Precision, Access, and the Patient Journey: Navigating the Complexities of Modern Oncology

While the scientific frontier of the oncology landscape is expanding at an unprecedented rate through genomics and novel therapeutic platforms, the operational and financial hurdles to delivering that care are becoming increasingly complex. At a meeting of the Institute for Value-Based Medicine^® (IVBM) in Miami, Florida, clinical leaders, pharmacists, and health-system administrators gathered to discuss the friction between innovation and implementation.

Although "precision medicine" is the goal, the path to achieving it requires a meticulous balance of high-tech diagnostics, multidisciplinary coordination, and aggressive advocacy against systemic barriers, the speakers explained throughout the discussions.

Bridging the Gaps in Breast Cancer Care: The Genomic Frontier

Modern breast cancer care has many opportunities with the use of antibody-drug conjugates (ADCs) revolutionizing care and circulating tumor DNA (ctDNA) moving into earlier stages of breast cancer. However, each new change brings additional real-world challenges, noted moderator Nicole Bentivegna, PharmD, BCOP, clinical pharmacy services manager and residency program director at Florida Cancer Specialists & Research Institute.

Siddhartha Venkatappa, MD, associate chief medical officer at Baptist Health Miami Cancer Institute (MCI), added that while the technology is transformative, its application requires a high degree of clinical nuance. Currently, ctDNA is primarily utilized for monitoring patients with advanced disease, often on a cycle of every 6 to 8 weeks for those with estrogen receptor–positive metastatic breast cancer. However, there are new challenges arising as patients increasingly request these tests for early-stage disease where the clinical utility is not yet supported by robust evidence.

Venkatappa emphasized that managing these requests is part of the “art of medicine” and requires psychological support. "With each individual patient, you're going to have a slightly different approach,” he said. “The key to me is to not poo-poo their anxiety, to say you're absolutely right to be anxious.”

The panel also addressed the dramatic shift in the therapeutic arsenal, specifically the rise of ADCs like trastuzumab deruxtecan (T-DXd). These therapies have redefined expectations for survival in HER2-low and metastatic settings, but they have also introduced significant operational burdens. Venkatappa envisions a scenario of a sequence of ADCs “because they are such an effective group of agents that we will be able to use [in the] first, second, [and] third lines.”

For now, there are trials ongoing—such as the SERIES (NCT06263543), TRADE-DXd (NCT06533826), and Alternating Schema (NCT07151586) trials—but it will take many years for data to come out that support the use of ADCs after other ADCs.¹

In addition to the logistical challenge of sequencing ADCs, there is also the issue of financial toxicity. Diana Van Ostran, PharmD, BCOP, clinical pharmacy specialist in breast oncology at MCI, highlighted that as these agents move into earlier lines of therapy, the questions of what to use next and how to pay for it become paramount. Organizations often rely on National Comprehensive Cancer Network guidelines, but in a field moving this fast, data presented at the latest medical congresses may not yet be codified into formal guidelines.

“In general, if we're following guidelines and we're treating patients per guidelines, we're not going to have any issues,” she said.

Beyond ADCs, there is an insurance issue with oral oncolytics, because sometimes the one that has overall survival data isn’t the best one for the patient, perhaps based on comorbidities. As a result, they run into barriers with the insurer and have to appeal decisions.

“The thing that has worked the most in our institution is having a group of really qualified pharmacy reimbursement technicians, without who I think we would be at a loss,” van Ostran said. They review all of the medications that typically have prior authorizations to ensure patients get access as soon as possible.

“[The pharmacy reimbursement technicians] will follow the patient from the moment that the oncologist sends in the prescription to the time it gets to the patient's home—with me, in between, bugging them if it's taking too long to call, because a lot of these patients are older, and they get really overwhelmed with the insurance drama…” she added.

The final segment of the discussion involved the ethical and legal dilemmas surrounding drug waste. Florida’s current regulations prevent the redistribution of unopened, dispensed medications. To address this, organizations like the MCI have begun partnering with nonprofits to facilitate out-of-state donations, bypassing restrictive local laws to ensure that lifesaving medications reach those in need in other states rather than ending up in a biohazard bin.

“It is important to change these laws, not because we're trying to make some money off of a bottle of pills, but because a bottle may be worth $3000 and there's no reason to dump it down the drain when it can safely be used by somebody else,” Venkatappa said.

The Operational Reality of Cellular Therapies

While breast cancer care focuses on refining established pathways, the world of hematology is grappling with the sheer scale of disruptive innovation. A panel discussion moderated by Ariel Grajales-Cruz, MD, assistant member in the Department of Malignant Hematology at Moffitt Cancer Center, focused on the transition of administering chimeric antigen receptor (CAR) T-cell therapies and bispecific antibodies in specialized academic centers to broader clinical settings.

In conditions like multiple myeloma, these therapies have "dramatically changed the treatment landscape," in early relapse, late relapse, and maybe one day in the newly diagnosed setting, Grajales-Cruz said.

However, the move toward outpatient administration is fraught with difficulty. Firas El Chaer, MD, chief of leukemia and medical director of infusion services at MCI, pointed out that the commitment to these therapies must be absolute from an institutional level, and right now, his institute is still doing CAR T-cell therapy in the inpatient setting because that’s how the whole system was set up. MCI only discharges patients once they are over the cytokine release syndrome and immune effector cell–associated neurotoxicity syndrome period. For now, bispecific antibodies are also administered on an inpatient basis, but when it sets up a remote patient monitoring system, MCI could move bispecific antibodies to be completely outpatient.

University of Miami Sylvester Comprehensive Cancer Center is looking into ways to transfer most CAR T-cell therapy to the outpatient setting because “we’re starting to see some issues with reimbursement with some Medicare patients [and] some Medicaid patients,” explained Alvaro Alencar, MD, chief medical officer.

Complications after CAR T-cell therapy don’t occur immediately after the infusion, which gives institutions a safe window to have patients receive their infusion in the outpatient setting and potentially be admitted within 48 to 72 hours if needed, he said. As for bispecific antibodies, most of those are given in an outpatient setting with a 23-hour observation and patients are only admitted if they really require it.

Meanwhile Mount Sinai Medical Center isn’t doing CAR T-cell therapy, which means clinicians have to refer patients out. There are multiple barriers that have prevented Mount Sinai from incorporating CAR T-cell therapy, including needing to have champions who are knowledgeable about the treatment, explained Arnold Blaustein, MD, assistant professor at the Columbia University Division of Hematology/Oncology at Mount Sinai Medical Center.

“The commitment has to be made by the hospital administration to understand the impact of what one needs to really run a CAR T service in…a really excellent way that requires a financial output by the hospital and understanding what it's going to take,” Blaustein said. “Part of that is an educational device. They have to understand the impact more than anything else.”

Alencar said his institution is not partnering with the community to do step-up dosing and transferring patients for maintenance when it comes to bispecific antibodies, because the institution loses money on the initial doses and it’s also just easier to do all of the treatment after the ramp up.

El Chaer echoed these sentiments and added it’s an issue he’s heard colleagues at other institutions mention. “When they're ramping up inpatient and sending them out to the outpatient to the local oncologist, ultimately, you're losing a lot of money as a hospital if you're not administering the continuation and maintenance therapy at your institution,” he said.

Evolving Landscape of Precision Medicine

Precision medicine has the potential to be transformative, but it presents persistent challenges . In a discussion moderated by Manmeet Ahluwalia, MD, MBA, FACP, chief of medical oncology at MCI, physicians representing Miami’s top health systems shared their experiences integrating molecular profiling and genetic sequencing into patient care across a spectrum of hematologic and solid tumors.

Precision oncology has dramatically advanced patient stratification and tailored therapies, particularly in diseases like leukemia and non–small cell lung cancer. Amer Beitinjaneh, MD, MPH, MSc, professor of clinical medicine at the University of Miami Sylvester Comprehensive Cancer Center, detailed how molecular profiling at the University of Miami guides both diagnosis and prognosis in hematologic malignancies, using in-house and commercial platforms integrated within electronic medical records for efficient decision-making. Minimal residual disease testing is also used to determine depth of response and to predict relapse.

In the realm of solid tumors, Santiago Aparo, MD, MS, gastrointestinal medical oncologist at MCI, and Mike Cusnir, MD, The Pulver Family Chief of Hematology and Oncology and the codirector of gastrointestinal malignancies at Mount Sinai Medical Center, discussed the philosophical and practical shifts from the broad use of chemotherapy to increasingly targeted and less invasive approaches, such as liquid biopsies. They also emphasized the importance of not overtreating patients when molecular data suggest otherwise.

The conversation addressed systemic and operational barriers to fully realizing precision oncology’s promise. Delays in obtaining comprehensive genetic panel results can complicate and slow timely treatment decisions, especially for patients with aggressive cancers.

“I think one of the things that we need to think about is that we need to run very limited panels to improve the turnaround time and to have the information that we know is useful on a timely manner,” Aparo said. “And I think we're doing a very poor job in that regard.”

While insurance coverage has improved, cost and administrative burdens remain concerns, as does the need for robust bioinformatics support to interpret large, complex datasets. Panelists agreed that extensive genetic panels sometimes yield uncertain actionable value and may overwhelm both clinicians and patients with information unrelated to immediate care.

Navigating Cost, Paperwork, and Payer Friction

The final session of the day brought the clinical and administrative worlds into direct contact, focusing on the friction between provider recommendations and payer policies. The panelists discussed how clinical pharmacists are being integrated into oncology clinics, as well as pilot programs like the pharmacy hub at MCI.

In the pilot program of MCI’s pharmacy hub, pharmacy technicians were hired to handle paperwork and make the necessary calls to ensure patients receive the treatment they need, explained Tiba Al Sagheer, PharmD, BCOP, BCACP, pharmacy quality improvement coordinator for transplant and cellular therapy and hematology clinical pharmacy specialist at MCI. The program reduced the time from when the physician prescribed a drug to the moment the patient received it in their hand by more than 50%.

The panel delved into several pressing barriers facing oncology pharmacy practice, most notably the soaring cost of cancer drugs and the complexity of navigating insurance requirements.

“The benefits of these drugs…when you look at hard outcomes…it's not patient satisfaction. It's response rates, it's progression-free survival, it's overall survival,” said Matthew Chui, PharmD, BCOP, clinical oncology pharmacy manager, University of Miami Sylvester Comprehensive Cancer Center. “If it's meaningful, our physicians want to use it, and our jobs are to figure out how to make that happen.”

Al Sagheer also brought up the challenge of payers dictating therapy locations and imposing site-of-care steerage policies, which sometimes force patients to receive treatment in suboptimal locations. She’s gotten letters from insurance companies mandating a patient gets therapy elsewhere, which requires explaining to someone on the insurance side who doesn’t really understand stem cell transplant why that’s a risk.

“It's really challenging, and it takes a long time to try to get that through…,” she said. “Trust me, I can get everything. That’s why I’m called the magician. But it takes a long time.”

Reference

1. McLaughlin S, Ravani LV, Moy B, et al. Current landscape of sequencing ADCs in metastatic breast cancer. Ther Adv Med Oncol. Published December 17, 2025. doi:10.1177/17588359251396656