MedicaidPrior AuthMedium impact
Qalsody™ (tofersen) (Revised)
Humana·KY, SC · Neurology, Internal Medicine·Medicaid
Effective date
Mar 25, 2026
We identified it
Jun 25, 2026
Summary
Humana revised its Qalsody (tofersen) prior authorization policy effective March 25, 2026, for Medicaid members in Kentucky and South Carolina with SOD1-ALS. The policy establishes six initial approval criteria (including SOD1 mutation confirmation, elevated baseline neurofilament levels, functional ADL status, and riluzole co-therapy) and three renewal criteria focused on neurofilament reduction and maintained functional independence. Billing teams must implement prior authorization requirements before administering this intrathecal medication.
Action Required
By March 25, 2026: Billing and prior authorization teams must implement prior authorization workflow for Qalsody (tofersen) intrathecal administration in Medicaid-Kentucky and Medicaid-South Carolina plans. Update prior authorization system to flag all Qalsody requests requiring documentation of: (1) ALS diagnosis from neurologist/neuromuscular specialist, (2) confirmed SOD1 gene mutation with genetic testing documentation, (3) baseline plasma neurofilament light chain (NfL) lab results showing elevation above reference range, (4) member's ability to perform activities of daily living independently or partially, and (5) current riluzole therapy or documentation of prior riluzole trial failure. For renewal/continuation requests, require updated plasma NfL lab results showing decrease from or maintenance below baseline, and confirmation of continued ADL independence without tracheostomy or invasive ventilation. Train prior authorization staff on the specific clinical criteria. Update provider communication templates to include all required documentation elements. Route all Qalsody requests to medical director review due to clinical complexity. Failure to obtain prior authorization before administration will result in claim denials. Contact Humana PAL at www.humana.com/PAL for medically billed claim coding.