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Spark's Gene Therapy Is On The Cusp Of Approval; Now It Gets Interesting

Executive Summary

Spark's Luxturna is all but guaranteed to reach the US market as the first gene therapy following a unanimous positive FDA advisory committee review. Discussions about cost and value are sure to intensify.

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Spark's Luxturna Approval Ushers In A New Gene Therapy Era

Spark's gene therapy for patients with an inherited form of blindness will be available in the US late in the first quarter, but on the big question – whether it will cost $1m for the one-time treatment – Spark would not say.

Capacity Shortages Unlikely To Hold Back Cell And Gene Therapies

The pharmaceutical industry's manufacturing capacity for cell and gene therapies is under pressure from an ever-increasing number of life sciences companies wanting to exploit rare expertise in the sector, but CMOs and government-backed facilities are rapidly coming on-stream, hoping to develop local clusters of companies to deliver the complete "living medicines" supply chain.

$1M For Luxturna? ICER Says Big Discount Needed To Be Cost Effective

Luxturna, a one-time treatment for a rare inherited form of blindness, would not be cost-effective at the $1m price level that has been suggested as a possibility, based on ICER's thresholds. But the small patient population would keep it from triggering ICER's US budget spending threshold.

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