How to access Kisunla from Saudi Arabia — the named-patient import pathway, 2026

By Reserve Meds · Clinical & regulatory team · Last reviewed 2026-04-23

A Saudi patient with early Alzheimer's disease — mild cognitive impairment due to Alzheimer's or mild Alzheimer's dementia — may receive a prescription for Kisunla (donanemab) from their treating neurologist, geriatrician, or cognitive specialist. Kisunla is FDA-approved for the treatment of early symptomatic Alzheimer's disease in patients with confirmed amyloid pathology, developed by Eli Lilly. It is the second generation of anti-amyloid monoclonal antibody in clinical practice, alongside Leqembi, and in its pivotal trial it demonstrated meaningful slowing of cognitive and functional decline with a time-limited treatment paradigm — patients could potentially complete therapy once amyloid-plaque clearance was achieved on follow-up imaging. In Saudi Arabia, Kisunla availability through hospital pharmacies is still emerging; for families whose neurologists want a documented, chain-of-custody start date, the SFDA named-patient import pathway is the established route.

This guide explains the pathway, eligibility screening (including amyloid-PET and ApoE4 genotyping), documentation your physician prepares, indicative timing and cost bands, and where Reserve Meds fits in.

The clinical situation

Kisunla is a humanised IgG1 monoclonal antibody that binds a modified N-terminal truncated form of amyloid beta found in plaques, driving efficient plaque clearance. Dosing is intravenous every four weeks with a gradual initial dose titration (350 mg for the first three doses, then 700 mg and later 1400 mg per labeling, typically reached by dose four). A distinctive feature of Kisunla is the option for time-limited therapy: follow-up amyloid-PET imaging after a defined treatment period can document plaque clearance, at which point your neurologist may stop therapy rather than continue indefinitely. Eligibility is narrow: patients must have mild cognitive impairment or mild Alzheimer's dementia, confirmed amyloid pathology via amyloid-PET or CSF biomarkers, and a structured baseline neurologic workup. ApoE4 genotyping is required for risk stratification, since ApoE4 homozygotes are at substantially higher risk of ARIA (amyloid-related imaging abnormalities — ARIA-E oedema and ARIA-H microhaemorrhage). Baseline MRI and periodic surveillance MRIs per labeling are essential. Anticoagulation is a relative caution.

Is Kisunla legally importable into Saudi Arabia?

Yes — through the Saudi Food and Drug Authority (SFDA) named-patient / special-access import framework. The pathway permits a Saudi-licensed physician to request import of a medicine when (a) the medicine is approved by a recognised reference authority such as the US FDA, (b) no clinically equivalent locally available option is suitable, (c) the physician accepts clinical responsibility, and (d) chain of custody is documented. For Kisunla specifically, the pathway additionally requires coordination with a tertiary infusion centre that can support the every-four-week IV schedule, MRI surveillance, ARIA monitoring protocol, and amyloid-PET follow-up imaging for the time-limited-therapy decision.

How the pathway works, step by step

1. Consultation with your treating neurologist or cognitive specialist. Cognitive staging (MMSE, MoCA, CDR), clinical interview, caregiver input, and review of comorbidity and medication profile.
2. Amyloid confirmation and eligibility workup. Amyloid-PET scan or CSF biomarker confirmation, ApoE4 genotyping for ARIA-risk stratification, baseline MRI, anticoagulation review, and informed consent on ARIA and time-limited-therapy paradigm.
3. SFDA named-patient application. Your physician or the hospital pharmacy files the application with clinical rationale, eligibility documentation, patient reference, product details, and chain-of-custody plan.
4. US-side sourcing. Reserve Meds coordinates with our US-licensed specialty wholesale partner to secure Kisunla from authorised distribution under DSCSA.
5. Cold-chain shipment. Kisunla ships under validated 2-8 °C conditions with temperature logging and chain-of-custody documentation.
6. Arrival and administration. IV infusion every four weeks at a Saudi tertiary infusion centre with MRI surveillance per labeling; amyloid-PET follow-up imaging at the interval your neurologist specifies to support the time-limited-therapy decision.

What documentation your physician needs

• Clinical rationale letter confirming early Alzheimer's diagnosis (MCI-AD or mild AD dementia)
• Verification of Saudi medical licence (SCFHS)
• Amyloid-PET or CSF biomarker report confirming amyloid pathology
• ApoE4 genotyping result (for ARIA-risk stratification)
• Baseline MRI report
• Anticoagulation status and cardiovascular history
• Planned infusion calendar (every four weeks with dose titration) and MRI surveillance cadence
• Patient identifier (anonymised reference preferred)

Reserve Meds provides a physician documentation kit that bundles the templates SFDA reviewers expect to see for anti-amyloid mAb named-patient imports, including the ARIA-monitoring, informed-consent, and time-limited-therapy-paradigm annex.

Typical costs and indicative timing

Kisunla's US cash-pay drug-only reference range in 2026 sits at roughly USD 32,000-36,000 per year of therapy at typical maintenance dosing, with total cost significantly influenced by the time-limited paradigm — patients achieving documented amyloid clearance may complete therapy earlier, substantially reducing lifetime treatment cost compared with indefinite dosing. Infusion-centre fees, amyloid-PET and follow-up PET, ApoE4 genotyping, and MRI surveillance are arranged locally and billed by your hospital. International cold-chain logistics, SFDA documentation handling, and concierge coordination are quoted separately. Reserve Meds issues a full transparent delivered quote at intake so your family sees one landed number before committing. These ranges are indicative, not guaranteed.

Indicative timing — not guaranteed — for first dose after cohort intake opens is approximately 7-14 days from the moment a complete SFDA application and eligibility workup are in hand. Eligibility workup (amyloid-PET, ApoE4, baseline MRI) typically runs in parallel with the import application.

Reserve Meds is in pre-launch. Fulfillment availability is limited to our first cohort, and all timelines published on this site are indicative. If your clinical situation is time-sensitive, flag that when you join the waitlist — we triage accordingly.

A brief culturally-aware note: Ramadan and Hajj seasons can affect scheduling across Saudi tertiary centres. Our concierge team coordinates the every-four-week infusion calendar and MRI surveillance with your family's preferences and your hospital's calendar.

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 authorised channels.
• Documentation. Regulatory package for your physician and SFDA review, including eligibility, ARIA monitoring, and time-limited-therapy-paradigm annex.
• Logistics. Validated 2-8 °C cold-chain shipment with temperature logging, timed to your infusion calendar.
• Concierge case lead. A named point of contact coordinating every-four-week deliveries, MRI surveillance timing, and follow-up amyloid-PET scheduling with your physician's office.

What we do not do: we are not the prescriber, we do not practise medicine, and we are not the dispensing pharmacy. We do not perform amyloid-PET, ApoE4 genotyping, or MRI — these are arranged at your Saudi clinical centre. All clinical decisions remain with your treating neurologist and the administering infusion facility. We operate on a waitlist basis during pre-launch.

Frequently asked

Is this legal in Saudi Arabia? Yes, when executed through the SFDA named-patient / special-access framework with appropriate documentation and a licensed administering facility. See our trust and compliance page for methodology.

How does Kisunla compare with Leqembi? Both are anti-amyloid monoclonal antibodies for early Alzheimer's. Kisunla is dosed every four weeks with dose titration; Leqembi is dosed every two weeks. Kisunla uniquely supports a time-limited-therapy paradigm — your neurologist may stop treatment after documented amyloid-plaque clearance on follow-up PET. Choice depends on clinical context, ApoE4 status, cadence preference, and local infusion-centre availability.

Why is ApoE4 genotyping required? ApoE4 homozygotes carry substantially elevated risk of ARIA-E (oedema) and ARIA-H (microhaemorrhage). ApoE4 status is required for informed consent, risk-benefit discussion, and some centres adjust dosing or surveillance intensity based on genotype.

What is the MRI surveillance schedule? Per labeling, a baseline MRI and surveillance MRIs at defined intervals (typically before doses 2, 3, 4, and 7) are recommended, plus clinically indicated scans for any new neurologic symptoms. Your neurologist will set the specific cadence.

Can Kisunla therapy really be stopped? Yes, in eligible patients. The time-limited paradigm is a distinctive feature — follow-up amyloid-PET can document plaque clearance, at which point therapy may be discontinued. Your neurologist decides based on imaging response and clinical judgement.

Is Kisunla a cure? No. It slows early-Alzheimer's decline but does not reverse established disease. Expectation-setting with the patient and family is a standard part of the workup.

Next step — join the first-cohort 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 enter intake for Kisunla coordination in Saudi Arabia.

Add me to the Kisunla waitlist

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Examples and timings above are composite illustrations drawn from published sources and typical named-patient patterns. Your individual case is assessed by your physician and our clinical-regulatory team; Reserve Meds does not guarantee outcomes or timelines.

Reserve Meds is a US-based concierge coordinator for cross-border specialty medicine. We are in pre-launch; service availability is limited to our first cohort and published timelines are indicative, not guarantees. Cash-pay. Export-only (US → overseas). Composite case examples. Not medical advice.

Clinical & regulatory review: Reserve Meds clinical team and AI regulatory-counsel review pipeline. Last medically reviewed: 2026-04-23.