January 10, 2020
Guidance for the Recent Release of AMCP Format Version 4.1
On December 23, the Academy of Managed Care Pharmacy (AMCP) released an update to the Format for Formulary Submissions (AMCP Format Version 4.1). Major changes include new guidance addressing how manufacturers can provide evidence, and information exchange between manufacturers and healthcare decision makers (HCDMs), for unapproved products and unapproved uses of already approved products. Xcenda and the FormularyDecisions team closely tracked the development AMCP Format Version 4.1 and are available to address questions and provide additional guidance surrounding these updates.
AMCP Releases Format for Formulary Submissions, Version 4.1
The Academy of Managed Care Pharmacy (AMCP) released its new Format for Formulary Submissions (Version 4.1). The Format provides updated guidance on the evidence and information exchange between industry and payers for unapproved products and for new indications under US Food and Drug Administration (FDA) review for approved products. It is anticipated these changes will impact the content manufacturers can share and the method by which they will provide this kind of pre-approval information. Xcenda and the FormularyDecisions team closely tracked the development of the new Format and are available to address questions and provide additional guidance surrounding these updates.
Turn to us to help align your organization’s information dissemination process with payers according to the new Format.