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Cornering The Market On Innovation? The First CAR-T And The First Gene Therapy

Executive Summary

It isn’t just the cutting-edge science. Novartis’ landmark approval also highlights regulatory and reimbursement innovation and also may set the rules that the next wave of cell and gene therapies have to follow.

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A New Drug Price Milestone

Much like Genzyme’s Ceredase did two decades ago, Novartis’ Zolgensma is setting a new pricing benchmark. The first million-dollar product is launching in the US and it will actually cost more than $2 million.

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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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