Inflectra (infliximab-dyyb), a biosimilar to Remicade (infliximab), is now covered by Medicare and Medicaid. Approved by the Food and Drug Administration in April 2016, Inflectra is the first biosimilar indicated for the treatment of rheumatic and inflammatory diseases to come to market in the United States. The Centers for Medicare and Medicaid Services added it to its pricing list beginning January 1, 2017.
“That means the drug is readily available,” explains Donald Miller, PharmD, professor of pharmacy practice at North Dakota State University, in Fargo.
A biosimilar is a highly similar, but not quite identical, copy of an already approved biologic drug, called the reference product or the originator drug. To be approved, a biosimilar must have no clinically meaningful difference from the reference product in terms of safety, efficacy or mode of administration – but biosimilars are expected to cost less. Two other biosimilars – Amjevita, a biosimilar to Humira, and Erelzi, a biosimilar to Enbrel – have also been FDA-approved, but neither is available because of pending patent litigation.
Inflectra became available to patients on November 21 in what is considered an “at-risk” launch – drug-maker Pfizer decided to release it despite unsettled patent issues with Remicade drug-maker Johnson & Johnson. Inflectra, an intravenous infusion like Remicade, is approved for the same conditions as its originator drug: rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, Crohn’s disease and ulcerative colitis.
Jonathan Kay, MD, professor of medicine at University of Massachusetts Medical School in Worcester and an expert on biosimilars, says he sees biosimilars as a welcome option for his patients and discusses the newly-available medication with them during follow-up visits.
“Patients can be reassured these aren’t knockoffs; rather they are carefully crafted replicas that have undergone rigorously testing,” Dr. Kay says. “My patients aren’t nervous about being treated with a biosimilar because I explain to them the data that show them to be highly similar. Patients are excited about the availability of a drug that will allow them the same treatment but at a lower cost.”
While some people may be reluctant to switch drugs if their disease is stable on their current medication, it’s expected that the lower cost may lure others to switch to or to start out with a biosimilar. Pfizer says Inflectra is being sold at 15 percent lower cost than Remicade – not including insurance and other discounts. But since biologics can cost thousands of dollars per dose, and other factors, such as insurance plans, come into play, some experts don’t think that’s enough of a difference.
“Fifteen percent will not be meaningful for most patients since actual savings to patients will depend on how their insurance is structured, fixed co-pay amounts, cost-sharing, etc.,” says Miller. “I don’t think the 15 percent will be enough to drive many rheumatologists to specifically prescribe Inflectra.”
The pricing of a drug is complicated and depends on a number of factors, including how insurance companies classify medications. Patients should check with their own insurance providers to understand the specific implications for them based on what their Pharmacy Benefit Managers (PBM) – the third-party companies that handle prescription drug programs for health plans – are doing. For example, the largest PBM, Express Scripts, began offering Inflectra in December, giving it the same formulary status as Remicade.
Still, some doctors say getting Inflectra on the market and onto insurers’ drug lists are important steps for biosimilars. Dr. Kay notes that in some countries, such as South Korea, competition from biosimilars has driven down prices of the originator drugs, which ultimately leads to more choices for patients.
Biosimilars were made possible by the Affordable Care Act (ACA), which created a special pathway for their approval. If the ACA (Obamacare) is repealed, Dr. Kay says it remains to be seen what will happen to the biosimilar pathway. He says he hopes lawmakers will pass other legislation to preserve this important route to keeping effective therapies reasonably priced.
Author: Jennifer Davis for the Arthritis Foundation
- Arthritis Foundation Position Statement on Interchangeable Biosimilar Substitution
- FDA Approves First Biosimilar for Arthritis
- FDA Approves Second Arthritis Biosimilar – Biosimilar Version of Drug Enbrel
- FDA Approves Third Biosimilar for Arthritis – Amjevita, a Biosimilar to Humira