Pharmacist Sees Cost, Programs, Safety as Key Payer and Provider Concerns With Biosimilars

The launch of a new infliximab biosimilar, recommendations for the approval of 2 oncologic biosimilars, and a wave of biologics license applications have providers, pharmacists, and health plans looking ahead to possible formulary changes that could switch patients from reference products to biosimilars. Kyle F. Skiermont, PharmD, COO of Fairview Pharmacy Services, spoke with The Center for Biosimilars^® about his experience with payers and providers as they prepare for the impact of biosimilar drugs and possible non-medical switching.

Many stakeholders are eagerly awaiting final FDA guidance on biosimilar interchangeability, but in Skiermont’s experience with health plans, “There’s not a lot of pushback in terms of clinical interchangeability from payers. We’re not seeing a big concern with switching.” Instead, payers are addressing their formularies in much the same way as they have in the past: “I look at it kind of like Humira and Enbrel. They both target the same mechanism of action, but are clearly different products. But lots of payers pick one over the other. With biosimilars, the payers, at least, aren’t really waiting for interchangeability…whether the product is interchangeable by FDA definition or not, it arguably has the same clinical effect in a patient.”

For payers, cost will instead be the primary issue in formulary decisions, and contracting with and rebates from reference product sponsors may play a significant role in their cost assessments. “We have not seen a big uptick in biosimilar use, and part of that has been…that it doesn’t make financial sense at this point to make the switch.” Biosimilar manufacturers, Skiermont says, may need to bring their prices down even further for payers to be incented to make such a switch: “We originally thought that, if there was a 15% to 20% price difference, we’d see a lot of movement. We don’t know, when we see that price difference, if the downstream costs really are that different. But we’ve not seen that be big enough to really drive behavior. It’s hard to know if, when it gets to 35%—and the newest infliximab that came out, that’s what they were touting—that [could] drive some change.”

Yet cost is not the sole factor that influences payers’ thinking on formularies; plans are also concerned about the kinds of services that biosimilar manufacturers can provide. “Testing, for example, with Remicade and its biosimilars, and patient assistance programs, have been key things where we’ve seen members push back on the payers, saying ‘we get that the biosimilar has a slightly lower cost, but there were all these other services that went along with the originator product that we’re now not getting with the biosimilar.’ That pushback—we’ve seen with at least 1 payer—has essentially made them reverse course on their formulary decision and go back to the originator product.”

Providers, too, see such programs as key to their willingness to switch patients to biosimilars. While some clinicians plan to wait for more data on biosimilars, “When we’re really sitting down with providers and having a conversation, we’re finding the bigger hurdle is some of these ancillary services that have been provided by the originator,” says Skiermont.

Yet unlike payers, providers tend to express some concerns about patient outcomes in relationship to switching. Often, these concerns are centered around the timeframe in which a provider could observe differences between the biosimilar and the reference product. “With a blood-stimulating factor, there was almost no pushback because…there’s very clear, measurable [evidence] of whether it’s working or not,” says Skiermont. However, “With Remicade and its biosimilars, it’s not as hard and fast…there’s some concern from providers as to whether it’s going to be weeks, months, or maybe even longer [before they can see] a difference in a patient from an originator to a biosimilar.” Skiermont also hears from providers who are wary of switching patients multiple times, and who are concerned that such repeated switching could cause problems with immunogenicity. Such switches could result from changes in a plan’s preferred products or a patient's moving to another health plan with a different formulary.

Among providers who have expressed concerns about switching, gastroenterologists have provided Skiermont the maximum feedback. “Our GI docs that treat inflammatory bowel disease, for example, are the ones who are more concerned that, even if it is a 1 in a million [chance] that somebody has a different reaction to a biosimilar, if it’s [their] patient that has that 1 in a million reaction, and they end up losing part of their intestine because of it, [the physician] can’t go back,” he says. Skiermont notes that, once therapeutic oncology biosimilars become readily available, oncologists will likely begin to have similar concerns: “We’ve got a wave of products that are going to be approved. We’d rather be having those conversations now versus when they come to market or when payers are requiring switches.”

As a pharmacist, Skiermont says that he feels comfortable switching patient medications. “There are arguably millions of patient days in Europe with biosimilars, and the data just aren’t showing that it’s a concern.” However, he notes that, “there’s still that humanistic side of me that says, ‘I’d probably monitor a patient more closely if I was switching back and forth.’ I may want to see that patient more frequently.”