Veterans Affairs won’t cover Biogen’s new “Alzheimer’s drug” given concerns over safety and lack of evidence

VA Health Sys­tem Won’t Cov­er Biogen’s Alzheimer’s Drug (The Wall Street Journal):

The Depart­ment of Vet­er­ans Affairs won’t cov­er Bio­gen Inc.’s new Alzheimer’s drug, the lat­est rebuke of the con­tro­ver­sial treat­ment since it was approved ear­li­er this summer.

The VA decid­ed not add the drug, called Aduhelm, to its for­mu­la­ry list of avail­able med­i­cines because of the drug’s risk of caus­ing seri­ous side effects and a lack of evi­dence that it improves cog­ni­tive func­tion, an agency spokes­woman said.

The VA pro­vides med­ical ben­e­fits to more than nine mil­lion vet­er­ans, and is the largest inte­grat­ed health­care sys­tem in the U.S. The agency is known for being a shrewd cus­tomer of pre­scrip­tion drugs, using its large pur­chas­ing pow­er to hag­gle steep dis­counts from man­u­fac­tur­ers. By law, the VA has greater lee­way than oth­er gov­ern­ment health pro­grams such as Medicare and Med­ic­aid to deny cov­er­age of med­i­cines it deems to be of poor val­ue … On Thurs­day, the VA post­ed on its web­site a doc­u­ment detail­ing its review of Aduhelm and its deci­sion. The doc­u­ment pro­vides guid­ance to doc­tors not to offer the drug to VA patients, but allows for doc­tors to seek excep­tions for cer­tain patients.

The Review:

VA’s Review of Aduhelm’s Clin­i­cal Evi­dence and Safe­ty (opens PDF). VA’s Pro­ject­ed Place in Therapy:

• AD is a pro­gres­sive neu­ro­log­ic dis­or­der affect­ing approx­i­mate­ly 6 mil­lion Amer­i­cans. More women than men are affect­ed, and African Amer­i­cans and His­pan­ics are at high­er risk of devel­op­ing AD. Safe and effec­tive agents that halt or delay the pro­gres­sion of AD are clear­ly need­ed. Adu­canum­ab-avwa is a human mon­o­clon­al anti­body that pro­motes clear­ance of betaamy­loid plaques from the brain and is indi­cat­ed for the treat­ment of AD, specif­i­cal­ly, in patients with mild cog­ni­tive impair­ment or mild demen­tia stage of disease.
• While VA PBM acknowl­edges the recent FDA deci­sion on adu­canum­ab-avwa, giv­en the lack of evi­dence of a robust and mean­ing­ful clin­i­cal ben­e­fit and the known safe­ty sig­nal, we rec­om­mend against offer­ing this agent to patients with Alzheimer’s demen­tia (mild or oth­er­wise) or mild cog­ni­tive impair­ment. How­ev­er, rec­og­niz­ing that there is an accel­er­at­ed FDA approval, we also rec­om­mend that if it is to be used by excep­tion then it should be uti­lized only in high­ly select­ed patients by experts and cen­ters that have the nec­es­sary diag­nos­tic and man­age­ment exper­tise— and only by those with the need­ed resources for close mon­i­tor­ing to assure safe­ty. As such, any use should be gov­erned by strin­gent reg­u­la­tion, and safe­ty and appro­pri­ate­ness of use mon­i­tored real time by VAMedSAFE.

News in Context:

• Alzheimer’s & Demen­tia researchers chal­lenge FDA’s approval of Aduhelm giv­en lack of evi­dence for beta-amy­loid as a marker
• Can the con­tro­ver­sial FDA approval of Aduhelm back­fire and delay the dis­cov­ery of actu­al Alzheimer’s treat­ments? (Yes, it can)
• Study chal­lenges the “seduc­tive” amy­loid hypoth­e­sis of Alzheimer’s dis­ease (AD)
• Cog­ni­tive train­ing, diet, exer­cise, and vas­cu­lar man­age­ment seen to improve cog­ni­tion even in peo­ple with genet­ic pre­dis­po­si­tion for demen­tia (APOE e4)