Donanemab is now infused in a Mexican public hospital. Lilly’s 2026 target: 30 patients — the gap between innovation and the system, in one number.

PHARMA · JULY 2026 · MEXICO / LATAM
💊 Industry: Lilly moves first in a Mexican public hospital; access capped by missing infrastructure
🏦 Payers: Neither drug nor biomarkers are on the public formulary; no coverage decision exists
⚖️ Litigation risk: Approved but unfunded is the classic trigger for LatAm judicialization
👨👩👧 Caregivers: A late-diagnosis, low-coverage system leans on unpaid care, 72% borne by women
This year, Mexico’s National Institute of Neurology and Neurosurgery (INNN) administered the first infusions of donanemab (Kisunla) in the country’s public health system — the first time a disease-modifying Alzheimer’s therapy has been infused in a Mexican public hospital. Lilly has set a target of 30 patients for 2026. In a country where 1.3 million people live with dementia and, by the makers’ own account, only 17% are diagnosed early enough to qualify, that number is not a corporate shortfall. It is the measure of the system Mexico still has to build for the innovation to reach anyone.
The infusions mark the physical end of a long regulatory chain. COFEPRIS, Mexico’s health regulator, cleared donanemab in April 2025 — making the country the fifth to approve it, after the United States, Japan, the United Kingdom and China — and in December the INNN and Eli Lilly signed an agreement to bring it into a public hospital. Donanemab is not the first anti-amyloid drug Mexico has authorised; the regulator approved lecanemab (Leqembi) in November 2024. But that approval has yet to become a public treatment programme, which is what makes the INNN infusions a first. The drug is a monthly intravenous antibody that clears amyloid plaque; in its pivotal trial (TRAILBLAZER-ALZ 2, JAMA, 2023) it slowed cognitive and functional decline by up to 35% in patients with less advanced disease and by 22% across the full cohort — a real but modest effect, weighed against amyloid-related brain swelling or microhaemorrhage (ARIA) in roughly 37% of treated patients and three treatment-related deaths. The course runs up to 18 months and stops once plaque is cleared. It is a genuine first for Mexican public medicine — and a therapy built for a health system that does not yet exist here.
The reason is eligibility. Donanemab is licensed only for early Alzheimer’s with confirmed beta-amyloid — and here the gate narrows to a point. Amyloid-PET, the diagnostic gold standard, is not available in Mexico; confirmation depends on lumbar puncture, and the country has less than a tenth of the MRI capacity of developed nations (Mimenza-Alvarado et al., Gaceta Médica de México, 2026). Diagnosis, when it comes, comes late: patients spend two to five years in primary care before referral, the average wait to a diagnosis runs three to ten years, and roughly 70% reach specialists only once the disease is advanced — past the window donanemab needs. Up to 90% of cases may never be diagnosed at all. “A person’s Alzheimer’s journey does not begin with the diagnosis; it begins long before,” says Laura Cortés of the patient coalition Acción Juntos Recordamos. A drug that presumes early, biomarker-confirmed diagnosis has been dropped into a country that diagnoses late, by clinical impression, and mostly in the capital.
Then there is who pays. COFEPRIS approves therapies; it does not fund them. Neither donanemab nor the biomarkers needed to prescribe it sit in the IMSS cuadro básico, the essential-medicines list that governs what the public system covers, and Mexico’s price for Kisunla is not yet public. Its U.S. list price — US$32,000 a year, before scans and the surveillance MRIs ARIA demands — is the only benchmark; Mexican specialists note anti-amyloid treatment starts near US$25,000, a figure that exceeds the country’s average annual income (Gaceta Médica de México, 2026). Roughly 85% of Alzheimer’s care costs already fall on households. Against that, “our goal this year is to benefit 30 patients,” as Lilly’s Rubén Ortiz put it, is not stinginess; it is an honest measure of how narrow the on-ramp is. A pioneering therapy reaching 30 people in a population of 1.3 million with dementia is the gap between innovation and infrastructure, stated as arithmetic — the same gap HealthSignals documented when Mexico’s public system stayed locked out of the GLP-1 boom.
There is a case for starting small. Early-access programmes generate real-world evidence on how these therapies perform in Latino populations largely absent from the pivotal trials — data the region will need whatever it ultimately decides on coverage. But that gap also has a legal afterlife across Latin America. When a drug is approved and not reimbursed, patients increasingly sue the state to obtain it — and courts increasingly agree. Brazil is where the pattern is best documented: the state of Rio de Janeiro alone recorded more than 53,000 medicine-supply lawsuits between 2010 and 2017 (Saúde em Debate, 2019), with parallel surges in São Paulo, Colombia, Argentina and Chile. An expensive, approved, unfunded Alzheimer’s therapy is a textbook candidate for that pipeline — regulatory risk for manufacturers, a precedent-setting burden for public budgets.
The weight of that unanswered question rests, as ever, on families. In Mexico, unpaid domestic and care work is valued at nearly a quarter of GDP, 72% of it performed by women (INEGI, 2024) — the informal safety net a late-diagnosis, low-coverage system leans on. The scaffolding for something better already exists on paper: Mexico has had a National Dementia Plan since 2014, updated in 2024, whose first strategy is cognitive screening at the primary-care level. What is missing is implementation — amyloid diagnostics in the public system, screening actually running in first-level clinics, and a coverage decision that puts the drug and its biomarkers on the formulary. Lilly can bring the therapy. Only the state can build the system that lets it land.
“Dementia is still diagnosed too little and too late. The National Plan is a step forward, but for it to work it has to be wired into health services, with the right tools at every level of care.” — Dr. Sara Gloria Aguilar Navarro, Head of Geriatrics, National Institute of Medical Sciences and Nutrition (INCMNSZ)
Why this is relevant
Patients
For the first time in the public system, Mexicans can access a therapy that slows Alzheimer’s rather than only managing symptoms. But the benefit is real only for those caught early with confirmed amyloid — a minority, given that just 17% are diagnosed in time and amyloid-PET is unavailable nationwide. Access to the drug is, in practice, access to timely diagnosis.
Industry
Lilly is positioning as a first mover in Latin America’s anti-amyloid market, and a small early-access programme has a defensible logic: it builds real-world evidence in a population underrepresented in trials. The reputational upside of pioneering public-hospital access is real; so is the risk of being the face of a therapy most patients cannot reach. The commercial future here depends less on the molecule than on whether Mexico builds diagnostic capacity.
Payers
COFEPRIS approval creates demand without a funding mechanism; neither donanemab nor its biomarkers are on the IMSS formulary. At a U.S. benchmark of US$32,000 a year plus imaging and monitoring, the cost sits with families in a country where roughly 85% of Alzheimer’s care costs already do. That coverage decision — or its absence — will define who the therapy reaches.
Litigation risk
Approved-but-unfunded high-cost therapies are a classic driver of health litigation in Latin America. Rio de Janeiro alone logged more than 53,000 medicine-supply lawsuits between 2010 and 2017, with parallel surges in São Paulo, Colombia, Argentina and Chile. Donanemab is a strong candidate to enter that pipeline, exposing both public budgets and manufacturers to precedent-setting cases.
Caregivers
The burden of a late-diagnosis, low-coverage system falls on relatives. In Mexico, unpaid domestic and care work is valued at nearly a quarter of GDP, 72% of it performed by women (INEGI, 2024). Any therapy requiring sustained monitoring adds to that load unless the public system absorbs the diagnostic and follow-up cost.
HEALTHSIGNAL Editorial | July 28, 2026 | Sources listed below.
🤖 This article was produced with AI assistance and reviewed against primary, publicly available sources. It was reviewed by a human writer/editor to ensure accuracy and quality control.
- Sims JR et al. — Donanemab in Early Symptomatic Alzheimer Disease (TRAILBLAZER-ALZ 2), JAMA (2023). DOI: 10.1001/jama.2023.13239
- Mimenza-Alvarado AJ et al. — El estado de la enfermedad de Alzheimer en México, Gaceta Médica de México (2026). doi.org
- Alzheimer’s Association — Donanemab (Kisunla) approval and cost. alz.org
- Medicina Digital — Lilly & INNN collaboration; 17% timely-diagnosis figure (Dec 2025). medicinadigital.com
- Medicina Digital / Economist Impact — Up to 90% undiagnosed; 3–10 year diagnostic delay; Dr. Aguilar Navarro (Sept 2025). medicinadigital.com
- Saludiario — “El Recorrido del Paciente con Alzheimer en México,” Acción Juntos Recordamos; Laura Cortés quote (Jun 2026). saludiario.com
- Revista FactorRH — First INNN infusions, 30-patient 2026 goal, 18-month cycle (Feb 2026). revistafactorrh.com
- Eisai / Biogen — Lecanemab (Leqembi) COFEPRIS approval in Mexico (Dec 2024). prnewswire.com
- Secretaría de Salud / INGER — Plan Nacional de Demencias. gob.mx
- Frontiers in Neurology — Alzheimer’s task force for Latin America (2023). frontiersin.org
- INEGI — Cuenta Satélite del Trabajo No Remunerado de los Hogares (2024). inegi.org.mx
- Saúde em Debate — Judicialization of medicines in Rio de Janeiro, 2010–2017. scielosp.org
- HealthSignals — GLP-1 Drugs Race to $100B — Mexico’s 14 Million Diabetics Watch From the Sidelines (2026). healthsignals.news
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