77075 Insurance Policy Changes

Asfotase alfa (Strensiq) (CPB 0901, reviewed 2026-01-13)

Aetna updated its clinical policy for asfotase alfa (Strensiq) for treatment of perinatal/infantile-onset and juvenile-onset hypophosphatasia (HPP), effective immediately. The policy establishes strict precertification requirements, prescriber limitations (endocrinologist, geneticist, or metabolic bone disorder specialist only), diagnostic criteria including genetic testing or specific lab/imaging findings, and dosage caps (9 mg/kg weekly for perinatal/infantile-onset, 6 mg/kg weekly for juvenile-onset). Continuation of therapy requires documented clinical improvement measured by specific functional assessments and ongoing monitoring for ectopic calcifications.