REMS Removed: Why CAR-T’s Expansion into Community Oncology Could Benefit the Big Three Wholesalers

By Greis Kapexhiu and Adam J. Fein, Ph.D.

In June 2025, the FDA announced that CAR-T therapies would no longer be subject to a REMS program.

The FDA’s removal of CAR-T REMS requirements eliminates one obstacle to expanding treatment beyond traditional academic medical centers. That change could disproportionately benefit the Big Three wholesalers, which have spent billions building positions in community oncology while simultaneously investing in cell-and-gene-therapy distribution and support infrastructure.

Read on for our review of this dynamic sector and ponder how wholesalers’ community oncology roll-up activities could interact with their cell and gene therapy (CGT) investments. Will wholesalers capture a growing share of CAR-T’s economics, or will hospitals continue to hold the upper hand?

CAR-T TIME

Chimeric Antigen Receptor T-cell therapies (CAR-T) are a highly innovative class of cell and gene therapies (CGT) targeting blood cancers, with the potential to cure certain indications outright. Despite that potential, severe barriers have persisted in market access to these drugs:

• CAR-T administration is highly complex. The patient is effectively part of the supply chain: T-cells are collected from the patient, cryogenically frozen, shipped to the manufacturer, genetically modified, shipped back, thawed, and finally administered to the patient. Patients are required to stay in proximity of the treatment center for weeks after treatment.

• CAR-T can only be administered in manufacturer-approved treatment sites. These therapies have been highly concentrated in academic medical centers and cancer hospitals. As of mid-2026, just over 250 CAR-T treatment centers held accreditation from the Foundation for the Accreditation of Cellular Therapy (FACT), the leading agency of cell therapy center accreditation. Geography is a major barrier to access in this market.

• High upfront cost. These products carry list prices upwards of $500,000, and, combined with the pre and post treatment intervention a patient needs, total treatment costs can reach upwards of $1 million. Cencora’s March 2026 survey found that 74% of payers covered CGTs using prior authorization criteria that were more restrictive than the therapies’ FDA-approved indications.

CAR-T IN THE U.S.A.

CAR-T therapies can be administered in three types of sites: inpatient hospital settings, hospital outpatient departments (HOPDs), and community oncology practices.

A Prime Therapeutics medical claims study showed a significant shift in CAR-T administration from inpatient hospitals to hospital outpatient departments (HOPDs). The HOPD share more than doubled, from 17% in 2022 to 35% in 2025.

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Site of care economics is a driving force for the outpatient shift. Our analysis also finds substantial reimbursement differences by site of care. Average reimbursement per CAR-T product was approximately 20% lower in outpatient settings for commercially insured patients and 16% lower for Medicare fee-for-service beneficiaries. These differences give payers another reason to encourage CAR-T administration in outpatient settings (when clinically appropriate).

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FIGHTING FOR THEIR RIGHT TO CAR-T

The outpatient shift should not be confused with a community-site shift. Much of outpatient CAR-T treatment continues to occur within hospital systems. Wholesalers could benefit from their MSO investments as CAR-T expands into community oncology, especially when treatment occurs at practices affiliated with wholesaler-backed MSOs.

Wholesalers have emerged as some of the largest buyers of private equity-backed management services organizations (MSOs). These MSOs oversee administrative operations for physician practices across specialties including dermatology, gastroenterology, oncology, ophthalmology, and urology. We highlighted these developments in The Future of Buy-and-Bill Market Access: Five Drivers of Wholesalers’ Vertical Integration with Physician Practices. We’ll provide a full update in the forthcoming 2026-27 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors.

The Big Three wholesalers' MSO platforms now encompass thousands of physicians across community oncology. Meanwhile, FACT has introduced an accreditation pathway designed for community-based cell therapy programs, which may further streamline the site approval process.

These investments, combined with emerging community CAR-T activity, could allow wholesalers to benefit from higher CAR-T volumes in community oncology practices in three ways:

• Practice footprint. More CAR-T volume could increase the economic value of wholesaler-backed oncology platforms. Community CAR-T creates opportunities for additional practice revenue, management fees, distribution economics, and ancillary services. But the economics will depend heavily on reimbursement, drug-acquisition terms, working-capital requirements, and the contractual relationship between each MSO and its affiliated practices.

• Capital and operational scale. Large MSO-backed practices may be better positioned to make the investment required to participate in CAR-T compared to independent, standalone community practices.
  
  We can already see this strategy emerging at several wholesaler-affiliated community oncology practices that offer CAR-T or are seeking accreditation:
  • Virginia Oncology Associates, which is part of McKesson’s US Oncology group
  • Tennessee Oncology, which is part of Cencora’s OneOncology business
  • Florida Cancer Specialists, which is part of McKesson’s US Oncology business through CORE Ventures
  The enormous acquisition cost of CAR-T also creates significant working-capital and reimbursement risk. Large, wholesaler-backed oncology platforms may be better positioned than standalone practices to absorb these financial demands while building the clinical and administrative infrastructure required for cell therapy.

• CGT infrastructure. Wholesalers have invested considerably in cell and gene therapy (CGT) capabilities supporting physicians, manufacturers, and patients. A larger volume of CAR-T, regardless of setting, translates into more revenue through these offerings.
  
  McKesson, Cencora, and Cardinal Health have each invested in specialized CGT distribution, logistics, patient services, and/or pharmacy infrastructure. We profile these services in Section 6.3.3. of our forthcoming 2026-27 wholesale report. The wholesalers don't need community oncology to capture all CAR-T volume to benefit. They can participate through the provider channel, the product channel, or both.

Hospitals won't surrender this market easily. Academic medical centers and cancer hospitals retain established cell therapy infrastructure, experienced clinical teams, inpatient backup for serious adverse events, and established manufacturer relationships and treatment-site approvals. Manufacturers also retain control over their authorized treatment-site networks.

The FDA's REMS decision doesn't hand the CAR-T market to community oncology. But it removes one piece of regulatory friction just as the Big Three wholesalers have assembled many of the assets needed to capitalize on decentralization.

If CAR-T's next phase is increasingly community-based, then the wholesalers have positioned themselves to capture economics both from the sites administering these therapies and from the infrastructure supporting them.

For the Big Three, removing REMS could add up to a bigger CAR-T party—and more reasons to keep rolling up oncology.