How to access Kisunla from the UAE, the named-patient import pathway, 2026
By Reserve Meds, Clinical and regulatory team. Last reviewed 2026-05-13.
An UAE patient with early Alzheimer's disease, that is mild cognitive impairment or mild dementia due to Alzheimer's, with confirmed amyloid-beta pathology may receive a prescription for Kisunla (donanemab-azbt) from their treating neurologist or geriatric specialist. Kisunla is FDA-approved in the United States and manufactured by Eli Lilly. It is a humanised anti-amyloid-beta monoclonal antibody administered by intravenous infusion. Local availability of Kisunla in the UAE can be inconsistent: the drug may not be on every specialty pharmacy's standing formulary, the specific indication may not match what is locally registered, or the strength required may be back-ordered. When that happens, a named-patient import pathway through MoHAP remains a legitimate route for the patient whose physician has already prescribed the drug.
This guide explains the pathway, the documentation your physician needs, typical costs and indicative timing, and where Reserve Meds fits in.
The clinical situation
Kisunla is a humanised anti-amyloid-beta monoclonal antibody. Mechanism: a humanised IgG1 monoclonal antibody that targets a modified form of amyloid-beta (N-terminal pyroglutamate) deposited in plaques. Dosing: 700 mg by intravenous infusion every 4 weeks for the first 3 doses, then 1400 mg every 4 weeks, with consideration of discontinuation when amyloid plaques are reduced to minimal levels on PET, per FDA labeling. Baseline workup per FDA labeling includes amyloid-beta confirmation (CSF biomarkers or amyloid PET), MRI within 1 year showing baseline ARIA risk, ApoE4 genotype where available, anticoagulant history, and cognitive testing. The FDA boxed warning covers amyloid-related imaging abnormalities (ARIA) with risk of serious or fatal intracerebral haemorrhage, especially in ApoE4 homozygotes. Other important warnings include amyloid-related imaging abnormalities (ARIA-E and ARIA-H), infusion-related reactions including hypersensitivity, and increased risk in ApoE4 homozygotes. Your specialist will discuss the risk-benefit profile and schedule monitoring before initiating therapy.
Is Kisunla legally importable into the UAE?
Yes, through the UAE Ministry of Health and Prevention (MoHAP) named-patient and personal-use import framework, coordinated through a UAE-licensed treating facility's pharmacy. The UAE has an established pathway for specialty medicines approved by reference authorities (US FDA, EMA, MHRA) but not stocked or registered for the specific indication locally.
The MoHAP named-patient route allows an UAE-licensed physician to request import of a medicine when: (a) the medicine is approved by a recognised reference authority, (b) no clinically equivalent locally registered alternative is suitable for the patient's indication and history, (c) the treating physician takes clinical responsibility for use, and (d) chain of custody is documented from the US source to the administering facility. Applications are typically filed through the dispensing institution's import pharmacy on the physician's behalf, with approval issued on a per-patient, per-cycle quantity basis.
How the pathway works, step by step
- Consultation with your treating specialist. The prescribing decision is clinical. Your specialist documents the indication, prior therapies where relevant, and rationale for Kisunla.
- Baseline screening. Amyloid-beta confirmation (CSF biomarkers or amyloid PET), MRI within 1 year showing baseline ARIA risk, ApoE4 genotype where available, anticoagulant history, and cognitive testing are confirmed and documented.
- MoHAP named-patient application. Your specialist or the facility's import pharmacy files the application with clinical rationale, patient reference, product strength, quantity requested, and chain-of-custody plan.
- US-side sourcing. Reserve Meds coordinates with our US-licensed specialty wholesale partner to secure product from Eli Lilly's authorised distribution under DSCSA chain-of-custody.
- Cold-chain shipment. Kisunla requires refrigerated transport at 2 to 8 degrees Celsius. Shipments include temperature-monitored packaging with continuous loggers and tamper-evident seals.
- Arrival and first dose. The dispensing pharmacy releases product against the physician's prescription, and your specialist initiates therapy.
What documentation your physician needs
Your physician will typically need to provide:
- A clinical rationale letter confirming diagnosis, prior therapies where relevant, and Kisunla as the indicated next step
- Verification of their UAE medical licence
- A patient identifier, anonymised reference where privacy is preferred
- Documented pre-treatment screening consistent with FDA labeling (see above)
- The planned dosing regimen (700 mg by intravenous infusion every 4 weeks for the first 3 doses, then 1400 mg every 4 weeks, with consideration of discontinuation when amyloid plaques are reduced to minimal levels on PET, per FDA labeling)
- A monitoring plan covering amyloid confirmation, MRI surveillance schedule per labeling, ApoE4 status, and anticoagulant review
Reserve Meds provides a physician documentation kit tailored for anti-amyloid Alzheimer's biologic therapies, including the templates MoHAP reviewers commonly request.
Typical costs and indicative timing
Reserve Meds gives you a drug-only reference range plus a transparent delivered quote at intake. As an illustrative composite case, the US cash-pay reference range for a typical 4-week cycle (one infusion) of Kisunla sits in an indicative 2026 band of approximately USD 13,000 to 15,000. International logistics, MoHAP documentation handling, cold-chain shipping, and concierge coordination add incremental cost. The delivered quote we issue at intake shows each line separately.
Indicative timing for first dose after cohort intake opens is approximately 4 to 8 weeks (MRI surveillance schedule adds time) from the moment a complete application is submitted, assuming the documentation package is clean on first pass. Refills ship on a rolling cadence aligned to the dosing schedule.
Reserve Meds is in pre-launch. Service availability is limited to our first cohort. All timelines are indicative, not guarantees.
Where Reserve Meds fits in
Reserve Meds is a US-based concierge coordinator for cross-border specialty medicine. For Kisunla specifically, we provide:
- Sourcing. Through our US-licensed specialty wholesale partner, operating under DSCSA chain-of-custody from manufacturer to export.
- Documentation. Regulatory package tailored for your physician and for MoHAP review, including anti-amyloid Alzheimer's biologic class templates.
- Cold-chain logistics. Temperature-monitored, internationally tracked shipment to your named dispensing facility with continuous temperature loggers.
- Concierge case lead. A named point of contact for your family and your physician across the full case arc.
We are a coordinator. We are not the prescriber, not a pharmacy, and not a dispensing facility. All clinical decisions remain with your treating specialist, and dispensing sits with the licensed UAE pharmacy of record. Reserve Meds operates on cash-pay only and does not bill insurance.
Frequently asked
Is this legal in UAE? Yes, when executed through the MoHAP named-patient and personal-use framework with appropriate documentation, clinical rationale, and a licensed dispensing facility. The pathway is routinely used across oncology, rare disease, and immunology at UAE tertiary centers.
What about the boxed warning? The FDA boxed warning on Kisunla covers amyloid-related imaging abnormalities (ARIA) with risk of serious or fatal intracerebral haemorrhage, especially in ApoE4 homozygotes. Your specialist performs the risk-benefit assessment, schedules monitoring, and counsels the patient per labeling. Reserve Meds does not make that clinical judgement, your physician does.
Will my private health insurance cover this? Cash-pay is the default posture. Some UAE private insurers (Daman, AXA, Mednet-administered plans) reimburse named-patient imports on a case-by-case basis when the documentation package is strong. We supply documentation for your submission but do not process insurance claims.
How does cold-chain affect timing? Kisunla ships refrigerated. We use validated packaging with continuous temperature monitoring, and arrival temperature data is logged on every shipment.
What if my physician has not filed a named-patient request before? Named-patient import is an institutional process most major UAE tertiary centers (Cleveland Clinic Abu Dhabi, Sheikh Shakhbout Medical City, American Hospital Dubai, and Mediclinic City Hospital) have encountered. Our documentation kit is written for first-time applicants and tracks what MoHAP reviewers commonly ask for.
Join the waitlist
Reserve Meds is opening to a limited first cohort in 2026. Add your case to the waitlist and our concierge case lead will reach out when we are ready to enter intake for Kisunla coordination in UAE.
Add me to the Kisunla waitlist
Composite case examples. Reserve Meds is in pre-launch. This content is for general information and does not constitute medical advice. Reserved for you.