Sickle Cell Disease - Adakveo (crizanlizumab) Utilization Management Medical Policy
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Defines prior authorization and medical necessity criteria for coverage of Adakveo (crizanlizumab-tmca) to reduce vaso-occlusive crises in patients with sickle cell disease for Aspirus Medicare Plans.
No material clinical or coverage changes in this revision.
Coverage Criteria for Adakveo (crizanlizumab)
FDA-Approved Indication Criteria
Covered when the following FDA-approved indication criteria are met. Approve for 1 year.
A) Initial Therapy
- A.i Age: Patient is >= 16 years of age>= 16 years
- A.ii Prior crises: Patient has had at least one sickle cell-related crisis in the previous 12 months>= 1 crisis in prior 12 months
- A.iii Hydroxyurea status: Patient meets ONE of: a) currently receiving hydroxyurea; OR b) tried hydroxyurea with inadequate efficacy or significant intolerance per prescriber; OR c) not a candidate for hydroxyurea per prescriber (examples: pregnancy/planning pregnancy or immunosuppressive condition)
- A.iv Prescriber specialty: Medication prescribed by or in consultation with a physician who specializes in sickle cell disease (e.g., a hematologist)
B) Currently Receiving Adakveo
- B.i Age: Patient is >= 16 years of age>= 16 years
- B.ii Clinical benefit: According to the prescriber, patient is receiving clinical benefit from Adakveo therapy (e.g., reduction in vaso-occlusive crises, delayed time to crises, reduced hospital days)
- B.iii Prescriber specialty: Medication prescribed by or in consultation with a physician who specializes in sickle cell disease (e.g., a hematologist)
Dosing Criteria
Approved dosing when covered:
Infusion over 30 minutes
Coverage is not recommended for any circumstances not listed in the Recommended Authorization Criteria.
Provider Requirements, Prior Authorization, and Documentation
Prior Authorization Required
Prior Authorization Required — Prior authorization is recommended. Approve for up to 1 year when the patient meets the listed FDA‑approved indication criteria and dosing. Extended approvals are allowed if the patient continues to meet the Criteria and Dosing. Requests for doses outside the dosing in this policy will be considered case‑by‑case by a clinician (e.g., Medical Director or Pharmacist). Because of specialized skills required for evaluation, diagnosis, and monitoring, Adakveo must be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., a hematologist).
- Approval duration: up to 1 year
- Dose exceptions reviewed case‑by‑case
Step Therapy Context
Step Therapy Context — Hydroxyurea is the preferred first‑line therapy for sickle cell disease per guideline recommendations. Authorize Adakveo for patients who are currently receiving hydroxyurea, for patients who have tried hydroxyurea and experienced inadequate efficacy or significant intolerance, or for patients who are not candidates for hydroxyurea (examples: pregnant or planning pregnancy, patients with immunosuppressive conditions).
- Hydroxyurea preferred first‑line therapy
- Adakveo may be authorized if patient is currently on hydroxyurea, has inadequate response/intolerance to hydroxyurea, or is not a candidate for hydroxyurea
Required Documentation
Required Documentation — The prescriber must document that the patient meets the FDA‑approved indication criteria (see criteria and dosing) and must include clinical rationale when hydroxyurea was not used or was inadequate/intolerable. Documentation must show patient age (≥16 years), history of sickle cell‑related crises in the prior 12 months (for initial therapy), evidence of clinical benefit if continuing Adakveo, and confirmation that the medication is prescribed by or in consultation with a specialist in sickle cell disease (e.g., hematologist).
- Document patient age and number of sickle cell‑related crises in prior 12 months for initial therapy
- If not on hydroxyurea, document trial and outcome or reason patient is not a candidate
- If continuing Adakveo, document clinical benefit (e.g., reduced crises, delayed time to crisis, reduced hospital days)
- Prescriber specialty or consultation with a hematologist must be documented
Denial Triggers
Denial Triggers — Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria.
- Denial likely if patient does not meet the FDA‑approved indication criteria or dosing requirements
Definitions
Background
Adakveo (crizanlizumab) is a monoclonal antibody indicated to reduce vaso-occlusive crises in patients with sickle cell disease who are ≥ 16 years of age. In the pivotal 52-week SUSTAIN trial, patients with a history of vaso-occlusive crises experienced a reduction in the annual rate of pain crises and delays to first and second crises versus placebo; approximately 60% of participants received concomitant hydroxyurea.
Adakveo is administered by intravenous infusion over 30 minutes with an approved dosing schedule of 5 mg/kg at Weeks 0 and 2, then every 4 weeks thereafter.
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