How Community Providers and Specialty Pharmacies Are Closing the Access Gap

The pipeline for advanced therapies is expanding at an incredible pace, with many new and exciting developments on the horizon. The health care delivery system, however, is not keeping up the way it needs to. Fran Gregory, vice president of emerging therapies at Cardinal Health; Leigh Denny, PharmD, senior director of value and evidence scientific engagement at Johnson & Johnson (J&J); and Philip Marjon, MD, a hematologist-oncologist at California Cancer Associates for Research and Excellence, spoke on this topic at AXS2026.

Gregory opened with a fictional but representative patient story about “Sarah,” a patient with relapsed lymphoma on her fourth line of treatment who is referred for chimeric antigen receptor (CAR) T-cell therapy, only to learn she must temporarily relocate hours away from her home to an academic medical center for nearly 2 months. "Think about how Sarah's experience could change if that treatment were available to her closer to home," Gregory said, framing the idea that the future of advanced therapy delivery should be community-based.

Advanced therapies, including CAR T-cell therapy, gene therapies, oncolytic viruses, and individualized neoantigen therapies, carry price tags ranging from $300,000 to more than $4 million per dose. The number of approved products, currently in the range of 50 to 60, is expected to grow exponentially over the next few years. Projections suggest more than 100,000 patients could be candidates for cell and gene therapies in the US by 2030, with over 200 new approvals projected by that time.¹

“Regardless of how wrong or right these slides are," Gregory acknowledged, "the future is extremely exciting for advanced therapy." However, she also acknowledges that this is a volume that academic medical centers simply cannot absorb alone.

Critically, oncology is no longer the only destination for these treatments. The pipeline now includes therapies for other specialties, ranging from cardiology to metabolic conditions to blindness. This expansion brings a new challenge as most nononcology specialists have never bought and billed a million-dollar drug. "Those providers have never infused a product in their office," Gregory noted. "They are really going to be turning to specialty pharmacies to help them manage some of those operational components."

Denny described some of the innovations in the field, from CAR T-cell products targeting dual antigens, trispecific antibodies on the horizon, checkpoint inhibitors with up to 18 approved cancer indications, and precision oncology increasingly guided by specific tumor markers. "We're seeing this huge trajectory of innovation take off," she said.

When talking about the economics, Denny said that "revenue should not be a curse word in our environment," noting that J&J invested $13.5 billion in research and development in 2024 alone, which is approximately 124% more than it spent on sales and marketing.

On the regulatory front, she said that the FDA's Real-Time Oncology Review program, the acceptance of minimal residual disease negativity as a clinical trial end point, and decentralized clinical trials that allow community providers to participate and patients to stay closer to home. "[Approximately] 45% of the US population is now within a 20-minute drive of a community oncology provider," she said. "That's so amazing."

Marjon, who practices in southern California, provided the ground-level view where he described 2 real cases in which eligible patients were delayed or denied access to curative therapies not because of clinical failure, but because of system failure:

• In one case, a patient with chronic lymphocytic leukemia who clearly needed CAR T-cell therapy had the treatment denied by insurance and redirected to a less effective agent, which ultimately led to disease progression.
• In another case, a 21-year-old with transfusion-dependent beta thalassemia for whom CRISPR-based gene therapy represented a potential cure experienced a 14-month delay stemming from administrative obstacles, including a requirement that he obtain a new primary care provider and an unrelated inability of a specialty pharmacy to supply his chelating agent. This caused his iron levels to rise and temporarily made him ineligible for treatment.

"The gap is no longer scientific," Marjon said. "[It] is operational. Patients are eligible, but the system is not delivering in time." This assessment aligns with the research data, which found that approximately 65% of community oncologists reported patient deterioration before CAR T-cell administration because of payer approval delays.²

Marjon also said that this work should not only take place in academic centers. Hematologist-oncologists, he noted, are almost all double board-certified in hematology and oncology and trained to handle bone marrow transplants and advanced therapies, but most live and work in communities, not in urban academic hubs. The path forward, he stated, requires payers to establish standardized authorization pathways, manufacturers to continue providing robust standard operating procedures, and community centers to build capacity. Specialty pharmacy partners, he added, are essential for managing the financial risk of products that community practices cannot afford to hold.

Gregory brought the session full circle, returning to Sarah. In an ideal world, she said, Sarah could receive her treatment at a practice like Marjon's community center, close to home, with a care team she trusts, and at lower total cost.

"The question is no longer whether community oncology can deliver advanced therapies," Marjon said in closing. "The question is how we will [get] the systems to do it reliably, safely, and at scale to serve all of our patients."

REFERENCES

1. Hippensteele A. Navigating the complexities of the cell and gene therapy landscape: insights from the 2025 Advanced Therapies Report. Pharmacy Times. May 22, 2025. Accessed April 29, 2026. https://www.pharmacytimes.com/view/navigating-the-complexities-of-the-cell-and-gene-therapy-landscape-insights-from-the-2025-advanced-therapies-report

2. Uttam Chandani K, Khera N. Bridging the gap: identifying and overcoming barriers to CAR-T access through streamlined and standardized pathways. Mayo Clin Proc Innov Qual Outcomes. 2026;10(1):100693. doi:10.1016/j.mayocpiqo.2025.100693