Breyanzi access in Pakistan: the DRAP named-patient pathway

Last reviewed 2026-05-16 by Reserve Meds clinical and regulatory team.

Quick orientation

Breyanzi (lisocabtagene maraleucel) is an autologous CD19-directed chimeric antigen receptor T-cell therapy approved by the US Food and Drug Administration in February 2021. The label has expanded across diffuse large B-cell lymphoma and other large B-cell lymphomas, chronic lymphocytic leukemia and small lymphocytic lymphoma (March 2024), follicular lymphoma (May 2024), and mantle cell lymphoma (May 2024). The product is manufactured by Bristol-Myers Squibb. The TRANSCEND pivotal trials reported overall response rates of approximately 73 percent with 53 percent complete response in heavily pretreated populations, with a safety profile that shows lower rates of severe cytokine release syndrome than some earlier CD19 CAR-Ts. Breyanzi is not registered with the Drug Regulatory Authority of Pakistan (DRAP), and access for a Pakistani patient runs through the personal-use Special Provision import combined with autologous cell collection at a CAR-T-authorised center.

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How Breyanzi reaches patients in Pakistan

Breyanzi (lisocabtagene maraleucel, an autologous CD19-directed CAR T-cell therapy from Bristol Myers Squibb and Juno Therapeutics, FDA-approved February 2021 for relapsed or refractory large B-cell lymphoma with subsequent label expansions to chronic lymphocytic leukaemia, mantle cell lymphoma, and follicular lymphoma) is not currently visible on the DRAP registered-product verification portal at dra.gov.pk/e-services/online-data-verification as of 2026-06-01. Patients access Breyanzi under the Special Permission for Import of Therapeutic Goods for Personal Use (the patient-named No Objection Certificate or NOC) and, more typically for cell therapy, under the Special Permission for Institutional Import of Unregistered Therapeutic Goods, administered by the Import and Export Section of the DRAP Quality Assurance and Laboratory Testing Division under the Drugs Act 1976 read with the Drugs (Import and Export) Rules 1976 and DRAP Guidance Document QALT/GL/IP/004 at dra.gov.pk Guidance. The application is filed online via the DRAP Special Permissions portal at dra.gov.pk Special Permissions. DRAP does not publish a fixed processing-time SLA; patient-org reporting indicates several working days when documentation is complete. For Breyanzi specifically, the file must reference confirmed CD19-positive B-cell malignancy with the eligible indication (LBCL, CLL, MCL, or FL with the appropriate prior-therapy criteria including chemoimmunotherapy plus a BTK inhibitor where applicable), the planned leukapheresis collection at the Pakistani treatment centre, the lymphodepleting cyclophosphamide plus fludarabine schedule, the cytokine-release-syndrome and immune-effector-cell-associated neurotoxicity-syndrome monitoring plan per the FDA REMS programme, and the post-infusion 30-day inpatient or proximate-residence requirement. The prescribing haematologist must be registered with the Pakistan Medical and Dental Council. Because Breyanzi is an individualised cell-therapy product manufactured from the patient's own T cells in the US, the NOC is paired with the leukapheresis appointment at the Pakistani CAR-T site and the BMS manufacturing slot.

Where Breyanzi is dispensed in Pakistan

Breyanzi is an autologous CAR T-cell product administered once intravenously at a certified cellular-therapy centre after lymphodepleting fludarabine and cyclophosphamide, with the patient remaining at or within close proximity to the certified centre for at least four weeks post-infusion under cytokine-release-syndrome and ICANS monitoring per the FDA REMS programme. Pakistan does not currently host a Bristol Myers Squibb-certified commercial CAR-T site for Breyanzi; named-patient cases typically combine Pakistani-side haematology coordination with referral abroad. The Pakistani haematology and BMT centres routinely involved in cellular-therapy referral coordination, leukapheresis, and post-infusion follow-up include Shaukat Khanum Memorial Cancer Hospital and Research Centre (SKMCH and RC) in Lahore with the Department of Medical Oncology and BMT, plus its Peshawar and Karachi campuses at shaukatkhanum.org.pk; Aga Khan University Hospital (AKUH) in Karachi with the Section of Haematology and the BMT programme at hospitals.aku.edu; the Armed Forces Bone Marrow Transplant Centre (AFBMTC) in Rawalpindi, Pakistan's pioneering allogeneic BMT centre; the National Institute of Blood Diseases and Bone Marrow Transplantation (NIBD) in Karachi with adult haematology and BMT; and Indus Hospital and Health Network in Karachi with paediatric and adult oncology programmes at indushospital.org.pk. SKMCH, AKUH, AFBMTC, and NIBD are the centres most frequently cited in Pakistani haematology reporting for BMT and CAR-T referral pathways.

What Breyanzi costs in Pakistan

The US wholesale acquisition cost for Breyanzi is approximately USD 410,300 for the one-time infusion at the FDA-labelled dose, per Bristol Myers Squibb disclosures and Drugs@FDA at accessdata.fda.gov/scripts/cder/daf. No public PKR benchmark for Breyanzi on the DRAP Maximum Retail Price database or in Pakistani patient-organisation reporting has been observed as of 2026-06-01; do not estimate. Price snapshot: 2026-06-01. Costs layered above the drug cost include validated cryogenic logistics of apheresed starting material to the BMS Summit New Jersey facility and of finished product back to the Pakistani receiving centre (dry-vapour-shipper cryoshippers with continuous monitoring), the receiving centre's apheresis collection fee, hospital fees for the inpatient infusion admission with cytokine-release monitoring (typically a 7 to 14 day inpatient stay extending up to 28 days for severe CRS or ICANS), four weeks of post-infusion monitoring within close proximity to the certified centre, and the Reserve Meds concierge fee itemised separately on every firm quote. Because Pakistan does not currently host a commercial Breyanzi treatment site, the dominant operational variant is referral abroad with all travel, accommodation, and foreign hospital costs added to the family budget. The State Bank of Pakistan outward remittance allowance for medical purposes at sbp.org.pk is a practical sequencing constraint. BMS US patient services do not extend to Pakistani residents.

Funding and access barriers for Breyanzi in Pakistan

Public-sector funding of named-patient CAR T-cell therapy in Pakistan is largely case-by-case. The Sehat Sahulat Programme at pmhealthprogramme.gov.pk covers inpatient hospitalisation and selected chronic-disease therapies for enrolled families; the per-family annual ceiling does not stretch to a US cell-therapy price point above USD 400,000 and the programme is built around in-network empaneled hospital treatment rather than imported cell-therapy procurement. Pakistan Bait-ul-Mal at pbm.gov.pk offers case-by-case grants for high-cost foreign-sourced treatment; haematology cases have historically used this channel. Major private insurers including Jubilee Life Insurance, EFU Life, State Life Insurance Corporation, and Adamjee Life do not publish unlicensed-drug formularies and cellular-therapy coverage is uncommon. Pakistan's out-of-pocket share of health expenditure consistently sits above 50 percent per World Bank data at data.worldbank.org; for relapsed-refractory B-cell lymphoma CAR-T cases the dominant pattern is self-pay supplemented by family fundraising, Bait-ul-Mal grants, SKMCH Zakat or Indus Hospital charity funds, and overseas-relative remittances. A structural access barrier specific to Breyanzi in Pakistan is the absence of a Bristol Myers Squibb-certified commercial CAR-T site; combined with the four-week post-infusion proximity requirement, this typically routes Pakistani CAR-T cases to a certified centre abroad (US, EU, or India) rather than in-country administration.

Recent regulatory and access news for Breyanzi

DRAP published the consolidated Guidance Document for Applicants on Import and Export Permissions of Therapeutic Goods (QALT/GL/IP/004) covering personal-use, institutional, and donation imports, the current operative reference for any Breyanzi NOC application; full notice at dra.gov.pk regulatory updates. The Federal Cabinet of Pakistan approved an exemption for the import of unregistered drugs in defined public-interest cases under Section 23 of the Drugs Act 1976, broadening the institutional-import lane for high-cost rare and oncology drugs not commercially available in Pakistan, reported at Express Tribune. On the manufacturer side, the FDA granted Breyanzi expanded labelling to follicular lymphoma in 2024 and the TRANSCEND CLL-004 chronic lymphocytic leukaemia indication has been accumulating post-marketing follow-up. No drug-specific DRAP bulletin for Breyanzi over the last 12 months has been observed as of 2026-06-01.

Where Reserve Meds fits in Breyanzi cases

Reserve Meds is a US-based concierge coordinator. For Breyanzi cases originating in Pakistan, our role spans US-side sourcing through BMS commercial supply, infusion-center identification and intake c