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IQWiG: Added Benefit Not Proven For Elocta, But Entresto Sails Through

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Executive Summary

Swedish Orphan Biovitrum AB (Sobi) is preparing to respond to an "added benefit not proven" decision on its long-acting recombinant Factor VIII product Elocta (efmoroctocog) from Germany's HTA body, IQWiG, a negative ruling that the company was expecting. The response will be submitted by April 22, just before a scheduled oral meeting with IQWiG in May, with a final decision by the top HTA body, the Federal Joint Committee (G-BA), expected later this year.

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