Chronic Kidney Disease is when the kidneys gradually get damaged over time and the kidneys are unable to complete functions such as removing wastes from your body, maintain blood pressure, and keeping your bones healthy.
AMCP Format for Formulary Submissions
The AMCP Format for Formulary Submissions provides pharmaceutical companies with guidelines to effectively present clinical and economic evidence to health care decision-makers (HCDMs). These guidelines help influence formulary, coverage, policy, and reimbursement decisions. While the AMCP Format is advisory and not mandatory, it empowers manufacturers to strategically communicate essential information to HCDMs.
AMCP Format for Formulary Submissions — Guidance on Submission of Pre-Approval and Post-Approval Clinical and Economic Information and Evidence
The AMCP Dossier Format supports the informed review, assessment, selection, and payment of medical products by:
- Identifying the evidence needed for evaluating the clinical and economic value of medical products.
- Standardizing the synthesis and organization of the evidence and information in a concise living document, known as the “AMCP dossier” or “product dossier,” that evolves with the life cycle of the product, from the pre-approval phase through the post-approval period.
- Establishing a framework for the provision of objective, credible clinical and economic information needed by HCDMs.
- Recommending economic analyses and models to project the budgetary and cost impact on the HCDM’s organization and its patient or member population as well as to assess the cost-effectiveness and economic value of a product (assessments of economic value apply only to Approved Product Dossiers).
- Encouraging a clear and transparent, bidirectional communication and sharing process between manufacturers and HCDMs.
Format 5.0 was released in April 2024 after being revised to include guidance on digital therapeutics, health disparities, guidance on PIE decks, and the need to incorporate brevity to streamline dossiers.
Previous Versions to AMCP's Format for Formulary Submission
Since the first publication of AMCP's Format for Formulary Submissions in October 2000, the Academy and Foundation has published several versions from the many comments received from AMCP members.
Additional Resources
FormularyDecisions.com
Access this platform for current product information, e-dossiers, and other resources to help you in formulary development.
AMCP eModel is the ultimate tool for communication of health economic models and value evidence. Find out more about this tech partnership and this health economic modeling platform to support the exchange of clinical and economic information between manufacturers and payers.
Related
Prescription Digital Therapeutics (PDTs) offer vast opportunities but require careful consideration for coverage and reimbursement. At the direction of the AMCP Board of Directors we have developed definitions and principles to simplify your decision-making and provide digital health innovators with essential insights for evaluating safety and efficacy.
The United States Pharmacopeia Convention (USP) and the United States Food and Drug Administration (FDA) have updated an educational resource on biosimilars to help healthcare practitioners improve patient confidence in the quality and effectiveness of these treatment options. The following are recommended social media, website, and email content you can use to share this resource with your network.
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