Big Rebates Already A Big Factor For Drugs On Medicare Negotiation List

Long-awaited list has a couple of surprises that are expected to face biosimilar competition either before negotiated prices are implemented in 2026 or during that year.

over inflated drugs
Many of the drugs picked by Medicare appear to have list prices inflated by rebates. • Source: Shutterstock

Most of the 10 drugs chosen for the first round of Medicare price negotiation by the Centers for Medicare and Medicaid Services are heavily rebated, which raises the question of how much lower prices will go in the negotiation process.

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Updated: US Likely To Lose Its First Approver Advantage After FDA Layoffs

Mass FDA layoffs on 1 April were designed to spare product reviewers, but still touched many who are critical to the application review process or drug development, which could mean fewer treatments are brought to the US market first.

England’s NICE Wants Industry Involvement In HTA Sandbox Projects

 

Pharmaceutical companies are being encouraged to reach out to NICE in relation to its HTA Innovation Lab, which provides a sandbox environment in which the health technology assessment body can test new methods of evaluating “innovative and disruptive” therapies.

Brazil Catches Up With International Standards on Viral Safety Evaluations For Biotech Products

 

The Brazilian medicines regulator will also offer more clarity on the requirements for radiopharmaceuticals that are exempt from registration.

Korea To Revise ‘Innovative Company’ Criteria Amid Calls From Foreign Industry

 
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South Korea announces planned revisions to a government scheme to designate "innovative" biopharma companies amid allegations of "discrimination" against foreign firms.

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Newest HHS Staff Cuts Could Stymie CMS Health Plan Oversight

 
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A former CMS manager worries casework and other necessary functions could suffer as a result of the 300 staff cuts at the agency that are part of a massive HHS restructuring.

Power Play: US FDA Likely Losing More Than Just Staff With Restructured Health Department

 

About 3,500 full-time FDA employees are expected to be laid off as part of a restructuring of the Health and Human Services Department and experts questioned whether the cuts could be implemented without harming FDA’s core mission.

German Ordinance To Implement HTA Reg Leaves Room For Doubt

 

A German ordinance implementing the EU Health Technology Assessment Regulation offers little clarity on how far joint clinical assessment reports should be considered by national authorities.