“We’re pushing hard, certainly in our network,” said Rifkin, whose practice is affiliated with The US Oncology Network, which includes 45 oncology practices across the United States. He is active in the development of biosimilars.
Biosimilars Put Downward Pressure on Prices
In the United States there are 2 rituximab biosimilars on the market. One is Truxima, which was launched in the United States late in 2019 and most recently won a prequalification designation from the World Health Organization (WHO) for the treatment of diffuse large B-cell lymphoma, chronic lymphocytic leukemia, and follicular lymphoma.
This raises the profile of the drug among physicians worldwide and encourages the use of this product. Truxima, which was developed by Celltrion Healthcare, became the second biosimilar after Ontruzant, a trastuzumab copy, to receive this WHO designation.
An additional rituximab biosimilar that adds to the downward pressure on prices and broadens treatment options for physicians is Pfizer’s Ruxience, which launched in January of this year. “It’s a competitive space, but clearly, what everybody is looking for is lower costs and increased access, which probably will be helped with the WHO’s recognition of Truxima,” Rifkin said.
On the physician side, when using biosimilars, it’s important to recognize that biosimilars may not have been FDA approved for all of the indications of the originator drug, so checking the label is important, Rifkin said. “The good news for Truxima is that they just got the rheumatoid arthritis indication.” This happened in early May. “So, that kind of levels the playing field.”
Ideal Placement in the Treatment Regimen
The US Oncology Network and group purchasing initiatives that Rifkin is involved with are helping to drive higher utilization of Truxima to achieve savings that can make a difference for patients. Patients may need to take this drug for long periods, particularly for treatment of rheumatoid arthritis, and knowing where to slot it in the treatment regimen is still a process of discovery, Rifkin said. “We’re putting it everywhere we can, up-front,” and the uptake numbers confirm that utilization is improving, he said.
Education on biosimilars helps. “I think our network is very well educated. We have a biosimilars toolkit that many of the [US Oncology] employees could look at if they wanted to and learn as much as they want about biosimilars.” Efforts are also made to ensure that all of the clinical data submitted for FDA approval are posted prominently for the health care workers and physicians so they can familiarize themselves with the evidence foundation for these products, Rifkin said.
With all of this work to support biosimilar adoption, uptake of these products is increasing slowly, but this pace is to be expected given that these are therapeutics rather than supportive-care products, Rifkin said.
That slow pace of acceptance and utilization is somewhat separate from the development pipeline. There are new biosimilar entrants in the pipeline for FDA and European regulatory approval, and growth like this is steadily increasing the number of biosimilars available to physicians or the medical community. There are already 5 trastuzumab biosimilars on the US market, 3 of which were launched in the first half of 2020, and Rifkin expects there to be more before the year closes out.
For physicians, this does complicate the process of choosing medications, he said, because contracts for use of these products are determined not at the provider level but higher up the supply chain and by payer organizations, and these are confusing to navigate.
“I think it’s going to be unrealistic to expect pharmacies, all of our big supply channels, and distributors to carry every single biosimilar. Certainly the originator [Herceptin] will remain there, and then I think various stakeholders will move toward the notion of a preferred biosimilar,” he said.
“I really think you probably need to carry only a couple, because it’s going to get too confusing if I have 5 trastuzumabs on the shelf plus the originator. That’s a supply chain–stock issue, but more importantly, that increases the opportunity for mistakes,” he said.
As to whether payers are hearing the message that business-based restrictions on biosimilar use may complicate matters for physicians, Rifkin noted that it may be difficult to persuade a payer to grant flexibility in the use of one biosimilar over another if the preferred biosimilar is clearly a better financial deal. “A lot of the payers already have preplanned arrangements with manufacturers. We can remind them that we don’t want to carry 5 of the same biosimilars, but that may not have any effect,” he said.