Ethical considerations explored for aducanumab in Alzheimer disease
Nov 19, 2021
Grounds insufficient to offer aducanumab for moderate, advanced Alzheimer dementia or patients without biomarker evidence of brain ß-amyloid
First appropriate use guidance published for Alzheimer’s drug Aduhelm
By
Alicia Lasek
Jul 28, 2021
The new guidelines cover how to choose appropriate patients, safely scale up to a full dose, monitor side effects and assess effectiveness. The authors also address when to stop therapy and what patients...
U.S. lawmakers ramp up scrutiny of FDA following agency’s approval of controversial Alzheimer’s drug
By
Alicia Lasek
Sep 07, 2021
The FDA is being asked to help explain how Aduhelm (aducanumab) met accelerated approval criteria when so many experts — including internal advisers — have flagged insufficient safety and efficacy...
To save itself, might Medicare deny coverage of controversial new Alzheimer’s drug?
By
Kimberly Marselas
Jun 28, 2021
The true price to administer aducanumab — a controversial new Alzheimer’s treatment — may actually be closer to $100,000 annually than other, lower estimates and is just one reason the Centers for...
House committees to investigate new Alzheimer’s disease drug approval
Jul 01, 2021
FDA approved Aduhelm earlier this month, despite advisory committee’s conclusion that there was not enough evidence to support its effectiveness
CMS to weigh national Medicare coverage for Aduhelm, other Alzheimer’s drugs
By
Alicia Lasek
Jul 14, 2021
The agency is considering whether to establish a national coverage policy for monoclonal antibody drugs that treat Alzheimer’s disease, including the newly approved drug aducanumab (Aduhelm).