• Disclosure
  • Privacy Policy
  • DMCA Policy
  • CCPA
  • Medical Disclaimer
Saturday, April 1, 2023
SLC Metro News
  • Home
  • News
  • Business
  • Technology
    • Crytpocurrency
    • Gaming
    • Gadgets
  • Sports
  • Health
  • General
    • Business Services
  • Travel
  • Press Releases
  • Popular
No Result
View All Result
  • Home
  • News
  • Business
  • Technology
    • Crytpocurrency
    • Gaming
    • Gadgets
  • Sports
  • Health
  • General
    • Business Services
  • Travel
  • Press Releases
  • Popular
No Result
View All Result
No Result
View All Result
Home News

U.S. Medicare Plans To Cover Biogen Alzheimer’s Drug Only For Trial Patients – Reuters

us.-medicare-plans-to-cover-biogen-alzheimer’s-drug-only-for-trial-patients-–-reuters
Share on FacebookShare on Twitter

A sign marks a Biogen facility in Boston, U.S., March 9, 2020. REUTERS/Brian Snyder

Register now for FREE unlimited access to Reuters.com

Jan 11 (Reuters) – The U.S. government Medicare program on Tuesday said it plans to cover Alzheimer’s treatments including Biogen Inc’s (BIIB.O) 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 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.

Register now for FREE unlimited access to Reuters.com

The final CMS coverage terms are expected to apply to all drugs in the class, including experimental medications in development by Eli Lilly & Co (LLY.N), Roche Holding AG 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. read more

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.

Register now for FREE unlimited access to Reuters.com

Reporting By Deena Beasley, in Los Angeles, Julie Steenhuysen in Chicago and Leroy Leo in Bengaluru; Editing by Caroline Humer, Bill Berkrot, Devika Syamnath, Peter Henderson and Lincoln Feast.

Our Standards: The Thomson Reuters Trust Principles.

SLC Metro News

© 2021 SLC Metro News

Navigate Site

  • Disclosure
  • Privacy Policy
  • DMCA Policy
  • CCPA
  • Medical Disclaimer

Follow Us

No Result
View All Result
  • Home
  • DMCA Policy
  • Medical Disclaimer
  • Privacy Policy
  • Disclosure
  • CCPA
  • Terms of Use

© 2021 SLC Metro News

We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. By clicking “Accept All”, you consent to the use of ALL the cookies. However, you may visit "Cookie Settings" to provide a controlled consent.
Cookie SettingsAccept All
Manage consent

Privacy Overview

This website uses cookies to improve your experience while you navigate through the website. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may affect your browsing experience.
Necessary
Always Enabled
Necessary cookies are absolutely essential for the website to function properly. These cookies ensure basic functionalities and security features of the website, anonymously.
CookieDurationDescription
cookielawinfo-checkbox-analytics11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics".
cookielawinfo-checkbox-functional11 monthsThe cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional".
cookielawinfo-checkbox-necessary11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-others11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other.
cookielawinfo-checkbox-performance11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance".
viewed_cookie_policy11 monthsThe cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.
Functional
Functional cookies help to perform certain functionalities like sharing the content of the website on social media platforms, collect feedbacks, and other third-party features.
Performance
Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors.
Analytics
Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc.
Advertisement
Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. These cookies track visitors across websites and collect information to provide customized ads.
Others
Other uncategorized cookies are those that are being analyzed and have not been classified into a category as yet.
SAVE & ACCEPT