CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Adakveo (crizanlizumab-tmca) — coverage criteria

Defines accepted indications, exclusion criteria, coding, and authorization expectations for Adakveo use in members and applies to payor medication requests processed by Evolent on behalf of the payer.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAdakveo (crizanlizumab-tmca) — coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document member meets criteria (age ≥16, ≥2 pain crises in past 12 months, and hydroxyurea conditions if applicable).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥16minimum member age for coverage

≥2required crises in prior 12 months

J0791HCPCS code

5 mg/kgsingle dose maximum

3 mohydroxyurea stable duration

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Initial therapy coverage criteria

Covered when ALL of the following are met

Sickle cell disease population and utilization: Member is aged 16 years or older AND has sickle cell disease (HbSS, HbSC, HbS/beta0-thalassemia, HbS/beta+thalassemia, or other genotypes) AND has had two or more sickle cell–related pain crises in the past 12 months

Hydroxyurea condition: If receiving hydroxyurea, hydroxyurea must have been prescribed for at least 6 months AND be on a stable dose for at least 3 months

Applies only if member is receiving hydroxyurea

Coverage excludes use of Adakveo (crizanlizumab-tmca) when any of the following apply: use after documented disease progression on the same regimen; the member is receiving chronic anticoagulation therapy other than aspirin (for example, warfarin or heparin); the member has a hemoglobin level < 4.0 g/dL; or proposed dosing would exceed the single-dose maximum of 5 mg/kg.

Off-label or investigational uses of Adakveo (crizanlizumab-tmca) that are not supported by sufficient evidence or that are not generally accepted by the medical community are considered not medically necessary. Sufficient evidence requires support from CMS-recognized compendia or acceptable peer-reviewed literature and should demonstrate that the patient population, the comparative regimen, and clinically meaningful outcomes are adequately represented. Case reports and meeting abstracts without a full peer-reviewed publication generally do not meet this standard.

Provider Actions, Authorization & Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Adakveo (crizanlizumab-tmca). Coverage is limited to members aged 16 years and older who meet the clinical criteria for sickle cell disease and when the request is billed with the appropriate code (J0791). Requests must be submitted to Evolent for authorization prior to administration; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

Prior authorization required for Adakveo (crizanlizumab-tmca).
Submit prior authorization requests to Evolent; unauthorized medications may be non-reimbursable.
Affected code: J0791 (Injection, crizanlizumab-tmca, 5 mg)

Prior Authorization

Hydroxyurea Requirement

If the member is receiving hydroxyurea, the member must have been on hydroxyurea therapy for at least 6 months and on a stable dose for at least 3 months prior to the Adakveo request.

Hydroxyurea use must be ≥ 6 months prior to request.
Hydroxyurea dose must be stable for ≥ 3 months before request.

Documentation Required

Required Supporting Documentation

Support for the medical necessity of Adakveo must include documentation consistent with accepted sources. The use of this drug must be supported by one of the following: FDA approved product labeling, CMS‑recognized compendia, NCCN or ASCO clinical guidelines, or peer‑reviewed literature that meets CMS standards.

Provide citation or documentation from FDA labeling, CMS compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature.

Denial Risk

Triggers for Denial

Requests may be denied when exclusion criteria are met, including disease progression on the same regimen, chronic anticoagulation therapy (other than aspirin), hemoglobin < 4.0 g/dL, dosing that exceeds the single‑dose limit (5 mg/kg), or investigational/off‑label uses lacking sufficient supporting evidence per CMS standards.

Denial triggers include disease progression on the same regimen.
Chronic anticoagulation (e.g., warfarin, heparin) other than aspirin is an exclusion.
Hemoglobin < 4.0 g/dL is an exclusion.
Single dose exceeding 5 mg/kg is not allowed.
Investigational or unsupported off‑label indications may be denied.

Background

Adakveo (crizanlizumab-tmca) is indicated to reduce the frequency of vaso-occlusive crises in patients with sickle cell disease and is subject to specific coverage criteria tied to documented genotype, crisis frequency, and concurrent therapy. Background considerations informing coverage include safety-related exclusions such as anticoagulation status and low hemoglobin, dosing limits, and the requirement that off-label uses be supported by robust evidence sources (for example, CMS compendia or peer-reviewed literature). These safety and evidence requirements guide application of the coverage criteria.