Breaking News
Get Actionable Insights with InvestingPro+: Start 7 Day FREE Trial Register here
Investing Pro 0
Ad-Free Version. Upgrade your Investing.com experience. Save up to 40% More details

U.S. Medicare plans to cover Biogen Alzheimer's drug only for trial patients

Stock MarketsJan 11, 2022 10:51PM ET
Saved. See Saved Items.
This article has already been saved in your Saved Items
 
© Reuters. FILE PHOTO: A sign marks a Biogen facility in Boston, U.S., March 9, 2020. REUTERS/Brian Snyder

By Deena Beasley and Leroy Leo

(Reuters) -The U.S. government Medicare program on Tuesday said it plans to cover Alzheimer's treatments including Biogen Inc (NASDAQ:BIIB)'s Aduhelm but will require patients to be enrolled in a clinical trial, limiting access to the treatment more than many expected.

Biogen shares were down 7.3% at $224 in extended trading on Tuesday. Shares of Biogen's Japanese partner Eisai Co (OTC:ESALY) Ltd slid 2.6% in Tokyo.

The decision from the U.S. Centers for Medicare and Medicaid Services (CMS), the health agency that runs Medicare, could change as it seeks comment from companies and patients. A final decision is due on April 11.

The final CMS coverage terms are expected to apply to all drugs in the class, including experimental medications in development by Eli Lilly & Co (NYSE:LLY), Roche Holding AG (OTC:RHHVF) and Eisai.

Patient advocacy group UsAgainstAlzheimer’s chairman George Vradenburg said he was angry Medicare placed conditions on the use of the drugs that were more limiting than the regulator, the Food and Drug Administration, put on Aduhelm, and that the Medicare decision applied to any amyloid drug.

The government's health service was "at war with itself," he said.

"The FDA has approved this drug and now Medicare has disapproved the drug," Vradenburg said.

The FDA approved the drug in June last year despite its 11-member committee of outside experts voting nearly unanimously in November 2020 that the drug should not be approved, citing inconclusive evidence the drug was effective.

Many experts have questioned the FDA's rationale for Aduhelm's approval without more definitive proof of benefit, and doctors have held back on prescribing it.

"The wholesale rejection of this product by payers and health systems around the country is notable but not shocking, given how little evidence the manufacturer produced at the time of its FDA approval," said Dr. Caleb Alexander, a professor with the Johns Hopkins Center for Drug Safety and Effectiveness, in Baltimore. Alexander was a member of the FDA advisory panel that voted not to approve the drug.

Demand for an Alzheimer's treatment, he said, "should fuel our investments in drug development, not a lowering of standards that Americans rely upon to know whether their drugs are safe and effective."

UNUSUAL RESTRICTIONS

The unusual move to require clinical trials for recipients of the already approved drug comes after a six-month process in which CMS had been working on a national coverage policy for the drug.

The decision to require the trial "will exclude almost all patients who may benefit," Biogen said in a statement.

The requirements "can take months to years to initiate," it said, and promised to urge the agency to align its coverage policy with the populations that have been studied in previous clinical trials.

"We believe Alzheimer's patients should have access consistent with other therapies with FDA accelerated approval," Biogen said.

Sales so far have been weak and Biogen last month cut the medication's list price by about half to $28,200 per year.

Cowen analyst Eric Assaraf said in a research note the decision to restrict coverage to clinical trial participants was more restrictive than he had expected, noting the agency could have simply required Biogen to maintain a registry of patients that documented responses to the drug. He said CMS may change its stance in the final decision.

Aduhelm's high price also has raised concerns over the toll it might take on the Medicare program, the U.S. government health plan for people age 65 and over. Because Alzheimer's is an age-related disease, around 85% of people who might use the medicine are in the government plan.

With the proposed decision, the cost will shift to patients, Vradenburg said.

"Unless you are a very wealthy person, you are not going to get access to the drug," he added.

Aduhelm, given as a monthly infusion, is a monoclonal antibody designed to remove a type of brain plaque associated with Alzheimer's Disease. Patients need to be monitored for potential side effects including brain swelling.

U.S. Medicare plans to cover Biogen Alzheimer's drug only for trial patients
 

Related Articles

Hong Kong regulator fines Citi unit $45 million
Hong Kong regulator fines Citi unit $45 million By Reuters - Jan 28, 2022

HONG KONG (Reuters) - Hong Kong's markets watchdog has fined a Citigroup (NYSE:C) unit HK$348.25 million ($44.68 million) for what it called serious regulatory failures over...

Add a Comment

Comment Guidelines

We encourage you to use comments to engage with other users, share your perspective and ask questions of authors and each other. However, in order to maintain the high level of discourse we’ve all come to value and expect, please keep the following criteria in mind:  

  •            Enrich the conversation, don’t trash it.

  •           Stay focused and on track. Only post material that’s relevant to the topic being discussed. 

  •           Be respectful. Even negative opinions can be framed positively and diplomatically. Avoid profanity, slander or personal attacks directed at an author or another user. Racism, sexism and other forms of discrimination will not be tolerated.

  • Use standard writing style. Include punctuation and upper and lower cases. Comments that are written in all caps and contain excessive use of symbols will be removed.
  • NOTE: Spam and/or promotional messages and comments containing links will be removed. Phone numbers, email addresses, links to personal or business websites, Skype/Telegram/WhatsApp etc. addresses (including links to groups) will also be removed; self-promotional material or business-related solicitations or PR (ie, contact me for signals/advice etc.), and/or any other comment that contains personal contact specifcs or advertising will be removed as well. In addition, any of the above-mentioned violations may result in suspension of your account.
  • Doxxing. We do not allow any sharing of private or personal contact or other information about any individual or organization. This will result in immediate suspension of the commentor and his or her account.
  • Don’t monopolize the conversation. We appreciate passion and conviction, but we also strongly believe in giving everyone a chance to air their point of view. Therefore, in addition to civil interaction, we expect commenters to offer their opinions succinctly and thoughtfully, but not so repeatedly that others are annoyed or offended. If we receive complaints about individuals who take over a thread or forum, we reserve the right to ban them from the site, without recourse.
  • Only English comments will be allowed.

Perpetrators of spam or abuse will be deleted from the site and prohibited from future registration at Investing.com’s discretion.

Write your thoughts here
 
Are you sure you want to delete this chart?
 
Post
Post also to:
 
Replace the attached chart with a new chart ?
1000
Your ability to comment is currently suspended due to negative user reports. Your status will be reviewed by our moderators.
Please wait a minute before you try to comment again.
Thanks for your comment. Please note that all comments are pending until approved by our moderators. It may therefore take some time before it appears on our website.
Comments (1)
Deborah Beal
Deborah Beal Jan 11, 2022 6:13PM ET
Saved. See Saved Items.
This comment has already been saved in your Saved Items
price too high for a drug not proven to work
 
Are you sure you want to delete this chart?
 
Post
 
Replace the attached chart with a new chart ?
1000
Your ability to comment is currently suspended due to negative user reports. Your status will be reviewed by our moderators.
Please wait a minute before you try to comment again.
Add Chart to Comment
Confirm Block

Are you sure you want to block %USER_NAME%?

By doing so, you and %USER_NAME% will not be able to see any of each other's Investing.com's posts.

%USER_NAME% was successfully added to your Block List

Since you’ve just unblocked this person, you must wait 48 hours before renewing the block.

Report this comment

I feel that this comment is:

Comment flagged

Thank You!

Your report has been sent to our moderators for review
Disclaimer: Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. All CFDs (stocks, indexes, futures) and Forex prices are not provided by exchanges but rather by market makers, and so prices may not be accurate and may differ from the actual market price, meaning prices are indicative and not appropriate for trading purposes. Therefore Fusion Media doesn`t bear any responsibility for any trading losses you might incur as a result of using this data.

Fusion Media or anyone involved with Fusion Media will not accept any liability for loss or damage as a result of reliance on the information including data, quotes, charts and buy/sell signals contained within this website. Please be fully informed regarding the risks and costs associated with trading the financial markets, it is one of the riskiest investment forms possible.
Continue with Google
or
Sign up with Email