Oncology Innovation Outpaces Managed Care’s Ability to Keep Up

The pace of oncology innovation has accelerated beyond managed care's capacity to keep up, with gaps persisting across biomarker testing, pharmacogenomics, chimeric antigen receptor (CAR) T-cell therapy access, clinical pathway adherence, and care navigation, according to a session titled "Oncology in Focus: What's Hot, What's Next!" presented at the annual meeting of the Academy of Managed Care Pharmacy (AMCP) in Nashville, Tennessee.

Abby Kim, PharmD, BCOP, senior director of clinical strategy and oncology specialty solutions at Prime Therapeutics, and Sneha Sharma, PharmD, director of specialty clinical solutions at Prime Therapeutics, alternated between the clinical and managed care dimensions of 6 topics, illustrating how each represents both an opportunity and a challenge for payers.

"The reality is we still have a lot of significant opportunity to close gaps, because innovation has moved faster than our ability to consistently deliver precision at scale," said Kim.

Precision Oncology Breaks Down in the Execution

Kim opened with precision oncology, noting that while the concept of matching the right drug to the right patient at the right time has been discussed for more than 2 decades, the execution remains inconsistent. Biomarker testing now spans the entire cancer continuum, from diagnosis and treatment selection to monitoring, resistance detection, and surveillance. There are now more than 100 FDA-approved precision oncology agents, and over 60% of oncology approvals in the past 5 years have been precision therapies, she said.

Despite this growth in new precision medicines, a study by Sadik et al published in JCO Precision Oncology found that among approximately 1000 patients with advanced non–small cell lung cancer (NSCLC) who were eligible for precision-guided treatment, only 35.6% ultimately received targeted therapy.¹ Patients were lost at each step of the pathway, from tissue biopsy and biospecimen collection to test ordering, result timing, and the final treatment decision.

"The promise of precision oncology really breaks down in the execution," Kim said. "And this is where managed care can have the greatest impact."

From a policy standpoint, Sharma noted that no federal legislation exists for precision medicine coverage, resulting in a patchwork of state-level laws. Fewer than half of the states have enacted biomarker testing coverage laws, with requirements varying widely. In California, for example, coverage requires stage 3 or 4 cancer and prior authorization, while Illinois and Louisiana have no prior authorization requirement.

Liquid Biopsy Expanding Beyond Companion Diagnostics

Closely related to precision oncology, Kim discussed the expanding role of liquid biopsy, which detects circulating tumor DNA (ctDNA) through a minimally invasive blood draw. While tissue biopsy remains the gold standard at diagnosis, liquid biopsy complements it by offering faster turnaround, accounting for tumor heterogeneity, and enabling serial assessment over time.²

Applications are expanding beyond companion diagnostics for treatment selection. Kim noted that liquid biopsy is increasingly being used concurrently with tissue biopsy in NSCLC, for treatment response monitoring, detection of emerging resistance mutations, and surveillance for recurrence, often before disease is visible on imaging. Multicancer early detection (MCED) tests represent the next frontier, though none have received FDA approval.

On the coverage side, Sharma noted that Medicare coverage aligns with National Comprehensive Cancer Network (NCCN) guidelines for minimal residual disease in hematologic cancers and is expanding in solid tumors. Commercial coverage, however, remains narrower, typically limited to actionable mutations when tissue biopsy is not feasible. The Medicare Multi-Cancer Early Detection Screening Coverage Act was introduced in 2023 but has not yet been enacted.

DPYD Testing: A $175 Test That Could Prevent $180,000 in Toxicity Costs

Next the duo turned to pharmacogenomics, focusing on DPYD testing prior to fluoropyrimidine-based chemotherapy as a longstanding gap in precision medicine delivery. Fluoropyrimidines, including fluorouracil (5-FU) and capecitabine (Xeloda), are among the most widely used chemotherapy agents, indicated across colorectal, gastric, breast, pancreatic, and head and neck cancers. The DPD enzyme, encoded by the DPYD gene, metabolizes 80% to 85% of 5-FU. Patients with DPYD variants, which occur in 4% to 8% of the population, have reduced or absent enzyme activity, leading to drug accumulation and potentially fatal toxicity.³

Kim noted that an estimated 700 to 1400 patients die annually in the US from 5-FU toxicity due to undiagnosed DPYD mutations. Preemptive DPYD testing costs $175 to $300 per test, she said, while treatment of severe fluoropyrimidine toxicity can exceed $180,000 per event. The antidote, uridine triacetate, carries an average wholesale price of $96,000, and outcomes are variable when intervention is delayed. In 2025, this risk was added to the NCCN guidelines and subsequently as a black box warning to the capecitabine label.

"I know that many health plans were already requiring testing prior to that, but if you weren't, the takeaway is this wasn't a sudden science problem," Kim said. "It was a delayed policy alignment."

Sharma shared the story of a patient advocate whose mother, diagnosed with anal cancer at age 73, was treated with 5-FU and developed continuous diarrhea, mouth sores, and dehydration before collapsing. She died within a month, not from cancer but from the impacts of having an undiagnosed DPYD mutation. The toxicity was documented in the emergency department chart but was not reported as an adverse drug event, and cardiac arrest was listed as the cause of death.

"Within a month, she passed away, but not from the cancer, but from the DPYD mutation she didn't know she was carrying," Sharma said. "The biggest intervention we as pharmacists can make is to have that patient and provider hold the drug until you get your test results back."

CAR T-Cell Therapy Shifting From Rare to Routine

CAR T-cell therapies have represented one of the more cutting-edge and exciting new therapies in oncology, and their use has been slowly gaining traction for nearly a decade. The full potential of these therapies could be better realized through better access to care at the community setting.

To start the discussion, Kim described how CAR T-cell therapy, first approved in 2017, has expanded with 7 approved products now covering indications across acute lymphoblastic leukemia (ALL), large B-cell lymphoma (LBCL), follicular lymphoma, mantle cell lymphoma, multiple myeloma, chronic lymphocytic leukemia, and most recently marginal zone lymphoma with the December 2025 approval of axicabtagene ciloleucel (Yescarta). Critically, these therapies are moving into earlier lines of treatment.

"CAR T is becoming no longer a rare last-ditch option," Kim said. "It's becoming part of standard treatment pathways for a growing number of patients much earlier in their disease course."

From a regulatory standpoint, Sharma noted that in 2025 the FDA discontinued the Risk Evaluation and Mitigation Strategies (REMS) program for BCMA- and CD19-targeting CAR T products, including idecabtagene vicleucel (Abecma), lisocabtagene maraleucel (Breyanzi), ciltacabtagene autoleucel (Carvykti), tisagenlecleucel (Kymriah), brexucabtagene autoleucel (Tecartus), and axicabtagene ciloleucel. Facilities are no longer required to obtain special certification to dispense CAR T or to have immediate access to tocilizumab. Postadministration monitoring has been reduced from 4 weeks to 2 weeks and driving restrictions have been shortened from 8 weeks to 2 weeks.⁴

This coincides with a push to expand CAR T beyond large academic medical centers into community and outpatient settings. The Foundation for Accreditation of Cellular Therapies (FACT) introduced flexible accreditation pathways and published standards for community clinical settings in 2025. Currently, nearly one-third of all inpatient CAR T procedures are performed at just 9 sites across California, Florida, and Texas, while Pennsylvania, Minnesota, and Tennessee performed 40% of outpatient CAR T procedures, Kim noted. More than 125 sites now administer CAR T, she added, though geographic access concerns remain for rural populations.

"I think the key implication here is that accreditation has shifted from becoming a barrier to access toward becoming an enabler of potential responsible expansion," said Kim. "With expanding indications and more adaptable accreditation frameworks, CAR T is probably no longer constrained to patients in academic centers. I think that is going to accelerate very quickly in the next 1 to 3 years."

Clinical Pathways Struggling to Keep Pace

Kim addressed the challenges facing clinical pathways, which were originally designed in response to rising drug costs and treatment complexity. However, pathways that worked well when oncology treatment was histology-driven with fewer biomarkers and fewer lines of therapy are now struggling to keep pace with rapid FDA approvals, complex biomarker requirements, overlapping indications, and chronic treatment paradigms, she said.

In a retrospective study published in JCO Oncology Practice,⁵ 8357 patients with metastatic solid tumors were assessed over 3 years. Of these, 65.3% were on pathway-recommended regimens, but that proportion trended downward from 74.3% in 2018 to 59.8% in 2021. Notably, patients on pathway regimens were more likely to visit the emergency department (27.7% compared with 23.3%), have treatment-related emergency visits (18.1% compared with 15.0%), and experience higher hospitalization rates (36.4% compared with 31.8%).

In another example, Kim noted that in KRAS G12C–mutated metastatic colon cancer, clinical pathways may recommend panitumumab or sotorasib (Lumakras), whereas clinical policy may prefer cetuximab (Erbitux).

"The role of pathways seems to be shifting a little bit," said Kim. "Pathways are increasingly being used not just to guide what to use, but really to help define what not to use."

Sharma added that pathways often do not account for biosimilar preferencing, drug wastage, or timely guideline updates, further limiting their utility as a cost management tool.⁶

Virtual Navigation Addressing What Utilization Management Cannot

In the final topic, Kim and Sharma discussed the shift from traditional utilization management toward digital enablement and virtual navigation. With over 2 million new cancer cases projected in the US in 2026 and oncology spend projected to hit $180 billion by 2028,⁷ Kim noted that traditional tools such as prior authorization and formulary design can influence drug choice but do not address what happens around the drugs.

"Oncology cost control is less about adding more utilization management at this point, and more about closing known care gaps that utilization management might not actually reach," said Kim.

Research has shown that virtual navigation programs can meaningfully reduce total cost of care among Medicare Advantage members with cancer, driven largely by reductions in acute care utilization.⁸ Sharma noted that most patients 65 years and older do not have a caregiver to help with their care, making virtual navigation particularly valuable for this population.

"Precision oncology is no longer optional," Sharma said in closing. "Everything brought forward today needs to be implemented."

References

1. Sadik H, Pritchard D, Keeling DM, et al. Impact of clinical practice gaps on the implementation of personalized medicine in advanced non-small cell lung cancer. JCO Precis Oncol. 2022;6:e2200246. doi:10.1200/PO.22.00246
2. Blair L, Annapragada A, Niknafs N, Velculescu VE, Anagnostou V. Liquid biopsies across the cancer care continuum. Nat Med. 2025;31(12):4006-4021. doi:10.1038/s41591-025-04093-9
3. Nguyen DG, Morris SA, Hamilton A, et al. Real-world impact of an in-house dihydropyrimidine dehydrogenase (DPYD) genotype test on fluoropyrimidine dosing, toxicities, and hospitalizations at a multisite cancer center. JCO Precis Oncol. 2024;8:e2300623. doi:10.1200/PO.23.00623
4. FDA eliminates Risk Evaluation and Mitigation Strategies (REMS) for autologous chimeric antigen receptor CAR T cell immunotherapies. News release. FDA. June 27, 2025. Accessed April 14, 2026. https://www.fda.gov/news-events/press-announcements/fda-eliminates-risk-evaluation-and-mitigation-strategies-rems-autologous-chimeric-antigen-receptor
5. Liu Y, Mullangi S, Debono D, et al. Association between oncology clinical pathway utilization and toxicity and cost outcomes in patients with metastatic solid tumors. JCO Oncol Pract. 2023;19(9):731-740. doi:10.1200/OP.23.00199
6. Oderda GM, Brixner DI, Biskupiak J, Harnett J, Chen CI, Quek RGW. Evolving oncology care management trends in the United States: a survey among health care decision makers. J Manag Care Spec Pharm. 2024;30(8):825-833. doi:10.18553/jmcp.2024.30.8.825
7. IQVIA Institute for Human Data Science. Global Oncology Trends 2024: Outlook to 2028. IQVIA; May 2024. Accessed April 14, 2026. https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/global-oncology-trends-2024
8. Mullangi S, Worland S, Hill B, et al. Association of patient navigation with cancer health spending among Medicare Advantage members: a difference-in-differences analysis. Presented at: ASCO Quality Care Symposium; September 30-October 1, 2022; Chicago, IL.