December 1, 2023

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U.S. health insurance explicitly restricts Biogen’s Alzheimer’s drug use in clinical trial patients

U.S. health insurance explicitly restricts Biogen’s Alzheimer’s drug use in clinical trial patients


U.S. health insurance explicitly restricts Biogen’s Alzheimer’s drug use in clinical trial patients.

A few days ago, Biogen’s controversial Alzheimer’s disease (AD) drug Aduhelm (aducanumab) suffered another regulatory setback.

The U.S. government has officially announced that Aduhelm’s coverage in the U.S. federal medical insurance (Medicare) will be strictly limited to only For patients participating in clinical trials.


U.S. health insurance explicitly restricts Biogen's Alzheimer's drug use in clinical trial patients


In the U.S., the majority of Alzheimer’s patients receive Medicare services through federal insurance plans, and this restrictive decision by U.S. Medicare officials on Aduhelm will severely impact patients’ access to the therapy.

An estimated 1.5 million people in the U.S. have been diagnosed with mild Alzheimer’s disease-related cognitive decline, which is exactly where Aduhelm is FDA-approved.


It is reported that Aduhelm is the first Alzheimer’s disease drug in the U.S. market in the past 20 years, and has been approved all the way under the FDA’s accelerated approval program. In recent months. 

However, the U.S. government has repeatedly signaled its intention to strictly limit Aduhelm’s coverage to patients enrolled in clinical trials. In January of this year, the U.S. Centers for Medicare and Medicaid Services (CMS) issued a restrictive announcement on the inclusion of Aduhelm in health insurance, soliciting comments from Biogen and the public.


At the time, Biogen responded that any decision to restrict Aduhelm could have serious negative consequences for current U.S. patients and the development of Alzheimer’s treatments in the future.

Brendan Manquin, vice president of market access and reimbursement at Biogen USA, said bluntly that if the draft goes through, only about 1,000-2,000 patients may be treated with Aduhelm in the next few years.


According to the “New York Times” report, the US CMS staff member Chiquita Brooks-LaSure said that the decision to restrict the use of Aduhelm therapy is to effectively protect American patients, while collecting real efficacy data so that it can be proved that Aduhelm can slow Alzheimer’s disease.

The rate of cognitive decline in the patient. Responding to the roughly 10,000 related draft comments received on the CMS website, Brooks-LaSure said a majority also favored limiting Aduhelm’s coverage to a truly controlled space so that CMS could continue to evaluate the therapy’s impact on Medicare suitability for the population. Biogen has yet to formally respond to the restrictive ruling.


In its report, Bloomberg quoted some analysts as saying that CMS’s decision to restrict health insurance may not only directly mean the death of Aduhelm, but also lead to Biogen being forced to take additional cost-cutting measures.

Just last month, Bojian has started a new round of layoffs, saying it will further cut up to 10% of its staff. Last year, the company also announced a $500 million cost-cutting plan, but now the cost savings from layoffs at that time may hardly make up for Aduhelm’s failure.


Even some early reports of Biogen layoffs suggest that many of the company’s internal business teams related to Alzheimer’s drugs may have long since been disbanded.

Biogen has been working hard for Aduhelm’s commercial performance since its approval in June 2021.

However, due to concerns about its efficacy and safety, Aduhelm’s market development has been hampered, and the drug’s sales in the third quarter of 2021.

At $300,000, only 2% of the projected target of $14 million.


It is worth noting that Aduhelm was also rejected by the European Union and Japan’s drug regulators at the end of last year. Both regulators said that there was not enough data to support them to approve the drug.

Combined with the recent strict restriction of the treatment’s application to clinical trial patients only, the future development of the first approved Alzheimer’s disease drug in the United States in nearly 20 years has become increasingly difficult.










Medicare Officially Restricts Coverage of Biogen’s Aduhelm

U.S. health insurance explicitly restricts Biogen’s Alzheimer’s drug use in clinical trial patients

(source:internet, reference only)

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