Contributor:
Jennifer Alkire, PharmD, Senior Associate, Value & Access, RTI Health Solutions
Jennifer attended the AMCP 2024 conference and brings back these insights.
The Academy of Managed Care Pharmacy (AMCP) dossier Format for Formulary Submissions (AMCP Format) was introduced in 2000 and has been updated several times since then. The AMCP Format provides evidence submission guidelines for manufacturers seeking reimbursement and/or formulary placement in the US healthcare system for new pharmaceuticals, biologics, and vaccines. Formulary submission dossiers in the AMCP Format provide information that healthcare decision-makers need to decide which products will be most beneficial to patients and cost-effective for health plans. The AMCP recently introduced version 5.0 of the AMCP Format; this newest version of the AMCP Format added guidance for digital therapeutics, health disparities, streamlining dossiers, preapproval information exchange (PIE), and real-world evidence (RWE).
What additional best practices are recommended in version 5.0 of the AMCP Format?
- Streamline the dossier and reduce page length of sections based on new AMCP format length recommendations (some of the suggested page limits have been shortened). The dossier should be comprehensive, yet concise.
- Highlight main points to enhance readability. Use tables and figures to convey data when possible.
- Update the dossier when there are significant changes, such as new treatment guidelines, new RWE, or new phase 3 clinical trial data.
- Include internal and external hyperlinking. This enhances brevity and avoids duplicating information.
How does version 5.0 of the AMCP Format address health disparities, PIE, RWE, and digital therapeutics?
The guidance now includes these recommendations:
- Include a description of health disparities related to social and demographic factors in the clinically studied population.
- Use subgroup analyses to help define unmet needs related to health disparities.
- Address the equity implications of an intervention, such as barriers to access.
- In general, include PIE information from ongoing and completed trials, as well as important timeline information and information relevant to patient access.
- Include RWE that contributes significantly to the knowledge base of the product as study summaries and evidence tables.
- Include specific types of information, such as unique evidentiary needs, recommended for digital therapeutics in the Product Information section.
It is important to note that the AMCP dossier format is guidance and not mandated. Manufacturers and their collaborating teams have the final consideration and approval for the content communicated within each dossier. Developers will need accurate, evidence-based, and scientifically focused materials to help communicate a product’s key clinical and economic evidence to healthcare decision-makers.
For more than 20 years, the Value & Access and Medical Communications experts at RTI Health Solutions have partnered with our pharmaceutical and biotech clients to develop rigorous AMCP dossiers that are scientifically focused, comprehensive, and concise and convey the overall value proposition of a product. We are particularly enthused to see the focus on streamlining AMCP dossiers, such as including hyperlinking as well as tables and figures, included in version 5.0. These streamlining methods have been part of our standard practices for many years.
We’ll be following up with more in-depth discussion about the implications of these changes. Meanwhile, please reach out to us if you have questions about AMCP dossiers and the new format guidance.