The Aduhelm Controversy -- It's not calming down...

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There continues to be controversy and consternation around the FDA's approval of Aduhelm, the monoclonal antibody therapy generically known as aducanumab.  Not so much any more about the very odd way it was approved -- with questions about whether it even works or not -- but more about the $56,000/year cost.  Some are afraid that if Biogen can get Medicare/Medicaid and the insurance companies to go along with the cost, it will green-light significantly higher costs for other drugs.  Considering how many elderly people might want to receive Aduhelm and how expensive Biogen is making it, government insurance payments could simply blow up the already ticking time bomb of Medicare.

So on June 23, Senators Elizabeth Warren (D-MA) and Dr. Bill Cassidy (R-LA) sent a letter to the chair and ranking member of the Senate finance committee expressing concern about the approval of the drug and its cost.  The thrust of the letter was to outline the political and practical uncertainties that approval of the drug brings forward with a long list of concerns.  They note specifically the questions about its effectiveness, and they state that government compensation must be contingent on clinically-demonstrated efficacy.  They propose a value-based system that connects payment arrangements with demonstration of clinical effectiveness.  (This sound to me like compensation will require another phase 3 trial, perhaps something more rigorous than what the FDA is already requiring of Biogen going forward.)

It seems to me that the letter does a good job of outlining the challenges that approval of Aduhelm brings with it.