FDA Change Smooths Way for Bispecific Access in Community Practice

A June decision by the FDA to eliminate Risk Evaluation and Mitigation Strategies (REMS) for currently approved chimeric antigen receptor (CAR) T-cell therapies should make it easier for community oncology practices to put these life-saving therapies within easy reach of patients. And that’s sorely needed, as only 20% of eligible patients with cancer receive cellular therapies, which include bispecific antibodies, according to Aaron Lyss, MBA, senior director, payment and policy innovation, OneOncology.

Aaron Lyss, MBA | Image Credit: © OneOncology

Brian Mulherin, MD | Image Credit: © LinkedIn

Ameet Patel, MD | Image Credit: © FCS

Bryan Loy, MD, MBA | Image Credit: © Humana

Lyss moderated Monday’s panel, “Ensuring Access and Reimbursement for High-Cost Therapies in Community Oncology Settings,” at the Community Oncology Alliance Payer Exchange Summit in Reston, Virginia. The panel included Brian Mulherin, MD, medical director, American Oncology Network; Ameet Patel, MD, hematologist/oncologist and director, cell therapy, Florida Cancer Specialists & Research Institute; and Bryan Loy, MD, MBA, vice president, who leads Humana's cancer initiatives and the payer’s laboratory and personalized medicine initiatives.

For years, Lyss said, regulatory barriers and payer issues have limited how many community oncology practices could administer cellular therapies. REMS also limited how many patients could put their lives on hold to receive them, due to significant requirements for patients to stay near the treatment facility.

But things are shifting with the recent FDA change and the sheer number of bispecific therapies on the horizon, he said. Mulherin then reviewed the recent wave of approvals.

“This is just the tip of the iceberg. When you look across clinical trial registries, there are over 600 trials that are ongoing for bispecifics,” Mulherin said. Much of the pipeline is solid tumor agents, a contrast with the early wave that was centered on blood cancers.

“This is important for a couple reasons. One, these are innovative, high-tech, cutting-edge, highly effective therapies, but they're also very challenging to administer,” he said. “These are acute toxicities that have to be managed after people receive the drug. So, you have to have the appropriate infrastructure and training in place in order to do that.

“In the community setting, we want to be able to administer these therapies to our patients and keep them close to home, where their community is, where their support is,” Mulherin said. “We need to be able to administer these therapies for our patients, or we're going to fade into irrelevance."

“The bispecific train has left the station,” he added. “You're either going to be on that train, or you’re going to be rolled over by it.”

The FDA’s change, taken after regulators balanced the risk against the benefit of expanding access, means that practices will no longer be required to obtain a joint certification with hospital partners to offer these treatments. Although this eases a burden on practices, Loy said it could raise some questions for payers.

Patel pointed to the many advantages that treatment in the community practices offers: reduced transportation time, proven outcomes in clinical trials, and—for payers—lower costs. Over the last 5 to 10 years, he said, oncologists in the community have learned how to manage CAR T-cell therapy in the community, and the therapies themselves have become less toxic. Uses of tocilizumab and remote monitoring have reduced the risk of cytokine release syndrome and the need for patients to spend long stretches away from home.

What’s challenging, Patel said, are payers who limit community practices to single-case agreements, because these arrangements are known to cause delays that can make a difference in survival times.

In his work as a transplant physician before moving to Florida, “a lot of patients will decide not to get some of these life-saving therapies because of geographical variables, payer-specific guidelines, perhaps delays,” Patel said.

Loy’s perspective was one of having to ensure quality and predictability. “There are nuances here that I don’t think are trivial,” he said. “Things are already in motion, and we’re going to find ourselves having to deal with issues reactively and proactively.”

It’s clear, he said, that the practices represented had made “enormous investments in relationships with hospitals.” He has worked with individual drug manufacturers, who have requirements before a practice can treat patients with their therapies. But absent the FDA requirement, Loy asked, is there a third-party association or some other credential that could signal to payers that a practice is ready to administer therapies that cost up to $500,000?

The panelists discussed solutions to ensure quality, such as “hub-and-spoke” models in which a multisite practice would designate 1 center fully resourced with cellular therapy infrastructure. Alternate payment models, such as risk pools, are being discussed at a national level to address concerns of employers about paying for the increasing number of cellular therapies. The panel also discussed the need for standardization in payer agreements and chain-of-custody protocols.

The shift will require a change in thinking about CAR T from all stakeholders. But as Lyss said, the FDA ultimately decided that more than a decade after the first CAR T clinical trials began, it was time to tilt the scale in favor of access.

“I couldn't have said it better than the FDA actually said it in terms of why they made these changes to the REMS programs,” he said. “They didn't think that there was a benefit in safety that was worth the constraints on the care delivery system that the prior REMS structure was imposing.”