Real-world evidence (RWE) has always been important, but as the cost of therapies continues to increase, insurance companies and the physicians prescribing the therapies are clamoring for more evidence. Furthermore, once a product is approved by the FDA and active marketing ensues, only claims that align with the product label are allowed. However, the FDA recently suggested it will evaluate RWE outcomes as part of the FDA approval submission opening the door to gathering RWE data along with the clinical trial. With this guidance, life sciences should continue to utilize RWE to help articulate the real-world use experience payers and provider organizations are seeking in their clinical and, more importantly, economic evaluation of a product for their investment.
Listen to Baker Tilly’s informative, on-demand webinar where our presenters discussed how life sciences companies can utilize RWE in their market access strategies to drive commercial success. Our presenters will also discuss how organizations can save time and drive profitability by finding other applications for RWE beyond its original intent, through the lens of a payer and provider executive