Systematic review finds more clinical harm than benefits in Alzheimer’s “treatments” lecanemab, aducanumab, and donanemab

Study ques­tions ben­e­fit of new Alzheimer’s drug (UGA Today): Last sum­mer, the U.S. Food and Drug Admin­is­tra­tion ful­ly approved the first drug shown to slow the progress of Alzheimer’s. But new research from the Uni­ver­si­ty of Geor­gia sug­gests that patients and care­givers may not expe­ri­ence any ben­e­fit from the drug in their dai­ly lives. The drug, Leqembi,…

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Beyond the clinic: Can digital therapeutics (DTx) help boost mental health in the workforce at scale?

Hop­ing to Avoid Pear’s Fate, Behav­ioral Health-Focused DTx Com­pa­nies Look to Employ­er Mar­ket (Behav­ioral Health Busi­ness): The dig­i­tal ther­a­peu­tics (DTx) indus­try is at a cross­roads after one of the most promi­nent com­pa­nies in the space, Pear Ther­a­peu­tics, filed for bank­rupt­cy ear­li­er this year. The tur­moil comes after DTx began catch­ing on in the behav­ioral health…

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Hopes and Questions raised by Alzheimer’s drug Leqembi (lecanemab)

The FDA has approved Leqem­bi, the first dis­­ease-mod­­i­­fy­ing treat­ment for ear­­ly-stage Alzheimer’s and a pre­cur­sor con­di­tion, mild cog­ni­tive impair­ment. Medicare has said it will pay for the ther­a­py. Med­ical cen­ters across the coun­try are scram­bling to final­ize poli­cies and pro­ce­dures for pro­vid­ing the med­ica­tion to patients, pos­si­bly by summer’s end or ear­ly autumn. It’s a…

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

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…

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CMS: anti-amyloid drug Leqembi (lecanemab) doesn’t meet the “reasonable and necessary” standard required for wider Medicare coverage

CMS Sticks to Sharply Lim­it­ed Cov­er­age of New Alzheimer’s Drug, Leqem­bi (Man­aged Health­care Exec­u­tive): For now, CMS (Note: Cen­ters for Medicare & Med­ic­aid Ser­vices) is stick­ing to the cov­er­age deci­sion it made for Aduhelm (adu­canum­ab) and apply­ing it Leqem­bi (lecanemab). The deci­sion lim­its Medicare cov­er­age of the two Alzheimer disease’s drugs to Medicare ben­e­fi­cia­ries who…

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