With the increasing number of cell and gene therapy products in clinical development, Cencora’s FormularyDecisions launched a new resource designed to provide healthcare payers with centralized access to information on approved therapies and products in the pipeline.
A secure online platform, FormularyDecisions provides healthcare decision-makers in the United States with access to evidence-based resources and facilitates information exchange between biopharma companies and payers. Through this CGT resource, registered healthcare payers – which collectively represent more than 269 million covered lives – will have access to a detailed overview of the CGT landscape and product-based information, such as clinical evidence and health economic information, launch status and designations awarded by the U.S. Food and Drug Administration (FDA).
“Cell and gene therapies offer tremendous promise but pose a unique challenge to payers due in part to their cost, one-time administration and limited durability data at the time of regulatory approval,” said Melissa McCart, Vice President of Commercialization Strategy & Access Solutions on Cencora’s Market Access and Healthcare Consulting team. “Through FormularyDecisions, payers can access product-based information and evidence, which will help them assess a product’s value and make coverage decisions.”
There are nearly 2,000 CGT clinical trials underway globally, according to the Alliance for Regenerative Medicine (ARM), which forecasts as many as 17 regulatory decisions on CGTs across the United States and Europe in 2024.
To date, most payers have developed individual product coverage policies or reviewed coverage on a case-by-case basis for each patient, according to a survey of Cencora’s Managed Care Network. When evaluating FDA-approved CGTs, the payers surveyed identified three types of evidence as the most important to inform their coverage decisions: safety and efficacy compared with approved therapies, guideline listings and real-world evidence.
“CGT developers should initiate discussions with payers early to foster open dialogue and better understand their expectations so they can develop an evidence package that not only showcases the therapy’s benefits and justifies its cost but also addresses payer concerns and priorities,” said Lung-I Cheng, Vice President and Head of Cell & Gene Therapy Service Line at Cencora.“Whether it is pre-approval or post-launch, FormularyDecisions can serve as an effective mechanism to engage payers and communicate product value information.
“This launch reflects the commitment across Cencora to introduce solutions that meet the needs of our biopharma partners, healthcare providers, payers and patients to advance innovation and access to these products.”
Cencora, which offers CGT developers support at every stage of the product lifecycle, also recently launched a CGT Integration Hub, which connects provider-facing platforms with patient services support programs to increase visibility across the therapy development and delivery process, streamlining the path-to-care.
SOURCE : BusinessWire