Pharmacy Prior Authorization Criteria

Qalsody (tofersen)

Indications for Prior Authorization

Qalsody (tofersen)

• For diagnosis of Amyotrophic Lateral Sclerosis
  Indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene. This indication is approved under accelerated approval based on reduction in plasma neurofilament light chain (NfL) observed in patients treated with Qalsody. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

Criteria

Qalsody

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)

• Diagnosis amyotrophic lateral sclerosis (ALS)
AND
• Molecular genetic testing confirms mutation in the SOD1 gene
AND
• Patient’s baseline functional ability has been documented prior to initiating treatment (e.g., speech, walking, climbing stairs, etc.)
AND
• Patient has a percent (%) slow vital capacity (%SVC) greater than or equal to 50% at the start of treatment [A]
AND
• Patient does not require permanent noninvasive ventilation or invasive ventilation
AND
• Prescribed by or in consultation with a neurologist with expertise in the diagnosis of ALS

Qalsody

Prior Authorization (Reauthorization)

Length of Approval: 6 Month(s)

• Patient demonstrates slowed disease progression from baseline
AND
• Prescribed by or in consultation with a neurologist with expertise in the diagnosis of ALS

P & T Revisions

2024-07-02, 2023-07-19

References

1. Qalsody Prescribing Information. Biogen MA Inc. Cambridge, MA. April 2023.
2. Miller TM, Cudkowicz ME, Genge A, et al. Trial of Antisense Oligonucleotide Tofersen for SOD1 ALS. New England Journal of Medicine. 2022;387(12):1099-1110.

---

End Notes

1. Those in the faster-progressing subgroup, which the primary and key secondary endpoints were formally tested, were required to have a slow vital capacity (SVC) greater than or equal to 65% of predicted value for sex, age, and height (from the sitting position) at screening. [2]

---

Revision History

• 2024-07-02: 2024 Annual Review - update to reauth language
• 2023-07-19: New Program

---