The Academy of Managed Care Pharmacy (AMCP) Format for Formulary Submissions is the industry standard for communicating clinical and economic information to meet the evidentiary requirements/needs of healthcare decision-makers (HCDMs) in the United States. The latest updates to the AMCP Format (version 5.0, published March 31, 2024) have added guidance on health disparities, real-world evidence (RWE), digital therapeutics, preapproval information exchange (PIE) and the need for brevity in medical communications.
Health Disparities
AMCP Format 5.0 provides guidance on incorporating information on health disparities related to social and demographic factors, as well as recommendations related to evaluations of pharmacoequity. Unique search strategies may now be needed to capture relevant information on health disparities in the disease space, as well as an evidence-generation plan if data is limited for the product or the disease area.
The EVERSANA team has long recognized the importance of health disparities research, having pioneered studies across multiple disease areas. Most recently, we empirically investigated the impact of race and other social determinants of health on survival in metastatic prostate cancer, as well as the unique challenges and unmet needs associated with access to care, diagnosis and treatment of psoriasis among patients with skin of color in Canada and the U.S. For a deeper understanding, access the articles below:
- Freedland, S.J., Samjoo, I.A., Rosta, E. et al. The impact of race on survival in metastatic prostate cancer: a systematic literature review. Prostate Cancer Prostatic Dis 26, 461–474 (2023). https://doi.org/10.1038/s41391-023-00710-1
- Freedland, S.J., Samjoo, I.A, Rosta, E. et al. The Impact of Social Determinants of Health Beyond Race on Survival in Metastatic Prostate Cancer: A Systematic Literature Review. Clin Pathways. 2023;9(6):51-59. doi:10.25270/jcp.2023.11.01
- Yadav G, Yeung J, Miller-Monthrope Y, et al. Unmet Need in People with Psoriasis and Skin of Color in Canada and the United States. Dermatol Ther (Heidelb). 2022;12(11):2401-2413. doi:10.1007/s13555-022-00811-0
Real-World Evidence
AMCP Format 5.0 provides additional guidance on where and what types of RWE should be included to support key sections, which is of particular importance for underrepresented populations. This highlights the increased recognition of the benefits that RWE can provide in supporting product value, thereby substantiating the need to capture or conduct such studies.
At EVERSANA, we recognize the pivotal role that RWE plays within the healthcare sector and in health technology assessments. Payers are not only accepting but increasingly requesting RWE to support clinical and economic decision-making. Developing an evidence plan that strategically integrates RWE, whether through complex observational safety studies or simple payer database claims analyses, provides the best avenue for broadly supporting health economic value from multiple stakeholder perspectives. For a contemporary view of RWE within the sector, access the article that EVERSANA colleagues contributed to in Pharmaceutical Commerce:
Digital Therapeutics
The rapidly growing and evolving class of digital therapeutics includes software, applications and programs intended to help prevent, treat and/or manage diseases. AMCP Format 5.0 provides specific guidance to manufacturers, outlining approaches to developing dossiers for these products. Specifically, a Digital Therapeutics section has been added under Special Content Considerations to outline how and what information should be conveyed.
EVERSANA appreciates the unique considerations and market access challenges applicable to digital therapeutics. Our growing experience in this field includes successful partnerships with over 50 medical device or diagnostic companies, including Cognoa and MedRhythms. EVERSANA is also a member company of the Digital Therapeutics Alliance (https://dtxalliance.org/), the leading international organization on digital therapeutic thought leadership and education.
Preapproval Information Exchange
AMCP Format 5.0 formalizes the recommendations and guidance for PIE communication tools, which may accompany an Unapproved Product or Unapproved Use AMCP dossier. In the preapproval phase, EVERSANA has supported manufacturers in developing compelling PIE materials and payer value stories. These materials allow our clients to proactively engage with HCDMs in a timely and appropriate manner.
Brevity and Streamlining
One of the most common complaints received from HCDMs is the excess length of dossiers. The updated AMCP Format further encourages brevity and streamlining of information throughout dossier. This includes a reduction in the suggested page limits in the Disease Description section, as well as recommendations to enhance readability, such as highlighting main points, using tables and figures to convey data and including internal and external hyperlinks to avoid repetition and duplication of information. At EVERSANA, our seasoned medical writers have partnered with many pharmaceutical and biotech companies to develop compelling dossiers and value tools to effectively communicate key clinical and economic evidence for hundreds of products.
Overall, generating supporting evidence and communicating it appropriately and effectively are crucial across the entire lifecycle of a product. The Value and Evidence team at EVERSANA is primed to work with our clients to help establish the clinical and economic value of products with a scientific approach. For further details on how EVERSANA can support you during the process, we invite you to contact us and learn about our array of services.
Author
Josh has medical writing experience in chronic myeloid leukemia, psoriatic arthritis, B-cell lymphomas, systemic light chain (AL) amyloidosis, and chronic kidney disease. He specializes in developing global value dossiers, clinical summaries, and other value…
Irene has extensive experience in clinical research, medical writing, and development of promotional and educational medical content for various audiences, including healthcare providers, patients, regulatory authorities, and payers. Areas of specialization at EVERSANA include…
As an accomplished professional in the healthcare industry, Deepika Thakur brings a wealth of experience and expertise to the table. With over a decade of involvement, spanning roles in both industry and healthcare economic…