Peter L. Salgo, MD: Should it, in the absence of any clinical difference, simply be a price issue with you guys?
Allan Gibofsky, MD: Well, it is a price issue.
Peter L. Salgo, MD: OK, fair enough.
Allan Gibofsky, MD: When you think of the factors that go into the rationale for developing biosimilars, it was to decrease cost.
Peter L. Salgo, MD: I didn’t mean that to be a pejorative. I meant that to be an advantage.
Allan Gibofsky, MD: No, no, it’s not. It’s not at all. And when you think of the factors that go into a physician’s choice of what therapeutic to use, it’s efficacy, safety, adherence, tolerability, individual patient characteristics, and cost. And, by definition, a biosimilar can’t compete on efficacy. It can’t compete on safety. It can’t compete on tolerability. It can’t compete on adherence (because it’s the same schedule of administration). It’s not going to differ from patient to patient in terms of who you can and can’t use it in. So, you’re left with the cost. It does become a financial factor in defining what it is we use and when we use it.
Peter L. Salgo, MD: That’s not a bad thing.
Allan Gibofsky, MD: No, not at all.
Peter L. Salgo, MD: If you get something that works just as well and it’s less expensive, where’s the problem here? There’s no problem.
Allan Gibofsky, MD: There’s no problem unless there is a switch and the patient doesn’t respond to the switch medication as well as they did to the original medication.
Vibeke Strand, MD: Or that the price savings doesn’t get translated to the patient at all.
Peter L. Salgo, MD: Let’s address this. Yes, maybe the co-pay is the same, but this is what Gary was talking about. If the entire system saves money so that more people get effective treatment for the same cost, doesn’t that benefit everybody?
Cole Wilson, PharmD: Yes, it absolutely does. I think the topics that we’re talking about here, especially when you start looking into the ambulatory space, deal with what these products are costing. And the underlying term, here, is the word rebates. And so now we have pharmaceutical manufacturers who are offering monetary discounts to a pharmacy benefit manager who is then sharing those savings with the payer. These discounts, or these rebates, can often affect the pricing of the drug significantly up to 50% of the cost.
Peter L. Salgo, MD: And again, to some degree, they are being driven by the fact that there are less expensive products that are biosimilars.
Cole Wilson, PharmD: Correct.
Allan Gibofsky, MD: Right.
Peter L. Salgo, MD: In terms of the formulary, are biosimilars going to be compared with and placed on the same tier, if you will, as the original drugs?
Allan Gibofsky, MD: No. I think that to the extent that now we see managed care companies tiering TNFs (tumor necrosis factors), for example, I think we’re going to see the same tiering based on the biosimilars within that class. So, if previously I had to use Remicade before I could use etanercept, now I’m going to have to use Inflectra before I can use the biosimilar, etanercept, for the same reason.
Vibeke Strand, MD: But that also might change at not even every year but every 6 months, depending on what’s being tiered.
Allan Gibofsky, MD: With each contract.
Vibeke Strand, MD: What contract? We’re not privy to any of those pieces of information.
Peter L. Salgo, MD: What we’re getting then, I hear, is that under the radar is the flip-flopping of biosimilars because they’ve been shown to be similar. But there may be price differences. And so, people are going to get switched, at least in part, based on price.
Vibeke Strand, MD: And we’ll never have a biosimilar versus biosimilar comparison, clinically, to look at.
Peter L. Salgo, MD: Because it’s not set up that way, right?
Vibeke Strand, MD: Right.
Allan Gibofsky, MD: Gary used the euphemism “nonmedical switching.” That euphemism is used to refer to the case when you’re switching a patient for reasons other than clinical efficacy and, predominantly, because of price.
Peter L. Salgo, MD: Well, if you’re doing that, is it necessarily bad, Mr Plan Administrator? Is it really bad to do a nonmedical switch if the evidence suggests that there’s no medical difference?
Cole Wilson, PharmD: Just as the biosimilars are unique, your process through P&T (pharmacy and therapeutics) is going to be completely unique for these agents. What does the clinical evidence say? We always start there. Do the product qualities even match our needs? There are certain originator products that come out in vials, but maybe the biologic comes out in syringes. Are we going to have to use more syringes that then negate the cost savings that we had? There are just multiple factors that play into the use, and it’s difficult to say, “Is one agent going to be preferred over another?” You almost have to look at each individually and make that assessment.
Peter L. Salgo, MD: If the biosimilars are cheaper, and we would like everybody to be on this class of drugs but we couldn’t put everybody on them because they were very expensive, and now the price is coming down, does the introduction of biosimilars mean that patients, many patients, are going to get put on the best drugs earlier?
Allan Gibofsky, MD: Well, we don’t really know.
Peter L. Salgo, MD: This is terrible. Everybody says, “We don’t really know.”
Allan Gibofsky, MD: Peter, we don’t really know because we haven’t yet seen the reduction in cost in the United States leading to an increase in access. I don’t think, as Vibeke commented earlier, that it’s going to change our algorithms and guidelines for how we do things. And it’s not going to change the prior authorization requirements for getting a drug to a patient.
Vibeke Strand, MD: Well, we wish it would.
Allan Gibofsky, MD: We wish it would, but we don’t really know.
Peter L. Salgo, MD: In answer to my question, you’ve got a wish list, and that’s one of the wishes?
Gary R. Lichtenstein, MD: Right. In the UK, it did as was referred to. This is with something that is a different structure as to payment and approval. If we follow that, then perhaps it will. And that’s part of the hope.