In July, the U.S. Food and Drug Administration (FDA) approved Kisunla (donanemab) for the treatment of people living with early symptomatic Alzheimer’s disease, which includes mild cognitive impairment and the mild dementia stage of Alzheimer’s disease, with confirmed amyloid plaques.
Kisunla, made by Eli Lilly and Company, is the latest in the new class of treatments that could slow cognitive decline in initial stages of the disease. Kinsula, administered by IV infusion every four weeks, treats those with mild Alzheimer’s disease and Mild Cognitive Impairment (MCI) caused by Alzheimer’s. The cost is estimated at $32,000 for a 12-month supply and coverage and reimbursement for Kisunla are now available for eligible patients on Medicare under a National Coverage Determination with Coverage and Development.
Additionally, as of October 2023, broad coverage and reimbursement for amyloid PET scans are available for eligible patients on Medicare. Out-of-pocket costs for treatment with Kisunla will depend on the length of treatment and their insurance. According to Eli Lilly and Company, Kinsula slowed cognitive and functional decline in patients by up to 35% compared to a placebo.
However, this treatment can cause headaches and brain swelling (ARIA) and bleeding, yet these side effects occurred in about 10% of patients. Other side effects include allergic reactions, hives, difficulty breathing, and infusion-related reactions such as skin irritation, nausea, chest pain, vomiting or sweating. In a July 2 news release from the Alzheimer’s Association, Joanne Pike, DrPH, Alzheimer’s Association president and CEO, noted, “This [approval of Kisunla] is real progress.
It allows people more options and greater opportunity to have more time. Having multiple treatment options is the kind of advancement we’ve all been waiting for — all of us who have been touched, even blindsided, by this difficult and devastating disease.” Because numerous FDA-approved Alzheimer’s treatments are now available, early detection and diagnosis are even more critical to ensure individuals receive the most benefit.
“Too many roadblocks have prevented individuals from getting equitable access to these beneficial treatments for far too long,” said Pike. “It is equally important that clinicians and health care systems are informed and prepared to help the individuals who could benefit." Adding additional statements to the news release, Maria Carrillo, chief science officer and medical affairs lead at the Alzheimer’s Association, commented about the latest treatments, “These recent approvals generate hope for continued advances.
For researchers, our next horizon is to develop new treatments that address different components of the disease, and that work together to have an even bigger effect on slowing or stopping disease progression for all communities.” Kisunla is the second drug of its kind approved behind leqembi (generic name lecanemab). A third drug — Biogen’s Aduhelm — was taken off the market and discontinued.
For more information about eligibility and treatment details of Kisunla and the official release from Eli Lilly, visit this link: ..
