Drug pricing watchdog joins the chorus of critics on Biogen's aducanumab: What about charging $2,560 per year?
As if Biogen’s aducanumab isn’t controversial enough, the researchers at drug pricing watchdog ICER have drawn up the contours of a new debate: If the therapy does get approved for Alzheimer’s by June, what price should it command?
Their answer: At most $8,290 per year — and perhaps as little as $2,560.
Even at the top of the range, the proposed price is a fraction of the $50,000 that Wall Street has reportedly come to expect (although RBC analyst Brian Abrahams puts the consensus figure at $11.5K). With critics, including experts on the FDA’s advisory committee, making their fierce opposition to aducanumab’s approval loud and clear, the pricing pressure adds one extra wrinkle Biogen CEO Michel Vounatsos doesn’t need as he orders full-steam preparation for a launch.
For RBC analyst Brian Abrahams, the report is less an indication of how aducanumab would be priced — Biogen has said that its price is already locked in, and drugmakers often charge higher than ICER recommendations — than further criticism on how the available clinical data are “insufficient” to determine a benefit.
“Regardless, we could see this hint at the potential for lower than currently anticipated pricing power, which may not be fully appreciated given limited potential benefits and substantial ancillary costs (such as screening, monitoring, and administration),” he wrote, adding that label restrictions could also undermine potential revenue.
ICER based its assessment on Phase III results that have already been thoroughly disclosed and debated by everyone from FDA insiders to adcomm panelists to outside scientists. The two studies, which had identical designs, were terminated and thought to spell doom for aducanumab until Biogen reversed itself and said one of them, dubbed ENGAGE, actually yielded positive data when you analyze it properly (the other, EMERGE, remained negative).
Biogen’s theory was that the difference had to do with patient characteristics and exposure to full-dose therapy.
While that is possible, ICER noted, “other explanations are equally or more likely.”
From the executive summary:
The post-hoc analyses do not consistently explain what was seen in the low- and high-dose arms of the trials, and one alternative explanation is that the differences between the trials are due to chance. Furthermore, there is disagreement about whether the degree of improvement seen in EMERGE is clinically important, and the relationship between clearance of beta-amyloid in the brain and clinical improvement has yet to be conclusively demonstrated, with negative results from more than 20 other trials of anti-amyloid drugs.
On the other side of the balance lies certain evidence that some patients receiving the antibody developed severe cases of amyloid-related imaging abnormalities, including bleeding into brain tissue, that led to discontinuations.
Those are “important ramifications” alongside budgetary concerns, ICER CMO David Rind said in a statement, that shouldn’t be ignored just because of a dreadful void of treatments for Alzheimer’s. Ultimately, more data are needed to prove aducanumab’s worth.
It’s not a new argument. But it’s a prominent one in an increasingly high-stakes showdown as the clock ticks on an FDA decision.