Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

US Medicare Agency Clarifies View Of Accelerated Approval

Executive Summary

CMS says it has not changed its historical policy towards drugs granted Accelerated Approval. The agency does, however, appear to be suggesting grounds for skepticism towards novel uses of the regulatory pathway.

You may also be interested in...



Medicare’s ‘Aduhelm’ Policy A Precedent For Accelerated Approvals But Not Cancer Drugs – Gottlieb

CMS has long been interested in applying Medicare coverage with evidence development requirements to drugs, the former US FDA commissioner and CMS senior advisor suggests.

Medicare And Alzheimer’s Drugs: Pressure To Relax Coverage Restrictions Rising Wtih Donanemab Data

Lilly's donanemab may be the second amyloid-targeting drug for Alzheimer’s headed toward a traditional US Food and Drug Administration approval this year, setting up a showdown with Medicare over its coverage with evidence development requirements.

Leqembi Coverage Expansion: US Medicare Head Promises Light Touch On Registry

Medicare is not envisioning an overly burdensome process to fulfill its requirement for a registry as a condition for coverage of ‘fully’ approved beta amyloid Alzheimer’s therapies, the head of the agency tells Congress. Biogen and Eisai still hope to have the registry obligation removed altogether.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS148223

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel