AMCP dossiers in the US

Pricing & Reimbursement
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1

Hello,

Are AMCP dossiers mandatory to obtain reimbursement in the US?

I couldn’t find the exact information. Thank you

2

Hi! Based on the information provided in the AMCP guidance (AMCP Format 4.1 Report 1219), the development of the AMCP dossier is at the manufacturer’s discretion. However these dossiers are widely accepted and can enhance the decision-making process.