Tofersen

This policy addresses use of Tofersen (Qalsody) for treatment of amyotrophic lateral sclerosis (ALS) in adults with a confirmed pathogenic SOD1 gene mutation. Coverage is limited: clinical trial evidence and the primary analysis apply to adults (trial ages 23–78) with baseline SVC ≥65% and rapid‑progression enrichment criteria with SOD1 confirmation as in the study, the drug has FDA accelerated approval but is considered not medically necessary because clinical benefit has not been established, and applicability is subject to HCSC Ohio membership and the member’s prescription drug benefit.

"For HCSC members residing in Ohio, coverage is provided for any FDA‑approved drug when prescribed for a use recognized as safe and effective in one or more standard medical reference compendia adop..."

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