Peter L. Salgo, MD: Now, I promised we were going to shift this way because there’s all this interesting stuff that is 95% better than other treatments, statistically better, clinically better. Where does the money fall? These are not cheap drugs, are they?
Maria Lopes, MD, MS: No, they’re not, and they’re all expensive. As we look at the reality of what are these priced at on an annual basis, we now have a plethora of options. We have an explosion. Let’s look at the facts. We have many different options now besides IV [intravenous], oral, or subQ [subcutaneous]. We have different mechanisms of action, different frequencies. It’s amazing to me that we can think about now going from something where you have to take it every day to once a month, every 6 months, to now the option of 2 years and maybe nothing thereafter, or 8 to 10 days a year over 2 years and then potentially remission. Can we call it that?
On the payer side, it’s a bit of an enigma in terms of how we think about it, given all these options and given what we know about the biology. I think we recognize that we need choice. But do we need all of them? And I think that’s probably where you’re going next is what does a payer do with all these different options that exist?
Peter L. Salgo, MD: What do you do? Exactly.
Maria Lopes, MD, MS: And in a world where there is still uncertainty about the disease, the progression. How do you match the right patient to the right choice to get the best outcomes?
Peter L. Salgo, MD: If you’ve only got one ICD-10 [International Classification of Diseases, 10th revision] code, it’s going to be tough to begin with. And the question really to me is am I about to hear from you about step therapy, start with the traditional agents, cheap stuff? Or am I about to hear this stuff is so good, go right to it because you’ve got a 6-month window?
Maria Lopes, MD, MS: Well, I think it actually starts not with ICD but it starts with the label indication for a therapy. And I would argue that most payers are not in a position to challenge a neurologist or an MS [multiple sclerosis] specialist to say, “You don’t have relapsed MS, you have secondary or primary progressive.” We are not the experts, nor is there a biomarker. So usually the prior authorization, the appropriateness and the medical necessities of the drug, begin with the label indication, and we’re going to rely on clinicians in terms of defining what type of MS does that patient have, as well as perhaps an understanding of what else they’ve been on. One of the things we are doing more in terms of managing, particularly the IVs, is the site of care. Because, in addition to the drug costs, where the drug is infused has a lot to do with the end result in terms of the claim, the total cost of that claim that we’re going to be paying. So the same drug in a hospital outpatient versus a physician office or infusion center makes big difference to us.
Peter L. Salgo, MD: So you may approve this expensive drug. By the way, how much are we talking? What are the numbers like?
Maria Lopes, MD, MS: The band usually is going to be anywhere between $60,000 to over $100,000 per year.
Peter L. Salgo, MD: Per year.
Maria Lopes, MD, MS: Per year.
Peter L. Salgo, MD: Per patient.
Maria Lopes, MD, MS: Per patient.
Peter L. Salgo, MD: This is serious money, right?
Maria Lopes, MD, MS: Yes.
Peter L. Salgo, MD: What I hear you saying is we need to control some aspect of this to make sure that the patients who get these drugs, if we approve them, are at least going to get them properly and get the best chance for success. So maybe you’re going to limit the sites at which they can be administered, yes?
Maria Lopes, MD, MS: Well, I look at the reality of what has lost patent. Copaxone, for example, right? Among the ABCR [Avonex, Betaseron, Copaxone, Rebif] drugs, glatiramer is now a fraction of the cost of perhaps other alternatives. And what this also means for patients in terms of the reality of what they may be paying for co-pay, coinsurance on a monthly basis, and then their affordability, which reflects on compliance. And if they’re not taking the drug, it’s not going to be effective. So these are all things that are in the context of value, right? What is the role of these treatments, what is their indication, what do we know about their efficacy, and who are they appropriate for? There is a reality of new options but also existing options that may be going off patent.