Bringing Bispecific Antibody Therapy to Community Oncology Centers

Courtney Van Houzen, PharmD

Over recent years, bispecific antibodies have emerged as new treatments for patients with cancer, including those with hematologic malignancies. Still, implementing these advanced therapies in a community cancer center presents unique challenges.

In an interview with Targeted Oncology^TM, Courtney Van Houzen, PharmD, a clinical pharmacist and PGY-2 oncology resident at Munson Healthcare, Cowell Family Cancer Center, shared her experience in bringing bispecific antibody treatments to a community setting. From overcoming financial and logistical hurdles to tailoring toxicity management protocols, Van Houzen offered advice for oncologists looking to expand their own bispecific programs.

Targeted Oncology: What were the key steps involved in developing and implementing the bispecific antibody program at your community cancer center?

Van Houzen: The groundwork for implementing bispecific therapy at Munson started before I joined, so I will do my best to speak to it. One of our medical oncologists had a patient on [teclistamab-cqyv [(Tecvayli)] for relapsed/refractory myeloma. The patient wanted to receive treatment here, as he was a "snowbird," traveling to warmer places during winter but wanting to continue care at our center. This sparked the conversation around bispecifics.

Our oncologist spoke with our pharmacy team to determine whether this therapy could be offered at a community site. This raised big questions, so we gathered key stakeholders, including upper administration, given the high cost of these drugs. For a community center, that’s a crucial consideration. We also included pharmacy purchasing, clinical oncology pharmacists, providers, and nursing managers (both inpatient and outpatient), because we realized that if we accepted patients for bispecific therapy, we’d also need to handle ramp-ups safely.

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Working as a group was vital, as there are many nuances to planning for new therapies. Bispecifics tend to have a more modest toxicity profile compared to cellular therapies like [chimeric antigen receptor (CAR) T-cell therapy). In recent years, we have seen an explosion of bispecific products on the market, and we want to be at the forefront of using them safely. Many of our patients are on Medicare or Medicaid, and traveling to referral sites is not an option for them. We want to offer these therapies close to home.

There are a few logistical pieces from a pharmacy perspective starting with the [FDA Risk Evaluation and Mitigation Strategy (REMS)] programs associated with these agents. We reached out to a drug representative for guidance on signing up providers, our pharmacy, and placing orders. Then, we looked at the financial side—[assessing the cost, reimbursement, and sustainability]. From the financial piece, it went to the clinical piece, so, how do we do this safely? What protocols do we need to have in place? How do we educate our nurses? What do they need to know from a review of systems and injection standpoint? We broke a lot down there with a lot of education, so educating the providers, because we knew that eventually we would want to tackle that inpatient ramp-up or outpatient ramp-up piece of it. We wanted to create some clinical order sets that the providers could comfortably order and manage any toxicities that might come up with those early first few doses. It was a lot of pharmacy-led education sessions for providers and nurses were key. We also consulted with Mayo Clinic and drug representatives to ensure our physician group had all the clinical pearls needed to provide this therapy safely.

Lastly, it was educating the patients to make them aware of this whole process. We [have had] patients tell us how much they appreciate the option to receive treatment locally. No one wants to travel far from home for care if they can receive it safely nearby.

How did the institution tailor the program to meet the specific needs of a community cancer center as opposed to a larger academic center?

The biggest challenge for a community center was financial navigation. Many of these products are not eligible for 340B pricing, which, for community centers who are serving the underserved, can be a struggle. Especially for that inpatient administration of these drugs, we tend to take a loss with the inpatient with the hopes of then being able to recoup some of those financial toxicities in that outpatient setting where we get a little bit better reimbursement. But again, you cannot rush the process of getting patients to outpatient. We want to make sure we are doing this safely. Not all of our providers feel safe with how we are taking care of these patients and how they are doing. That was a big hurdle to get over. Once we decided that was something we could take on, it was then that clinical safety piece.

Large academic centers often have specialized teams, but community hospitals may not. For us, medical oncologists round on patients but are not in the hospital 24/7. We had to work closely with our inpatient oncology unit, [intensive care unit (ICU)], and [emergency room (ER)] teams to ensure everyone was prepared to manage potential toxicities because we know that for most bispecific patients, we do see a little bit more modest toxicity profile, and we would expect just grade 1, maybe some grade 2 cytokine release syndrome or neurotoxicity. But we do know that it can escalate, and they would maybe need some ICU-level care. We had to navigate a lot of these blending of medical teams and getting everyone on the same page.

For a lot of community centers, this is the situation, and it is not necessarily easy to navigate, but I think with open communication and getting everyone on the same page, we all want to treat our patients and our communities, and we want the best for them. I think most parties will buy into it. It is just kind of getting everyone in the room and having these conversations.

The biggest takeaway for community centers is the need for strong interprofessional teamwork. It’s essential to communicate openly and get everyone on the same page. We were fortunate to have ICU intensivists and nurses willing to take on these patients. We created educational modules to prepare staff across various departments, ensuring that they know how to handle cytokine release syndrome and other potential toxicities.

What were the primary considerations in developing the toxicity management protocols? How does this differ from other standard protocols?

Recent consensus guidelines, such as those from the International Myeloma Working Group, have helped shape our toxicity management protocols for bispecifics. Before these guidelines, we were using CAR T-cell therapy protocols to manage cytokine release syndrome and neurotoxicity, which wasn’t inappropriate but left room for improvement.

For simplicity, we created a single order set for all bispecific products. Physicians can select the grade of toxicity the patient is experiencing, and appropriate treatment options drop down. We also included anti-infective prophylaxis agents. This streamlined approach ensures that physicians have all the necessary information in front of them and reduces the risk of missing something important.

Based on your experience, what advice would you give to other community cancer centers looking to implement a similar program?

I think incorporating bispecific therapies into community centers is a great idea, but every center is different in terms of size, patient population, and resources. My advice is to gather key stakeholders early on, including financial navigators, pharmacy teams, and interested providers, and identify the barriers specific to your institution.

Financial challenges are common, but every center will face different issues, whether it is resistance from certain provider groups or budget constraints. However, with the growing number of bispecific products, including those for solid tumors, community centers need to prepare to offer these therapies. Referring all patients to academic centers may not be sustainable.

I also recommend reaching out to other centers that have implemented similar programs. We have been contacted by other community health systems, and drug representatives can connect you with institutions using their products. Do not hesitate to ask questions—it is feasible, and we owe it to our patients to explore ways to offer these therapies close to home.

REFERENCE:

Van Houzen C. Implementation of a bispecific T-cell engager therapy program at a community cancer center. Presented at: Association of Cancer Care Centers 41st National Oncology Conference; October 9-11, 2024. Minneapolis, Minnesota.