India gets its first Alzheimer’s therapy, will cost nearly a lakh per dose
The drug is likely to remain out of reach for most, with the current cost standing at Rs 91,688 for a single vial. The treatment lasts 18 months.
Pharmaceutical giant Eli Lilly is launching donanemab in the Indian market under the brandname Lormalzi. (Credit: Unsplash) Alzheimer’s patients in the country will now have the option of receiving a new treatment, with pharmaceutical giant Eli Lilly launching donanemab in the Indian market under the brand name Lormalzi. The once-a-month 350 mg infusion has been shown to slow the progression of the disease by dissolving the amyloid beta protein plaques in the brain — a classical sign of the neuro-degenerative disease.
It is a monoclonal antibody treatment for Alzheimer’s. This is a disease-modifying therapy that uses laboratory-made proteins to target and remove amyloid-beta plaques from the brain, slowing cognitive decline in early-stage patients by roughly 30%. Approved therapies, including lecanemab (Leqembi) and donanemab (Kisunla), are administered intravenously to reduce plaque buildup.
Winselow Tucker, president and general manager, Eli Lilly and Company (India), said in a release: “Alzheimer’s is a complex, progressive condition that places a significant emotional, clinical and societal burden on patients, caregivers, and healthcare systems. The launch of Lormalzi in India reflects our long-standing commitment to advancing innovation and supporting evidence-based intervention for people living with Alzheimer’s.” He added: “We are committed to strengthening patient access by collaborating closely with stakeholders across the healthcare ecosystem.”
How much will it cost?
The innovative drug — third to be approved for the disease by the US Food and Drug Administration (USFDA) and the first one to be launched in India — will be prohibitively expensive. A single dose of the drug will cost Rs 91,688. The company will run an access programme to ensure that patients can get the drug at lower prices. Despite this, not many are likely to be able to afford the drug.
Who can get the treatment?
The treatment is meant for patients in early stages of Alzheimer’s disease — those who have mild cognitive impairment and mild dementia. It is not meant for those who have already progressed to advanced stages — and this is an important caveat. While the drug can dissolve the build-up of amyloid beta protein in the brain, it cannot reverse the damage that has already happened.
Why is the drug important?
Considering the increasing burden of Alzheimer’s disease in India, the drug is an important innovation. Dementia currently affects approximately 8.8 million people in India, with Alzheimer’s disease accounting for the majority of cases. This number is projected to nearly double to 16.9 million by 2036.
Experts say that therapies for the treatment of the neuro-degenerative disease have been notoriously elusive. And, while these therapies may be inaccessible to many now, they present hope for more affordable options becoming available in the future.
What do we know about the treatment so far?
Donanemab is a monoclonal antibody that reduces amyloid beta protein plaques in the brain to slow down cognitive decline in patients with early Alzheimer’s disease.
The phase 3 study with 1,736 patients, 860 of whom received the infusion every four weeks till the amyloid clumps cleared, showed that donanemab slows down cognitive decline in early Alzheimer’s patients by 35.1% in 76 weeks. The drug is, however, known to cause amyloid-related imaging abnormalities (ARIA) such as swelling or bleeding in the brain, most of which is asymptomatic. The study showed that 24% participants had ARIA involving brain swelling, and 19.7% involving brain bleeds. The study reported three treatment-related deaths.
Donanemab remains a preferred choice because the infusion needs to be given every four weeks instead of two weeks with lecanemab. Also, the treatment can be halted, with the patients switching over to placebo after there was a certain level of protein clearance in the donanemab study. “In the absence of amyloid PET imaging, which is currently not available in India, the evidence-based approach is to treat patients with donanemab for 18 months,” the company said.
What are the challenges of the drug in India?
Treatment with donanemab would require an early diagnosis, something that hardly happens with Alzheimer’s patients in India. It would also require careful selection of patients, screening the eligible among them, and following up with expensive tests while watching for severe adverse events that may lead to death. Those being screened would have to be tested for the APOE4 gene, which has been associated with a higher risk of adverse events.
The health systems in India may not be ready for this and it would further add to the cost of the medicine. An editorial published alongside the phase III data on donanemab in the journal JAMA said: “…The modest benefits would likely not be questioned by patients, clinicians, or payers if amyloid antibodies were low-risk, inexpensive, and simple to administer. However, they are none of these.”
What are the other drugs available globally?
There are two other therapies approved by the US FDA, both of which work on the same principle. The two therapies by Eisai-Biogen were approved within two years of each other. While the approvals led to a lot of excitement among clinicians treating the condition, the approval for the first drug aducanumab was mainly based on a “surrogate endpoint” of reducing the amyloid beta plaques, which does not guarantee better cognition in the patients. The second medicine lecanemab did show slowing of cognitive decline.
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