Outpatient Delivery of High-Cost Therapies at Scale

The next era of advanced therapy delivery. 

CAR-T and bispecific T-cell engagers (BiTEs) are no longer emerging treatments confined to academic centers—they are becoming mainstream therapies reshaping how care is delivered across multiple conditions.

The FDA’s June 2025 removal of REMS requirements for all currently approved CAR-T therapies reflects growing confidence in the ability of providers to deliver these treatments safely. Combined with updated label changes that shorten monitoring windows, this opens the door for widespread adoption of high-cost cell and specialty therapies in community and even home settings.

For providers, this creates an opportunity to expand specialty service lines, capture new revenue, and retain patients closer to home. For pharma and biotech, post-market success now depends on ensuring delivery pathways exist outside of high-capacity academic hubs.

 

Market momentum: growth that demands scale. 

The trajectories of CAR-T and BiTEs highlight why community adoption will become increasingly important: 

• CAR-T: Global sales were estimated at $6.37 billion in 2024 and are projected to reach $16.35 billion by 2032. Other forecasts anticipate even faster expansion, from $10.39 billion in 2024 to $128.55 billion by 2034. 

• BiTEs (bispecific T‑cell engagers): The broader bispecific antibody market — which includes BiTEs — is poised to surge from $8.0 billion in 2023 to $192.6 billion by 2033. While this category includes other bispecific formats, it underscores the explosive growth opportunity for BiTEs in oncology. 

For providers: These numbers signal new revenue opportunities in oncology and beyond, as indications expand into autoimmune and other specialties.

For pharma/biotech: They underscore the need for delivery strategies that scale far beyond academic centers to achieve full commercial penetration.

 

At Current Health, we see this shift firsthand. Our clinical operating system supports outpatient CAR-T and BiTE programs with continuous safety monitoring, efficient escalation pathways, and integrated documentation. These capabilities position our partners to adapt quickly as this category grows—ensuring both modalities can be delivered safely and at scale in the community. 

 

Closing the access gap. 

 

Despite the growth, many patients eligible for advanced therapies remain unable to access them due to distance, monitoring requirements, or lack of local infrastructure.

Rural communities especially face persistent obstacles in oncologic care—including fewer specialists, longer travel distances, and exclusion from clinical trials. 

Post-REMS, these barriers are falling: shorter monitoring periods and reduced restrictions mean more patients can now be treated locally. Providers who act early will capture demand, while pharma companies that support provider readiness will accelerate uptake.

 

Outpatient-based trials, especially when coupled with decentralized elements like telehealth, remote monitoring, and community infusion sites, can dramatically expand access. By reducing the burden of frequent long-distance trips, outpatient protocols enable participation from rural patients who otherwise remain excluded. 

 

Evidence behind outpatient and community delivery. 

Operationally and clinically, outpatient CAR‑T is no longer hypothetical. Multiple studies and real-world programs confirm that high-cost therapies can be delivered safely outside the hospital:

• Sarah Cannon: >75% of CAR-T patients treated outpatient; LOS reduced from 16 → 4 days; 1,200+ hospital bed days saved.

• OUTREACH Trial: 70% outpatient infusion; 25% never required hospitalization; strong response rates and safety outcomes.

• Safety Window Evidence: A 2024 Blood study (Sarah Cannon + Current Health) and FDA’s REMS review confirmed that 98% of CRS and 96% of neurologic events occur within the first 15 days post-infusion. These findings validate shorter monitoring requirements and support safe delivery in community and outpatient settings.

For providers, these results prove the operational feasibility of outpatient and community-based programs. For pharma, they provide the payer-ready evidence needed to support broad adoption across multiple therapeutic areas.

 

Policy and payment shifts enabling broader delivery.

 

The regulatory and reimbursement environment is evolving to support safe, scalable adoption of high-cost therapies beyond academic centers:

• FDA: The June 2025 removal of REMS requirements for all approved CAR-T therapies reflects confidence that community and regional providers can deliver safely with standard safeguards in place. This shift lowers certification barriers and empowers more sites to participate in delivery.

• CMS: Steps such as designating CAR-T administration codes as separately reimbursable under OPPS and issuing billing guidance for outpatient settings signal recognition that high-cost therapies must be financially viable outside the inpatient setting.

 

While collection and preparation remain non-payable (seen as part of manufacturing), the shift in reimbursement logic opens room for health systems and outpatient settings to plan for financially sustainable care models—especially with further developments likely as delivery moves closer to patients.

 

Together, these changes send a clear signal: policy and payment models are aligning to make community and home delivery of high-cost therapies both safe and sustainable. Providers now have a stronger business case to expand service lines, and pharma has a clearer pathway to accelerate adoption.

 

The strategic edge for providers and pharma who act sooner. 

 

For providers, REMS removal and new reimbursement clarity eliminate some of the biggest barriers to offering high-cost therapies locally. That opens the door to:

• Expanding oncology and specialty service lines into outpatient and community settings without the need for costly new inpatient infrastructure.

• Capturing high-margin therapies and retaining patients who would otherwise be referred to academic centers.

• Positioning as a regional hub for advanced therapies, building durable referral networks that extend beyond oncology into other specialties as CAR-T and BiTE indications broaden.

 

For pharma and biotech, success post-market depends not just on FDA approval, but on whether providers are ready to deliver therapies at scale. By enabling outpatient and community adoption, pharma can:

• Accelerate uptake beyond academic centers, ensuring faster and broader commercial adoption.

• Strengthen payer negotiations with real-world cost-efficiency data, supported by evidence that community delivery reduces LOS and total cost of care.

• Differentiate assets in a competitive market, showing that therapies are not only effective, but practical and scalable in real-world settings.

 

The bottom line: Clinical evidence and regulatory policy have created a window of opportunity. Providers who act early will capture growth, and pharma who enable them will unlock adoption at scale. Those who wait risk being left behind as community-first delivery models reshape the competitive landscape.

 

Shaping the path forward.

 

The shift is clear: advanced therapies like CAR-T and BiTEs are moving into community and home care programs across oncology, autoimmune, and beyond. Providers who invest in safe outpatient models today will define regional referral patterns and capture long-term revenue growth. Pharma and biotech who enable this shift will secure faster adoption, broader access, and payer alignment.

 

At Current Health, we provide the clinical operating system that powers this transition—combining monitoring, escalation protocols, patient engagement, and EHR integration to make specialty therapy delivery safe and scalable beyond the hospital.

 

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