ICER Eyes Gene Therapy: Category-wide Policy In Works As Spark Moves To Approval
Institute for Clinical and Economic Review launches value assessment of Spark's blindness treatment vortigene neparvovec, the first gene therapy likely to reach the US market, in an effort to facilitate development of coverage policies.
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Valuing Drugs In The US: How We're Doing And What's Ahead
Numerous value frameworks launched over the past few years have encouraged acceptance of cost effectiveness assessments in the US and ICER's influence in the field is growing. Employers may be the next group to promote the concept.
Spark's Gene Therapy Is On The Cusp Of Approval; Now It Gets Interesting
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.
Spark Therapeutics' Vision Loss Gene Therapy Gets FDA Panel Review
Voretigene neparvovec moves closer to being the first to market a gene therapy in the US with FDA advisory committee review on Oct. 12.