Evolution of the AMCP Format for Formulary Submissions: Yesterday, Today and Tomorrow

The ongoing development of vaccines and treatments for COVID-19 is raising hopes as the world awaits the return to a normal way of life. But as seen in the past decades in the fight against cancer, HIV/AIDS and heart disease, developing a new treatment is only the first step on the journey to ensuring patient access. The next step – determining which treatments to cover and for whom– can be complicated. This process requires the exchange of clinical and economic information to meet the current public health needs such as COVID-19 and the health concerns of the future. 

Insurance providers and other population decision-makers need timely and high-quality clinical and economic information to determine formulary coverage and to budget for new treatments. Biopharmaceutical manufacturers sharing information to inform these decisions must also meet the Food and Drug Administration’s (FDA) strict regulations about the kinds of information that can be shared with health insurance companies. 

This year marks the 20th anniversary of the Academy of Managed Care Pharmacy’s (AMCP) Format for Formulary Submissions, a practical guide for biopharmaceutical manufacturers to exchange the information to inform those health coverage decisions.  As outlined in the recent Reflection in the June issue of the Journal of Managed Care & Specialty Pharmacy (JMCP), and co-authored by Jennifer Graff, PharmD, NPC Vice President of Comparative Effectiveness Research, the Format was developed to share safety, efficacy and value data with health care decision-makers as they consider products for coverage and formulary placement.

Over the past two decades, treatments have become more targeted and personalized. Health care has evolved how it is delivered and paid for, so too has the exchange of information. Alongside this evolution, the AMCP Format has been through four major and several minor revisions, including the most recent Version 4.1, released earlier this year, which focuses on the exchange of information with population decision-makers about products before FDA approval. Despite these changes, the Format maintains the original vision to create a platform for the efficient exchange of scientific and economic information about a pharmaceutical product.

Although the evolution in the Format and the exchange of information has come very far in the last 20 years, many new challenges lie ahead. This is a crucial point in time for our health care system. Everyone is watching how manufacturers, scientists and health experts are working together on developing vaccines and treatments for COVID-19. But at the same time, people are asking themselves an all-too-familiar question: will my insurance plan cover the new treatment? 

We are seeing in real-time amidst the COVID-19 pandemic the need to remove barriers and ensure more efficient decision-making and coverage for patients. This efficiency is just as crucial for patients awaiting new personalized therapies for cystic fibrosis, better-targeted cancer treatments or a cure for sickle-cell disease. Over the next two decades, biopharmaceutical manufacturers, health plans and policymakers will need to: 

1. Ensure the communication of information keeps pace with the innovative cell and gene therapies and corresponding novel payment mechanisms. Until recently, the exchange of information had not kept pace with the growing sophistication of the products available to treat conditions and the ways health care is organized, delivered and reimbursed.  
    
2. Develop bi-directional pathways — rather than uni-directional — for the exchange of information between population health decision makers and biopharmaceutical companies. As reimbursement continues to trend toward a basis on quality and value, rather than volume, clear bi-directional communication channels between biopharmaceutical manufacturers and decision-makers are more important than ever.
    
3. Foster a dialogue across the health care community to discuss the appropriate use of medications in the rapidly changing health care environment. Appropriate patient access is critical not only amidst a pandemic, but for everyday care concerns for patients and their families as well. 

By following these three guideposts, the Format will have the ability to evolve in its role as a living guide for evidence-based information exchange to guide coverage for new vaccines and treatments and the public health concerns of the time. Read the full article in the June issue of JMCP.
 
NPC recognizes that payers desire more, and better, information to inform coverage decisions, but they are often limited by the type and quality of the available information. Our research seeks to improve the generation, adoption, and communication of high-quality evidence to inform decision-making. NPC is proud to have contributed to the updates as the Format has evolved. NPC research has informed the Format’s recommendations on how to use comparative effectiveness research, assess the value of companion diagnostic tests and evaluate real-world evidence using tools developed for payers.