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.
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What you need to know about pre-approval information exchange: lessons learned
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