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FDA adviser abandons “Probably the worst” decision to approve Alzheimer’s disease

WASHINGTON (AP) – A new $ 56,000-a-year drug for Alzheimer’s disease would boost Medicare premiums, and some patients prescribed the drug could pay about $ 11,500 a year, according to a study report published in Thursday.

The drug, called Aduhelm, was approved by the Food and Drug Administration this week and quickly sparked controversy over the price tag and dubious benefits. An FDA adviser called the decision “probably the worst drug approval decision in recent US history” in a letter he presented when he resigned over Thursday̵

7;s decision.

A new analysis by the non-partisan Kaiser Family Foundation estimates that if only 500,000 Medicare recipients are prescribed Aduhelm, it will cost the program nearly $ 29 billion a year, much more than any other drug.

“At this price, only the price of this one drug can exceed all others covered by Medicare if used extensively,” said Trisha Neumann, co-author of the report.

Separately, Dr. Aaron Kesselheim of Harvard University became the third member of the FDA’s advisory committee to oppose the drug’s withdrawal. Last November, the 11-member group voted almost unanimously against recommending approval for the drug, citing shortcomings in the company’s studies. The FDA is not required to follow such recommendations.

In his resignation letter from the Associated Press, Kesselheim said recent FDA drug approval decisions would undermine public confidence, medical innovation and the “accessibility of the health care system.” Earlier in the week, two neurologists also left the panel.

Aduhelm is the first drug for Alzheimer’s disease in nearly 20 years. This does not cure the life-threatening neurological condition, but the FDA has determined that its ability to reduce plaque lumps in the brain is likely to slow dementia. Many experts say the benefits are not clear.

The drug’s approval came as Democrats in Congress tried to reach a consensus on legislation that would allow Medicare to negotiate the prices of prescription drugs.

Senate Finance Committee Chairman Ron Wyden, a Democratic senator from Oregon, said Thursday that Aduhelm’s price list was “unscrupulous.” Although President Joe Biden has called for powers to negotiate Medicare, the prospects for the bill are uncertain.

Medicare has not made a formal decision to cover the drug for Alzheimer’s disease, but traditionally the costs are not included in such considerations. Drug maker Biogen said the price of Aduhelm was responsible.

Alzheimer’s affects about 6 million Americans, most of whom are old enough to qualify for Medicare.

In addition to higher taxpayer costs, Kaiser’s analysis found that domino effects would include higher Part B outpatient premiums for Medicare coverage and an increase in monthly premiums of millions with additional Medigap plans. As an infusion medicine to be administered in a doctor’s office, Aduhelm is covered by Medicare’s outpatient benefit. The standard premium for Part B, paid by most entrants, is currently $ 148.50 per month.

In addition to the monthly premiums, this would also have an impact on costs that are not available. Many patients taking medications, including those registered in Medicare Advantage plans by private insurers, can face thousands of dollars in co-payments. The maximum could reach about $ 11,500, the researchers estimate, well above the budget of a typical Medicare candidate.

“Because Aduhelm is not a cure for Alzheimer’s disease, patients can bear these annual costs out of pocket for several years,” the report said.

Biogen, which developed the drug for Alzheimer’s disease with Japan’s Eisai Co., said earlier this week that it expects gradual absorption rather than a sharp jump in “hockey.”

The price of the drug was determined after careful research, said Chirfi Guindo, head of Biogen’s global product. The company is committed not to increase prices for four years.

Guindo said the company has looked at prices for modern drugs to treat cancer and other complex conditions. “We rated Aduhelm at approximately one-third the level of cancer immunotherapy,” he told a teleconference this week. “So, we think it’s a really responsible price and we think it’s a price that’s sustainable 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 not yet said how the program with Aduhelm will continue. It is possible that Medicare will cover the drug based on clinical efficacy.

The program covers more than 60 million people, including those aged 65 and over, as well as people with disabilities or serious kidney disease. Medicare costs close to $ 1 trillion a year.

This story has been adjusted to reflect that the Kaiser Family Foundation’s report was published on Thursday, not Wednesday.

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