CommercialPrior AuthMedium impact
Crizanlizumab-tmca (Adakveo) (CPB 0964, reviewed 2025-12-09)
Aetna·Hematology, Internal Medicine, Pediatrics·Medical Policy
Effective date
Dec 9, 2025
We identified it
Aug 12, 2026
Summary
Aetna has issued a fresh medical policy (CPB 0964, effective 2025-12-09) establishing coverage criteria for crizanlizumab-tmca (Adakveo), a P-selectin monoclonal antibody for reducing vaso-occlusive crises in sickle cell disease patients aged 16+. The policy mandates precertification for all commercial plans, requires hematologist/sickle cell specialist prescription, and establishes specific clinical criteria including prior VOC history and either alternative genotypes or hydroxyurea failure/contraindication/concurrent use.
Action Required
By December 9, 2025: Billing team must implement the following: (1) Update billing system to require MANDATORY precertification for all Adakveo (J0791) claims before submission—route precertification requests to Aetna at (866) 752-7021 or fax (888) 267-3277; (2) Configure system to validate that prescriber is a hematologist or sickle cell disease specialist before processing claims; (3) Build clinical validation rules requiring documentation of: member age ≥16 years, at least one VOC in prior 12 months, AND either (a) non-HbSS/HbSβ0 genotype OR (b) HbSS/HbSβ0 genotype with prior hydroxyurea inadequacy/intolerance/contraindication or concurrent hydroxyurea use; (4) Link CPT 96365 (infusion administration) to J0791 to prevent billing infusion code without drug code; (5) Add continuation of therapy validation requiring documented VOC reduction since initiation to support renewal authorizations; (6) Update provider communications to clarify that Site of Care utilization management policy applies and specify infusion site requirements per separate UM policy. Claims lacking precertification or failing to meet clinical criteria will be denied. Providers must complete Statement of Medical Necessity (SMN) forms available through Specialty Pharmacy Precertification portal.