When it comes to bringing bispecifics into outpatient settings to treat multiple myeloma, the structural roadblocks create more barriers than clinical challenges, according to experts from the Tampa, Florida, area who convened for a Stakeholder Interchange hosted by The American Journal of Managed Care® (AJMC®) on July 8, 2026.
The discussion was moderated by Kenneth Komorny, PharmD, BCPS, vice president and chief pharmacy officer at Moffitt Cancer Center, with a panel spanning academic and community practice: Syeda Saba Kareem, PharmD, BCOP, clinical pharmacy supervisor for malignant hematology at Moffitt; Ankit Kansagra, MD, and Lizbeth Haker, PharmD, BCOP, both of Tampa General Hospital’s myeloma, transplant, and cellular therapy program; Aaron Denson, MD, a private practice hematologist-oncologist with Advanced Cancer Treatment Centers in Brooksville; and Ameet Patel, MD, director of cellular therapy at Florida Cancer Specialists & Research Institute.
Labeling Language, Not Data, Is the Sticking Point
Key Takeaways
Community oncologists say FDA labeling language, not clinical evidence, is what’s holding back outpatient administration of bispecifics. Large academic centers can deviate from “must hospitalize” language in practice, but smaller practices say they cannot take on that liability.
Tampa General Hospital and Moffitt Cancer Center are both racing to expand outpatient capacity, from added observation bays to an “inpatient-outpatient” triage model, while still debating whether prophylactic tocilizumab or dexamethasone is the better default.
Reimbursement for tocilizumab, not teclistamab plus daratumumab, is the more persistent payer obstacle, with 1 center reporting only 10 of its past 19 tocilizumab claims paid, and 4 denied on appeal.
Komorny opened the discussion by noting that teclistamab (Tecvayli) plus daratumumab (Darzalex), the successful regimen from the phase 3 MajesTEC-3 trial (NCT05083169),1remains a category 1 recommendation by the National Comprehensive Cancer Network (NCCN) after a single prior line of therapy,2 and that a March 2026 label revision removed the requirement for hospitalization after teclistamab’s third step-up dose.3 When Kansagra asked whether the panel was administering step-up dosing fully outpatient, Kareem said Moffitt does so for most patients, “but there are some patients who may not have the social backbone to support an outpatient setup,” including some who are on dialysis.
Denson said the real barrier is the gap between what large centers can do in practice and what smaller practices are willing to risk while the FDA labeling still calls for hospitalization. “It’s hard for me as Joe Blow community doc, even though you guys are doing it—you’re Moffitt, you can get away with it,” he said. “I wonder when they’re going to update [the FDA labels] to make it seem more legit.”
He added that his patients cannot count on a nearby hospital partner to stock tocilizumab. “Even though [Tampa General Hospital] is 5 minutes from my office, I can’t reliably trust them to be there to back me up.”
Kareem agreed that the label itself carries outsized weight. “I completely agree with you regarding the labeling. I think the labeling makes a big difference. ‘Should hospitalize,’ ‘must’—there are 2 things,” she said, noting that myeloma bispecifics remain the only bispecific class with a Risk Evaluation and Mitigation Strategy requirement,4 “which adds another issue.”
Weighing Bispecifics Against CAR T, and Against Each Other
Asked how regimens based on teclistamab or talquetamab (Talvey), both from Johnson & Johnson, fit into the treatment picture as they move into the second line,5,6 Patel framed the decision around patients’ eligibility for chimeric antigen receptor (CAR) T-cell therapy. “The major decision point is, are they CAR T eligible?” he said, noting that, unlike patients in registration trials, patients in community practice often have comorbidities such as chronic kidney disease or reduced ejection fraction. Because registration trial populations don't reflect these patients, he argued, real-world community-based trials are needed, as they establish what payers ultimately seek. “That’s really the proof of concept, to understand how you can really implement this in the community and provide confidence,” Patel said.
Kansagra pushed the discussion toward duration of therapy rather than efficacy alone, arguing that finite-duration bispecific regimens alter the cost of care over time even if the drugs themselves are expensive. “The question is not [do] they work. The question is how long do you need to keep giving these drugs for them to be effective?” he said. “You get these patients in deep remission. Now we’re managing hypertension, diabetes,” and other chronic conditions, rather than active cancer therapy, he added.
Building “KPOP” With Space, Staffing, and the Right Mindset
Much of the session centered on the operational lift required to keep step-up dosing outpatient. Kareem described Moffitt’s approach. “We have a program called IPOPS service, so that’s an inpatient-outpatient service.... We put the bispecifics on our IPOPS service,” she said, with patients initially seen daily, but now, with more clinical experience and routine prophylactic tocilizumab, they are seen only on treatment days. Kansagra offered a counterpart term for his team’s effort. “I love the IPOP analogy.... I challenged my team to call it KPOP—Keep Patients Outpatient,” he said, arguing that some of the monitoring intensity built into current protocols may be more about easing physician anxiety than tracking real risk. “You don’t need 24-hour temperature monitoring to figure out who is having CRS [cytokine release syndrome]. That patient’s going to tell you.”
Haker described the capital investment behind Tampa General’s expansion. “We went from what we call a cellular therapy unit of 3 bays…and we literally created 13 additional bays,” she said, alongside efforts to recruit and train nurses with specialized bone marrow transplant backgrounds and to prepare the hospital’s emergency department for this shift. “This isn’t sepsis; treat it [as sepsis] if you want to, but this could also be CRS or ICANS [immune effector cell-associated neurotoxicity syndrome],” Haker said.
As for patient selection, proximity is often the deciding factor, she said, asking, “Can this patient reasonably make drives, especially between several doses? [Are they] health literate enough to understand taking their prophylactic” medications between step-up doses?
A Split on Prophylaxis, and an Unresolved Reimbursement Gap
Panelists differed on whether prophylactic tocilizumab or dexamethasone is the better default, with Haker noting that colleagues at other institutions, including AdventHealth Orlando, have moved to dexamethasone-only prophylaxis for outpatient bispecific administration. Kareem said Moffitt’s practice varies by disease state, with prophylactic tocilizumab for myeloma and prophylactic dexamethasone for lymphoma bispecifics. She acknowledged that the data show a real limit to what prophylaxis accomplishes. “The part that potentially bothers me...is that we’re not putting it down to zero. Patients get [prophylactic tocilizumab], and [some still] get recurrent CRS.”
