Eisai is on the brink of a major breakthrough this summer, with the potential full FDA approval of Leqembi (lecanemab), a new drug for Alzheimer’s, which has already received accelerated approval in January. With this approval, families and caregivers living with the disease will have access to a new therapeutic option.
Ivan Cheung, chairman and CEO of Eisai Inc., revealed to CNBC on Thursday that full approval of their product could come as soon as July, thanks to the priority review granted in January.
Leqembi, an anti-amyloid antibody developed in partnership with Biogen, has achieved full approval – a major milestone that paves the way for Medicare coverage of the treatment. This is an exciting breakthrough for those seeking an effective way to combat the effects of amyloid-related diseases.
At an eye-watering cost of $26,500 per year, the drug is out of reach for many without insurance coverage. Private insurers are often in wait for the Centers for Medicare & Medicaid Services to make their decision on coverage, leaving many on tenterhooks.
Eisai has created an innovative program to provide uninsured patients with their life-saving drug Leqembi at no cost. Not only is this a compassionate step towards helping those in need, it also makes the drug more affordable for everyone, as the annual cost is expected to be reduced over time.
On January 6th, Chiquita Brooks-LaSure, the Administrator of the Centers for Medicare & Medicaid Services (CMS), released an important statement on behalf of the agency.
CMS recently announced that if lecanemab receives traditional FDA approval, they will provide broader coverage for it using the framework they announced last year, under coverage with evidence development. This coverage will take effect on the same day the traditional FDA approval is received.
On a call with reporters Tuesday, CMS Administrator Chiquita Brooks-LaSure expressed the agency’s desire to gain a deeper understanding of the effects of a certain class of drugs, saying “we really wanted to have more information”.
Dr. Jean-Christophe Cheung of Biogen recently expressed his enthusiasm for the Phase III data of Leqembi, a drug designed to slow the decline of cognitive function in Alzheimer’s patients. The results showed a high level of evidence that Leqembi is both effective and safe, with minimal risk of brain hemorrhages. Cheung expressed his confidence that these findings will open the door to a more successful treatment of Alzheimer’s disease.
Earlier Detection Critical
The clock is ticking for the 100,000 people who will be diagnosed with early-onset Alzheimer’s by 2026, the same year Leqembi’s rollout will reach its third year. This is a race against time for those afflicted, and the urgency of the situation cannot be understated.
Leqembi is dedicated to helping those affected by mild cognitive impairment or mild dementia, working hard to identify and diagnose Alzheimer’s in its earliest stages. Presenting a unique challenge, the team is committed to providing the best care and support for individuals and families dealing with these conditions.
To ensure success in the fight against Lewy Body Disease, Dr. Michael Cheung has suggested that CMS provide reimbursement for expensive diagnostic tests such as PET scans. With too few treatments available, the potential for early diagnosis of the disease is often overlooked, resulting in missed opportunities for successful interventions. By providing reimbursement for these important tests, CMS can help make sure that patients receive the care they need when they need it.
On Friday, a group of 20 bipartisan senators led by Susan Collins (R-ME) and Shelley Moore Capito (R-WV) issued a call to HHS Secretary Chiquita Brooks-LaSure and Xavier Becerra to expand Medicare coverage for FDA-approved anti-amyloid antibodies. This plea comes as a step to make these life-saving treatments more accessible for millions of Americans.
In a joint letter to the Centers for Medicare and Medicaid Services, Senators urged the reconsideration of the April 2022 National Coverage Determination (NCD), warning that without it, access to lifesaving treatments such as lecanemab and other disease-modifying therapies for Alzheimer’s disease will be severely restricted.
In April 2022, the CMS issued guidance on a class of Alzheimer’s drugs, which limited coverage of Aduhelm (aducanumab), developed by Eisai and Biogen, to patients participating in clinical trials. This decision opened the door for further research into new treatment options for those living with this debilitating condition.
On January 7th, 2023, Eisai submitted a supplemental Biologics License Application to the FDA, in pursuit of traditional approval of the groundbreaking medication Leqembi.