CommercialPrior AuthMedium impact
Crovalimab-akkz (PiaSky) (CPB 1064, reviewed 2026-03-27)
Aetna·Hematology, Internal Medicine, Critical Care +1 more·Medical Policy
Effective date
Mar 27, 2026
We identified it
Aug 12, 2026
Summary
Aetna has established a new medical policy (CPB 1064, effective 2026-03-27) for crovalimab-akkz (PiaSky), a complement C5 inhibitor for treating paroxysmal nocturnal hemoglobinuria (PNH) in patients 13+ years old weighing ≥40 kg. The policy requires precertification, strict diagnostic criteria including GPI-AP deficiency confirmation via flow cytometry, clinical disease manifestations, and prohibits concurrent use with other complement inhibitors. Continuation of therapy requires documentation of positive response and absence of unacceptable toxicity.
Action Required
By 2026-03-27: (1) Billing team must implement mandatory precertification requirement for all crovalimab-akkz (PiaSky) claims—contact Aetna at (866) 752-7021 or fax (888) 267-3277 before claim submission; (2) Update billing system to enforce precertification flag for HCPCS code J1307; (3) Create documentation checklist requiring providers to document: patient age ≥13 years, body weight ≥40 kg, confirmed PNH diagnosis with GPI-AP deficiency ≥5% via flow cytometry, clinical disease manifestations (LDH >1.5 ULN, thrombosis, renal dysfunction, pulmonary hypertension, or dysphagia), and confirmation of no concurrent complement inhibitor use (Empaveli, Fabhalta, Soliris, Ultomiris); (4) For reauthorization claims, require documentation of positive response (improved hemoglobin, normalized LDH) and no unacceptable toxicity; (5) Providers must complete Statement of Medical Necessity (SMN) precertification forms per Specialty Pharmacy Precertification process; (6) Review Site of Care Utilization Management Policy to ensure appropriate site selection for specialty drug infusions; (7) Update encounter forms and billing templates to reflect new diagnostic and clinical requirement documentation. Claims submitted without completed precertification or missing required medical necessity documentation will be denied.