Adakveo (crizanlizumab) — coverage criteria for sickle cell disease
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Clinical criteria for medical-benefit coverage and prior authorization of Adakveo (crizanlizumab) for members with sickle cell disease, including initial and continuation criteria, quantity limits, coding, and documentation expectations.
Added continuation criteria requiring documentation of reduction in acute complications since initiation.
Updated description for ICD-10 diagnosis codes D57.00-D57.819.
Coverage Criteria for Adakveo (crizanlizumab)
Initial Therapy
Covered when ALL of the following are met:
May be used with or without hydroxyurea.
Continuation Therapy
Covered when the following is met:
Not Medically Necessary / May Not Be Approved
Requests that do not meet the initial or continuation criteria may also be denied.
Concomitant use of crizanlizumab (Adakveo) with voxelotor (Oxbryta) is listed as an exclusion/contraindication for approval due to limited or no data supporting safety and efficacy of the combination. Clinical review should therefore consider combination therapy with voxelotor as a reason to withhold approval unless robust supporting evidence is provided.
Requests that do not include required documentation may be considered not medically necessary. Required information includes proof that the individual is 16 years of age or older, documentation of a diagnosis of sickle cell disease, and evidence of at least two sickle cell–related crises in the prior 12 months. Additionally, requests that propose concomitant use of voxelotor (Oxbryta) with crizanlizumab should be considered for denial or deemed not medically necessary because there is currently limited or no data to support the safety and efficacy of this combination.
Coding and Diagnosis Codes
| J0791 | Injection, crizanlizumab-tmca, 5 mg [Adakveo] |
| D57.00-D57.819 | Sickle-cell disorders |
Prior Authorization and Provider Requirements
Prior Authorization Required
Prior authorization is required for Adakveo (crizanlizumab-tmca). Initial approvals: member must be ≥16 years old, have a documented diagnosis of sickle cell disease, and documentation showing at least two sickle cell–related crises in the prior 12 months. Continuation approvals: documentation must show a reduction in acute complications of sickle cell disease (for example, fewer vaso-occlusive episodes or acute chest syndrome) since starting therapy. Requests that do not meet these criteria may be denied.
- HCPCS: J0791 (Injection, crizanlizumab-tmca, 5 mg [Adakveo])
- ICD-10: D57.00-D57.819 (Sickle-cell disorders)
Concomitant Therapy Caution
There is limited to no data supporting the safety and efficacy of concomitant use of voxelotor (Oxbryta) with crizanlizumab (Adakveo). Concomitant use with voxelotor may be a reason to deny approval; provide justification and supporting clinical documentation if treating concomitantly.
- If concomitant voxelotor use is reported, include rationale and supportive clinical records
Required Documentation
Required documentation must be submitted with the prior authorization request: diagnosis confirming sickle cell disease and clinical records demonstrating at least two sickle cell–related crises in the prior 12 months for initial authorization. For continuation, submit documentation showing clinical benefit (reduction in acute complications).
- Include relevant encounter notes, emergency visits, hospitalizations, or transfusion records supporting crisis counts
- Include dosing and administration records if available
Triggers for Denial
Requests may be denied if the member is under 16 years of age, lacks documentation of ≥2 sickle cell–related crises in the prior 12 months for initial therapy, or lacks evidence of benefit for continuation requests. Use with voxelotor (Oxbryta) may also be a basis for denial.
- Denial considerations apply regardless of submitted HCPCS/ICD codes (J0791; D57.xx)
Background on Crizanlizumab
Crizanlizumab (Adakveo) is a monoclonal antibody that targets and inhibits P‑selectin, reducing adhesion of sickled red blood cells to the endothelium and platelets and thereby decreasing vaso‑occlusive crises (VOCs). It is administered by infusion on a monthly schedule (with initiation dosing as specified in the dosing guidance) and may be used with or without hydroxyurea in appropriate patients.
Definitions
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