Qalsody™ (tofersen intrathecal injection)

EviCore does not recommend approval of Qalsody (tofersen); although the FDA granted accelerated approval for adults with SOD1‑mutation ALS based on reduced plasma NfL, clinical efficacy has not been established. Continued FDA approval may require confirmatory trials verifying clinical benefit, and this policy specifies no additional documentation or test requirements.

"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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