Those of us without evidence of cognitive impairment certainly remember the hubbub over the release of Aducanumab, the first FDA-approved drug to treat Alzheimer’s Disease. A short, to-the-point research letter in JAMA clarifies why it has the potential for abuse – and what the FDA needs to do to prevent it.
aducanumab
Biopharmaceutical companies, insurers, pharmacy benefit managers and the government can and must work together to keep each other accountable and embrace value-based or outcomes-based reimbursement. The guiding principle being that “IF” the new innovative medicine delivers the outcomes and value promised to patients and the U.S. economy, the therapy will be rewarded.
The FDA’s controversial approval of Aduhelm, the drug intended to treat Alzheimer’s Disease, has resulted in resignations from their advisory committee and now investigations, both internal and Congressional. The FDA and editors of JAMA Internal Medicine are speaking out before the investigational circus comes to town.
There has been a lot of ink spilled, and bytes spent this week discussing the FDA’s approval of aducanumab, brand-name Aduhelm, for the treatment of Alzheimer’s Disease. I have mixed feelings; there are advantages to a Phase 4 study, but how do you say no to hope?