CONSHOHOCKEN, PA — As the cell and gene therapy (CGT) sector continues to flourish, healthcare payers are faced with the complex task of understanding and evaluating an ever-growing list of new treatments. To aid in this process, Cencora, Inc., a leader in the pharmaceutical industry, has launched a unique resource: FormularyDecisions.
FormularyDecisions is a secure online platform designed to provide U.S. healthcare decision-makers with centralized access to evidence-based resources and information on both approved therapies and products still in development. The platform facilitates information exchange between biopharma companies and payers, granting registered users – representing over 269 million covered lives – a detailed overview of the CGT landscape.
The platform delivers product-based information including clinical evidence, health economic data, launch statuses, and designations awarded by the U.S. Food and Drug Administration (FDA).
“Cell and gene therapies hold great promise but present unique challenges to payers due to their cost, one-time administration, and limited durability data at the time of regulatory approval,” explained Melissa McCart, Vice President of Commercialization Strategy & Access Solutions on Cencora’s Market Access and Healthcare Consulting team. “FormularyDecisions provides payers with the information they need to assess a product’s value and make coverage decisions.”
The importance of such a resource is underscored by the sheer volume of CGT clinical trials currently underway. According to the Alliance for Regenerative Medicine (ARM), there are nearly 2,000 CGT clinical trials globally, with as many as 17 regulatory decisions on CGTs expected across the United States and Europe in 2024 alone.
Historically, most payers have developed individual product coverage policies or reviewed coverage on a case-by-case basis for each patient. When evaluating FDA-approved CGTs, payers have identified three types of evidence as the most crucial to inform their coverage decisions: safety and efficacy compared with approved therapies, guideline listings, and real-world evidence.
Lung-I Cheng, Vice President and Head of Cell & Gene Therapy Service Line at Cencora, stressed the importance of early and open dialogue between CGT developers and payers. “Developing an evidence package that not only showcases a therapy’s benefits and justifies its cost but also addresses payer concerns and priorities is key,” he said. “FormularyDecisions can act as an effective mechanism to engage payers and communicate product value information.”
Cencora’s commitment to advancing innovation and access to CGT products extends beyond FormularyDecisions. The company recently launched a CGT Integration Hub, which connects provider-facing platforms with patient services support programs. By increasing visibility across the therapy development and delivery process, this hub streamlines the path-to-care, demonstrating Cencora’s ongoing dedication to supporting CGT developers throughout the product lifecycle.
With the launch of FormularyDecisions, Cencora is offering a valuable resource to healthcare payers navigating the complex world of cell and gene therapies. As more CGT products advance toward regulatory approval, such resources will be vital in ensuring these innovative treatments are evaluated accurately and efficiently, ultimately benefiting both healthcare providers and patients.
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