A panel of independent FDA advisers is meeting today to consider the merits of Spark Therapeutics’ (ONCE) Luxturna, a one-time gene therapy meant to treat a rare, inherited form of childhood blindness.

If the panel votes yes and the FDA follows its recommendation, Luxturna would become the first therapy meant to replace or repair a defective gene approved in the U.S. Spark hasn’t disclosed pricing, but analysts estimate Luxturna could cost $1 million or more per patient, a price that might force payers and insurers to rethink their coverage and reimbursement models.

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