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Payer Transparency Reforms: Moving From Rebates To Drug Access Restrictions

 
• By Cathy Kelly

Institute for Clinical and Economic Review analysis of whether payers are providing ‘fair access’ to fairly priced drugs was hampered by a lack of transparency among payers, leading to calls for reform.

Drug pricing transparency (Nielsen Hobbs; the Pink Sheet | Alamy images)
Shining more light on pricing Could Ensure Fair Access To Drugs, ICER Says • Source: Nielsen Hobbs; the Pink Sheet | Alamy images

A new “exploratory” report from the Institute for Clinical and Economic Review highlights the lack of information available on US payer decisions regarding formulary placement and utilization management restrictions for prescription drugs, suggesting a new area of focus in the broader push for US payer transparency.

ICER’s first annual “Barriers to Fair Access” assessment of prescription drug coverage policies among US commercial insurers looks at the coverage policies established by the largest payers for 28...

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

 
• By Francesca Bruce

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 Cathy Kelly

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

 
• By Neena Brizmohun

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 Cathy Kelly

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.

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

 
• By Derrick Gingery

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

 
• By Francesca Bruce

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 Vibha Sharma

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.