Logistics, Payer Rules, and Care Coordination Shape Access to Cancer Innovation

Getting new cancer therapies to patients increasingly depends on logistics, payer rules, and care coordination as much as on clinical eligibility, according to oncologists and pharmacists who discussed access barriers in blood cancers, breast cancer, bladder cancer, and pharmacy operations at an Institute for Value-Based Medicine event held September 17, 2026, in St. Louis, Missouri.

The program brought together faculty from local organizations, including Washington University in St. Louis (WashU) and Mercy. Across the sessions, the panelists agreed that treatments are advancing faster than the systems built to deliver them.

Hematologic Malignancies: A Large Gap Between Need and Access

Only a fraction of patients who could benefit from chimeric antigen receptor (CAR) T-cell therapy receive it, said Armin Ghobadi, MD, director of the cellular therapies at Siteman Cancer Center at Barnes-Jewish Hospital and WashU Medicine. Using what he described as back-of-the-envelope estimates, Ghobadi said roughly 25,000 to 30,000 patients in the United States each year have an indication eligible for treatment with a chimeric antigen receptor (CAR) T-cell therapy, but approximately 5000 received it last year, or roughly 20%.^1,2

This estimate is consistent with those from advocacy groups such as the CAR T Vision Steering Committee, which has called for steps to make CAR T-cell therapy more widely available.³

One driver, he said, is that patients are never referred to a CAR T-cell center because of misperceptions about eligibility. Unlike stem cell transplant, CAR T-cell therapy has no age cutoff, Ghobadi said, noting that his center has treated a 93-year-old patient. He cited research that patients older than 65 years had similar outcomes as younger patients.^4-6

Although there are exceptions, such as patients with significant comorbidities or high disease burden or those without a caregiver, Ghobadi said his default is to treat CAR T as an outpatient therapy in part because inpatient administration is financially unsustainable for hospitals.

“I want to give it to any as many patients as needed” and that is why Siteman created an outpatient cell therapy center, he said. “To me, CAR T is an outpatient treatment until proven otherwise, or until basically you can’t give it outpatient.”

Zachary Crees, MD, assistant clinical director of WashU’s Center for Gene and Cellular Immunotherapy, echoed that barriers that might prevent a patient from receiving CAR T-cel therapy in the outpatient setting. For instance, patients must stay within 30 minutes of the medical center for the first 2 weeks after infusion and within 2 hours afterward. Both Crees and Ghobadi said they have found no payer or manufacturer support for paid caregivers, but it’s important that a patient has someone who can be there to monitor symptoms and transport them to the emergency department if signs of cytokine release syndrome emerge.

Amy Zhao, MD, chief resident in the internal medicine residency program at WashU and a specialist in neoplasms, noted that lodging services like Hope Lodge and social workers have been particularly helpful finding ways for patients to stay close to the treatment center.

Payer policy is another barrier that to care that physicians have to navigate, Crees noted. He explained that while there has been an explosion of new therapies in the hematologic malignancy space, insurance policies don’t adapt as quickly as the FDA approves new options. Zhao said inclusion in the National Comprehensive Cancer Network (NCCN) guidelines can help secure coverage for off-label use, citing luspatercept (Reblozyl; Bristol Myers Squibb), which isn’t technically approved for myelofibrosis.

“But it’s in the NCCN guidelines,⁷ so we have been able to get it for our patients and get insurance to cover it,” she explained.

More Options, More Gray Zones in Breast Cancer

The expansion of antibody-drug conjugates (ADCs) and targeted agents has made treatment selection in breast cancer far more nuanced, said Nusayba Bagegni, MD, associate professor of medicine at WashU Medicine and an oncologist at Siteman Cancer Center. She noted that survival in metastatic triple-negative disease has moved from approximately 1 year to 2 years, and with more ADCs in the space, the conversation is becoming more nuanced.

“A lot of how I decide which antibody-drug conjugate to consider is looking at the efficacy data, looking at being able to combine with immunotherapy if the disease is PD-L1 positive, and then looking at some of the toxicities that we can see with these therapies,” Bagegni said.

Moderator Lindsay Peterson, MD, MSCR, associate professor of medicine at WashU Medicine, added that more goes into these decisions than just the trial data. There have been patients who live far from the clinic may opt for every-3-week regimens when other factors are equal.

Right now, sequencing guidance is still unclear, Bagegni said. Patients tend to benefit most from the first ADC they receive, and that whether to “sandwich” chemotherapy between ADCs remains unresolved. “The jury’s still out there as to whether that actually makes a difference or not,” she said. “It seems like it probably doesn’t.”

Bagegni said there is a need for more ADCs with different payloads, but on the access side, Peterson noted that approval does not guarantee availability, as pharmacies may not yet stock a new drug. Bagegni said gedatolisib, which was approved in July for PIK3CA wild-type disease,^8,9 is not yet commercially available but is accessible through an extended access program.

On disparities, Foluso Ademuyiwa, MD, MPH, MSCI, professor of medicine at WashU Medicine, said gaps for Black and younger women begin early and are disparities are multifactorial. When these patients see doctors, their symptoms are minimized before they are diagnosed and sent to see an oncologist or genetic services.

“Their care is not escalated as it should be, and therefore that leads, ultimately, to disparities in care,” she said.

Furthermore, there is research showing minority women are less likely to even be referred for genetic counseling and testing even when eligible.^10,11 “It’s not really a patient refusal problem. It’s more of a system-wide problem,” she said.

The remedies Ademuyiwa suggested included patient navigation, point-of-care testing, tele-navigation, and automatic referral triggers for patients with triple-negative disease or those below a certain age. Peterson added that many patients decline testing out of the misconception that results will affect health insurance when the concern is life insurance. Ademuyiwa named improved screening adherence across all racial groups as the area most likely to “move the needle.”

For older adults, Katherine Clifton, MD, associate professor of medicine at WashU Medicine, said a small percentage of participants in pivotal CDK4/6 inhibitor trials were 65 years and older. While they do receive a benefit, there isn’t a much data in this population and there aren’t great toxicity calculators for oral therapies.

“[CDK4/6 inhibitors] are not without toxicity, but also we don’t want to rule patients out and just automatically count them out from CDK4/6 because they’re older,” she said. Instead, she discusses the risk-benefit ratio with the patient. For instance, abemaciclib (Verzenio; Eli Lilly and Company) has more diarrhea but it’s only given for 2 years in the adjuvant setting vs ribociclib (Kisqali; Novartis), which is better tolerated but given for 3 years and requires liver monitoring.

Panelists also weighed the newly approved strategy of switching therapy when an emerging ESR1 mutation is detected in circulating tumor DNA (ctDNA), based on the SERENA-6 trial of camizestrant (Etcamah; AstraZeneca),¹² which received accelerated FDA approval in September.¹³ Clifton said that survival data are not yet available but that patients may be drawn by better tolerability, and she expects to adopt the approach, with more discussion for patients stable for years. Ademuyiwa said she would test more frequently and be selective, while Bagegni raised workflow concerns, including how ctDNA testing would be coordinated with scans, how quickly results would return, and the potential for added patient anxiety.

Reclassifying Risk and Rethinking Bladder Preservation

Bladder cancer is among the costliest cancers to treat per patient because of frequent recurrence, repeated cystoscopies, and expensive drugs, said panelist Gautam Agarwal, MD, director of precision medicine and urologic oncologist at Mercy Hospital. However, it’s primarily a blue-collar disease, disproportionately affecting patients with lower socioeconomic status and occupational or environmental exposures, he added.

Agarwal said updated International Bladder Cancer Group recommendations help subdivide the broad intermediate-risk category of non–muscle invasive disease using clinical and pathologic features such as tumor size, number, and recurrence.¹⁴ However, he said the field still cannot reliably match patients to specific new therapies.

On biomarkers, panelists agreed that ctDNA is not yet routine in non–muscle invasive disease. Somasekhara Bandi, MD, medical oncologist at Mercy who leads a trial of ctDNA-guided escalation and de-escalation at Mercy, said plasma tests appear more accurate than urine tests, which may produce false positives. Agarwal added that older, smaller-panel assays may miss low-volume disease, whereas newer whole-genome approaches are more sensitive, and no urine assay is yet ready for clinical use.

On bladder-sparing strategies, Agarwal cautioned against getting ahead of the evidence. “There’s never been a trial that showed that it’s safe to not take out the bladder in muscle-invasive disease for these perioperative regimens,” he said. If a patient doesn’t complete the prescribed therapy on a trial after not removing the bladder, there’s a chance of a recurrence, although he sees the potential in the future.

Trials are testing whether negative ctDNA, imaging, and cystoscopy can support bladder retention. However, patients have to undergo radiation, which may impact quality of life with patients experiencing “miserable” bladder-related adverse effects. A large patient-reported outcomes study found that patient satisfaction at 9 months was similar for patients who underwent cystectomy and those who kept their bladder.¹⁵

Moderator Russell Pachynski, MD, associate professor of medicine and director of genitourinary oncology research at WashU Medicine, raised the challenge of counseling curative-intent patients on perioperative enfortumab vedotin (Padcev; Astellas/Pfizer) plus pembrolizumab (Keytruda; Merck).^16,17 Bandi and Yifan Tu, MD, hematology/oncology physician at Mercy, said they set expectations early about skin toxicity, neuropathy, and hyperglycemia, and that dose reductions and brief interruptions have allowed most patients to complete treatment. Some patients question adjuvant therapy after a pathologic complete response, the panelists said, and ctDNA may eventually help guide those conversations.

Pharmacy Operations: Where Approvals Meet Reality

The final panel focused on the gap between FDA approval and patient access. Sebastian Cerdeña, PharmD, BCOP, oncology pharmacy clinical specialist at Barnes-Jewish Hospital, described how bispecific antibodies in multiple myeloma have shifted from required inpatient observation to outpatient administration with telehealth follow-up. However, selection patients who live far away for outpatient treatment requires careful consideration because they still need to come back for ramp-up doses or be treated for emergent toxicities.

“But I think [outpatient treatment] is kind of where everything is heading,” Cerdeña said. “It also opens up inpatient beds for the patients who really, really need them, and we don’t have as many patients sitting in the hospital waiting for a potential toxicity.”

Moderator Janelle Mann, PharmD, BCOP, manager of clinical pharmacy services at WashU Medicine, said one of the largest barriers is how quickly a new drug appears in the electronic health record (EHR). It can take approximately 3 weeks after FDA approval before the drug record is available in the First Databank database for IT analysts to build on.

“We have run into situations where, yeah, the pharmacy has it on their shelf, but we have no way to send an actual order,” she said.

Mara Hofherr, PharmD, oncology clinical pharmacist at WashU Medicine, said her team often completes prior authorizations in advance so that when the drug becomes available, the patient can receive it.

Panelists were sharply critical of white bagging, in which payers require drugs to be dispensed to a hospital or clinic by a designated specialty pharmacy, or brown bagging, in which the drugs are brough in by the patient. Hofherr described a patient with union insurance who could receive cyclophosphamide at the institution but would have had to obtain docetaxel for home administration.

“It’s a nonsensical way of them trying to save money, and it’s really harming the patient,” she said. Mann warned that each added hurdle “brings a risk that a patient decides to not go forward,” and urged advocacy with state regulators and health systems.

On waste, Cerdeña and Mann said automated dose rounding in the EHR has reduced manual work and helped conserve drug during shortages such as ifosfamide.¹⁸

References

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