CurrentBlue Cross Blue Shield - WisconsinPolicy CC-0153

Adakveo (crizanlizumab) — Coverage Criteria

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Clinical criteria governing medical-benefit coverage and prior authorization for Adakveo (crizanlizumab) in individuals with sickle cell disease; applies to providers requesting therapy under the payer's medical benefit.

Policy Summary

PayerBlue Cross Blue Shield - Wisconsin

PolicyAdakveo (crizanlizumab) — Coverage Criteria

Policy CodePolicy CC-0153

Change TypeMinor review — no material changes

Effective DateJul 1, 2025

Last ReviewMay 16, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document age ≥16, diagnosis of sickle cell disease, and ≥2 sickle cell–related pain crises in the prior 12 months for initial approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥2sickle cell pain crises required in prior 12 months for initial approval

16+minimum age for initiation

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CurrentBlue Cross Blue Shield - WisconsinPolicy CC-0153

Adakveo (crizanlizumab) — Coverage Criteria

Customize your policy alerts

Sign up for Blue Cross Blue Shield - Wisconsin Policy CC-0153 alerts

Get alerted when Policy CC-0153 changes without checking for updates manually.

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Policy Summary

PayerBlue Cross Blue Shield - Wisconsin

PolicyAdakveo (crizanlizumab) — Coverage Criteria

Policy CodePolicy CC-0153

Change TypeMinor review — no material changes

Effective DateJul 1, 2025

Last ReviewMay 16, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document age ≥16, diagnosis of sickle cell disease, and ≥2 sickle cell–related pain crises in the prior 12 months for initial approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥2sickle cell pain crises required in prior 12 months for initial approval

16+minimum age for initiation

Coverage Criteria for Adakveo (crizanlizumab)

Initial Therapy

Initial requests for Adakveo (crizanlizumab-tmca) may be approved if ALL of the following are met:

Initial Approval Criteria: I. Individual is 16 years of age or older; AND II. Individual has a diagnosis of sickle cell disease; AND III. Documentation is provided that individual had at least two episodes of sickle cell–related pain crises in the past 12 months.

Provide documentation of age, diagnosis, and crisis history (see provider documentation requirements).

Continuation Therapy

Continuation requests may be approved when the following is met:

Continuation Criteria: Documentation is provided that the individual experienced a reduction in acute complications of sickle cell disease (e.g., reduction in number of vaso-occlusive episodes or acute chest syndrome episodes) since initiation of Adakveo.

Include clinical evidence of benefit (reduction in VOCs or other acute SCD complications) and dosing consistent with 5 mg/kg every 4 weeks.

Not Medically Necessary / Not Approved

May not be approved:

Not Approved Conditions: Use of crizanlizumab in combination with Oxbryta (voxelotor); AND any request that does not meet the stated initial or continuation criteria (age, diagnosis, required crisis frequency, or documented clinical benefit).

Limited to no data supporting safety and efficacy of concomitant use with voxelotor (Absiola 2022).

Use of crizanlizumab (Adakveo) in combination with voxelotor (Oxbryta) is not supported by the available evidence. The policy notes there is limited to no data on the safety and efficacy of concomitant use, and combination therapy may not be approved pending robust supporting data.

Requests that do not meet the stated initial or continuation criteria — including age 16 years, a documented diagnosis of sickle cell disease, at least ≥2 sickle cell–related pain crises in the prior 12 months for initial approval, or documentation of clinical benefit for continuation — are not approved.

Coding

HCPCSHCPCSCovered

J0791

Injection, crizanlizumab-tmca, 5 mg [Adakveo]

ICD-10 DiagnosisICD-10

D57.00-D57.819

Sickle-cell disorders

Dosing limit

Maintenance dosing limit5 mg/kg every 4 weeks

Initiation dosing scheduleMay approve 5 mg/kg at Week 0 and Week 2

Vial concentration referencedAdakveo (crizanlizumab-tmca) 10 mg/mL vial

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Adakveo (crizanlizumab-tmca). Initial requests will be approved only when age, diagnosis, and crisis-history criteria are met; continuation requests require documentation of clinical benefit.

Age ≥ 16 years required
Diagnosis: Sickle cell disease (ICD-10: D57.00–D57.819)
History: ≥ 2 sickle cell–related pain crises (vaso-occlusive crises) in the prior 12 months
HCPCS: J0791 (crizanlizumab-tmca, 5 mg)

Step Therapy

Step Therapy / Concomitant Therapy

No explicit step-therapy requirement is stated in the policy. Adakveo may be used with or without hydroxyurea; the policy notes a disallowed combination with Oxbryta (voxelotor).

No step-therapy required vs hydroxyurea documented

Definitions

Sickle Cell Crises — definition and operational details

Operational definitionAdmission to an emergency room (ER) or medical facility for Sickle Cell Crises–related pain treated with a parenterally-administered narcotic or parenterally-administered ketorolac in the previous year.

Setting criteriaCounts ER visits or medical facility admissions specifically for Sickle Cell Crises–related pain, not routine outpatient visits.

Treatment requirement for event inclusionPain must have been treated with a parenteral narcotic or parenteral ketorolac to meet the definition.

Background

Crizanlizumab is a monoclonal antibody that binds to and inhibits P‑selectin, a cell adhesion molecule involved in vaso‑occlusion. By inhibiting P‑selectin, crizanlizumab reduces interactions between endothelial cells, platelets, and sickled red blood cells, which can decrease the frequency of vaso‑occlusive crises (VOCs) in individuals with sickle cell disease. Adakveo is administered by weight-based intravenous infusion on a monthly schedule and may be used with or without hydroxyurea; however, combination use with voxelotor lacks sufficient safety and efficacy data.