All Alzheimer’s Eyes On Medicare: CMS Will Take The Lead On Tailoring Access To Aduhelm
Biogen/Eisai’s newly-approved Alzheimer’s drug could be headed to CMS’ Medicare advisory committee, which is chaired by vocal drug pricing reform advocate Peter Bach.
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Biogen’s recent contentious approval put the cat amongst the pigeons in the debate on surrogate markers as a basis for accelerated approval. The history of such approvals goes back to the last century.
The butterfly effect is an elegant analogy to describe the seemingly unpredictable and far-reaching implications of a relatively small and inconsequential event. The FDA’s approval of Aduhelm is not so much a butterfly gently flapping its wings, but rather a sonic boom emanating from a jet engine. Most immediately, it provides a new therapeutic option for millions of patients in dire need of hope, vindicating Biogen’s faith with a revenue stream running into many billions of dollars. Longer-term the reverberations may be felt across the entire industry, throwing into question the evidentiary requirement for drug development.
Biogen has warned that uptake for its newly approved Alzheimer’s therapy will be slow in the beginning and doctors confirm it will take time to figure which patients can and should be treated.