Qalsody™ (tofersen intrathecal injection)

Approval is not recommended (effectively excluded) by Evicore due to lack of clinical efficacy data, despite FDA accelerated approval of Qalsody for ALS with a SOD1 mutation based on reduced plasma NfL. If requested, the patient must have the FDA‑approved SOD1‑mutation ALS diagnosis and meet Evicore’s specific coverage and safety criteria, though no explicit documentation requirements or effective date are provided.

"Qalsody is indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene."

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