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A recent ACCC virtual office hours session unpacked the real-world challenges of Bispecific Antibodies—from reimbursement roadblocks to operational logistics—and offered strategies to navigate them more effectively.
Bispecific antibodies (BsAbs) are a rapidly advancing drug class of immuno-oncology agents that offer new hope for patients with solid tumors and hematologic malignancies. Yet, as highlighted in an August 2025 ACCC virtual office hours session, science is only half the story. Titled Bispecific Antibodies: Navigating Reimbursement, Waste Management, and Operational Efficiency, the discussion underscored that behind every infusion lie operational and financial decisions that demand cross-functional coordination, communication, and planning.
“These drugs are T-cell redirected, engineered to simultaneously bind 2 different antigens. The pharmacist in me is super excited about the science behind these,” said Sarah Hudson-DiSalle, PharmD, RPh, FACCC, assistant director of infusion reimbursement services at The Ohio State University Comprehensive Cancer Center—The James.
The session unpacked the real-world challenges of BsAbs—from reimbursement roadblocks to operational logistics—and offered strategies to navigate them more effectively.
BsAb therapies present unique challenges in the prior authorization (PA) process and institutions must treat the PA process as a strategic imperative.
“If you don’t address [PA hurdles] ahead of time, and you’re not prepared with a plan, you can end up causing delays in therapy,” Hudson-DiSalle said. At The James, a foundational policy was put in place: PA approvals from payers must be in place and in writing when possible, prior to starting therapy. Supportive medications often come with site-of-care restrictions or sourcing requirements, so a system was implemented to alert teams when these restrictions apply.
Hudson-DiSalle explained that “For plans and drugs that have sourcing restrictions, a flag gets placed on the treatment plan—it tells the PA team to take extra time and ensure it’s done right.” The approval process differs significantly between inpatient and outpatient settings and teams must be trained to understand these distinctions and review payer policies regularly.
BsAbs are increasingly used in combination with other immunotherapies, which can trigger off-label status, even if each agent is approved individually. Hudson-DiSalle advised taking a predetermination step and confirming you have published literature support, which is critical for avoiding denials and ensuring timely access to care. Institutions must also establish robust systems to manage transitions of care—ensuring seamless coordination and thorough documentation as patients move between inpatient and outpatient, and from academic to community settings.
BsAb therapies often involve complex induction schedules, which require coordination across clinical and administrative teams. It’s critical that staff understand the full treatment plan, including loading, step-up, and maintenance doses, to ensure prior authorizations reflect the correct dosing at each stage.
A dosage mismatch can lead to costly errors and treatment delays. Teams must not only anticipate these dosing transitions but ensure that payers and reviewers are aligned from the outset.
For institutions treating Medicare Fee-for-Service patients in the inpatient setting, New Technology Add-On Payment (NTAP) offers a reimbursement pathway for these high-cost therapies. NTAP enables additional payment to hospitals above the standard Medicare Severity Diagnosis-Related Group (MS-DRG) amount.
“If you are using these innovative technologies that have a big price tag, and if you’re going that inpatient route, it becomes an opportunity to recoup some additional funds,” said Hudson-DiSalle. This will require coordination between the pharmacy department, revenue cycle, and medical information management (MIM) teams.
Waste billing and vial optimization are essential to avoid reimbursement losses and audit risk. Pharmacy teams must align closely with revenue cycle, denial management, and infusion staff to ensure accurate documentation of discarded waste, proper use of the JZ modifier to indicate when waste wasn’t discarded, and awareness of concentration and vial strengths to prevent inappropriate takebacks.
The financial burden of BsAbs must be addressed early—ideally at the point of therapy initiation. Patients should be screened for financial assistance, grants, and co-pay support, though not all bispecific therapies offer manufacturer-sponsored programs. This is especially true for off-label use or Medicare populations, where free drug access is often unavailable.
Beyond drug costs, institutions must consider expenses such as home infusion nursing, and travel and lodging for repeated hospital visits, as they can become cost-prohibitive, especially for rural patients who travel far. Remote monitoring offers a promising solution—both to reduce travel burden and as a billable service that can help offset costs.
The PA team should conduct benefit checks and flag patients at risk for high out-of-pocket costs, prompting outreach for co-pay assistance. Adopting this best practice can help streamline financial support and ensure that patients aren’t surprised by unexpected expenses.
Denials often reflect evolving payer policies, especially for high-cost agents. What was previously covered may now require updated documentation or new authorization criteria. Denial teams should proactively share coverage changes with front-end staff to prevent disruptions in active treatment plans.
Hudson-DiSalle cautioned, “Precertification or prior authorization does not guarantee payment.” Accurate coding—particularly for supportive care linked to adverse events—requires close collaboration with the MIM team.
Expect automatic denials and record requests for BsAbs. To mitigate risk, monitor payer trends, document medical necessity, and educate staff on dosing schedules and vial concentrations. When denials become systemic, engage managed care teams to escalate and advocate for clarity.
Hudson-DiSalle shared at the close of the virtual office hours session, “These agents will become part of your practice. And if you have a good foundation on how you work with other medications, such as PD-L1 agents, you can utilize those best practices.”