Tofersen (Qalsody) (CPB 1031, reviewed 2026-08-10)

Effective immediately (policy reviewed 2026-08-10): (1) Billing and Prior Auth teams: Implement mandatory precertification requirement for tofersen (J1304) by calling Aetna at (866) 752-7021 or faxing (888) 267-3277 before dispensing or administration. Obtain Statement of Medical Necessity (SMN) forms from Specialty Pharmacy Precertification portal. (2) Update billing system edits to block J1304 claims without prior authorization documentation. (3) Providers: Ensure tofersen is prescribed only by neurologists, neuromuscular specialists, or ALS specialists; verify patient meets ALL initial approval criteria before submission (age ≥18, SOD1 mutation confirmed via CPT 81404, FVC/SVC >45% predicted, no tracheostomy). (4) Front desk/Schedulers: Verify patient meets criteria and obtain genetic testing results (CPT 81404) and pulmonary function testing (CPT 94010, 94060, or 94200) BEFORE scheduling procedures. (5) Confirm administration occurs only at Aetna Institutes GCIT Designated Network facilities (unless member's plan waives this requirement). (6) For continuation of therapy claims, document clinical benefit from prior tofersen doses and verify invasive ventilation/tracheostomy not required. Failure to obtain precertification will result in claim denials; failure to verify SOD1 mutation and pulmonary function criteria will result in medical necessity denials.