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FDA Advisor Drops “Probably Worst” Alzheimer’s Drug Approval Decision

WASHINGTON (AP) – A new $ 56,000-a-year Alzheimer’s drug would dramatically increase Medicare premiums, and some patients prescribed the drug could face a co-payment of around $ 11,500 a year. year, according to a research report released Thursday.

The drug, called Aduhelm, was approved by the Food and Drug Administration this week and quickly sparked controversy over its price and questionable benefits. An FDA adviser called the move “possibly the worst drug approval decision in recent US history,” in a letter he submitted Thursday when he resigned following the decision.

The new analysis from the Kaiser Family Foundation estimated that if just 500,000 Medicare beneficiaries were prescribed Aduhelm, it would cost the program nearly $ 29 billion per year, far more than any other drug.

“At that price, the cost of this one drug could exceed all others covered by Medicare, if it is widely used,” said Tricia Neuman, co-author of the report.

Separately, Dr. Aaron Kesselheim of Harvard University became the third member of an FDA advisory committee that opposed the drug’s resignation following the ruling. Last November, the 11-member group voted almost unanimously against the recommendation for approval of the drug, citing flaws in the company’s studies. The FDA is under no obligation to follow such recommendations.

In his resignation letter obtained by The Associated Press, Kesselheim said recent FDA drug approval decisions would undermine public confidence, medical innovation “and the affordability of the healthcare system.” Earlier in the week, two expert neurologists also left the panel.

Aduhelm has been the first drug against Alzheimer’s disease for almost 20 years. It doesn’t cure life-destroying neurological disease, but the FDA has determined that its ability to reduce plaque buildup in the brain is likely to slow dementia. Many experts say the benefit has not been clearly demonstrated.

The drug’s approval came as Democrats in Congress try to build consensus around legislation that would allow Medicare to negotiate the prices of prescription drugs.

Senate Finance Committee Chairman Democratic Senator Ron Wyden of Oregon on Thursday said Aduhelm’s list price was “unreasonable.” Although President Joe Biden has called for the granting of Medicare bargaining power, the prospects for the bill are uncertain.

Medicare has not made a formal decision on coverage for the Alzheimer’s disease drug, but cost has not traditionally been a consideration. Drugmaker Biogen has said it is pricing Aduhelm responsibly.

Alzheimer’s disease affects an estimated 6 million Americans, the vast majority old enough to qualify for Medicare.

In addition to the higher costs to taxpayers, Kaiser’s analysis found that the domino effects would include higher “Part B” premiums for outpatient Medicare coverage and monthly premium increases for millions of people with plans. Additional “Medigap”. As an infusion drug that would be administered in a doctor’s office, Aduhelm is covered by Medicare’s outpatient benefit. The standard Part B premium, paid by most registrants, is currently $ 148.50 per month.

Beyond the monthly premiums, there would also be impacts on reimbursable expenses. Many patients taking the drug, including those who have purchased Medicare Advantage plans from private insurers, could face thousands of dollars in user fees. The maximum could reach around $ 11,500, the researchers estimated, well beyond the budget of a typical Medicare member.

“Because Aduhelm is not a cure for Alzheimer’s disease, patients could incur these annual out-of-pocket expenses over several years,” the report notes.

Biogen, which developed the Alzheimer’s drug with Japanese company Eisai Co., said earlier this week that it expects gradual adoption, not a sharp “hockey stick” spike.

The drug’s price was determined after extensive research, said Chirfi Guindo, global product manager at Biogen. The company has pledged not to increase its prices for four years.

Guindo said the company has looked at the prices of drugs advanced to treat cancer and other complex conditions. “We rated Aduhelm at about a third of the level of cancer immunotherapies,” he said on a teleconference this week. “So we see it as a really responsible price and we see it as a sustainable price for the system.”

Medicare has a review process known as Determining National Coverage to assess new treatments that could have far-reaching implications for the program. Officials have yet to say how the program will play out with Aduhelm. Medicare may set conditions to cover the drug, depending on its clinical effectiveness.

The program covers more than 60 million people, including those 65 and over, as well as people with disabilities or severe kidney disease. Medicare spending is approaching $ 1 trillion per year.

This story has been corrected to reflect that the Kaiser Family Foundation report was released on Thursday, not Wednesday.

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