Tony Hagen is senior managing editor for The Center for Biosimilars®.
Pharmacy experts discuss their level of confidence with biosimilars and some of the hurdles that stand in the way of optimizing these lower-cost medicines.
Biosimilars have helped to transform the treatment of breast cancer in recent years, given that there are multiple trastuzumab biosimilars now available, according to Jacob Kettle, PharmD, BCOP, who led a recent discussion on the topic for Pharmacy Times®.
Kettle, with the University of Missouri Health Care, Columbia, spoke with Allison Butts, PharmD, BCOP, of the University of Kentucky Markey Cancer Center in Lexington. They discussed payer policy and its influence on choice of biosimilars, along with concerns about use of biosimilars in place of originator drugs.
Open to Using Biosimilars
The Markey Cancer Center has been open to the use of biosimilars, Butts said, indicating that she feels comfortable substituting these products for reference trastuzumab and hasn’t noticed much “pushback” against biosimilars from the clinician community at Markey.
FDA standards for approval give her confidence in biosimilars, although Butts said she pays close attention to infusion reactions. “Infusion reactions are interesting when we’re talking about monoclonal [antibodies] because that’s certainly a concern with any [biosimilars] across the board. Does that rate of infusion reaction change or not?”
Biosimilars are more widely accepted as supportive care drugs, but in the oncology curative setting, there’s nervousness among physicians because the stakes are higher, Kettle noted. He asked Butts whether Markey clinicians experienced the same concerns about using trastuzumab biosimilars in the curative setting.
Butts replied there were no concerns. “They can show that it’s effectively targeting HER2-[positive breast cancer]. It’s effectively clearing out and leaving the body as it’s supposed to,” she said.
Payer Mandates and Choice
For his part, Kettle said that University of Missouri encounters difficulty employing and optimizing biosimilars amid multiple payer mandates that dictate which biosimilars may be used. “We have a lot of different payer mandates in the mix that preclude us from being able to drive the ship to what may be best for our own institution,” he said. “One payer may prefer product A for clinical, operational, and financial reasons—what have you. Another payer may like product B, and another may like product C.
“Half of patients are still on the originator product because they’ve been on it for 5 years, and we don’t want to disrupt them,” he said.
“That creates a nightmare scenario from [the perspective of] ordering, authorizations, and drug dispensing. To me, that is the bigger hurdle that we’ve encountered with biosimilars and how they play a role in cancer therapy,” he said.
University of Missouri Health Care finds these issues a challenge in getting the most out of biosimilars, Kettle said.
“That’s a great point,” Butts said. “You have to draw the line somewhere. You can’t have 10 trastuzumab products sitting in your refrigerator” because each payer requires something different.
Click here to find out how Emory Healthcare in Atlanta, Georgia, succeeded in getting physicians to incorporate use of biosimilars.