Health payers–including Medicare and Point32Health–to question Aduhelm pricing and its “reasonable and necessary” use

State’s Sec­ond-Largest Health Insur­er Slams Bio­gen For Cost­ly Alzheimer’s Drug (The Boston Globe): The state’s sec­ond-biggest health insur­er is threat­en­ing to lim­it or not cov­er Biogen’s new Alzheimer’s drug, accus­ing the Cam­bridge biotech of putting “exces­sive cor­po­rate prof­its” ahead of patients by charg­ing $56,000 a year for the con­tro­ver­sial treat­ment. Michael Sher­man, chief med­ical officer…

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Can the controversial FDA approval of Aduhelm backfire and delay the discovery of actual Alzheimer’s treatments? (Yes, it can)

The U.S. Food and Drug Admin­is­tra­tion (FDA) recent­ly approved adu­canum­ab, the first treat­ment that aims to slow the pro­gres­sion of Alzheimer’s dis­ease. But approval of the drug has pro­voked mixed reac­tions from the sci­en­tif­ic com­mu­ni­ty. Alzheimer’s dis­ease is char­ac­ter­ized by pro­gres­sive mem­o­ry loss, spa­tial dis­ori­en­ta­tion and many oth­er cog­ni­tive and behav­iour­al dis­or­ders that ulti­mate­ly lead…

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US Senator Joe Manchin calls for a new FDA Commissioner to replace current (acting) one who “has repeatedly ignored public health concerns and shown a dereliction of duty” over opioids and aducanumab

Key Demo­c­rat Manchin Bash­es FDA Leader on Alzheimer’s Approval (Bloomberg): Sen­a­tor Joe Manchin, a mod­er­ate Demo­c­rat con­sid­ered a cru­cial vote with­in the party’s slim Sen­ate major­i­ty, said Janet Wood­cock, the tem­po­rary head of the Food and Drug Admin­is­tra­tion, should be quick­ly replaced with a per­ma­nent leader. Manchin blast­ed an FDA deci­sion to approve the controversial…

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First, do no harm? Six reasons to approach anti-amyloid drug Aduhelm cautiously, if at all

6 ways the FDA’s approval of Aduhelm does more harm than good (STAT News): Like many peo­ple, I was shocked when the Food and Drug Admin­is­tra­tion ignored the advice of its neu­ro­log­i­cal drugs advi­so­ry pan­el and broad­ly approved Biogen’s new drug, Aduhelm, even for pop­u­la­tions nev­er includ­ed in the clin­i­cal tri­als to assess the drug.

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Growing backlash against the FDA approval of unproven Alzheimer’s treatment Aduhelm, by Biogen

ICER Issues State­ment on the FDA’s Approval of Adu­canum­ab for Alzheimer’s Dis­ease (Insti­tute for Clin­i­cal and Eco­nom­ic Review): The Insti­tute for Clin­i­cal and Eco­nom­ic Review (ICER) believes that the FDA, in approv­ing adu­canum­ab (Aduhelm™, Bio­gen) for the treat­ment of Alzheimer’s dis­ease, has failed in its respon­si­bil­i­ty to pro­tect patients and fam­i­lies from unproven treat­ments with…

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