Amtagvi access in Pakistan: the DRAP named-patient pathway
How patients in the Islamic Republic of Pakistan legally obtain Amtagvi (lifileucel) when the locally registered indication, stocked presentation, or payer coverage does not match what the prescribing physician has written.
Last reviewed 2026-05-12 by Reserve Meds clinical and regulatory team.
Quick orientation
Patients in Pakistan access Amtagvi (lifileucel) for unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody and, if BRAF V600 mutation-positive, a BRAF inhibitor with or without a MEK inhibitor through the DRAP named-patient pathway, a Drug Regulatory Authority of Pakistan-administered mechanism that allows a Pakistani-licensed physician at a registered facility to import the FDA-labelled product for a specific named patient. This page details the documentation, approval timeline, and real cost in PKR.
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How Amtagvi reaches patients in Pakistan
Amtagvi (lifileucel, an autologous tumour-infiltrating lymphocyte one-time cell therapy from Iovance Biotherapeutics, FDA accelerated approval 16 February 2024 for adults with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody and, if BRAF V600 mutation-positive, a BRAF inhibitor with or without a MEK inhibitor) 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 Amtagvi under the Special Permission for Import of Therapeutic Goods for Personal Use (the patient-named No Objection Certificate or NOC), 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 Amtagvi specifically, the file must reference confirmed unresectable or metastatic melanoma, prior PD-1 blocking-antibody exposure, BRAF V600 mutation status, the tumour resection plan for TIL starting-material collection, the lymphodepleting chemotherapy schedule (cyclophosphamide plus fludarabine), the high-dose interleukin-2 administration plan, and ICU-capable supportive care for IL-2 toxicities. The prescribing medical oncologist must be registered with the Pakistan Medical and Dental Council. Because Amtagvi is a one-time individualised cell-therapy product manufactured at an Iovance Authorized Treatment Center under a defined product-release protocol, the NOC is paired with a TIL collection appointment, an Iovance manufacturing slot, and a return-shipment plan from the US to the Pakistani receiving site. A parallel hospital-led pathway under the Special Permission for Institutional Import framework allows institutional importers to file on the prescribing physician's behalf.
Where Amtagvi is dispensed in Pakistan
The certified-cell-therapy footprint that Amtagvi requires (a qualifying tumour-resection theatre, a same-day cryopreservation handoff into a validated dry-vapour shipper, a bone-marrow-transplant-grade lymphodepletion ward, and ICU adjacency rated for IL-2 capillary-leak management) is not yet operational on a commercial basis inside Pakistan as of 2026-06-01. No Iovance Authorized Treatment Center has been listed for any Pakistani site on public Iovance materials. The realistic operational shape is therefore a cross-border infusion model: the lesion biopsy or starting-material resection is scheduled at a Pakistani cancer centre, the cryoshipper leaves for the Iovance Philadelphia manufacturing plant, the patient travels for the conditioning-plus-infusion-plus-IL-2 inpatient stay at a foreign certified centre (KFSHRC Riyadh and King Hussein Cancer Center Amman are the closest regional centres routinely accepting Pakistani referrals; US ATCs accept cash-pay self-referral), and post-discharge surveillance returns to the Pakistani team. Local nodes that have run resection-and-shipment legs of cell-therapy referrals include Shaukat Khanum Memorial Cancer Hospital, Lahore, which operates the longest-running adult BMT programme in the country and a Surgical Oncology service (shaukatkhanum.org.pk), and Aga Khan University Hospital, Karachi, whose adult Haematology and BMT service plus Medical Oncology can coordinate the institutional-import filing and the tumour-collection appointment (hospitals.aku.edu). The Indus Hospital and Health Network in Karachi (indushospital.org.pk) handles charitable adult oncology volume and can host the surveillance leg.
What Amtagvi costs in Pakistan
The US wholesale acquisition cost for Amtagvi at launch is approximately USD 515,000 for the one-time TIL infusion (Iovance Biotherapeutics disclosed an effective launch price band of USD 473,800 to USD 556,200 per dose depending on manufactured TIL cell count), per Iovance launch communications and Drugs@FDA at accessdata.fda.gov/scripts/cder/daf. No public PKR benchmark for Amtagvi 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 resected tumour starting material to the Iovance Philadelphia facility and of finished TIL product back to the receiving site (dry-vapour-shipper cryoshippers with continuous monitoring), inpatient costs for the lymphodepletion week and IL-2 administration week with ICU back-up (typically a 7 to 14 day inpatient stay), and the Reserve Meds concierge fee itemised separately. Because Pakistan does not currently host an Iovance ATC, the dominant operational variant is referral abroad (typically to a US or EU ATC) rather than in-country administration, which adds travel, accommodation, and US hospital costs the Pakistani family must budget. The State Bank of Pakistan outward remittance allowance for medical purposes at sbp.org.pk is a practical sequencing constraint. Iovance US patient services do not extend to Pakistani residents.
Funding and access barriers for Amtagvi in Pakistan
The dominant funding question on a Pakistani Amtagvi case is not the DRAP NOC and not even the half-million-USD product invoice itself; it is the layered, cell-therapy-specific cost stack and the cross-border travel arithmetic that follows from there being no in-country Authorized Treatment Center. Cell therapy at this price point sits outside the design envelope of every Pakistani public health-finance instrument: Sehat Sahulat (pmhealthprogramme.gov.pk) caps annual family entitlement well below a single TIL dose and was scoped around in-network inpatient care, and Khyber Pakhtunkhwa's Sehat Card Plus, the most expansive provincial card, has not historically funded a one-time autologous cell-therapy procedure. Pakistan Bait-ul-Mal at pbm.gov.pk can grant against case files but at quantums typically two orders of magnitude below the all-in cell-therapy cost; the grant is best modelled as travel-and-incidental support, not as a primary funder. Private insurers (Jubilee Life Insurance, EFU Life, State Life Insurance Corporation, Adamjee Life) take cellular therapy as a category-by-category underwriting question; corporate group policies have occasionally covered CAR-T cycles but TIL is recent enough that Pakistani precedent is thin. Pakistan's out-of-pocket share of health spend remains above 50 percent per the World Bank series at data.worldbank.org, and on a TIL case the practical funding mix becomes patient self-pay or family wealth as the floor, charitable hospital fundraising at SKMCH Zakat or Indus Hospital as a secondary layer, and overseas-relative remittances routed through the State Bank of Pakistan medical-purpose outward allowance to cover the foreign hospital invoice, the travel-companion stay during the IL-2 inpatient window, and the post-discharge surveillance flights.
Recent regulatory and access news for Amtagvi
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 Amtagvi 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, Iovance Biotherapeutics has continued post-marketing trial commitments (TILVANCE-301 confirmatory phase 3, NCT05727904) supporting the FDA accelerated approval and the EMA Marketing Authorization Application for European Amtagvi access. No drug-specific DRAP bulletin for Amtagvi over the last 12 months has been observed as of 2026-06-01.
Where Reserve Meds fits in Amtagvi cases
Reserve Meds is a US-based concierge coordinator. We do not replace your treating physician, we do not replace DRAP, and we do not replace your dispensing pharmacy. For Amtagvi specifically, we orchestrate the US-side sourcing through a DSCSA-compliant specialty channel, build the documentation packet your physician submits, coordinate validated logistics (cold-chain with continuous temperature logging where the FDA label requires it) into Pakistan, and assign a single named coordinator through the case. Standard named-patient coordination under our specialty playbook applies. Presentation selection, dose-band confirmation, and patient onboarding for self-administration where applicable are the recurring operational fundamentals we expect for this drug.
Operationally, a typical Amtagvi case runs across four parallel tracks. The clinical track is the physician's: justification letter, dosing plan, monitoring schedule, and the next patient-facing follow-up. The regulatory track is the DRAP application packaged by the importer; we provide the documentation template, the dispensing facility license check, and the chain-of-custody attestation. The logistics track is the US-side sourcing and the validated international shipment with continuous temperature logging and customs broker coordination. The patient-experience track is the named coordinator who keeps everyone aligned on dates, addresses dispensing-pharmacy questions, and confirms the medicine has been received and stored correctly. The four tracks are run in parallel rather than in series; that is the operational difference between a 3-week and a 9-week case.
Amtagvi requires a certified Authorised Treatment Centre, a Lifileucel REMS-style protocol, pre-conditioning lymphodepletion, high-dose IL-2 administration, and ICU-capable supportive care; coordination with Iovance Biotherapeutics is mandatory.
Next step
If your Pakistani physician has prescribed Amtagvi and you are weighing the cross-border route, the next step is a short intake. We confirm eligibility within 24 to 48 hours and send a documentation kit to your physician.
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