Leqembi access in the UAE: the MOHAP and EDE named-patient pathway

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

Quick orientation

Leqembi (lecanemab-irmb) is an anti-amyloid monoclonal antibody approved by the US FDA in 2023 for adults with mild cognitive impairment or mild dementia stage of Alzheimer's disease, where amyloid pathology has been confirmed by PET imaging or cerebrospinal fluid biomarker testing. In the United Arab Emirates, registration and stocking are not yet routine, and family members of patients with confirmed early-stage Alzheimer's frequently look for a structured legal route to obtain the medicine. That route is the unregistered-medicine import permit administered through the Ministry of Health and Prevention (MOHAP) and, from 29 December 2025, through the Emirates Drug Establishment (EDE) portal. A UAE-licensed neurologist or geriatrician submits the application for a specific patient. Reserve Meds handles the US-side sourcing, the cold-chain logistics, and the documentation kit your physician needs.

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Why UAE patients need Leqembi via the named-patient pathway

The UAE federal regulatory environment is one of the most developed in the Gulf, with MOHAP holding the national drug register and the EDE assuming 44 core regulatory services in December 2025. Even with that maturity, three structural patterns sit between a UAE family and Leqembi access. The drug may be on a manufacturer's pipeline for the region but not yet on the federal register; it may be registered but not stocked at a particular hospital; or the early-Alzheimer's indication itself may not have routine commercial visibility in the emirate where the patient is being treated. The Emirati Genome Programme and We the UAE 2031 are accelerating local clinical capacity, but the structural lag between FDA approval and routine UAE availability is real, and it is the gap a named-patient pathway exists to close.

Leqembi's profile reinforces why the pathway is the right route. International registration is patchy: the EMA granted authorization only in April 2025 with a restriction excluding ApoE4 homozygotes, the UK MHRA approved in August 2024 but NICE declined NHS funding, and registration across MENA jurisdictions lags US and Japan timing. The eligible population (early-stage, amyloid-confirmed, ApoE4 status established) is small, motivated, and time-sensitive. The clinical window in which Leqembi is consistent with the approved indication is limited. Families in the UAE seeking anti-amyloid therapy for a parent or spouse are typically working against disease progression, which is what makes the documented named-patient pathway, rather than ad hoc effort, the appropriate operating model.

The MOHAP and EDE named-patient pathway for Leqembi

The federal pathway for a UAE-licensed physician to obtain a medicine that is not registered or not stocked locally is the unregistered-medicine import permit. Historically administered by MOHAP, the framework moved to the EDE portal at ede.gov.ae from 29 December 2025 under Federal Decree-Law No. 38 of 2024. The framework allows hospitals and licensed pharmaceutical establishments to import a specific medicine for a specific patient when the medicine is approved by a recognised reference authority (typically the US FDA, EMA, MHRA, PMDA Japan, or Health Canada) and a clinically equivalent locally registered alternative is not suitable.

A complete Leqembi application typically includes:

• A clinical justification letter from the treating neurologist or geriatrician (diagnosis of mild cognitive impairment or mild dementia stage of Alzheimer's disease, confirmation of amyloid pathology by PET or CSF biomarker, ApoE4 genotype status, prior therapies, why Leqembi is the appropriate next step)
• The treating physician's UAE medical license verification (MOHAP, DHA, DOH, or Sharjah Health Authority, matched to the emirate of the dispensing facility)
• A patient identifier (anonymised reference is preferred where the EDE submission allows)
• Full product details: Leqembi (lecanemab-irmb), Eisai Inc., 200 mg per 2 mL or 500 mg per 5 mL single-dose vials, with the specific quantity tied to the patient's weight-based 10 mg/kg biweekly dosing and the planned treatment cycle
• The destination dispensing facility (the infusion center where the medicine will be administered), its pharmaceutical establishment license number, and the pharmacy in charge
• A chain-of-custody plan describing how Leqembi will move from the US specialty wholesaler through the importer to the infusion pharmacy under continuous 2 to 8 degree Celsius cold chain, with documented temperature logging at every handoff

For Leqembi, the clinical justification letter carries a specific weight. The application benefits from explicit documentation of amyloid-pathology confirmation (PET or CSF), ApoE4 genotype (because homozygotes carry the highest ARIA risk and EU and UK labels restrict accordingly), a recent baseline brain MRI within one year, and a plan for the FDA-labeled MRI surveillance schedule prior to the 5th, 7th, and 14th infusions. Approval timelines for routine UAE cases are typically 5 to 15 business days. A first-time import of a novel-mechanism biologic with cold-chain requirements may extend to 4 to 6 weeks. Timelines are at the authority's discretion and are not promised.

Where Leqembi gets dispensed in the UAE

Leqembi is an intravenous biologic that requires an infusion center with capacity for ARIA monitoring (access to MRI), APOE4 genotyping coordination, and infusion-suite logistics. The institutions in the UAE that fit this profile and routinely handle named-patient imports include Cleveland Clinic Abu Dhabi (the M42 group's 364-bed multispecialty hospital on Al Maryah Island, with neurology and pharmacy services accredited by the American Society of Health-System Pharmacists), Sheikh Khalifa Medical City in Abu Dhabi (the SEHA network's 586-bed JCI-accredited tertiary center, managed by the Cleveland Clinic), American Hospital Dubai (a Mayo Clinic Care Network member with neurology services), King's College Hospital London Dubai (UK-affiliated with strength in neurology), and Mediclinic City Hospital in Dubai Healthcare City.

Tawam Hospital in Al Ain (SEHA network, developed in collaboration with Johns Hopkins) and the larger NMC Healthcare sites also hold pharmaceutical establishment licenses and can route the import through in-house import pharmacy. For families in the Northern Emirates (Ajman, Umm Al Quwain, Ras Al Khaimah, Fujairah) without a local infusion center suitable for ARIA monitoring, the practical pattern is to route to a Dubai or Abu Dhabi center where the treating neurologist holds joint privileges or where the case is co-managed with a UAE-licensed specialist.

Real cost picture for Leqembi in the UAE

The UAE dirham is pegged to the US dollar at approximately 3.67 AED to 1 USD, so cost ranges quoted in USD translate predictably into AED. Eisai set the US wholesale acquisition cost for Leqembi at approximately USD 26,500 per patient per year at launch, based on a reference body weight of 75 kg and the 10 mg/kg biweekly IV regimen. That is roughly AED 97,200 per year for the drug product itself, with per-vial WAC of USD 254.81 for the 200 mg vial and USD 637.02 for the 500 mg vial.

The drug cost is the first line item, not the only one. International logistics for a refrigerated biologic with continuous temperature monitoring typically runs USD 600 to 1,500 (approximately AED 2,200 to 5,500) per shipment, depending on the destination emirate and urgency window. UAE customs and EDE permit fees are nominal relative to the drug cost. The dispensing hospital's infusion administration fee, baseline and surveillance MRI, APOE4 genotyping, and amyloid-confirmation testing (PET or CSF) sit on the hospital's side of the ledger. Reserve Meds itemises the US-side drug procurement, the international logistics, and the concierge coordination fee separately on every firm quote.

On the insurance side, UAE health insurance is mandatory. Daman National Health Insurance is the largest insurer in Abu Dhabi and administers Thiqa for UAE nationals. GIG Gulf, Sukoon Insurance, ADNIC, Orient Insurance, and Al Buhaira National Insurance handle named-patient imports case by case. We do not promise coverage. We supply the documentation set that allows your insurer to assess the case; the claim sits with you or your hospital.

Typical timeline for Leqembi in the UAE

For a routine UAE Leqembi case, the EDE permit window is typically 5 to 15 business days from a complete filing. The biologic class extends the operational timeline by another 2 to 3 days beyond ambient-product shipments because of validated 2 to 8 degree Celsius packaging and continuous temperature monitoring across multi-leg international transit. A first-time import of Leqembi at a given UAE infusion center, where the establishment has not previously stocked the product, can add 2 to 3 weeks for institutional pharmacy onboarding. Once the first cycle is in place, subsequent biweekly shipments follow the same chain on a planned cadence rather than as one-off cases.

What your physician needs to provide

The clinical justification letter is the cornerstone of the EDE application and, for Leqembi, the strongest letters consistently include: a confirmed diagnosis of mild cognitive impairment or mild dementia stage of Alzheimer's disease per the FDA-approved indication; objective confirmation of amyloid pathology by amyloid PET imaging or cerebrospinal fluid biomarker testing, with the report in the patient file; ApoE4 genotype testing performed prior to initiation, with the rationale where the patient is a homozygote (label awareness of higher ARIA risk); a recent baseline brain MRI within one year prior to treatment; the proposed dosing plan (10 mg/kg every two weeks, with patient weight and the corresponding vial selection), and the surveillance MRI plan (additional MRIs prior to the 5th, 7th, and 14th infusions); and the prescribing physician's UAE license verification matched to the emirate of the dispensing infusion center.

The treating physician retains the clinical decision and the pharmacovigilance reporting obligation under UAE Good Vigilance Practice. Reserve Meds supplies the structured documentation template and the chain-of-custody packet from the US side; we do not write the clinical letter and do not direct dosing.

Common questions about Leqembi in the UAE

Will Daman, Thiqa, GIG Gulf, Sukoon, ADNIC, or Orient cover Leqembi?

Each insurer assesses named-patient imports case by case. Some reimburse in full when the medicine is on their formulary even if not stocked, some reimburse a percentage subject to copay, and several require pre-authorisation. Thiqa, the government-funded programme for UAE nationals administered by Daman, has the broadest specialty coverage in Abu Dhabi. We do not promise coverage from any insurer. We supply the documentation set that allows your insurer to assess; the claim sits with you or your hospital.

Will a DHA-licensed or DOH-licensed neurologist's letter be sufficient?

Yes. Any UAE-licensed physician practicing in good standing in the emirate of the dispensing facility has signing authority on the clinical justification letter. A DHA-licensed neurologist filing through a Dubai infusion center, or a DOH-licensed specialist filing through Cleveland Clinic Abu Dhabi or SKMC, both meet the requirement. Joint-privilege physicians who hold licenses in multiple emirates can file in any emirate where they are credentialed.

What is the safety profile we should be aware of?

The FDA label carries a boxed warning for amyloid-related imaging abnormalities (ARIA), including ARIA-E (edema) and ARIA-H (microhemorrhage and superficial siderosis). Most ARIA cases are asymptomatic and detected on surveillance MRI; serious and rare fatal events have been reported. Infusion-related reactions are common, particularly with the first dose. APOE4 homozygotes carry the highest ARIA risk. The treating neurologist manages the clinical surveillance plan, which includes the label-required MRI schedule.

Is there an alternative to Leqembi?

Donanemab (Kisunla, Eli Lilly) is another FDA-approved anti-amyloid monoclonal antibody for early Alzheimer's disease. Comparative selection between Leqembi and Kisunla is a clinical decision that belongs with the treating physician, not with the coordinator.

Can Leqembi reverse Alzheimer's disease?

No. The Clarity AD confirmatory trial reported a slowing of decline on the CDR-SB scale at 18 months compared with placebo. Leqembi is not a cure and does not reverse established neurodegeneration. Families approach treatment with that expectation and the treating physician sets the goals of care.

Can we receive infusions at home in Dubai or Abu Dhabi?

The dispensing facility for an IV biologic must be UAE-licensed. Leqembi requires an infusion suite with MRI access for the label-required surveillance schedule. Direct-to-home infusion without a licensed dispensing facility and MRI capability in the chain is not the operating model.

Where Reserve Meds fits in Leqembi cases

Reserve Meds is a US-based concierge coordinator. We do not replace your neurologist, do not replace the EDE or any emirate-level authority, and do not replace the dispensing hospital pharmacy. What we do is orchestrate the US-side specialty wholesaler sourcing under DSCSA serialization with full pedigree, the cold-chain logistics under validated 2 to 8 degree Celsius packaging with continuous temperature monitoring, and the documentation kit your physician needs for the EDE application. A single named concierge stays on the case from intake through the biweekly dose cadence. Leqembi has no prior Reserve Meds case experience as of this review, so the operating posture is standard NPP coordination with particular attention to cold-chain integrity across multi-leg transit, destination-site MRI access, APOE4 genotype documentation, and amyloid-pathology confirmation in the patient file before any procurement step.

Next step

If a UAE family member has a confirmed amyloid-positive early Alzheimer's diagnosis and your treating neurologist is considering Leqembi, add the case to the waitlist. We will respond within 24 to 48 hours with a documentation kit for your physician and an indicative cost range.

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This guide is informational, not medical or legal advice. The named-patient framework requires a licensed UAE physician's clinical judgment; Reserve Meds is the coordinator, not the prescriber.