Presentation (CTI)

OBJECTIVES: Cell therapies, innovative treatments for burdensome diseases, are increasingly being launched in the US. However, their high costs can have profound impact on payer budgets and may lead to barriers to patient access. This research aims to evaluate trends in price and payer coverage of cell therapies in the United States.
METHODS: FDA databases were used to identify approved cell therapies; hematopoietic progenitor cell transplantation, cellularized scaffold products, and cell-based gene therapies were excluded from analysis. Therapies’ annual Wholesale Acquisition Costs (WACs) were calculated and analyzed together to understand key differences. Publicly available coverage policies from 10 of the largest commercial plans (by covered lives) were compared to FDA indication statement and pivotal trial inclusion / exclusion criteria to assess access. Financial reports, press releases, and coverage policies were used to analyze price and market access trends.
RESULTS: Cell therapies are usually covered by the selected plans; prior authorization are largely aligned to pivotal trial criteria. Cell therapies for competitive diseases with lower unmet need face more restrictions such as step edits or non-coverage compared to those in higher need diseases which may be covered to FDA indication statement. For example, Lantidra for type 1 diabetes is generally not covered whereas oncology drugs will be approved based on indication statement / NCCN guidelines, highlighting contrasting access.
CONCLUSIONS: Differences in access is reflective of indication specific competitive dynamics rather than the cell therapy mechanism (e.g., time on market, disease prevalence, urgency to treat with a cell therapy, and efficacy / value of the treatment). As more treatments come to market and lower the need to treat with high-cost cell therapies, payers may look to limit access. Early value and access strategy planning is essential to avoid prospective commercialization hurdles.