Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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

Medicare CAR-T Coverage Decision Appears Hung Up In Political Review, Former CMS Official Says

Executive Summary

Proliferation of expensive accelerated approval products requires "a revision to the existing evidence and policy approach for payers," Sean Tunis tells the DIA annual meeting.

You may also be interested in...



CAR-T Coverage: CMS Takes Gradual Approach With Eye Toward New Entrants, Indications

As final decision looms, initial move to hold off on DRG but increase payment for CAR-T therapies shows CMS taking a slow and steady approach to paying for the products.

Medicare Coverage For CAR-T Will Require Additional Patient Data Collection

Draft national coverage decision addresses current indications and hospital sites of care. CMS expects to “leverage” existing FDA post-market data collection requirements but seeks additional data on patient-reported outcomes in some cases.

Pink Sheet Podcast: NIH Director Leaving, Federal COVID-19 Messaging Issues, FDA Assessment Costs

Pink Sheet editor and reporters discuss the impact of Francis Collins’ departure as NIH director, whether FDA and CDC COVID-19 messaging should be harmonized, and the narrowing gap between standard and priority assessment costs.

Topics

Related Companies

UsernamePublicRestriction

Register

PS125539

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