Medicare officers are proposing to limit protection of a controversial Alzheimer’s drug, Aduhelm, to contributors within the federal medical insurance program who’re enrolled in qualifying scientific trials.
In a assertion, the Centers for Medicare & Medicaid Services stated Tuesday that it primarily based its proposal on an evaluation of the advantages and dangers of the drug, which has raised issues about Aduhelm’s excessive price and efficacy.
“While there may be the potential for promise with this treatment, there is also the potential for harm to patients,” stated Dr. Lee Fleisher, chief medical officer at CMS and director of the Center for Clinical Standards and Quality, within the assertion. “This harm may range from headaches, dizziness and falls, to other potentially serious complications such as brain bleeds.”
The company stated will make a last choice on overlaying the drug by April 11. Medicare’s choice on whether or not to pay for Aduhelm is necessary as a result of it impacts whether or not well being insurers will cowl the price.
The Food and Drug Administration authorized Aduhelm final June, the primary drug to cleared by authorities well being officers for treating Alzheimer’s in practically 20 years. But the remedy has additionally sparked criticism, with the FDA’s outdoors panel of neurological specialistsabout its effectiveness.
When Biogen initially launched Aduhelm, it set the value at $56,000 yearly, however laterto about $28,200 following an outcry.
Pointing to ongoing questions in regards to the drug, Dr. Fleisher stated Medicare decided “the right decision” can be to restrict protection to individuals enrolled in scientific trials.
In an emailed assertion to CBS MoneyWatch, Biogen took difficulty with Medicare’s proposed coverage, saying it could deny the remedy to many individuals affected by Alzheimer’s.
“This draft coverage determination denies the daily burden of people living with Alzheimer’s disease,” the drugmaker stated, including that “Coverage with evidence development (CED) under a randomized clinical trial will exclude almost all patients who may benefit.”
Biogen’s inventory fell greater than 7% in after-hours buying and selling on Tuesday.