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

Accelerated Approvals In Medicaid: Drug Coverage Exclusion Authority Sought In Oregon

Executive Summary

If approved, Oregon would be the first state granted the authority to exclude coverage of accelerated approval drugs, even if manufacturers provide the statutory rebates required for Medicaid.

You may also be interested in...



US FDA Accelerated Approvals Could Expire Under New Legislation, But Big Loophole Included

The bill, some version of which is undoubtedly destined for the FDA user fee package, also would codify existing labeling guidance for products cleared through the pathway.

Sen. Wyden Using Califf Nomination To Extract Accelerated Approval Reforms

The unexpectedly tight fight to get Robert Califf confirmed as FDA commissioner is giving lawmakers additional leverage to extract commitments. However, the Senate Finance Chair may be overestimating FDA’s ability to swiftly pull accelerated approvals without new legislation.

Accelerated Approval Reforms Complicated Because Most Drugs Have Regular Indications Too

Because Medicare and Medicaid do not reimburse based on indication, it would be hard to target specific accelerated approvals for pricing discounts. This could penalize drug manufacturers even if the accelerated indication represents a minor share of the drug’s use, researchers say.

Related Content

Topics

Related Companies

Latest News
UsernamePublicRestriction

Register

PS145820

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