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US Payers Rate ICER Assessment Updates Using Real World Data As Potentially ‘High Impact’

 
• By Cathy Kelly

ICON survey finds payers increasingly use ICER reports at multiple ‘touchpoints’ during the drug evaluation and decision-making process and the most common use reported in 2020 was as a reference in rebate and pricing negotiations.

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ICER Will Pilot Use Of RWE In Drug Assessment Updates

US commercial payers expect the Institute for Clinical and Economic Review’s efforts to update its cost effectiveness assessments using real world evidence could be the most impactful of the changes to its methodology implemented this year, according to a recently-released survey by contract research organization ICON.

The survey of 30 payers explored several aspects of ICER’s cost effectiveness methodology update for 2020-2023, which was released early this year. Survey respondents included regional and national managed care...

More from Real-World Evidence

US FDA’s Prasad: ‘We Will Always Embrace Surrogate Endpoints’

 
• By Sarah Karlin-Smith

The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.

UK And US Regulators In Sync On RWD External Control Arms

 
• By Vibha Sharma

The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.

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.

UK MHRA’s Clinical Trial Lead On Combined Reviews, The Notification Scheme & Increasing Diversity

 
• By Eliza Slawther

In light of the UK’s MHRA announcing a major overhaul of its clinical trial legislation, the agency’s deputy director for clinical investigations and trials, Andrea Manfrin, tells the Pink Sheet what sponsors can expect from the new regulation.

More from Clinical Trials

EU To Track Decentralized Clinical Trials In CTIS To Support Innovation

 
• By Vibha Sharma

Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.

Pink Sheet Podcast: US FDA’s Big Vaccine Policy Week

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector.

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.