The narrative centers on (and sets its hook!) around whether Aduhelm® will (or should) retain its US FDA approval, after Biogen pulled its new drug application entirely, in the EU at EEMA -- due to the high price "needed", and very modest clinical benefit (likely candidly acknowledging that EU health authorities were highly unlikely to approve it for any meaningful level of reimbursement).
To be certain, we have been over this ground literally hundreds of times here -- with other drug candidates, and FDA approvals (Vytorin®, Celebrex® and Asenepine® leap immediately to mind -- as just three).
And so, I won't let my chin-waggle go on, and on -- at any great length then -- here. You may go read the June 2021 reviews for yourself.
Certainly, everyone wants to see Alzheimer's patients achieve a "gain, in function". However, the clinical results (in my experienced opinion) do not support a $55,000 to $65,000 per year price tag. The gains are modest, so too the price ought to be (if it is to remain on market, at all).
Here is the story, in pertinent part, from FiercePharma's steady keyboard:
. . .Biogen’s aducanumab, already hamstrung in the U.S. by a stifling coverage decision, won’t be hitting the European market anytime soon.
Biogen has scrapped its filing for the Alzheimer’s disease drug in the European Union after talks with regulators made it clear the data provided so far are unlikely to support marketing approval, the company said Friday.
Aducanumab, also known as Aduhelm, has been mired in controversy over its data and pricing ever since it won its U.S. green light last summer. Meanwhile, the Centers for Medicare & Medicaid Services (CMS) this month confirmed a highly restrictive coverage plan for the drug, which limits the use of Aduhelm and other meds like it to patients in certain clinical trials. . . .
Indeed, Alzheimer's is a very tough, often tragic very high burden disease. But the wealthy should not assume this is a panacea of any sort. My advice? If you are going the private pay route. . . here, do not expect miracles, even though the price looks a lot like the "miracle" pricing (in oncology) for pembrolizumab (Keytruda®).
Onward -- so that's the one "power alley" post, for the day, before my lunch-time ride by the lake -- on bikes. Grin.
नमस्ते
No comments:
Post a Comment