By using this site, you agree to the Privacy Policy and Terms of Use.
Accept
IndebtaIndebta
  • Home
  • News
  • Banking
  • Credit Cards
  • Loans
  • Mortgage
  • Investing
  • Markets
    • Stocks
    • Commodities
    • Crypto
    • Forex
  • Videos
  • More
    • Finance
    • Dept Management
    • Small Business
Notification Show More
Aa
IndebtaIndebta
Aa
  • Banking
  • Credit Cards
  • Loans
  • Dept Management
  • Mortgage
  • Markets
  • Investing
  • Small Business
  • Videos
  • Home
  • News
  • Banking
  • Credit Cards
  • Loans
  • Mortgage
  • Investing
  • Markets
    • Stocks
    • Commodities
    • Crypto
    • Forex
  • Videos
  • More
    • Finance
    • Dept Management
    • Small Business
Follow US
Indebta > Markets > Stocks > US to require patient data for payment of Leqembi, similar Alzheimer’s drugs
Stocks

US to require patient data for payment of Leqembi, similar Alzheimer’s drugs

News Room
Last updated: 2023/06/02 at 10:00 AM
By News Room
Share
5 Min Read
SHARE

© Reuters. FILE PHOTO: The Alzheimer’s drug LEQEMBI is seen in this undated handout image obtained by Reuters on January 20, 2023. Eisai/Handout via REUTERS/File Photo

By Julie Steenhuysen

(Reuters) -The U.S. Medicare health plan said on Thursday it would limit reimbursement for Eisai Co (OTC:) Ltd and Biogen Inc (NASDAQ:)’s Alzheimer’s drug Leqembi to patients whose doctors participate in a health agency database should the drug win full approval, a move advocates say will hinder its use.

The decision marks the first time that Medicare has required data-collection through a so-called registry for the intended use of a drug that has been deemed safe and effective by the U.S. Food and Drug Administration.

Leqembi received accelerated approval from the FDA in January, based on limited evidence suggesting it would slow cognitive decline in early Alzheimer’s patients. A panel of FDA advisers will discuss whether Leqembi should receive traditional approval next week, and a decision could come by early July.

Medicare, the government health plan for Americans 65 and over, currently pays for Leqembi only if patients are enrolled in a clinical trial. The agency said the registry requirement would broaden access to the drug.

It would require doctors to submit evidence on how the drug works in routine practice, and collect information in an “easy-to-use” portal maintained by the Centers for Medicare and Medicaid Services (CMS) upon traditional approval.

The CMS decision would apply to all Alzheimer’s treatments that reduce a protein called beta amyloid from the brain, including Eli Lilly (NYSE:) and Co’s donanemab, which recently reported positive results from its late-stage trial.

“Until CMS announces the registry design and details, it is difficult to understand how a registry will impact patient access to Leqembi,” Eisai said in a statement. Historically, such programs have limited access to patients in underserved communities, the company added.

Lilly called on CMS to revise its decision and urged the agency to provide full Medicare coverage for FDA-approved Alzheimer’s medicines, saying the move would set a precedent for all new medicines.

“We strongly believe that mandating patient enrollment in registries will continue to pose unnecessary barriers and contradicts CMS’ promise of broad coverage to all Medicare beneficiaries,” a Lilly spokesman said in a statement.

In April, Lilly said it believed Medicare would back down from its registry requirement as more evidence emerged showing that clearing amyloid brain plaques can help patients.

Such “coverage with evidence development” requirements are rare and historically used by Medicare to evaluate medical devices rather than drugs.

“We continue to believe that registry as a condition of coverage is an unnecessary barrier,” the Alzheimer’s Association said in a statement. The group said it supports collecting information on how such treatments work, but not as a requirement for coverage of an FDA-approved drug.

Biogen’s shares were 2.6% higher, while Eli Lilly was up 1.3%.

Duke University economist Dr. Mark McClellan, who has served both as FDA commissioner and a CMS administrator, said it appears CMS is trying to make the registry less cumbersome, but that it must provide more details. “That needs to happen pretty quickly.”

To receive Medicare coverage, people will need to be diagnosed with mild cognitive impairment or early dementia caused by Alzheimer’s and have a qualified physician participating in a registry.

William Blair analyst Myles Minter did not see the registry requirement significantly limiting patient access. “We believe that registries at specialist centers where Leqembi is likely to be initially administered will not be a substantial hurdle.”

A CMS spokeswoman said the initial registry will be administrated by the agency should Leqembi gain full approval and was hopeful other organizations would create additional registries to collect data.

Read the full article here

News Room June 2, 2023 June 2, 2023
Share this Article
Facebook Twitter Copy Link Print
Leave a comment Leave a comment

Leave a Reply Cancel reply

Your email address will not be published. Required fields are marked *

Finance Weekly Newsletter

Join now for the latest news, tips, and analysis about personal finance, credit cards, dept management, and many more from our experts.
Join Now
Client Challenge

Client Challenge JavaScript is disabled in your browser. Please enable JavaScript to…

Donald Trump’s escalating attacks on Federal Reserve unnerve investors

Unlock the White House Watch newsletter for freeYour guide to what Trump’s…

Spain overtakes Germany as top EU asylum destination

Unlock the Editor’s Digest for freeRoula Khalaf, Editor of the FT, selects…

Brussels stalls probe into Elon Musk’s X amid US trade talks

Unlock the Editor’s Digest for freeRoula Khalaf, Editor of the FT, selects…

The fight to revive Europe’s shrinking rural areas

Nicolás de la Fuente, a 92-year-old walking his dog on the desolate…

- Advertisement -
Ad imageAd image

You Might Also Like

Stocks

Playa Hotels & Resorts (NASDAQ:PLYA) Delivers Strong Q4 Numbers By Stock Story

By News Room
Stocks

ON24 (NYSE:ONTF) Posts Better-Than-Expected Sales In Q4 By Stock Story

By News Room
Stocks

Evolent Health shares leap on Q4 earnings beat and upbeat guidance By Investing.com

By News Room
Stocks

Chuy’s (NASDAQ:CHUY) Reports Q4 In Line With Expectations But Stock Drops

By News Room
Stocks

Red River Bancshares raises dividend to $0.09 per share

By News Room
Stocks

Ecolab appoints Microsoft executive to board

By News Room
Stocks

Semilux secures $50 million equity deal with White Lion Capital

By News Room
Stocks

US government debt trajectory to push long-term yields higher, says PIMCO

By News Room
Facebook Twitter Pinterest Youtube Instagram
Company
  • Privacy Policy
  • Terms & Conditions
  • Press Release
  • Contact
  • Advertisement
More Info
  • Newsletter
  • Market Data
  • Credit Cards
  • Videos

Sign Up For Free

Subscribe to our newsletter and don't miss out on our programs, webinars and trainings.

I have read and agree to the terms & conditions
Join Community

2023 © Indepta.com. All Rights Reserved.

Welcome Back!

Sign in to your account

Lost your password?