Top Concerns as FDA Plans to Speed Up Gene Therapy Approvals


To bring gene therapies to market sooner the FDA plans to speed up approvals by evaluating these therapies’ impact on “surrogate end points.” With the rush to make these therapies available to patients, payers are becoming increasingly troubled by how this will impact their coverage strategies. Jeremy Schafer highlights payers’ top concerns with high upfront cost for treatments that have yet to produce concrete clinical benefit.

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