Sickle Cell Disease - Adakveo Utilization Management Medical Policy
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This policy governs prior authorization and medical benefit coverage criteria for Adakveo (crizanlizumab-tmca) to reduce vasoocclusive crises in patients with sickle cell disease age ≥16 across all UCare plans.
No material clinical or coverage changes in this revision.
Recommended Authorization Criteria
Initial Therapy and Continuation Therapy
Approve for 1 year if the patient meets ONE of the following (A or B):
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Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria. Criteria will be updated as new published data are available.
Prior Authorization & Documentation Requirements
Prior Authorization Required
Prior authorization is required for Adakveo. Approvals are provided for up to 1 year when the patient meets either the Initial Therapy or Currently Receiving Adakveo criteria. Requests for doses outside the dosing documented in the policy will be reviewed case-by-case by a clinician. Because evaluation and monitoring require specialty expertise, Adakveo must be prescribed by or in consultation with a physician who specializes in sickle cell disease (e.g., a hematologist).
- Approve for 1 year when criteria met
- Specialist prescribing or consultation required
Hydroxyurea Requirement for Initial Approval
For initial approval, patients must meet the policy's hydroxyurea requirement: the patient is ≥16 years and has had ≥1 sickle cell–related crisis in the prior 12 months, and the patient must meet ONE of the following regarding hydroxyurea: currently receiving a hydroxyurea product; OR tried hydroxyurea with inadequate efficacy or significant intolerance per the prescriber; OR not a candidate for hydroxyurea therapy (examples: pregnancy/planning pregnancy, immunosuppressive condition such as cancer). The medication must be prescribed by or in consultation with a sickle cell specialist.
- Hydroxyurea: current use, prior trial with inadequate efficacy/intolerance, or documented not a candidate
- Age and crisis history requirements for initial approval
Prior Authorization Documentation
Approval requires documentation that the patient meets the specified criteria: age (≥16 years), history of sickle cell disease with at least one sickle cell–related crisis in the prior 12 months for initial therapy, hydroxyurea status per above, or documentation of clinical benefit for continuing Adakveo. Documentation must also show that the medication is prescribed by or in consultation with a physician who specializes in sickle cell disease. Requests for non-standard dosing should include supporting clinical rationale for review.
- Document age and crisis history for initial therapy
- Document hydroxyurea status (current use, prior failure/intolerance, or not a candidate)
- For continuation, document clinical benefit from Adakveo (e.g., reduced vasoocclusive crises, delayed time to crisis, fewer hospital days)
- Include specialist prescribing/consultation and rationale for non-standard dosing
Key Definitions
Background and Clinical Context
Adakveo (crizanlizumab‑tmca) is a monoclonal antibody indicated to reduce the frequency of vasoocclusive crises in patients with sickle cell disease aged ≥16 years. In the pivotal 52‑week SUSTAIN trial, eligible patients had a history of 2–10 vasoocclusive crises in the prior 12 months, and about 60% of participants were receiving concomitant hydroxyurea. The trial demonstrated a significant reduction in annual crisis rates, delayed time to first and second crises, and fewer hospitalized days versus placebo, supporting the use of Adakveo to reduce vasoocclusive events.
Per this policy, dosing follows the trial and product guidance: 5 mg/kg IV at Week 0 and Week 2, then every 4 weeks, and authorization decisions consider age, prior crisis history, hydroxyurea status, and prescriber specialty.
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