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Copay Maximizers May Be Restricted In Small Private Plans Under CMS Proposal: Will Broader Impact Follow?

 
• By Cathy Kelly

The Centers for Medicare and Medicaid Services requests stakeholder feedback on how extensively copay maximizers are being used by insurers, which could help pave the way for restrictions on large employer and self-insured plans. 

Copay Maximizers, Accumulators And Alternative Funding Programs Aim To Counter Or Exploit Manufacturer Assistance • Source: Shutterstock

The Centers for Medicare and Medicaid Services is proposing to formalize its policy against private insurance plans designating some covered drugs as “non-essential health benefits,” which could limit the use of copay maximizer programs.

Key Takeaways

  • CMS 'codifies' policy barring individual and small group plans from designating covered drugs as 'non-EHB' and not subject to annual limits on cost sharing.

  • ...

The proposal is part of the CMS Notice of Benefit and Payment Parameters for 2025 proposed rule released on 15 November.

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Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 
• By Neena Brizmohun

Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Nielsen Hobbs

This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Nielsen Hobbs

We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.

Brazil Pilots Digital Drug Pack Inserts

 
• By Francesca Bruce

A new pilot aims to take Brazil closer to ‘digital transformation.’

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US Most Favored Nations Policy: Higher Drug Spending In Germany Is ‘Difficult To Imagine’

 
• By Francesca Bruce

Germany’s federal health care decision-making body, the G-BA, tells the Pink Sheet that German drug prices are fair and speculation of price rises in the market due to the US MFN policy is fear mongering.

Autolus’s Aucatzyl And GSK’s Blenrep Among 10 New Drugs To Get EMA Nod

 
• By Vibha Sharma

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Europe’s UPC Issues Landmark Ruling On Second Medical Use Claims

 
• By Neena Brizmohun

The verdict by the Unified Patent Court in the dispute between Sanofi/Regeneron Pharmaceuticals and Amgen explains what companies should look out for when deciding whether infringement has taken place when it comes to second medical use patents.