CAR-T available in only 6 countries

What this therapy area looks like

This page is about access to CAR-T cellular therapy. CAR-T products are autologous or allogeneic cell therapies manufactured under tight apheresis-to-infusion timelines. Cross-border access is complicated by the need for apheresis at a qualified center, cryopreserved shipping, and tight infusion-window scheduling.

Why cross-border access comes up

Patients and physicians reach out about CAR-T cellular therapy when the therapy is not registered in the destination country or when it is registered but unavailable locally. In each case, the question is whether a Named Patient Program or personal-import pathway in the destination country permits lawful import of a specific quantity for a specific patient, and whether the supply chain from the US source to the treating physician can be coordinated without compromising DSCSA provenance or cold-chain integrity.

Clinical considerations

Access is necessary but not sufficient. For CAR-T cellular therapy, the treating physician is the accountable decision-maker on appropriateness, dosing, and monitoring. A cross-border sourcing partner should never substitute for that judgment. Where relevant, eligibility screening, for example, mutation confirmation, titer testing, weight or age limits, or prior-therapy requirements, must be complete before a shipment is authorized.

Supply and handling

For CAR-T cellular therapy, the practical handling profile typically requires cold-chain (2-8°C) or frozen (−20 to −70°C) storage with documented temperature logs, specialty-pharmacy supply through a US-licensed pharmaceutical wholesale partner, and DSCSA-compliant chain-of-custody from the wholesaler through the final hand-off. Shipments to the destination country are sent under documented carrier protocols to the treating physician or a hospital pharmacy; we do not ship direct-to-patient for these categories.

Pricing and financing

Financing options include patient savings, employer health-benefit carve-outs, manufacturer patient-assistance programs, charitable and disease-specific foundations, and in some MENA jurisdictions, sovereign or charitable funds. Reserve Meds can signpost these options; we do not evaluate patient creditworthiness or run financing.

How to start

The fastest path is a short intake at reservemeds.com/contact including the drug name, indication, destination country, and a one-line summary of the patient’s clinical status. Our clinical team returns a feasibility note within one business day.

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