What US market access professionals need to know about pre-approval information exchange

Written by Nicole Lodowski

As payers’ evidence needs continue to evolve and formulary and budgetary decision-making becomes more complex, manufacturers have a prime opportunity to create added value by engaging with payer customers earlier and more often through pre-approval information exchange (PIE) programs. 

This free article discusses: 

• why, historically, manufacturers have been limited in what information they were permitted to share with payers and similar entities prior to FDA approval of a drug
  
  
• how legislation and FDA guidance has now created useful communication pathways and safe harbor for manufacturers to share much-needed pre-approval product information with payers
  
  
• the opportunities for payers to gain valuable insights about new products and therapy areas well in advance of FDA approval and make earlier and more informed coverage and reimbursement decisions.