Medicare Part D Redesign Will Sharpen Policy Focus On Protected Classes

Manufacturers worry that the redesign will prompt tighter controls in the protected classes, while some research indicates plans are already using all the tools at their disposal to manage some key classes, such as cancer drugs, suggesting they may need to be able to do more.

eyeglasses
With Costs Growing, Particularly For Cancer Drugs, The Focus On Protected Class Won't Go Away • Source: Shutterstock

Upcoming changes in the Medicare Part D benefit that involve increasing the risk borne by insurers in the catastrophic phase may boost pressure on plans to control costs in the six protected classes and manufacturers are worried about what that might lead to.

Key Takeaways
  • Manufacturers are worried that the incentives to better manage costs imposed on Part D plans by the Inflation Reduction Act might lead to stricter management of...

Under the Inflation Reduction Act, Part D plan obligations for drug costs will increase from 15% to 60% in the catastrophic phase beginning in 2025, while Medicare’s will decrease from...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Market Access

US ‘Most Favored Nation’ Pricing Could be Game Changer for Drug Access In Germany

 

In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.

US FDA Will Help States Apply To Import Cheaper Drugs From Canada

 
• By 

The FDA is not currently signaling that stringent rules for the process will be relaxed, but the agency's change in approach is notable.

Global Pandemic Deal Adopted As 124 Countries Say Yes; US Sits Out

 

Now that the landmark Pandemic Agreement has finally been adopted, work will start on drafting a pathogen access and benefit sharing system that will be voluntary for use by drug companies.

HHS Negotiating With Manufacturers On Most Favored Nation Drug Pricing

 
• By 

MFN policy would would apply to all single source drugs in all insurance markets, according to HHS release. Secretary Robert F. Kennedy Jr. said the department is discussing the plan with drug sponsors.

More from Pink Sheet

Non-User Fee Dollars Increased In US FDA’s Updated FY 2026 Budget Request

 

The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.

US ‘Most Favored Nation’ Pricing Could be Game Changer for Drug Access In Germany

 

In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.

ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
• By 

The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.