Smoking Cessation: Medicare Decision May Give OTC Products A New Angle
This article was originally published in The Pink Sheet Daily
Executive Summary
National coverage determination could lead to 2.8 mil. new eligible beneficiaries for treatment. OTCs and prescription nicotine replacement therapy products could get a boost as a result of the decision, assuming other private plans follow suit.
You may also be interested in...
US Medicare Plans 'Can' Cover Wegovy, CMS Says, But Will They?
Medicare is making clear that Part D ‘can’ cover GLP-1 inhibitors that are approved for cardiovascular indications – but in language that seems to leave plans considerable discretion for now. The formulary review process for 2025 may be a more important milestone for changes.
An Artificial Intelligence Milestone For US FDA
A project to validate a depression severity measurement tool that employs artificial intelligence for use in drug trials is moving forward at FDA. The milestone is a sign of things to come – and of the incremental process for AI adoption by the regulator.
Advanced Manufacturing Technology Designation Guidance Uses Broad Criteria For ‘Novel’
In US FDA’s draft, mandated by in the current user fee legislation, contract manufacturers can also vie for a designation. CDER ETT and CBER CATT teams will play a key role in the process.