Post by miamianne67 on Jan 11, 2022 22:30:49 GMT
Medicare officials said they would cover Biogen Inc.’s BIIB 2.64% controversial Alzheimer’s disease drug Aduhelm as part of randomized clinical trials.
The clinical trials are intended to gather evidence on the drug’s safety and effectiveness and would apply to similar drugs if they are approved, the Centers for Medicare and Medicaid said in a proposed policy issued Tuesday.
Patients enrolling in trials supported by the National Institutes of Health would also be eligible for coverage, according to CMS’s draft policy.
CMS said the Aduhelm studies must limit enrollment to patients in the early-stages of disease and have lab tests confirming that their brains have accumulated amyloid, a sticky protein linked to Alzheimer’s disease that Aduhelm is designed to clear.
Aduhelm has faced widespread criticism since its approval in June, in part because concerns that its price would balloon Medicare drug spending if millions of patients start taking it.
The clinical trials are intended to gather evidence on the drug’s safety and effectiveness and would apply to similar drugs if they are approved, the Centers for Medicare and Medicaid said in a proposed policy issued Tuesday.
Patients enrolling in trials supported by the National Institutes of Health would also be eligible for coverage, according to CMS’s draft policy.
CMS said the Aduhelm studies must limit enrollment to patients in the early-stages of disease and have lab tests confirming that their brains have accumulated amyloid, a sticky protein linked to Alzheimer’s disease that Aduhelm is designed to clear.
Aduhelm has faced widespread criticism since its approval in June, in part because concerns that its price would balloon Medicare drug spending if millions of patients start taking it.
