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
UsernamePublicRestriction

Wanted: “Imaginative and Original Thoughts” On Coverage With Evidence Development

This article was originally published in RPM Report

Executive Summary

The Centers for Medicare & Medicaid Services is revisiting its policy on Coverage with Evidence Development. Here is how two key officials from CMS’ Coverage & Analysis Group described their thinking during a conversation with The RPM Report as part of the FDA/CMS Summit for Biopharma Executives in December.

You may also be interested in...



Coverage With Evidence Development and Expedited Approvals: Policy Proposals For FDA and CMS

Based on stakeholder consultations, former FDA and CMS head Mark McClellan and former CMS official Sean Tunis present a potential upside for biopharma in broader use of Medicare coverage with evidence development. Pfizer executives participate in workshop on coordinating expedited drug approval, CED policies.

Is The Opioid REMS Too Big To Study?

US FDA’s workshop to discuss new ideas to assess the impact of the opioid REMS comes after the industry collaboration behind the REMS has deemed the task essentially impossible.

Growing Pains For US FDA Oversight Of Opioids: Starting Over On Assessment Of REMS

Whether CME for pain management has the intended impact on prescribing is likely focus of new ‘suite of studies’ intended to assess the opioid REMS program. The challenges for FDA include teasing out the impact of the risk management program amid all the other public health efforts on opioids.

Topics

UsernamePublicRestriction

Register

OM006051

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