Eli Lilly is pushing back the timeline for its experimental treatment, donanemab, after recent Medicaid decisions have restricted coverage for Alzheimer’s drugs. The company has decided to defer its application for the drug’s accelerated approval citing that coverage changes would hinder market success.
Last month, U.S. Center for Medicaid and Medicare Services announced that it would restrict coverage for Alzheimer’s drugs to patients taking part in approved clinical trials. As a result of this policy, Eli Lilly is delaying its application for donanemab past the end of March, as originally planned.
"We're trying to take investor focus off the exact timing of accelerated approval, given our very limited expectations for the impact of that accelerated approval commercially," said Daniel Skovronsky, Eli Lilly's Chief Scientific Officer.
Eli Lilly’s drug works by targeting amyloid-beta plaques, a sticky protein buildup in the brain that has long been a target of Alzheimer’s drug development. In phase 2 trials, data showed Eli Lilly’s drug reduced protein buildup in the brain and resulted in better cognitive functioning when compared to the placebo group. In June 2021, donanemab received FDA fast track designation following the positive phase 2 results.
Following on the heels of Biogen’s Aduhelm — which has sparked controversy due to high costs and inconsistent results — other companies are vying for a spot the Alzheimer’s market. Roche and Eisai are also developing Alzheimer’s drugs, called spinraza and lecanemab, respectively.
