Thinking Citizen Blog — Aduhelm — Did the FDA Approve the Drug Too Soon? Who Is to Say? By What Logic?

Thinking Citizen Blog — Thursday is Health, Health Care, Health Insurance and Global Health Policy Day

Today’s Topic: Aduhelm — Did the FDA Approve the Drug Too Soon? Who Is to Say? By What Logic?

Aduhelm is an “amyloid beta-directed moncolonal antibody” designed to treat Alzheimers. It was developed by the biopharmaceutical company Biogen and approved by the FDA in June 2021. The billed cost would be about $56,000 per year. The copayment would be about $11,000 per year for a Medicare patient. After the FDA approval, three members of FDA review panel resigned in protest while Alzheimer’s advocacy groups applauded the FDA decision. Which side would you be on? Is Medicare a bank without a security guard (to use the metaphor of David Goldhill, my favorite health care system critic)? Experts — please chime in. Correct, elaborate, elucidate.

HARVARD MEDICAL SCHOOL PROFESSOR RESIGNS IN PROTEST

1. “This might be the worst approval decision that the F.D.A. has made that I can remember,” (Professor Aaron Kesselheim, Harvard Medical School).

2. “There’s no good evidence that the drug works.” (Kesselheim)

3. Not one of the eleven members of the FDA review panel thought that the drug was efficacious. Ten voted against approval. One was undecided.

NB: “Approval of a drug that is not effective has serious potential to impair future research into new treatments that may be effective,” (Dr. Joel Perlmutter, Washington University School of Medicine in St. Louis).

SPECIFIC COMPLAINTS — the breadth of the approval, amyloid reduction, duration of trial

1. “One issue is that the F.D.A. approved the drug for a much broader group of patients — anyone with Alzheimer’s — than many experts were anticipating. The clinical trials tested the drug only on patients with early-stage Alzheimer’s or mild cognitive impairment from the disease.”

2. “The other issue is that a significant part of the F.D.A.’s rationale for granting approval was its contention that the drug’s ability to attack the amyloid protein in patients’ brains would help slow their cognitive symptoms…While amyloid is considered a biomarker of Alzheimer’s disease because its accumulation in the brain is a key facet of the condition, there has been very little scientific evidence that reducing amyloid can actually help patients by easing their memory and thinking problems.”

3. “The timeline that they provided for the so-called confirmatory trial, nine years, is problematic. There’s going to be a lot of use of the product during that time.” (Kesselheim)

ADVOCACY GROUPS APPLAUD THE DECISION

1. “Patient advocacy groups lobbied heavily for the approval of the drug because of its novel status for a debilitating condition with very few therapy choices.”

2. These included: Alzheimer’s Association, Alzheimer Society of Canada, and Alzheimer’s Foundation of America.

3. “Because amyloid is a hallmark of the disease through its entire course, the expectation is that this drug will provide benefit across that spectrum.” (Dr. Peter Stein, director of the FDA Center for Drug Evaluation and Research’s Office of New Drugs)

SO WHAT? (The Atlantic) Let’s do a little math, is $112 billion a year a big number? without a vote?

1.”Less appreciated is how the drug’s approval could trigger hundreds of billions of new government spending, all without a vote in Congress, or indeed any public debate over the drug’s value.” (third link)

2.”If even one-third of the estimated 6 million people with Alzheinmer’s in the United States receives the new treatment, health care spending could swell by $112 billion annually.”

3. “Most of the costs will be borne by taxpayers. But Medicare beneficiaries will take an additional hit. Because Aduhelm is an infusion drug that will be administered in doctors’ office and clines, not taken at home it will be covered by Medicare Part B — not Part D. Under Part B, beneficiaries pay 20% of the costs of their care, which for a single year of Aduhelm treatment, will be at least $11,200…that would be quite hard on seniors, many of whom live on fixed incomes.”

NB: “States will also come under pressure. Some patients prescribed the drug will be under 65 and won’t be eligible for Medicare. But they may be eligible for Medicaid, which state and federal governments jointly fund. Plus, about 12 million people nationally are eligible for both Medicare and Medicaid (they’re called “dual eligibles”) meaning that the states are responsible for covering much of their out-of-pocket costs. “

THE BIG QUESTION UNASKED BY THE FDA

“The FDA’s decision will effectively transfer many billions of dollars of government and patient money to a single drug manufacturer. Whether that’s a good use of our collective resources is not a question that the FDA considered. But it’s a question that may haunt the health-care system for years to come.” (Altantic, third link)

https://en.wikipedia.org/wiki/Aducanumab

https://www.nytimes.com/2021/06/10/health/aduhelm-fda-resign-alzheimers.html

https://www.theatlantic.com/ideas/archive/2021/06/aduhelm-drug-alzheimers-cost-medicare/619169/

‘Medicare Is a Bank Without Security Guards:’ Media Exec David Goldhill vs. Princeton’s Paul Starr

‘Medicare Is a Bank Without Security Guards:’ Media Executive David Goldhill Debates Princeton’s Paul Starr

https://www.npr.org/2021/06/11/1005567149/3-experts-have-resigned-from-an-fda-committee-over-alzheimers-drug-approval

For the last three years of posts organized by theme:

PDF with headlines — Google Drive

YOUR TURN

Please share the most interesting thing you learned in the last week related to health, health care or health care policy — the ethics, economics, politics, history…. Or the coolest, most important thing you learned in your life related to health are or health care policy that the rest of us may have missed. Or just some random health-related fact that blew you away.

This is your chance to make some one’s day. Or to cement in your mind something really important you might otherwise forget. Or to think more deeply than you otherwise would about something that matters.