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Accelerated Approval Reforms Complicated Because Most Drugs Have Regular Indications Too

 
• By Cathy Kelly

Because Medicare and Medicaid do not reimburse based on indication, it would be hard to target specific accelerated approvals for pricing discounts. This could penalize drug manufacturers even if the accelerated indication represents a minor share of the drug’s use, researchers say.

Variable Rebates For Accelerated Approvals? Not So Fast, Researchers Caution • Source: Alamy

Efforts to develop reimbursement-based policy reforms to address concerns about drugs approved through the US Food and Drug Administration’s accelerated approval pathway will be complicated by the fact that the majority of drugs with accelerated approvals in Medicaid and Medicare also have regular approvals for other indications, according to two recent studies by researchers at Brigham and Women’s Hospital.

One study published in the December issue of Health Affairs by Benjamin Rome and Aaron Kesselheim looked at accelerated approvals in Medicaid to assess a proposal by the Medicaid...

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More from Pricing Debate

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.

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.

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.

More from Market Access

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.