Balancing Innovation With Administrative Burdens in Cancer Care

Across central Florida, cancer care delivery is marked by the heavy footprint of Medicare Advantage (MA) and the increased demands of prior authorization (PA), including requirements that primary care providers be part of decisions that may be beyond their expertise.

If the process seems designed to slow decision-making, it works. Yet providers seem determined to make it work to give patients access to therapies that work better than ever across rare blood cancers and disorders, multiple myeloma, breast cancer, and bladder cancer. Experts across these fields gathered at the Marriott Orlando Downtown for a session of the Institute for Value-Based Medicine on December 4, 2025, on the eve of the annual meeting of the American Society of Hematology taking place across town at the Orange County Convention Center.

How to Ensure Access in Rare Blood Cancers

The first panel, “Quality Care Initiatives in Rare Hematology,” highlighted barriers patients face when trying to access advanced treatments for rare hematologic conditions, such as myelodysplastic syndromes, acute myeloid leukemia, and sickle cell disease.Moderator Dina Khalaf, MD,clinical associate professor, adult malignant hematology and stem cell transplant and cellular therapy at the University of Florida College of Medicine, led a panel that included the following:

• Ansh Mehta, MD, hematologist/oncologist, University of Florida Department of Medicine
• Joe Mirrow, director of managed care, Moffitt Cancer Center
• Asmita Mishra, MD, MBA, senior member, Department of Blood and Marrow Transplant and Cellular Immunotherapy, and medical director, payer strategies, Moffitt Cancer Center

A central theme was the impact of MA plans in Florida, where 60% of Medicare-eligible patients elect this coverage.¹ Mishra emphasized that these plans often feature narrow networks that limit access to specialized cancer centers, creating significant obstacles for patients in rural areas who need expert care. The panelists noted that site-of-care restrictions increasingly lead to fragmented treatment, with payers limiting coverage to acute phases while denying coverage when patients later experience complications—which creates problems for transplant and cellular therapy patients who require long-term monitoring.

In addition, Mirrow and Mishra said, patients and clinicians face barriers to genetic testing. Although testing technology has advanced dramatically—making comprehensive panels more affordable—payers often deny broader panels, approving only 50 genes instead of 100, Mirrow said.

This shows little understanding of what it takes to perform tests or how physicians use them, Mishra said. “From the clinical side, it’s very easy for us to run a very large panel, so that is not an issue,” she said. “The challenges on the clinical side [are] then, the interpretation of what these 10,000 genes…actually mean?”

When payers say they will only cover testing needed to pay for a targeted therapy in a current indication, Mishra said, “As you can imagine, as a clinician, we take a lot of umbrage with this, because we are trying to get ahead of the curve for several reasons. One, we want to look at the next target. We have clinical trials that patients could potentially be eligible for. But additionally, we want to know predictive and prognostic information.”

This personalized medicine approach is essential yet often denied, panelists said, with hematologic malignancies facing 10% to 15% denial rates.

Financial toxicity emerged as another major concern, with Mirrow warning that out-of-pocket now rise beyond $10,000 per year for patients with lower incomes. As 2025 drew to a close, he and other panelists were looking ahead to the loss of subsidies for patients who purchased coverage on the exchanges under the Affordable Care Act.² Some would likely lose coverage mid-treatment, taking hospital emergency departments (EDs) back to the days of being “insurers of last resort,” bearing the financial burden of uncompensated care.

“The hospital provides a lot of financial assistance, but it is very administratively burdensome to do,” Mirrow said.

The panel discussed what happens when patients have complications from novel treatments, such as chimeric antigen receptor (CAR) T-cell therapy and bispecific antibodies. As use of bispecifics increases, more patients will experience emergencies at community hospitals that may be unfamiliar with managing these sophisticated treatments. “They show up at a local emergency department, probably a 5-bed ED with an emergency doctor who’s not seen these complications,” Khalaf said. “He has no idea about complications of these drugs or disease. So, how do we establish partnership with our community colleagues, and how do we expand the education and the awareness about these conditions, medications, and complications?”

Larger academic centers have established 24/7 call lines and forged partnerships to prevent these scenarios, Mehta said, yet fragmentation of care remains a problem. Mishra stressed that expecting community partners to master all intricacies of emerging therapies is unrealistic, and she called for shared responsibility among providers, payers, and pharmaceutical partners.

Finally, Mehta highlighted the underutilization of allogeneic stem cell transplantation (ASCT) for sickle cell disease, which offers a 5-year survival rate of more than 90% with expanded donor pools including haploidentical options.³ The option of ASCT exists alongside a promising role for FDA-approved gene therapies, he said, despite insurance approval challenges.

In Breast Cancer, Balancing Personalized Medicine With Payer Requirements

The panel discussion, “Innovations in Breast Cancer Treatment,” examined the challenge of maintaining or increasing access to care as breast cancer treatment becomes more stratified through biomarker testing and targeted therapies. These changes bring new administrative burdens, putting time and cost pressures on health systems and practices.

Moderator Lisa Spiguel, MD, associate professor at the University of Florida Department of Surgery, opened by sharing an observation from Julie Gralow, MD, chief medical officer for the American Society of Clinical Oncology, that precision oncology is “taking common cancers and turning them into rare cancers.”⁴ Coy Heldermon, MD, PhD, associate professor of medicine, Division of Hematology and Oncology at the University of Florida Department of Medicine, acknowledged that although targeted approaches have improved progression-free and overall survival, the financial burden can be overwhelming, particularly for poorly insured patients who do not qualify for assistance programs. The panel noted that cancer care has become a leading cause of bankruptcy among health-related financial crises.⁵

Three physicians who practice at different locations of Orlando Health—Susan Constantino, MD,medical oncologist/hematologist; Amy Laughlin, MD, medical oncologist; and Nikita Shah, MD, medical oncologist—shared their perspectives on trying to bring innovation to patients while balancing more documentation demands, even for standard treatments.

Shah noted that some protocols call for performing circulating tumor DNA testing every month to 6 weeks, even “when we don’t have clear evidence of how that information really impacts survival in breast cancer.” What patients want, and what insurance companies see as necessary, can be far apart, she said. “I’m having to do peer-to-peers for standard chemotherapy that we never had to do before. I mean, trying to get a PET scan has almost become impossible. So yes, there are definitely more administrative burdens that are falling on us.”

Laughlin highlighted new requirements for primary care physician (PCP) approval for Oncotype DX—a standard-of-care test—that adds weeks to already lengthy turnaround times and burdens PCPs with decisions outside their expertise. PCP requirements now extend to routine scans and other elements considered standard of care.

Antibody-drug conjugates in earlier settings. If one can deal with the hurdles, there is the opportunity to deliver antibody-drug conjugates (ADCs), which have shown impressive responses in HER2-positive early-stage breast cancer in neoadjuvant and adjuvant settings. The panel noted evidence that had been presented at the October 2025 meeting of the European Society for Medical Oncology in Berlin, Germany.^6,7 Heldermon described the remarkable efficacy but also significant adverse effects of trastuzumab deruxtecan (Enhertu; Daiichi Sankyo and AstraZeneca). “When it works, it’s amazingly fast, and you see amazing responses, but you also see some pretty impressive toxicities. And it’ll be interesting to see what criteria the insurances are going to select for the neoadjuvant setting,” he said.

Laughlin welcomed chemotherapy-free options, noting that current neoadjuvant regimens, such as the regimen known as TChP (docetaxel [Taxotere], carboplatin, trastuzumab [Herceptin], pertuzumab), can result in substantial emergency department visits and admissions.⁸

However, the panel cautioned against overselling chemotherapy-free options, as these treatments can come with serious risks. “It’s targeted chemotherapy, yes,” said Laughlin, cautioning that ADCs can cause interstitial lung disease. Shah noted the risk of hypothyroidism or renal failure. “If the patient ends up on dialysis,” she said, “you’ve done them more harm at that point.”

“When it goes well, it goes well,” Laughlin said. “When it doesn’t, it doesn’t.”

Quality of life and mental health. The panel emphasized that mental health coverage for patients with cancer remains inadequate, compounded by counselor shortages and high turnover. Constantino noted the absence of available counselors at her institution, while patients specifically seek cancer-experienced therapists who understand their unique challenges. Spiguel shared her evolution toward referring all patients with breast cancer to psycho-oncology after realizing she could not predict who would struggle emotionally, implementing routine referrals regardless of age or presentation.

The panel stressed that supportive services such as physical therapy, occupational therapy, and psycho-oncology should be integrated into oncology care packages rather than asking patients to provide another co-pay that creates barriers, especially for patients traveling long distances.

Breast cancer screening. The panel confirmed that rates have generally rebounded to prepandemic levels, with improved access through extended hours and weekend screening. However, Shah highlighted ongoing confusion caused by frequently changing screening guidelines from different organizations, affecting patients and primary care providers regarding appropriate starting ages and intervals. Access bottlenecks persist for MRI breast imaging and biopsies, particularly affecting newly diagnosed patients. The panel discussed emerging technologies such as contrast-enhanced mammography and abbreviated MRI protocols as potential solutions, as well as artificial intelligence (AI), noting that reimbursement remains challenging. Heldermon noted significant radiologist shortages, exacerbated by the post–COVID-19 shift to remote reading, leaving fewer in-person radiologists available for diagnostic procedures and biopsies.

“I do think it’s the golden era of AI right now,” Spiguel said. “For radiologists, you have AI that’s augmenting what you can do. You’re doing it more, you’re doing it faster, more efficiently—or you’re catching things that maybe you wouldn’t have noticed. But ultimately, maybe AI will take over.”

In Myeloma, Another Wave of Innovation Beckons With Bispecifics

Multiple myeloma has already seen tremendous innovation over the past decade, and more is on the way. Only recently, clinicians became accustomed to quadruplet therapy, anchored by anti-CD38 monoclonal antibodies. Now, bispecific antibodies, currently approved for patients after extensive prior treatment, are being evaluated for use in earlier lines of care.⁹

As moderator Brooke Adams, PharmD, BCOP, clinical pharmacist at Orlando Health Care Institute, noted in opening the panel, “Innovations in Multiple Myeloma Treatment,” this shift raises questions on everything from the biology of T cells to the ability of health systems to treat new waves of patients in search of these complex therapies. The panel featured a return appearance from University of Florida’s Mehta, along with Arlene Gayle, MD, medical oncologist/hematologist, AdventHealth; and Ariel Grajales-Cruz, MD, medical oncologist/hematologist, Moffitt Cancer Center.

Adams noted that studies to be presented at ASH would raise new questions about bispecific delivery. When does outpatient delivery make sense for these treatments? What happens if a patient does not have a ready caregiver? How should clinicians handle sequencing? Payers, of course, may have a say in all this.

The conversation opened with discussion of adding anti-CD38 monoclonal antibodies—such as daratumumab (Darzalex; Johnson & Johnson) or isatuximab (Sarclisa; Sanofi)—to triplet backbones, often VRd (bortezomib [Velcade], lenalidomide [Revlimid], dexamethasone). Mehta highlighted that daratumumab-based quadruplets achieve minimal residual disease (MRD) negativity rates exceeding 60% compared with traditional triplet regimens.^10,11 This deeper response raises questions about transplant necessity for MRD-negative patients.

“We cannot cure myeloma today,” Gayle said. “Although we really want to think that we’re doing that; I think we’re getting there. So, the goal then is to get the patient into the deepest possible remission. And the deepest possible remission that we can achieve is an MRD.”

Grajales-Cruz was emphatic about the universal application of quadruplet therapy, stating there is “little to no reason in this era to not give 4 drugs to a patient with a diagnosis of myeloma” regardless of transplant eligibility. However, he cautioned that community physicians must adapt dosing strategies from clinical trials to real-world settings. “That’s the biggest message that we always have to convey to the community doctors,” he said. “It’s better to have 4 drugs at lower doses than 3 drugs at full doses.”

The panel agreed that anti-CD38 therapy should be the standard, with Grajales-Cruz noting the importance of achieving deep responses because “it’s better to be high risk and MRD negative than standard risk and MRD positive.”

Regarding maintenance therapy, the panel discussed the evolving landscape beyond lenalidomide, with the phase 3 CASSIOPEIA trial (NCT02541383),¹² demonstrating daratumumab’s role in maintenance. Gayle presented the emerging paradigm that dual-drug maintenance makes sense for patients not achieving MRD negativity, as the method of reaching deep response matters less than actually achieving it.

The discussion extensively addressed bispecific antibodies moving to outpatient delivery. Gayle stressed this transition is “mandatory.”

“Most of the clinical trials now are using bispecifics in combination, and in the frontline setting,” she said. Although it’s not clear how many years it will take, once these therapies move into frontline care, “You will not have enough hospital beds to put these patients.”

Adams agreed, highlighting the necessity of educating emergency department and critical care staff about cytokine release syndrome and neurotoxicity, because patients experiencing a fever at 2 AM will show up at local emergency departments. The panel stressed that academic centers must support community providers in this transition, with education and other resources, if they want to encourage outpatient bispecific administration.

The sequencing debate—which should come first, CAR T-cell therapy or a bispecific—revealed the complexity of care decisions. “CAR T gives something to the patient that no other drug has so far, which is freedom,” Grajales-Cruz said, emphasizing that real-world toxicity profiles, particularly severe cranial nerve palsies reaching 50% in earlier settings compared with 7% in trials, raise serious concerns.

He cautioned against prematurely moving these therapies into earlier lines of care, asking “what’s the point” if patients start using wheelchairs despite myeloma response. Gayle noted the practical advantage that bispecifics are “on the shelf” for urgent treatment needs. Mehta suggested preferring CAR T-cell therapy when logistics allow, although he acknowledged the higher infection risk.¹³ The panel concluded that sequencing decisions must be highly individualized based on disease burden, urgency, social support, and patient-specific factors.

What is clear, Adams said, is how quickly change is coming to multiple myeloma treatment. “Buckle up,” she said, “because it’s about to get more exciting.”

New Therapies, Biomarkers Advance Bladder Cancer Treatment

Bladder cancer has historically stood out as the highest-cost cancer from diagnosis to death,¹⁴ according to Zachary Smith, MD, a urologist from AdventHealth who moderated the evening’s final panel. This has been due to everything from the cost of therapies to the methods used to detect or confirm cancer, which could be invasive and even require surgery.

“There’s a lot of new tools that we’ve had in the last 15 years, but in the last few years, it has really kind of come to the forefront…how can we avoid the invasive stuff?” Smith said. “How can we avoid cystoscopies? How can we avoid biopsies? How can they pee in a cup?”

Joining Smith were panelists Daniel Araujo, MD, medical oncologist/genitourinary specialist, University of Florida; and Jay Amin, MD, a urologist with Orlando Health Cancer Institute.

Because of bladder cancer’s costs, PA is still a reality for physicians in this field, as cystoscopy remains an essential tool for diagnosis and surveillance despite the emergence of noninvasive urine biomarker tests from Cxbladder. Amin agreed, noting that Cxbladder tests can yield negative results despite visible tumors on cystoscopy; thus, despite PA challenges, cytology—or use of noninvasive cell analysis by a pathologist—remains a practical option.

The most significant advance discussed was the ADC enfortumab vedotin (EV, Padcev; Astellas and Pfizer) plus pembrolizumab (Keytruda; Merck) in metastatic disease, which has received FDA approval in 2 indications: in first-line treatment for locally advanced or metastatic patients not eligible for cisplatin chemotherapy, and as perioperative (neoadjuvant/adjuvant) treatment for patients with muscle-invasive bladder cancer (MIBC) also ineligible for cisplatin.^15,16 However, an analysis appearing in the journal Value in Health found that the cost of this combination would have to be reduced 76% to be considered cost-effective.¹⁷

Araujo explained this combination demonstrates apparent synergistic rather than merely additive effects, with patients achieving prolonged responses on maintenance pembrolizumab. He noted this raises questions about potential cures, similar to what is being seen in melanoma and renal cell carcinoma.

This was different from what had been seen for EV monotherapy in third-line treatment. “You had good response rates, but the duration of response is not the best,” he said. By contrast, when results for EV plus pembrolizumab in first-line treatment were released, “This was very, very surprising.... We are seeing patients [who] receive a few cycles of EV and pembro, and they stay on maintenance pembro past 1 to 2 years, and they don’t recur.”

The regimen has proven effective even for urothelial variants and squamous cell bladder cancer, although prospective data for tumors with significant divergent differentiation remain limited. Smith said the FDA approval, based on the phase 3 KEYNOTE-905 data (NCT03924895), for perioperative use in patients with MIBC who are cisplatin-ineligible, was particularly valuable for node-positive or T3/T4 patients who previously lacked good treatment options before surgery, as distant metastasis remains the primary cause of death in muscle-invasive disease.¹⁸

The panel extensively discussed non–muscle-invasive bladder cancer management amid chronic shortages of the immunotherapy BCG.Amin described the challenges of rationing BCG during severe shortages, including dose-splitting strategies and difficult allocation decisions. Gemcitabine-docetaxel has emerged as an effective alternative, developed without formal Institutional Review Board approval but now widely used with 75% to 80% complete response rates at 2 years—comparable to BCG at a fraction of the cost.¹⁹

However, newer intravesical agents like mitomycin intravesical solution (Zusduri; UroGen Pharma) cost over $12,000 per round, creating intense scrutiny from institutional cost committees. Smith expressed frustration that health systems now track per-patient treatment costs, potentially penalizing physicians for using expensive but effective therapies for low-grade disease that could be fulgurated in-office.

Personalizing treatment selection represents the next frontier, panelists said. There is potential to harness AI to use urinary tumor DNA panels to predict treatment response and identify which patients can avoid cystectomy.

“It’s time, perhaps, for us to try to figure it out: Who needs what?” Araujo said. “What absolutely requires local therapy? Who are the patients we should be treating aggressively with EV and pembro? Who are the patients for BCG and so forth?”

“The holy grail of urology is, who can avoid cystectomy,” Smith said. “I mean, I’m the guy that takes bladders out [and] everyone hates me…cystectomy is the worst operation in the world.”

Yet Smith believes the day may come when what he does might no longer be necessary—the keys will be better predictive tools and better treatments, and both are slowly improving. “Almost every study we’ve seen that shows that we look at clinical complete response, the patients who had the MRI and the cystoscopy and then went on to cystectomy anyway, which shows that we just haven’t gotten there yet. It’s very hard to predict who has a complete response pathologically.”

“We certainly need to make some improvement in prediction of all of these things, both treatments and surgery, but I think we’ll get there,” Smith said.

References

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