Make or break for Bio­gen: How the na­tion­al cov­er­age de­ci­sion for amy­loid-tar­get­ed Alzheimer’s drugs will shake out

Ever since Bio­gen’s con­tro­ver­sial Alzheimer’s drug Aduhelm won an ac­cel­er­at­ed ap­proval in June, de­spite scant ev­i­dence of clin­i­cal ben­e­fit, the coun­try has turned its at­ten­tion to who might use the drug and who would pay for it.

So far, not too many have done ei­ther, with Bio­gen haul­ing in just $300,000 in ear­ly sales, and in­sur­ers still wait­ing to see what CMS will do with its na­tion­al cov­er­age de­ci­sion, or NCD. The NCD will serve as the ba­sis for how in­sur­ers de­cide to cov­er Aduhelm. The de­ci­sion will pro­vide CMS’ think­ing be­hind whether Aduhelm and oth­er po­ten­tial amy­loid-tar­get­ed drugs ei­ther are or are not “rea­son­able and nec­es­sary” for the treat­ment of Alzheimer’s dis­ease.

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