Purpose
The purpose of this document is to communicate the Company's coverage position for tofersen (Qalsody®) for Independence Medicare Advantage members. Coverage for tofersen (Qalsody) for Medicare Advantage members is retroactively effective to April 25, 2023.
Background
On April 25, 2023, the US Food and Drug Administration (FDA) approved the use of tofersen (Qalsody) for the treatment of amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene.
Coverage Statement
Tofersen (Qalsody) is an antisense oligonucleotide covered for the treatment of amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene, in consideration of the individual’s medical history, and in accordance with the US Food and Drug Administration (FDA) approval. This indication is approved under accelerated approval by the FDA based on reduction in plasma neurofilament light chain observed in patients treated with tofersen (Qalsody). Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).
Coding
J1304
