#China #Beijing #Eisai #Leqembi #Alzheimer's Disease

Leqembi's Inclusion in China's Innovative Drug List

In a significant development for Alzheimer's care in China, Eisai, BioArctic AB's partner, announced the addition of Leqembi® (lecanemab) to the newly established Commercial Insurance Innovative Drug List. The initiative from the National Healthcare Security Administration (NHSA) aims to enhance access to innovative medications for patients and signifies a pivotal step in addressing Alzheimer's Disease (AD) treatment in the country.

Significance of the Commercial Insurance Innovative Drug List

The Commercial Insurance Innovative Drug List, introduced by the Chinese government, intends to bridge the gap between essential coverage provided by the National Reimbursement Drug List (NRDL) and the innovative treatments that target critical health issues. This innovative approach aims to extend coverage options, encouraging dialogue between pharmaceutical companies and commercial insurance firms about potential reimbursement scenarios. The effective date for this list is set for January 1, 2026.

Growing Demand for Alzheimer's Treatments

Eisai estimates that as of 2024, there were approximately 17 million individuals in China suffering from mild cognitive impairment (MCI) or mild dementia related to Alzheimer's disease, with numbers expected to rise as the population ages. The urgency to provide effective treatment options can therefore not be overstated.

Since Leqembi's introduction in the Chinese market in June 2024, the initial response has been promising. The antibody, a product of joint efforts by BioArctic and Eisai, aims to slow the progression of early-stage Alzheimer's, ultimately contributing to enhanced patients' quality of life.

What is Leqembi?

Leqembi, known scientifically as lecanemab, is a humanized monoclonal antibody that targets both soluble and insoluble forms of amyloid-beta (Aβ), a protein implicated in the pathology of Alzheimer's disease. The drug has garnered approval in 51 countries worldwide and is undergoing regulatory review in several others.

The drug's treatment regimen entails intravenous maintenance doses after an initial phase of bi-weekly infusions, which has been authorized in various regions, including the UK, the US, and China. Notably, in the US, an autoinjector version of Leqembi for subcutaneous administration has been introduced, catering to patient convenience and compliance.

Ongoing Clinical Studies

Eisai is currently conducting Phase 3 clinical research titled AHEAD 3-45, which focuses on patients with preclinical Alzheimer's disease, evidenced by the accumulation of amyloid in the brain. This extensive four-year study is conducted in partnership with Biogen and aims to provide robust evidence supporting the efficacy of Leqembi in early-stage treatment scenarios.

Moreover, the Tau NexGen study for Dominantly Inherited Alzheimer’s Disease (DIAD) continues to include lecanemab as a foundational therapy, further exploring its long-term benefits.

Collaboration Between BioArctic and Eisai

Since their collaboration began in 2005, BioArctic and Eisai have developed a strategic partnership that has been pivotal in advancing Alzheimer's treatments. Significant agreements such as the Development and Commercialization agreements for lecanemab underline this productive partnership, allowing BioArctic exclusive commercialization rights in the Nordic region while Eisai oversees global regulatory processes.

Future Outlook

As the world grapples with the burgeoning challenge posed by neurodegenerative diseases, particularly Alzheimer's, the inclusion of Leqembi in China's Commercial Insurance Innovative Drug List presents a promising opportunity to expand treatment access. The anticipated collaboration between commercial insurers and pharmaceutical entities may not only improve patient outcomes but also reshape the landscape of neurological care in China.

This progression signifies hope for millions, aiming to address the immense unmet needs encompassing Alzheimer's prevention and management. With continued research and development, therapies like Leqembi could drastically shift the course of Alzheimer's care, potentially delaying disease progression and enhancing cognitive function for those affected.

In conclusion, the recent addition of Leqembi to China's innovative drug list marks a transformative moment in Alzheimer's treatment, promising greater accessibility and efforts towards long-term solutions for a pressing global health concern.