Eli Lilly's Alzheimer's drug donanemab approved in India, but neurologists flag cost, access barriers

Hyderabad: Alzheimer's, a progressive neuro-degenerative disease, has no cure. For decades, treatment has largely focused on managing symptoms rather than slowing the disease itself. That changed with the launch of Eli Lilly's anti-amyloid drug donanemab, branded as Lormalzi (Kisunla US, EU, etc.), and recently approved in India.

But neurologists in India caution that its real-world impact in India could be limited by high costs, delayed diagnosis, lack of specialised monitoring requirements and most critically, questions revolving about the extent of benefit.

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On its part, Winselow Tucker, President and General Manager, Eli Lilly and Company (India) says regulators had conducted thorough independent reviews of the data and that the company remains confident in the therapy's benefit-risk profile.

The launch of donanemab comes as India faces a rapidly growing dementia burden. Dementia affects an estimated 8.8 million people in the country, with Alzheimer's disease accounting for the majority of cases, according to estimates cited by Eli Lilly.

The Big Debate

Donanemab is approved for patients with mild cognitive impairment or mild Alzheimer's disease, making early diagnosis critical.

The drug works by clearing amyloid plaques in the brain, a biological hallmark of Alzheimer's, and is among a new generation of therapies designed to alter the course of the disease itself. In the Phase III TRAILBLAZER-ALZ 2 clinical study, donanemab slowed cognitive and functional decline by around 35% in patients with early symptomatic Alzheimer's . However, experts stress that the figure is often misunderstood.

"The 35% slowing should not be interpreted as a 35% improvement in memory. Patients generally continue to show decline, but slower than expected. Some families may notice a meaningful delay in deterioration, while others may perceive little visible difference," Dr Sudhir Kumar, senior consultant neurologist at Apollo Hospitals Hyderabad says, adding that for some patients, that could mean preserving independence for longer and delaying the need for assistance.

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That distinction lies at the heart of a debate that has followed anti-amyloid drugs globally, with questions over whether the clinical benefit justifies the risks and cost. The European Medicines Agency initially issued a negative opinion on donanemab, citing concerns around its benefit-risk profile, before backing approval in a narrower patient population considered less likely to experience serious side effects.

Neurologists acknowledge the concerns but add the context matters.

"The debate is justified because both sides have valid arguments. The key question is not whether the drug works. It clearly does biologically. The question is whether the degree of benefit is meaningful enough for the cost, monitoring burden and risk," Kumar said.

Treatment Costs

While the extent of benefit is a point of debate, cost is another hurdle.

The treatment could cost patients roughly Rs 16-18 lakh over an 18-month fixed course, excluding associated testing and monitoring. Regular MRI scans are required to watch for amyloid-related imaging abnormalities (ARIA), including brain swelling and small brain bleeds.

"I strongly feel that cost is a big hurdle in a country like India," said Dr Subash Kaul of KIMS Hospitals.

Currently, most Alzheimer's patients in India are treated with medicines such as donepezil and memantine, which help manage symptoms but do not alter the underlying disease. Dr Kaul says they also recommend low-cost lifestyle interventions such as exercise, social engagement and management of hearing loss and vascular risk factors supported by scientific evidence, remain a key part of Alzheimer's care.

The market could soon become more competitive with Eisai and Biogen's lecanemab (branded Leqembi), another anti-amyloid therapy approved in several global markets, also expected to enter India, which could eventually alter pricing dynamics.

Diagnosis Gap

Trial data on donanemab also raised concerns about brain swelling and bleeding associated with anti-amyloid therapies, and neurologists say careful patient selection will be critical in managing those risks.

Dr M.V. Padma Srivastava, chairperson of neurology at Paras Health, Gurugram, said physicians evaluate genetic risk factors, microbleeds, blood pressure control and other co-morbidities before deciding whether a patient is suitable for therapy.

"Regulatory approval of donanemab followed a thorough, independent assessment of the totality of clinical evidence. We remain steadfast in our confidence in its clinical effectiveness and the value it brings to patients. Lilly is committed to ensuring that regulators, the medical community, and patients have strong evidence of donanemab’s benefit/risk profile as a treatment option for Alzheimer’s disease," Lilly's Tucker said.

Besides, neurologists point to a critical diagnosis gap. Dr Umesh T, clinical director at CARE Hospitals, Hyderabad, said families frequently dismiss early memory problems as age-related decline, with many patients reaching specialists only after the disease has significantly progressed despite donanemab being intended primarily for people with mild cognitive impairment or early Alzheimer's disease.

Lilly acknowledges this challenge with Alzheimer's being significantly underdiagnosed in India, with many identified only at later stages, and only one in 10 with dementia currently receiving a diagnosis, treatment or care.

"Early diagnosis is critical to enabling patients to benefit from disease-modifying therapies such as donanemab," Tucker says.
Neurologists are also divided on whether India's diagnostic infrastructure is ready for the care pathway patients on donenamab will require. They argue that India has limited access to specialised tests such as amyloid PET scans and biomarker analysis, and that expertise,is currently restricted to major urban centres.

Lilly says it is working to strengthen diagnostic capability.

Even so, at present, Kumar says, widespread adoption in India is likely to remain limited. Neurologists like Dr Srivastava also point out that most medical innovations begin as expensive therapies before costs gradually fall.

Lilly, on its part, says the high cost reflects donanemab's limited-duration treatment approach and once-monthly dosing schedule. "Lilly is establishing an Alternate Access Program to help expand access to donanemab in India for eligible patients," Tucker added.