Manufacturer Communications With Payers Easier Under US FDA Guidance, But Challenges Remain
Process for sharing health care economic and other information has been simplified for manufacturers, and payers are seeing more economic modeling data earlier as a result. However, there is still uncertainty as to the scope of who may communicate the information, and to whom, under the agency’s 2018 final guidance, experts said.
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Final guidance on drug manufacturer communications with payors adopts industry call to include exchanges about unapproved uses; they will not be considered evidence of intended use.
Draft guidance provides clarity on what health care economic information firms can provide to payors, formulary committees and similar entities.
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