Ma­jor health sys­tems refuse to ad­min­is­ter Aduhelm as top FDA lead­ers meet be­hind closed doors to talk with pay­ers

Nor­mal­ly when a new drug wins FDA ap­proval, the com­mer­cial launch plays out qui­et­ly in the back­ground for a few years, with hard­ly ever any FDA in­volve­ment, be­fore there’s some con­sen­sus on whether the drug is a com­mer­cial or clin­i­cal suc­cess, fail­ure or some­where in be­tween.

For Bio­gen’s new Alzheimer’s drug, how­ev­er, that launch is kick­ing off with a deaf­en­ing bang as two ma­jor health sys­tems — the Cleve­land Clin­ic and Mount Sinai — are now re­fus­ing to ad­min­is­ter the drug. And the FDA is not on­ly lead­ing but fund­ing the dis­cus­sion over how in­sur­ers will deal with Aduhelm — a rar­i­ty for an agency that typ­i­cal­ly steers clear of such con­tention.

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