Nicolle Rychlick, PharmD
An unusual convergence of market factors has made the early going less than spectacular for Inflectra and Renflexis, the biosimilars competing for market share with the originator infliximab product, Remicade. Instead of taking the market by storm, they have made little headway against Remicade and its hegemony as the biologic for 1.3 million Americans with rheumatoid arthritis.
The biggest challenge facing Inflectra (marketed by Pfizer) and Renflexis (marketed by Merck) has been winning over payers. It has been an uphill battle, in part because most commercial payers receive rebates from Johnson & Johnson on Remicade, so it has maintained its preferred spot on many formularies.
In terms of cost, the two newcomers are competitively priced but, judging by the wholesale acquisition cost, they fall well short of the 30% to 40% price difference with Remicade that many were hoping for. Pfizer brought Inflectra to market in 2016 priced 19% below Remicade. Last summer, Merck did Pfizer one better by pricing Renflexis 15% lower than Inflectra. But the rebate deals Johnson & Johnson is privately striking with insurers are apparently enticing enough in the aggregate to give Remicade most-favored status—at least for now.
So what could change the current market dynamics?
Patients with rheumatoid arthritis tend to be savvy health care consumers, but many are wary of biosimilars, especially if their disease is stable on Remicade. One of the biggest concerns is that biosimilars are getting approved based on results from small studies and data extrapolated from studies of other diseases. Attitudes could change once there is more data that show people do well after switching from Remicade to Inflectra or Renflexis.
Studies have found a correlation between awareness of biosimilars and willingness to be prescribed one. This suggests that patient education could make a real difference in increasing the use of biosimilars.
Meanwhile, a growing body of research shows that even modest levels of cost sharing result in patients skimping on medications—or skipping them altogether. An increasing number of health plans have high deductibles or hefty copays or coinsurance. The average annual cost of a Remicade prescription is $28,906, according to the Institute for Clinical and Economic Review. So from both an adherence and a patient expense standpoint, biosimilars will be the wiser choice for many patients, even if the price differences are relatively modest.
Informed patients and physicians both value choice, and health plans value their relationship with physicians and members, so it makes good business sense to allow competition at the level of treatment. In Europe, where 28 biosimilars are currently approved (vs. five in the United States), physician perception and patient acceptance were found to be highly favorable conditions for market uptake of biosimilars. And physicians in this country may start to push back against formulary decisions that give Inflectra and Renflexis second- or third-tier status (or advocate for biosimilars during the prior authorization process), if only to defend their clinical autonomy. Any reservations that physicians may have about biosimilars are being actively dispelled by educational initiatives at many hospitals and health systems, FDA website postings, and presentations at industry conferences.
Most states have issued guidance about when a biosimilar can be substituted for a biologic by a pharmacist without the approval of a physician. The FDA has yet to give biosimilars an “interchangeability” designation—a long-awaited move favored by a wide range of health care groups and interests, including some companies with branded products. Perhaps by the time that happens, biosimilars will be as easily dispensed, and prescribed, as any generic drug. That kind of competition favors everyone by reducing costs for the entire health care system.