Akeega access in Pakistan: the DRAP named-patient pathway
How Pakistan patients legally obtain Akeega (niraparib and abiraterone acetate (dual-action tablet)) when the locally registered indication, stocked presentation, or payer coverage does not match what the prescribing physician has written.
Last reviewed 2026-05-16 by Reserve Meds clinical and regulatory team.
Quick orientation
Akeega (niraparib and abiraterone acetate (dual-action tablet)) is fixed-dose combination of a PARP inhibitor and an androgen-biosynthesis inhibitor approved by the US FDA in August 2023 for BRCA-mutated (germline or somatic) metastatic castration-resistant prostate cancer (mCRPC) in adults, in combination with prednisone. The drug is manufactured by Janssen. Pakistan patients use the Drug Regulatory Authority of Pakistan named-patient pathway when the locally registered indication, the stocked presentation, or the available payer coverage does not match what the prescribing physician has written. Reserve Meds coordinates the US-side sourcing through a DSCSA-compliant specialty channel, builds the documentation packet your physician needs to file, and orchestrates the logistics into Pakistan with a single named coordinator carrying the case end-to-end.
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How Akeega reaches patients in Pakistan
Akeega (niraparib plus abiraterone acetate fixed-dose dual-action tablet, FDA-approved August 2023 for BRCA-mutated metastatic castration-resistant prostate cancer) is not currently visible on the DRAP registered-product verification portal at dra.gov.pk/e-services/online-data-verification as of 2026-05-31. Patients access the drug 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. The application is filed online via the DRAP Special Permissions portal at dra.gov.pk/therapeutic-goods/import-export/special-permissions. DRAP does not publish a fixed processing-time SLA; patient-org reporting indicates several working days when documentation is complete. For Akeega specifically, the clinical justification must reference confirmed BRCA1 or BRCA2 mutation status (germline or somatic) per the FDA label, the patient's mCRPC line of therapy, the fixed-dose combination rationale (reduced pill burden versus separate niraparib plus abiraterone administration as shown in the MAGNITUDE phase 3 trial, NCT03748641), and the prescribing oncologist's registration with the Pakistan Medical and Dental Council. The NOC is single-consignment; chronic-therapy patients re-file per shipment cycle, typically up to three months of supply per application per the DRAP guidance convention. A parallel hospital-led pathway under the same Special Permission framework allows institutional importers (Shaukat Khanum, AKUH) to file on the prescribing physician's behalf.
Where Akeega is dispensed in Pakistan
Akeega is an oral oncology agent administered in the outpatient medical oncology or genitourinary oncology setting with monthly haematology, liver function, blood pressure, and PSA surveillance. The Pakistani tertiary oncology centres equipped for this profile and routinely involved in named-patient specialty imports include Shaukat Khanum Memorial Cancer Hospital and Research Centre (SKMCH and RC) in Lahore with the Department of Medical Oncology, plus its Peshawar and Karachi campuses, accessible at shaukatkhanum.org.pk; Aga Khan University Hospital (AKUH) in Karachi with the Department of Oncology and the Cancer Care Service, accessible at hospitals.aku.edu; the Indus Hospital and Health Network in Karachi with its Oncology service, at indushospital.org.pk; Jinnah Postgraduate Medical Centre (JPMC) in Karachi with its Department of Oncology under public-tertiary funding; and the Atomic Energy Cancer Hospital and Nuclear Medicine, Oncology and Radiotherapy Institute (NORI) in Islamabad. SKMCH and AKUH publish departmental leadership and are the most-frequent dispensing nodes for cross-border specialty oncology imports because they hold institutional import licences under the Special Permission for Institutional Import framework.
What Akeega costs in Pakistan
The US reference wholesale acquisition cost (WAC) for Akeega is in the range of USD 16,000 to USD 18,000 per 30-day supply at the labelled dose of 200 mg niraparib plus 1,000 mg abiraterone once daily, sourced from manufacturer disclosures and Drugs@FDA at accessdata.fda.gov/scripts/cder/daf. Annual WAC at the labelled dose runs in the range of USD 200,000 to USD 220,000 before logistics and dispensing. No public local-currency benchmark for Akeega in PKR is observed on the DRAP MRP (maximum retail price) database or in Pakistani patient-organisation reporting as of 2026-05-31; do not estimate. Price snapshot: 2026-05-31. Cost layers stacked on top of the drug cost include ambient-temperature international logistics into Pakistan (low to mid four-figure USD range depending on origin and urgency; Akeega is a stable oral solid and does not require cold-chain), DRAP permit and customs duties (nominal relative to drug cost), the dispensing hospital's administration fees, and the Reserve Meds concierge fee itemised separately on every firm quote. The State Bank of Pakistan outward remittance allowance for medical purposes is a practical sequencing constraint families plan around.
Funding and access barriers for Akeega in Pakistan
Public-sector funding of named-patient specialty oncology imports in Pakistan is largely case-by-case. The Sehat Sahulat Programme (Prime Minister's National Health Programme) at pmhealthprogramme.gov.pk covers inpatient care and selected chronic-disease therapies for enrolled families; coverage of unregistered named-patient imports through the card is historically limited. Khyber Pakhtunkhwa's Sehat Card Plus has the broadest specialty oncology coverage. Pakistan Bait-ul-Mal at pbm.gov.pk offers case-by-case grants for high-cost foreign-sourced treatment. Major private insurers with specialty-drug exposure include Jubilee Life Insurance, EFU Life, State Life Insurance Corporation, and Adamjee Life; none publishes an unlicensed-drug formulary, and coverage decisions on Akeega-class targeted-therapy imports are assessed case-by-case, typically requiring documented BRCA test results and prior-therapy failure for step-therapy adjudication. Pakistan's out-of-pocket share of health expenditure consistently sits above 50% per World Bank data at data.worldbank.org; for adult oncology named-patient imports, self-pay supplemented by family fundraising, Bait-ul-Mal grants, and SKMCH Zakat or Indus Hospital charity funds is the dominant pattern. The import permit experience for stable oral solids like Akeega is straightforward relative to cold-chain biologics; DRAP customs processing centres on documentation completeness rather than handling.
Recent regulatory and access news for Akeega
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, which is the current operative reference for an Akeega NOC application. The full notice is at dra.gov.pk regulatory updates. The Federal Cabinet of Pakistan approved (reported mid-2025) 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; source: Express Tribune coverage. No drug-specific DRAP bulletin for Akeega over the last 12 months has been observed as of 2026-05-31.
Where Reserve Meds fits in Akeega cases
Reserve Meds is a US-based concierge coordinator. We do not replace your Pakistani specialist, we do not replace the DRAP, and we do not replace your dispensing pharmacy. For Akeega specifically, we orchestrate the US-side sourcing through a DSCSA-compliant specialty channel, build the documentation packet your physician submits, coordinate logistics into Pakistan, and assign a single named coordinator through the case. The pharmacist-of-record review, prescription validation, biomarker confirmation, and physician sign-off are the recurring operational fundamentals for this drug.
Next step
If your Pakistani physician has prescribed Akeega 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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