence in the cases of Gilenya and natalizumab. It’s real and it happens, and I’d think it becomes very costly for a payer in those situations.

Transcript edited for clarity.