Alyftrek access in Pakistan: the DRAP Special Permission pathway

Last reviewed 2026-05-12 by Reserve Meds clinical and regulatory team.

1. Quick orientation

Alyftrek is the brand name for vanzacaftor/tezacaftor/deutivacaftor, a next-in-class once-daily oral triple combination cystic fibrosis transmembrane conductance regulator (CFTR) modulator developed, manufactured, and commercialised by Vertex Pharmaceuticals. The US Food and Drug Administration approved Alyftrek on December 20, 2024 for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who have at least one F508del mutation or one of approximately 94 other responsive mutations in the CFTR gene. The label covers approximately 31 additional non-F508del mutations not included on the Trikafta label. UK MHRA approval followed in March 2025 and the European Commission granted EU marketing authorisation on July 1, 2025. Cystic fibrosis is less common in Pakistan than in Western Caucasian populations and CF awareness is concentrated at a small number of pediatric pulmonology centres, but confirmed CF patients with a label-eligible genotype reach Alyftrek through the Drug Regulatory Authority of Pakistan (DRAP) Special Permission / Personal Use Import No Objection Certificate.

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How Alyftrek reaches patients in Pakistan

Alyftrek (vanzacaftor plus tezacaftor plus deutivacaftor, a once-daily oral triple CFTR modulator from Vertex Pharmaceuticals, FDA-approved 20 December 2024 for cystic fibrosis in patients aged 6 and older with at least one F508del mutation or one of approximately 94 other responsive CFTR mutations) 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 Alyftrek 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 (available at dra.gov.pk Drugs Act) 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 Alyftrek specifically, the clinical justification must reference the patient's CFTR genotype with the testing platform and laboratory named (most Pakistani CFTR testing is performed at AKUH genomics services or via international reference laboratories), confirm at least one F508del allele or a label-listed responsive mutation per the FDA Alyftrek label (including the approximately 31 non-Trikafta mutations newly covered), confirm patient age 6 years or older, document weight-banded tablet strength selection from the label table, and reference the SKYLINE 102 and SKYLINE 103 phase 3 evidence (NCT05033080, NCT05076149) for non-inferiority to Trikafta on percent predicted FEV1 and superiority on sweat chloride. The prescribing pulmonologist or paediatric pulmonologist must be registered with the Pakistan Medical and Dental Council. The NOC is single-consignment, typically scaled to three months of supply per the DRAP guidance convention, and chronic CFTR modulator therapy requires re-filing each shipment cycle.

Where Alyftrek is dispensed in Pakistan

Alyftrek is a room-temperature small-molecule oral tablet supplied in two weight-banded strengths per the FDA label in a 28-day commercial pack. There is no cold chain, no reconstitution, and no infusion infrastructure required. The dispensing site must, however, sit within a paediatric or adult CF service that can run the boxed-warning monitoring stack (baseline and quarterly liver function tests with label-defined thresholds for dose interruption, baseline and follow-up ophthalmology for paediatric cataract surveillance as a CFTR-modulator class effect, and a CYP3A drug-interaction review at every regimen change). Pakistani institutions with paediatric or adult CF capability appropriate to this profile include Aga Khan University Hospital (AKUH) in Karachi with paediatric pulmonology, adult pulmonology, medical genetics, inherited metabolic disorders, and the in-house genomics service at hospitals.aku.edu; The Children's Hospital and Institute of Child Health in Lahore, the largest paediatric tertiary centre with paediatric subspecialties and genetic and metabolic disorders capability; the National Institute of Child Health (NICH) in Karachi, a public paediatric tertiary referral centre; Indus Hospital and Health Network in Karachi with paediatric subspecialty capacity at indushospital.org.pk; and Shifa International Hospital in Islamabad with multi-specialty adult pulmonology. For families whose treating CF specialist sits outside these centres, the practical route is to coordinate the dispensing leg with one of the above while the treating physician retains clinical oversight, or to file through a DRAP-licensed specialty importer in Karachi or Lahore.

What Alyftrek costs in Pakistan

The US wholesale acquisition cost for Alyftrek at launch is approximately USD 370,269 per patient per year (approximately USD 28,404 per 28-day pack) at the FDA-labelled adult dosing band, per Vertex Pharmaceuticals launch disclosures and Drugs@FDA at accessdata.fda.gov/scripts/cder/daf. This is approximately 7 percent above the Trikafta WAC of approximately USD 346,048 per year, positioning Alyftrek as a successor at a modest list-price premium reflecting once-daily dosing and broader mutation coverage. No public PKR benchmark for Alyftrek 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. Cost layers above the drug cost include ambient-temperature international logistics into Pakistan (a stable oral solid does not require cold chain or active loggers, low to mid four-figure USD range depending on origin and urgency), DRAP NOC and Federal Board of Revenue customs fees (nominal relative to drug cost), the dispensing hospital's outpatient pharmacy fees, and the Reserve Meds concierge fee itemised separately. The State Bank of Pakistan outward remittance allowance for medical purposes at sbp.org.pk is a practical sequencing constraint families plan around for chronic indefinite CFTR modulator therapy. Vertex GPS US patient services do not extend to Pakistani residents.

Funding and access barriers for Alyftrek in Pakistan

Public-sector funding of named-patient CFTR modulator imports in Pakistan is largely case-by-case. The Sehat Sahulat Programme (Prime Minister's National Health Programme) at pmhealthprogramme.gov.pk carries a per-family annual ceiling structured around in-network empaneled hospital treatment rather than imported drug procurement; the ceiling does not stretch to a US WAC of roughly USD 370,000 per year. Khyber Pakhtunkhwa's Sehat Card Plus has the broadest provincial specialty cover but does not generally underwrite chronic CFTR modulator therapy. Pakistan Bait-ul-Mal at pbm.gov.pk offers case-by-case grants for high-cost foreign-sourced treatment that paediatric CF families occasionally access. Major private insurers including Jubilee Life Insurance, EFU Life, State Life Insurance Corporation, and Adamjee Life do not publish unlicensed-drug formularies, and chronic CFTR modulator coverage is uncommon given the indefinite duration and annual budget impact. Pakistan's out-of-pocket share of health expenditure consistently sits above 50 percent per World Bank data at data.worldbank.org; for CFTR modulator named-patient imports, self-pay supplemented by family fundraising, Bait-ul-Mal grants, hospital charity funds (SKMCH Zakat, Indus Hospital free-care model), and overseas-relative remittances (GCC, UK, North America) is the dominant pattern. DRAP customs processing for stable oral solids like Alyftrek is straightforward relative to cold-chain biologics; the binding step is documentation completeness rather than handling.

Recent regulatory and access news for Alyftrek

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 Alyftrek 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 drugs not commercially available in Pakistan, reported at Express Tribune. On the manufacturer side, the EU Commission granted Alyftrek (Symkevi-line successor) marketing authorisation on 1 July 2025 and the UK MHRA followed in March 2025, supplying reference-authority approvals frequently cited in DRAP justifications. No drug-specific DRAP bulletin for Alyftrek over the last 12 months has been observed in Pakistan as of 2026-06-01.

Where Reserve Meds fits in Alyftrek cases

Reserve Meds is a US-based concierge coordinator. We do not replace your treating CF specialist, DRAP, the dispensing hospital pharmacy or specialty importer, or your insurer. What we do for an Alyftrek case is verify eligibility within 24 to 48 hours; supply your physician's team with a documentation kit referencing the FDA prescribing information, the once-daily weight-banded dosing, the CFTR genotype framing including the approximately 31 non-Trikafta mutations now covered, and the LFT and ophthalmologic monitoring stack; align US-side sourcing through Vertex's contracted specialty pharmacy channel under DSCSA-compliant chain-of-custody; coordinate ambient shipment with a qualified specialty 3PL; and provide a single named Patient Concierge Coordinator across repeat shipments, pediatric dose-step checkpoints, and chronic refill cadence. Because CFTR modulator therapy is sole-sourced globally by Vertex, indefinite in duration, and supply-chain-stable, the case complexity sits in regulatory documentation and chronic-cadence planning rather than in physical logistics. No prior Reserve Meds case experience predates this page; standard NPP coordination applies.

Next step

If your Pakistani CF specialist has confirmed a label-eligible CFTR genotype and recommends Alyftrek, start the request and we will reach out within 24 to 48 hours.

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