Eisai: cross-border access for the specialty portfolio

Quick orientation

Eisai Co., Ltd. is a Japanese global pharmaceutical company headquartered in Tokyo, with US operations in Nutley, New Jersey. Eisai's strategic focus is on neurology - particularly Alzheimer's disease and epilepsy - and oncology, with a long-standing partnership with Biogen on the Alzheimer's franchise and with Merck on the Lenvima oncology franchise. Eisai trades on the Tokyo Stock Exchange. FDA approval scale spans multiple oncology and neurology products, anchored by the Leqembi launch as the first amyloid-targeting Alzheimer's therapy with clear regulatory traction and a substantial commercial role for Lenvima in liver, kidney, and thyroid cancers.

Eisai portfolio in cross-border NPP scope

Leqembi (lecanemab-irmb), co-developed with Biogen, is an FDA-approved anti-amyloid beta protofibril antibody for the treatment of Alzheimer's disease in patients with mild cognitive impairment or mild dementia (FDA traditional approval July 2023, following accelerated approval January 2023). Leqembi is administered by intravenous infusion every two weeks, with detailed MRI monitoring required for amyloid-related imaging abnormalities (ARIA). US list pricing is approximately US$26,500 per year, before discounts and patient assistance. The product is the first amyloid-targeting therapy with a clinical efficacy signal sufficient for traditional FDA approval and is the leading edge of disease-modifying Alzheimer's therapy.

Lenvima (lenvatinib), co-promoted with Merck/MSD, is an FDA-approved oral multikinase inhibitor for differentiated thyroid cancer, hepatocellular carcinoma (in combination with Keytruda or as monotherapy), advanced renal cell carcinoma in combination with everolimus or Keytruda, and endometrial carcinoma. US list pricing is approximately US$25,000-$28,000 per month depending on weight-based dosing.

Halaven (eribulin) is an FDA-approved microtubule inhibitor for metastatic breast cancer and liposarcoma. Fycompa (perampanel) is an FDA-approved antiepileptic for partial-onset seizures and primary generalised tonic-clonic seizures. Banzel (rufinamide) is approved for Lennox-Gastaut syndrome.

Why patients route through cross-border NPP

Leqembi is the dominant cross-border NPP demand driver in the Eisai portfolio. The Alzheimer's mild cognitive impairment to mild dementia patient population is enormous globally, and the addressable patient pool is amplified by improved diagnostic capability - amyloid PET imaging and cerebrospinal fluid amyloid testing are now available at major academic centers in the GCC, India, and Southeast Asia. However, the commercial availability of Leqembi outside the United States lags significantly. The European Commission approved Leqembi in April 2025 with a restricted patient population (excluding ApoE4 homozygotes), and country-by-country reimbursement is unfolding slowly. In the GCC, India, Turkey, and most of MENA, confirmed-amyloid mild cognitive impairment or mild dementia patients with appropriate clinical workups face a multi-year wait for local commercial supply.

The Leqembi protocol requires baseline and serial MRIs to monitor for ARIA, biweekly infusion capacity, and treating-physician familiarity with the dose adjustment and discontinuation criteria. Reserve Meds intake confirms that the local site has the imaging and infusion capability before initiating supply.

Lenvima access is uneven across cross-border destinations, particularly for the newer indication combinations (with Keytruda for endometrial cancer; with Keytruda for hepatocellular carcinoma). Patients with confirmed indication and prescriber-led treatment plan route through cross-border NPP where local supply is unavailable.

Common cross-border destinations

The highest-frequency NPP destinations for Eisai products from US-approved inventory are India, the United Arab Emirates, Saudi Arabia, Qatar, and Turkey. Major memory centers, neurology departments, and oncology centers in Mumbai, Bangalore, Delhi, Dubai, Abu Dhabi, Riyadh, Doha, and Istanbul drive most inbound referrals.

Manufacturer engagement posture

Reserve Meds coordinates Eisai-sourced US commercial product through DSCSA-compliant US specialty distributors. We are not affiliated with Eisai or its commercial partners. Our role is patient-facing coordination on behalf of named individual patients with a verified prescription. For Eisai medical affairs or US commercial teams interested in cross-border NPP pathways, our BD contact is [email protected].

What Reserve Meds provides

For each Eisai product request, Reserve Meds coordinates: prescription verification with the treating physician (neurologist or geriatrician for Leqembi; oncologist for Lenvima and Halaven; neurologist for Fycompa and Banzel); diagnostic confirmation documentation review (amyloid PET or CSF for Leqembi; pathology and biomarker reports for oncology indications); DSCSA serialized chain-of-custody from Eisai through licensed US wholesalers to the named patient; cold-chain shipping (2 to 8 degrees C) for Leqembi and other biologics with temperature data-loggers; ambient shipping for oral products; destination-country regulatory documentation for Ministry of Health named-patient approvals and customs clearance; and a dedicated coordinator from prescription to delivery.

Clinical governance and prescription review

Every prescription for a product on this page is reviewed by a US-licensed pharmacist before dispensing. Reserve Meds does not substitute generic equivalents for branded specialty products without an explicit prescriber instruction, and we do not dispense any product whose chain-of-custody we cannot serialize back to the FDA-authorised manufacturer or its licensed wholesale partner. Our clinical review confirms indication-on-label appropriateness based on the documentation submitted by the treating physician, identifies any standard drug-drug interaction or contraindication concerns, and confirms that the requested dose, dosing schedule, and dosage form match the prescription. Where the prescription is unclear or where the indication on the prescription is off-label, our pharmacist contacts the prescriber directly. We do not provide medical advice to patients beyond drug-information counseling at dispensing.

Supply chain integrity

Supply integrity is the foundation of Reserve Meds operations. Every shipment carries a serialized DSCSA pedigree document confirming the chain of ownership from the FDA-registered manufacturer or its authorised distributor through a licensed US wholesale distributor to Reserve Meds and onward to the named patient. We do not source through parallel-import channels, third-country re-import, or unverified online wholesale markets. Cold-chain shipments are packed in qualified shippers with temperature data-loggers reading and logging temperature throughout the journey; data-logger reads are reviewed on arrival, and any out-of-specification excursion triggers our quality-hold protocol. For frozen products such as gene therapies and certain antibody-drug conjugates, we use validated frozen-shipper systems with dry-ice replenishment as required.

Destination-country regulatory pathways

Cross-border named patient access operates under jurisdiction-specific regulatory frameworks. In the United Arab Emirates, the Ministry of Health and Prevention (MOHAP) and Dubai Health Authority operate import-permit pathways for unregistered or restricted medicines on a named-patient basis. Saudi Arabia, Qatar, Kuwait, Bahrain, and Oman each operate analogous Ministry of Health named-patient frameworks with country-specific documentation requirements. India operates a personal-import pathway under the Drugs and Cosmetics Rules for quantities consistent with personal therapeutic use, typically up to three months supply per shipment. Turkey, Egypt, Jordan, Lebanon, and Morocco each operate distinct named-patient or import-permit pathways. Reserve Meds maintains current regulatory intelligence for each of these jurisdictions and prepares the documentation package required for each shipment.

What to expect through the coordination process

Patients beginning a request receive an initial coordinator contact within one business day of submission. The coordinator reviews the prescription, identifies the documentation required for the destination country, and provides an indicative cost range. Once required documents are uploaded - prescription, prescriber license verification, patient identification, and any indication-specific documentation such as genetic test results or biomarker reports - we issue a firm quote inclusive of product cost, packaging, shipping, regulatory documentation, and our coordination fee. Patients confirm acceptance of the firm quote before any sourcing or shipping is initiated, and Reserve Meds does not collect any deposit at intake. Once the firm quote is accepted and payment is received, the coordinator initiates sourcing through our licensed wholesale partners and prepares the destination-country regulatory package. Typical end-to-end timing from accepted quote to delivery is two to four weeks for ambient-shipped products and three to five weeks for cold-chain shipments, with variability driven by destination-country customs and regulatory turnaround times.

Not affiliated with the manufacturer

Reserve Meds is an independent operator of named patient program coordination. We are not a subsidiary, affiliate, authorised distributor, or licensed representative of any pharmaceutical manufacturer, and no statement on this page should be read as a partnership, endorsement, or representation by the named manufacturer. Trade names and product references on this page are used for informational purposes to identify the FDA-approved products that Reserve Meds coordinates through US specialty wholesale channels on behalf of named individual patients.

Privacy and data handling

Patient data submitted to Reserve Meds is handled under our HIPAA-aligned privacy policy and our destination-country data protection commitments. We minimise data collection to what is necessary for prescription verification, regulatory documentation, and shipping logistics. Patient identifiable information is shared with US wholesalers, destination-country regulatory authorities, and shipping carriers only as required to complete the coordination, and is not used for any marketing purpose.

Next step for patients

Patients with a treating-physician prescription for an Eisai product can begin a request now. Start a Leqembi request ›

Next step for Eisai teams

Eisai medical affairs or commercial teams interested in cross-border NPP coordination for non-US territories can reach our BD team at [email protected].

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