Dear clients and friends: Given your interest in health and medicine, we would like to share with you our collection of the most interesting perspectives on our industry's trends and developments. We are happy to share them with you — and hope you share your thoughts with us.

1. Patients and Families: A Treatment Option, At Last

In all of the discussion surrounding the science, the politics, and the pricing, it’s almost easy to forget what the treatment means to people living with Alzheimer’s disease. From The Washington Post:

Peter Bristol, a 77-year-old horticulturist who lives in Wakefield, R.I., and whose mother and brother died of Alzheimer’s, hasn’t taken aducanumab but is hoping it will be available if he needs it. He has mild cognitive impairment, a precursor to Alzheimer’s. “Lots of people out there are looking for hope,” he said.

2. Trial Participants: Validation

Ditto that for thousands of trial participants. Aldo Ceresa, who joined a UK trial, shares how the drug improved his life:

“I really, really enjoy this journey that I'm going through – and obviously the benefits I'm getting from it, which I'm very, very grateful for. I feel like I'm not quite as confused. Although it's still there, it's not quite as bad. And I'm just getting that bit more confident now.”

Mr. Ceresa says his family has noticed improvements too. “Before, if I was going to get something, I couldn't remember, you know, where to find things in the kitchen. That has become less of a problem,” he says.

3. ICER: I Would Like The Cheapest Car on the Lot, Please

“Only new treatment in nearly 20 years? See what you can find between the couch cushions.”

Or so ICER would seem to say, with its conservative report on Aduhelm’s value.

Although ICER’s preliminary judgment is that substantial uncertainty remains regarding the health benefits of aducanumab, a base-case cost-effectiveness analysis was performed using the combined results from the two contradictory phase III randomized trials. Results showed estimates of small overall health gains commensurate with value-based prices at traditional cost-effectiveness thresholds between $2,500-$8,300 per year.

We knew the low recommended price was a foregone conclusion from the onset.

4. Researchers: Scientific Non-Consensus

The research community’s response has been wide ranging. Posts from leading experts on AlzForum show the diverging opinions:

This is face-saving by the FDA, who were obviously closely involved and strong advocates for aducanumab’s “substantial” effectiveness. Efficacy was not established as the post hoc analyses, at best, showed a trivial difference.
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Hallelujah! A new drug for Alzheimer’ disease at last. The FDA has taken a courageous stand to approve a drug when there were many loud—and often well-reasoned—voices to the contrary. The development program was irregular, but the data on dose-exposure efficacy are compelling and complemented by the biomarker observations.

The approval of aducanumab is obviously a seismic event for our field, and hopefully heralds a new era that will be characterized by early, biomarker-supported diagnosis and biologically specific therapies. That said, I do wish the clinical efficacy of this “first-in-class” drug were better-established prior to approval.

Medical consensus will likely come as patients and doctors begin to work together to address the disease in the clinic with the new treatment.

5. The FDA: An Eye Towards the Future

The FDA’s response to skeptical doctors and researchers centers on the certainty of Alzheimer’s devastating toll on people and families over the coming years:

Taking the advisory committee’s input into account, we considered the application further and determined that although there was residual uncertainty about clinical benefit, as the committee told us, Aduhelm does reduce amyloid plaque. FDA further concluded that it is reasonably likely that this reduction in amyloid plaque will result in meaningful clinical benefit to patients. Given the unmet needs for patients with Alzheimer’s disease—a serious, progressive, and ultimately fatal disease—the Agency chose to use the accelerated approval pathway to allow earlier access to patients while we continue to acquire data on the drug’s benefit.