CommercialPrior AuthMedium impact
Asfotase alfa (Strensiq) (CPB 0901, reviewed 2026-01-13)
Aetna·Endocrinology, Genetics, Pediatrics +2 more·Medical Policy
Effective date
Jan 13, 2026
We identified it
Aug 12, 2026
Summary
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.
Action Required
By 2026-01-13: Billing and prior authorization team must implement the following: (1) Update prior authorization system to require mandatory precertification for all asfotase alfa (Strensiq) claims through Aetna; include contact numbers (866-752-7021 or fax 888-267-3277) in authorization workflow; (2) Configure billing system to flag claims if prescriber specialty is not endocrinology, genetics, or metabolic bone disorders - reject or route for manual review; (3) Update claim validation rules to verify dosage does not exceed 9 mg/kg weekly (perinatal/infantile-onset HPP) or 6 mg/kg weekly (juvenile-onset HPP); (4) Create precertification checklist requiring documentation of: ALPL gene pathogenic variant OR all of the following (radiographic skeletal abnormalities per Appendix B, serum ALP below age/gender reference range, elevated TNSALP substrate levels, baseline ophthalmology exam, baseline renal ultrasound); (5) For reauthorization claims, require documentation of clinical improvement per RGI-C scale, z-score changes in height/weight (if <18 years), MPOMA-G gait assessment, 6MWT, TUG, Chair Rise Test, or LEFS score improvement from baseline; (6) Ensure all supporting documentation requirements are communicated to providers. Claims submitted without proper precertification or missing required clinical documentation will be denied. Route all Strensiq claims through specialty pharmacy precertification process before adjudication.