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.
Ask about Akeega in Pakistan
Tell us the medicine and your country. We reply within one business day. On WhatsApp we usually reply the same day.
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 supply through a US-licensed pharmaceutical wholesale partner, builds the documentation packet your physician needs to file, and orchestrates the logistics into Pakistan with a single point of contact 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 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.
What Akeega costs in Pakistan
Medicine price: quote on request. You get a written quote for your case before you commit. 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. Private insurers do not publish 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. 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 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 digital health company. 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 supply through a US-licensed pharmaceutical wholesale partner, build the documentation packet your physician submits, coordinate logistics into Pakistan, and give you one point of contact 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 reply within one business day, then send a documentation checklist to your doctor.
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