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brain swelling

Four reasons to question “new generation” monoclonal antibody Alzheimer’s drugs such as aducanumab (Aduhelm), lecanemab (Leqembi), donanemab

September 25, 2023 by SharpBrains Leave a Comment

New Alzheimer’s Drugs Don’t Deserve the Hype (Being Patient):

A promi­nent child­hood mem­o­ry is of my grand­par­ents liv­ing with and then dying from demen­tia. As is uni­ver­sal with demen­tia, there was a dou­ble blow: watch­ing my grand­par­ents lose their iden­ti­ty and see­ing the suf­fer­ing of those clos­est to them. [Read more…] about Four rea­sons to ques­tion “new gen­er­a­tion” mon­o­clon­al anti­body Alzheimer’s drugs such as adu­canum­ab (Aduhelm), lecanemab (Leqem­bi), donanemab

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Filed Under: Brain/ Mental Health Tagged With: aducanumab, Aduhelm, Alzheimer's drugs, brain bleeding, brain swelling, dementia, donanemab, hype, lecanemab, Leqembi, monoclonal antibody Alzheimer's drugs, MRI-scans

Price tag for a questionable Alzheimer’s treatment: $109,000 per patient, per year. Unclear yet: For how many years?

August 2, 2023 by SharpBrains Leave a Comment

The real costs of the new Alzheimer’s drug, Leqem­bi — and why tax­pay­ers will foot much of the bill (CBS News):

The first drug pur­port­ing to slow the advance of Alzheimer’s dis­ease is like­ly to cost the U.S. health care sys­tem bil­lions annu­al­ly even as it remains out of reach for many of the low­er-income seniors most like­ly to suf­fer from dementia.

Medicare and Med­ic­aid patients will make up 92% of the mar­ket for lecanemab, accord­ing to Eisai Co., which sells the drug under the brand name Leqem­bi. In addi­tion to the com­pa­ny’s $26,500 annu­al price tag for the drug, treat­ment could cost U.S. tax­pay­ers $82,500 per patient per year, on aver­age, for genet­ic tests and fre­quent brain scans, safe­ty mon­i­tor­ing, and oth­er care, accord­ing to esti­mates from the Insti­tute for Clin­i­cal and Eco­nom­ic Review, or ICER. [Read more…] about Price tag for a ques­tion­able Alzheimer’s treat­ment: $109,000 per patient, per year. Unclear yet: For how many years?

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Filed Under: Brain/ Mental Health Tagged With: Alzheimers-disease, amyloid plaques, brain hemorrhaging, brain scans, brain swelling, dementia, lecanemab, Leqembi, Medicaid, Medicare, PET-scan, taxpayers

Growing controversy over role of FDA and Medicare in promoting anti-amyloid drugs given limited benefit, high cost, severe side-effects

June 21, 2023 by SharpBrains

The War Over Whether Medicare Should Pay For The New Anti-Alzheimer’s Drugs (Forbes):

The pow­er­ful Alzheimer’s Dis­ease lob­by is fight­ing a mul­ti-bil­lion-dol­lar bat­tle on two fronts. It is qui­et­ly try­ing to lim­it restric­tions the Food and Drug Admin­is­tra­tion puts on the use of new drugs aimed at slow­ing the pro­gres­sion of the brain dis­ease. And it is pub­licly press­ing Medicare to pay for the wide­spread use of the mon­o­clon­al anti­bod­ies FDA already has con­di­tion­al­ly approved as well as oth­ers in the pipeline. [Read more…] about Grow­ing con­tro­ver­sy over role of FDA and Medicare in pro­mot­ing anti-amy­loid drugs giv­en lim­it­ed ben­e­fit, high cost, severe side-effects

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Filed Under: Brain/ Mental Health Tagged With: Alzheimer's experts, Alzheimer’s Disease, Anti-Alzheimer’s Drugs, Biogen, brain swelling, Eisai, europe, FDA, lecanemab, Medicare

Six guidelines to navigate the Aduhelm controversy and (hopefully) help patients with Mild Cognitive Impairment and early-stage Alzheimer’s Disease

October 13, 2021 by Kaiser Health News

The approval of a con­tro­ver­sial new drug for Alzheimer’s dis­ease, Aduhelm, is shin­ing a spot­light on mild cog­ni­tive impair­ment — prob­lems with mem­o­ry, atten­tion, lan­guage or oth­er cog­ni­tive tasks that exceed changes expect­ed with nor­mal aging.

After ini­tial­ly indi­cat­ing that Aduhelm could be pre­scribed to any­one with demen­tia, the Food and Drug Admin­is­tra­tion now spec­i­fies that the pre­scrip­tion drug be giv­en to indi­vid­u­als with mild cog­ni­tive impair­ment or ear­ly-stage Alzheimer’s, the groups in which the med­ica­tion was studied.

Yet this nar­row­er rec­om­men­da­tion rais­es ques­tions. What does a diag­no­sis of mild cog­ni­tive impair­ment mean? Is Aduhelm appro­pri­ate for all peo­ple with mild cog­ni­tive impair­ment, or only some? And who should decide which patients qual­i­fy for treat­ment: demen­tia spe­cial­ists or pri­ma­ry care physi­cians? [Read more…] about Six guide­lines to nav­i­gate the Aduhelm con­tro­ver­sy and (hope­ful­ly) help patients with Mild Cog­ni­tive Impair­ment and ear­ly-stage Alzheimer’s Disease

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Filed Under: Brain/ Mental Health Tagged With: Aduhelm, Alzheimer’s Disease, attention-problems, brain bleeding, brain swelling, cognitive problems, dementia, dementia specialists, early-stage Alzheimer’s, Food and Drug Administration, language problems, memory problems, mild-cognitive-impairment, neuropsychological, neuropsychological-tests, normal cognition, primary care physicians, tests

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

June 14, 2021 by SharpBrains

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 known harms. [Read more…] about Grow­ing back­lash against the FDA approval of unproven Alzheimer’s treat­ment Aduhelm, by Biogen

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Filed Under: Brain/ Mental Health Tagged With: aducanumab, Aduhelm, Alzheimer’s Disease, Alzheimer’s disease treatment, amyloid, amyloid plaques, amyloid-related imaging abnormalities, ARIA, Biogen, brain, brain swelling, clinical benefit, FDA, ICER, Janet Woodcock, Neurons, serious side effects, tangles, tau

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