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New Alzheimer’s disease drug may require $ 11,000 out-of-pocket

The FDA approved Aduhelm earlier this week, which is already facing a significant portion of the controversy.

Washington — A new $ 56,000 annual Alzheimer’s drug raises Medicare premiums significantly, with some patients prescribed the drug out-of-pocket about $ 11,500 a year, according to a study released Thursday. You may face it.

Drug called Aduhelm approved by the Food and Drug Administration this week And soon It caused controversy over its price tag and suspicious benefits.

It does not cure a life-threatening neurological condition, but it is the first drug for Alzheimer’s disease in almost 20 years. The FDA has determined that its ability to reduce plaque mass in the brain is likely to delay dementia. However, many experts, including government advisors, say the benefits are not clearly shown.

On Thursday, a third member of the FDA’s advisory board, who opposed the drug, resigned from the authorities’ decision. In November last year, a group of 11 members voted almost unanimously to recommend drug approval because of flaws in the company’s investigation and lack of data. The FDA does not have to follow the group’s advice.

In a resignation obtained by the Associate Press, Dr. Aaron Kesselheim, a medical researcher at Harvard University, said the FDA’s recent approval decision was public trust, medical innovation, and “affordable health care systems.” “It will hurt. At the beginning of the week, two specialist neurologists also left the panel.

new Analysis by the nonpartisan Kaiser Family Foundation Democrats in Congress are trying to build consensus on a bill that empowers Medicare to negotiate prescription drug prices.

Senator Ron Wyden of the Democratic Party of Oregon, chairman of the Senate Finance Committee, said the list price of drugs for Alzheimer’s disease was “not conscientious.” President Joe Biden has called for Medicare’s bargaining power, but the outlook for the bill is uncertain.

Kaiser reports that if only 500,000 Medicare recipients are prescribed, the cost of the program will be close to $ 29 billion annually, much higher than any other drug.

“At this price, the cost of this one drug alone could outweigh all the other drugs covered by Medicare if it is widely used,” said report co-author Tricia Neuman. I will.

Medicare has not made a formal decision to cover Aduhelm, but costs have traditionally not been included in such considerations. Pharmaceutical company Biogen says it responsibly priced Aduhelm.

Alzheimer’s disease affects about 6 million Americans, the majority of whom are old enough to qualify for Medicare. “Aduhelm’s approval provides the latest and notable example of the potential budgetary consequences of Medicare’s role as a price taker in the pharmaceutical market,” Kaiser’s analysis concludes.

In addition to increased taxpayer costs, the domino effect includes higher “Part B” premiums for outpatients in Medicare and increased monthly premiums for millions due to supplemental “MediGap” plans It is included. As an infusion drug given in the clinic, Aduhelm is eligible for Medicare outpatient treatment benefits. The standard Part B premium paid by most registrants is currently $ 148.50 per month.

It affects not only the monthly insurance premium but also the out-of-pocket expenses. Many patients taking medication, including those enrolled in a Medicare Advantage plan from a private insurance company, can face thousands of dollars out-of-pocket costs. Researchers estimate that the maximum amount can reach about $ 11,500.

Its cap cost from the patient’s budget corresponds to nearly 40% of the median estimated median income of $ 29,650 for Medicare recipients.

“Because Aduhelm is not a cure for Alzheimer’s disease, patients may incur these annual out-of-pocket costs over multiple years,” the report said.

Eisai of Japan and Biogen, which developed the drug for Alzheimer’s disease, said earlier this week that they expect to take it gradually rather than a sharp “hockey stick” surge.

After careful research, Biogen has decided on the price of the drug, said Chilfi Gind, Global Product Head of Biogen. Biogen has promised no price increases for four years.

According to Guindo, the company has considered the prices of advanced medicines to treat cancer and other complex conditions. “We have set the price of Aduhelm to about one-third the level of cancer immunotherapy,” he said in a conference call this week. “Therefore, we think this is a really responsible price and a sustainable price for the system.”

Medicare has a review process known as National Coverage Determination to assess new treatments that may have widespread impact on the program. Authorities have not yet stated how the program will proceed in Aduhelm. Medicare may set conditions to cover the drug based on its clinical efficacy.

The program targets more than 60 million people, including those over the age of 65, as well as people with disabilities and severe kidney disease. Medicare spending is approaching $ 1 trillion annually.

New Alzheimer’s disease drug may require $ 11,000 out-of-pocket

Source link New Alzheimer’s disease drug may require $ 11,000 out-of-pocket

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