Medicare Seeks To Limit Coverage For Controversial Alzheimer’s Drug Aduhelm
Topline
The Facilities for Medicare and Medicaid Companies proposed limiting protection for Alzheimer’s drug Aduhelm to sufferers collaborating in medical trials Tuesday, after many medical specialists claimed the drug — which U.S. regulators controversially authorized final 12 months — comes with potential risks and few confirmed advantages.
Biogen headquarters in Cambridge, Massachusetts on March 21, 2019.
John Tlumacki/Boston Globe through Getty Pictures
Key Info
If CMS’s choice is finalized, Medicare will solely cowl the drug — which is manufactured by Biogen — for sufferers in hospital-based trials authorized by CMS or supported by the Nationwide Institutes of Well being, enormously decreasing the quantity of people that may in any other case take it.
CMS is anticipated to make a last choice following a 30-day remark interval which started Tuesday.
CMS has designated solely 21 other treatments for protection restricted to medical research, together with gadgets like pacemakers and cochlear implants.
Moreover, hospitals just like the Cleveland Clinic, Johns Hopkins, the College of California Los Angeles and the College of Michigan have determined to not supply sufferers Aduhelm, citing an absence of proof for the drug’s effectiveness, Stat reported.
Key Background
Billed as an “vital, first-in-class” therapy, Aduhelm was authorized by the Meals and Drug Administration in June. Later that month, two congressional committees opened investigations into the FDA’s approval course of for the drug, and lawmakers argued the FDA ignored the issues of specialists, together with members of the company’s personal Peripheral and Central Nervous System Medicine Advisory Committee. Three members of that committee resigned following the FDA’s approval. In a statement last year, 18 dementia researchers and different specialists argued the FDA didn’t exhibit that the drug had any significant advantages which might offset probably harmful unwanted side effects like falling and mind bleeding. The FDA has additionally launched an internal review of its dealing with of Aduhelm. Although Biogen, the drug’s producer, initially predicted that 10,000 sufferers can be taking the drug by the tip of 2021, by September solely about 100 sufferers had taken the drug, Stat reported.
Essential Quote
“It’s a reasonably darn distinctive scenario,” former CMS chief Sean R. Tunis told the Washington Put up. “There haven’t been very many FDA selections which have been this extensively questioned each on course of and on substance.”.
Large Quantity
$28,200. That’s how a lot Biogen is charging for one 12 months of Aduhelm. Initially, the drug carried an annual price ticket of $56,000.
Contra
Advocacy group UsAgainstAlzheimer’s urged CMS final week to cowl Aduhelm as broadly as potential, for the reason that FDA has declared the drug secure and efficient. CMS should both cowl Aduhelm or “inform Alzheimer’s sufferers and their family members they’re on their very own,” said UsAgainstAlzheimer’s chair George Vradenburg.
Additional Studying
“Medicare Proposes to Cover Aduhelm Only for Patients in Clinical Trials” (New York Occasions)
