The Academy of Managed Care Pharmacy (AMCP) Format for Formulary Submissions (AMCP Format) is designed to simplify communication between US healthcare decision-makers (HCDMs) and pharmaceutical manufacturers. The AMCP dossier is widely accepted as the best practice format for presenting clinical and economic evidence and information to HCDMs who make or influence formulary, coverage, policy, and reimbursement decisions for new and existing medical products.
With the publication of Version 5.0 on March 31, 2024,1 the AMCP dossier framework has evolved to reflect the rapidly changing healthcare landscape and the increasing emphasis on value-based care. While this update creates opportunities for enhanced collaboration between manufacturers and HCDMs through evidence-based decision-making, it also presents new challenges that manufacturers must overcome to ensure successful product launches and optimal patient access.
In this article, Suki Kandola, Global Head of Value & Access at Envision Pharma Group, outlines the key changes introduced with the AMCP Format 5.0 and the challenges they may create for organizations. She also discusses strategies for crafting AMCP dossiers designed to help with efficient product launches and improved patient access.
Understanding the key updates in the AMCP Format 5.0
The AMCP Format 5.0 builds on the foundation of previous versions, incorporating valuable feedback from stakeholders and adapting to emerging trends in the pharmaceutical industry. The most notable changes in the updated guidance include further guidance on early engagement and pre-approval information exchange (PIE).
Previous versions of the AMCP Format emphasized the importance of early engagement and the sharing of information about investigational drugs or new indications for existing drugs with HCDMs before they receive regulatory approval in the form of PIE.
The updated format further encourages proactive communication between manufacturers and payers while aligning guidance with recent legislation and formalizing recommendations for PIE communication tools. These changes include:
- A dedicated appendix providing formal recommendations and guidance for PIE communication tools that can serve as a checklist for medical and value communications professionals when developing PIE materials
- Updates to align AMCP guidance on PIE with relevant legislation, specifically the Pre-approval Information Exchange Act passed in 2022
- Guidance on timelines for PIE, suggesting that pre-approval dossiers should be provided 6–12 months ahead of anticipated product approval
By embracing these PIE updates, manufacturers can demonstrate their commitment to value-based care, accelerating formulary decisions, and improving patient access.
In the pre-approval phase, Envision has developed compelling PIE materials and payer value stories to enable manufacturers to proactively engage with HCDMs in a timely and appropriate manner.
Integration of real-world evidence (RWE)
The AMCP Format 5.0 acknowledges the growing importance of RWE in demonstrating the effectiveness and value of new therapies, particularly for underrepresented populations. The updated format encourages manufacturers to include RWE alongside traditional clinical trial data to provide a more comprehensive picture of a product's impact on patient outcomes and healthcare utilization. High-quality, relevant RWE focusing on clinical utility and economic value can complement and strengthen the overall value proposition of a product.
Guidance on digital therapeutics (DTx)
In recognition of the growing role of DTx in healthcare, the AMCP Format 5.0 provides guidance for incorporating evidence related to these innovative solutions. The AMCP defines DTx as products (software, apps, or programs) designed to stand alone or work in combination with existing medications or treatments to help patients prevent, treat, and/or manage their diseases while ensuring optimal health outcomes from therapy. By standardizing DTx communication, the AMCP Format 5.0 offers a systematic approach to evaluating and incorporating DTx.
Focus on health disparities
The updated format emphasizes addressing health disparities and considering the diverse needs of various patient populations. Manufacturers are encouraged to present data on how their product may impact diverse populations, reduce these inequalities, and address access barriers for underserved populations. The focus on health equity aligns with broader industry trends recognizing and addressing disparities in healthcare access and outcomes.
Brevity and streamlining
As well as these specific inclusions, the AMCP Format 5.0 also focuses on streamlining the dossier structure, including a reduction in the suggested page limits in the Disease Description section and practical recommendations to enhance readability, such as hyperlinks to avoid repetition and duplication of information. With a more concise and user-friendly structure, the AMCP Format 5.0 dossiers facilitate easier navigation and quicker review. This enables manufacturers to communicate their value proposition to HCDMs simply and clearly, accelerating the evaluation process.
Updated guidance creates new considerations
The updates to the AMCP Format are designed to improve communication and decision-making processes, leading to optimal patient access and enhanced outcomes. However, the updated guidance also presents a set of new considerations for manufacturers developing dossiers to effectively communicate the clinical and economic benefits of their products.
The emphasis on early engagement, combined with an increased focus on RWE, DTx, and health disparities necessitates a sophisticated and comprehensive approach to evidence generation. Pharmaceutical manufacturers are tasked with implementing robust data collection and analysis strategies. Without high-quality, comprehensive evidence, manufacturers may struggle to produce dossiers that meet the requirements of the updated format and support their value propositions effectively.
Developing a comprehensive AMCP dossier is a resource-intensive endeavor, made more intensive by the additional considerations in Version 5.0. Significant time, expertise, and financial resources are required to ensure accurate and complete dossier development. Crafting a compelling narrative to payers and HCDMs with data requires a well-coordinated effort across multiple departments and functions within an organization.
The AMCP Format 5.0 also reflects the evolving expectations of HCDMs, who are increasingly prioritizing value-based care and the real-world impact of new therapies. Although this can be of great benefit to manufacturers, the changing communication landscape comes with its challenges. To succeed in this environment, manufacturers must be prepared to engage in meaningful dialogues with HCDMs, demonstrating a deep understanding of their needs and priorities. Manufacturers must shift their mindsets from a transactional approach to a collaborative and consultative engagement model.
Adopting a strategic approach to AMCP Format 5.0
Organizations can overcome the challenges introduced with the AMCP Format 5.0 by adopting a seamless, cross-functional strategic approach to evidence generation and dossier development. At Envision, we prioritize creating a differentiated and integrated product value narrative early in the dossier development process, ensuring that it resonates with (and is validated by) our exclusive network of HCDMs. This approach effectively demonstrates the clinical and economic value of the product from the outset – consistently and coherently – ensuring that the dossier and other value communications succeed in securing optimal reimbursement and, consequently, patient access.
A strategic approach to developing clear and compelling AMCP dossiers includes:
- Payer strategy development: Develop payer and HCDM engagement strategies that align with overall business objectives and address the unique needs of each target audience
- Value narrative development and communication: Articulate the product's value proposition using evidence-based messaging in a clear, concise, and compelling way that resonates with HCDMs
- Budget impact modeling (BIM): Use robust budget impact data to quantify the potential economic impact of new therapies, providing valuable insights for formulary decision-making
- PIE decks: Create engaging and informative PIE decks that facilitate early dialogue with HCDMs, ensuring a smooth and efficient review process
- Dossier development, leveraging literature review and writing expertise: Use data and evidence collected to develop concise, comprehensive AMCP dossiers that adhere to 5.0 guidelines and effectively communicate the value proposition of new therapies
To streamline value proposition development, pharmaceutical manufacturers should align dossier development with key stages of their drug development programs. Engaging with HCDMs in pre-clinical and phase 1 can help to gather insights from the outset and inform evidence-generation strategies. Incorporating RWE and seeking early input into its study design sooner, ensures the RWE will be of sufficient quality to meet HCDM and payer needs. Additionally, with early input into RWE study design, organizations can ensure this evidence is of sufficient quality to meet HCDM and payer needs.
Implementing these strategies during phase 2 and phase 3 can generate the clinical and economic evidence required to produce an unapproved product dossier 6–12 months before approval. In anticipation of regulatory approval, manufacturers can then develop a comprehensive approved product AMCP dossier to submit following product clearance.
Following formulary submission and review, manufacturers should be prepared to address any questions or concerns that arise during the review process. Post-product launch, the AMCP dossier is used as a living document that should be updated in response to new evidence and regulatory changes.
Turning challenges into opportunities and demonstrating value
The release of the AMCP Format 5.0 marks a new era in communication between pharmaceutical manufacturers and HCDMs. While the updated format presents new challenges, it also offers significant opportunities for manufacturers that are prepared to adapt and embrace the changing landscape. A strategic partnership with Envision’s value and access experts offers a comprehensive suite of services and support throughout the entire product life cycle. Having one partner to support all the required projects and functions associated with dossier development can also provide seamless continuity and a complete solution to the AMCP Format 5.0 changes.
Envision’s value and access experts can assist manufacturers in navigating the changes introduced, ensuring that products achieve optimal market access with the aim of improving patient outcomes. By developing a deep understanding of the payer landscape, clearly articulating a value narrative, and supporting dossier development with BIM and PIE decks, manufacturers can overcome the AMCP Format 5.0 challenges.
Ultimately, this strategic approach enables manufacturers to craft compelling AMCP dossiers that effectively communicate the value proposition of their products and help accelerate decision-making, improve patient access, and enhance healthcare outcomes.
Reference
1. Academy of Managed Care Pharmacy. AMCP Format for Formulary Submissions Version 5.0. J Manag Care Spec Pharm. 2024;30(4-b Suppl):1-64. doi:10.18553/jmcp.2024.30.4-b.s1.