REVIEW OF CELL THERAPY ACCESS LANDSCAPE
Author(s)
Kevin Brooks, M.B.A.1, Maxine Sy Chu, M.S.2;
1Red Nucleus, Denver, CO, USA, 2Red Nucleus, San Francisco, CA, USA
1Red Nucleus, Denver, CO, USA, 2Red Nucleus, San Francisco, CA, USA
OBJECTIVES: As more cell therapies have been developed and approved in the United States during the past few years, their high costs may impact payer budgets and create patient access challenges. This research aims to evaluate emerging trends in price and payer coverage of cell therapies in the United States.
METHODS: FDA databases of approved cell therapy products were used to identify relevant drugs for analysis; hematopoietic progenitor cell transplantation, cellularized scaffold products, and cell-based gene therapies were excluded from analysis. The Wholesale Acquisition Costs (WACs) of products were calculated and evaluated to contextualize key differences between prices. Publicly available coverage policies from 10 of the largest US commercial plans (by covered lives) were compared to FDA indication statement and pivotal trial inclusion / exclusion criteria to evaluate coverage trends between plans. Financial reports, press releases, and coverage policies were used collectively to determine trends in price perception and access.
RESULTS: Cell therapies are generally covered by the selected sample of plans, with prior authorization requirements closely aligned to pivotal trial criteria. Access is driven largely in part due to the competitive landscape of the treatment area itself. Products in disease spaces with a higher unmet need are typically covered to their FDA indication statement, while products in more competitive disease spaces with a lower unmet need may face greater restrictions such as step edits, and may risk non-coverage.
CONCLUSIONS: Differences in access are driven more by indication-specific competitive dynamics than by the cell therapy modality itself, including factors such as time on market, disease prevalence, urgency of treatment, and the therapy’s demonstrated efficacy and value. As more treatments enter the market, potentially reducing reliance on high-cost cell therapies, payers may increasingly impose access restrictions. As a result, early value demonstration and access strategy planning may be critical to mitigating future barriers to commercialization.
METHODS: FDA databases of approved cell therapy products were used to identify relevant drugs for analysis; hematopoietic progenitor cell transplantation, cellularized scaffold products, and cell-based gene therapies were excluded from analysis. The Wholesale Acquisition Costs (WACs) of products were calculated and evaluated to contextualize key differences between prices. Publicly available coverage policies from 10 of the largest US commercial plans (by covered lives) were compared to FDA indication statement and pivotal trial inclusion / exclusion criteria to evaluate coverage trends between plans. Financial reports, press releases, and coverage policies were used collectively to determine trends in price perception and access.
RESULTS: Cell therapies are generally covered by the selected sample of plans, with prior authorization requirements closely aligned to pivotal trial criteria. Access is driven largely in part due to the competitive landscape of the treatment area itself. Products in disease spaces with a higher unmet need are typically covered to their FDA indication statement, while products in more competitive disease spaces with a lower unmet need may face greater restrictions such as step edits, and may risk non-coverage.
CONCLUSIONS: Differences in access are driven more by indication-specific competitive dynamics than by the cell therapy modality itself, including factors such as time on market, disease prevalence, urgency of treatment, and the therapy’s demonstrated efficacy and value. As more treatments enter the market, potentially reducing reliance on high-cost cell therapies, payers may increasingly impose access restrictions. As a result, early value demonstration and access strategy planning may be critical to mitigating future barriers to commercialization.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
HPR85
Topic
Health Policy & Regulatory
Topic Subcategory
Insurance Systems & National Health Care, Reimbursement & Access Policy, Risk-sharing Approaches
Disease
SDC: Rare & Orphan Diseases, STA: Genetic, Regenerative & Curative Therapies