Forbes February 3, 2025
An insurer’s decision to delay reimbursement of drugs licensed under the Food and Drug Administration’s accelerated approval program has sparked controversy. Independence Blue Cross’s recently announced policy bars coverage of FDA approved treatments until 18 months after accelerated approval.
The accelerated approval program was created in 1992, at the height of the HIV/AIDS epidemic. Its aim is to expedite the licensing of certain drugs indicated for serious or life-threatening conditions. Rather than wait to evaluate clinical trial evidence that shows benefits on clinical end points, the program allows the FDA to approve products that demonstrate improvements in surrogate end points that are “reasonably likely to be associated with clinical benefits.” Manufacturers are typically obligated to conduct confirmatory post-approval clinical trials...
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