Expedite payer coverage with surrogate endpoints
The idea of surrogate endpoints isn’t new, but they have matured with the increased adoption of accelerated pathways for regulatory approval. FDA will grant limited approval, but require confirmatory studies and as a result, sponsors need to prepare data and develop strategies earlier – for both regulators and payers.
Related Insights
Blog
Unpacking NICE’s review of the HST routing criteria: implications for manufacturers
Oct 3, 2024
Whitepaper
Addressing the Challenges of Artificial Intelligence used for Data Extraction in Systematic Literature Reviews
Mar 15, 2023
Article
Three strategies for articulating a coherent product value story
Dec 18, 2021
Blog
Pragmatic Trials: Targeting evidence generation to inform market access and meet payers’ needs
Feb 8, 2022
Article
How biotechs can strengthen their value story with advanced analytics
Feb 15, 2022
Whitepaper
Overview of China's Market Approval Policy Med Insurance Payment System
Apr 7, 2022
Webinar
China's Market Approval Policy and Medical Insurance Payment System for Rare Disease
Jul 21, 2022
Blog
Preparing for a new era in European Market Access
Jul 22, 2022
Blog
U.S. price reforms 2022: How can drug manufacturers best prepare for the Inflation Reduction Act?
Aug 17, 2022
Podcast
Why Rare Disease Therapeutics Need Early Market Access Planning
Jan 4, 2023
Blog
Innovative modeling method could speed patient access to critical IO therapies
Jan 4, 2023
Playbook
Are you using real-world evidence?
Feb 1, 2023
Related Insights
Blog
Unpacking NICE’s review of the HST routing criteria: implications for manufacturers
Oct 3, 2024
Whitepaper
Addressing the Challenges of Artificial Intelligence used for Data Extraction in Systematic Literature Reviews
Mar 15, 2023
Article
Three strategies for articulating a coherent product value story
Dec 18, 2021
Blog
Pragmatic Trials: Targeting evidence generation to inform market access and meet payers’ needs
Feb 8, 2022
Article
How biotechs can strengthen their value story with advanced analytics
Feb 15, 2022
Whitepaper
Overview of China's Market Approval Policy Med Insurance Payment System
Apr 7, 2022
Webinar
China's Market Approval Policy and Medical Insurance Payment System for Rare Disease
Jul 21, 2022
Blog
Preparing for a new era in European Market Access
Jul 22, 2022
Blog
U.S. price reforms 2022: How can drug manufacturers best prepare for the Inflation Reduction Act?
Aug 17, 2022
Podcast
Why Rare Disease Therapeutics Need Early Market Access Planning
Jan 4, 2023
Blog
Innovative modeling method could speed patient access to critical IO therapies
Jan 4, 2023
Playbook
Are you using real-world evidence?
Feb 1, 2023