CurrentCignaPolicy IP0120

Sickle Cell Disease - Adakveo

Covers medical necessity and coverage criteria for Adakveo (crizanlizumab-tmca) IV infusion to reduce vaso-occlusive/sickle cell-related crises in patients with sickle cell disease age ≥16 for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicySickle Cell Disease - Adakveo

Policy CodePolicy IP0120

Change TypeTerminology, eligibility and examples clarified/added

Effective DateApr 15, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document age ≥16, qualifying sickle cell-related crisis history or clinical benefit, hydroxyurea status or documented ineligibility, and specialist prescription.

SourceLink

POLICY UPDATE CHANGES

Replaced the requirement 'vaso-occlusive crisis (VOC) in the previous 12-month period' with 'sickle cell-related crisis'.

Added a note detailing examples of patients who are not candidates for hydroxyurea (e.g., pregnant or planning pregnancy, immunosuppressive conditions).

Added examples of clinical benefit for patients currently receiving Adakveo (reduction in number of crises, delay in time to crises, reduction in hospital days).

Policy name updated from 'Crizanlizumab-tmca' to 'Sickle Cell Disease - Adakveo.'

≥16age eligibility

1 yrinitial approval

5 mg/kgdose

Policy Summary

PayerCigna

PolicySickle Cell Disease - Adakveo

Policy CodePolicy IP0120

Change TypeTerminology, eligibility and examples clarified/added

Effective DateApr 15, 2025

Next Review DateN/A

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria for Adakveo (crizanlizumab-tmca)

inv-01: FDA-Approved Indication 6 Initial and Continued Therapy

Approve for 1 year if the patient meets ONE of the following (A or B):

Overall Approval Pathways: Pathway A (Initial Therapy) OR Pathway B (Currently Receiving Adakveo)

Pathway A: Initial Therapy

Age: Patient is ≥ 16 years of age
Event history: Patient has had at least one sickle cell-related crisis in the previous 12-month period
Hydroxyurea status: Patient meets ONE: (a) currently receiving a hydroxyurea product; OR (b) tried a hydroxyurea product and experienced inadequate efficacy or significant intolerance per prescriber; OR (c) prescriber states patient is not a candidate for hydroxyurea therapy (examples: pregnant or planning pregnancy; immunosuppressive condition)
Examples provided in policy
Prescriber specialty: Medication is prescribed by or in consultation with a physician who specializes in sickle cell disease (e.g., a hematologist)

Pathway B: Currently Receiving Adakveo

Age: Patient is ≥ 16 years of age
Clinical benefit: Prescriber documents the patient is receiving clinical benefit from Adakveo therapy (examples: reduction in number of vaso-occlusive/sickle cell-related crises; delay in time to crises; reduction in days hospitalized)
Examples listed in policy
Prescriber specialty: Medication is prescribed by or in consultation with a physician who specializes in sickle cell disease (e.g., a hematologist)

inv-02: Dosing Criteria 6 Dosing regimens approved when coverage is available and medically necessary

Dosing regimens approved when coverage is available and medically necessary:

Approved dosing: A) Up to 5 mg/kg given by intravenous infusion at Weeks 0 and 2; AND B) Up to 5 mg/kg given by intravenous infusion once every 4 weeks thereafter5 mg/kg; Weeks 0, 2, then every 4 weeks

Dose, frequency and duration should be reasonable and supported by evidence; receipt of sample product does not satisfy criteria.

Any use of Adakveo (crizanlizumab-tmca) that is not described in this policy as an approved, covered indication is considered experimental, investigational, or unproven. Such uses are not covered and may be denied; the policy will be updated if new published data support additional indications.

Uses of Adakveo outside the approved indication(s) set forth in this policy are considered not medically necessary, experimental, or investigational and are not covered. Providers should request prior authorization only for indications and clinical scenarios that meet the policy’s specified criteria.

Coding and Dose Information

Coding notemixed

No codes listed

Dose

Dose per infusion5 mg/kg per infusion

Infusion schedule (induction)Given by IV infusion at Week 0 and Week 2

Maintenance scheduleThen 5 mg/kg IV once every 4 weeks

Infusion durationAdministered over approximately 30 minutes

Provider Requirements and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Approvals may be granted for up to 1 year when the documented criteria are met (age, crisis history or current benefit, hydroxyurea status, and prescriber specialty). Receipt of sample product does not satisfy criteria for coverage.

Approval duration: up to 1 year
Applies to codes/therapy under Policy IP0120

Documentation Required

Hydroxyurea Trial or Documented Ineligibility Required

For initial therapy, the patient must either be currently receiving hydroxyurea, have tried hydroxyurea and experienced inadequate efficacy or significant intolerance, or have documented ineligibility for hydroxyurea (examples: pregnancy, planning pregnancy, or an immunosuppressive condition such as cancer).

Initial therapy requirement: hydroxyurea use, trial with inadequate efficacy/intolerance, or documented ineligibility

Background

Adakveo (crizanlizumab-tmca) is a targeted monoclonal antibody therapy used to reduce the frequency of vaso-occlusive/sickle cell-related crises in patients with sickle cell disease. The policy defines covered use according to the FDA‑approved indication and supporting clinical evidence; therapies or indications not described in the policy are considered experimental, investigational, or unproven and are therefore not covered.

Definitions

Definition — sickle cell-related crisis

Policy termsickle cell-related crisis

Meaning in policyTerminology used to describe qualifying painful vaso-occlusive events in the prior 12 months (replaces prior wording 'vaso-occlusive crisis [VOC]')

Examples supporting qualificationHistory of 1 or more sickle cell-related crises in the previous 12 months is required for initial therapy

Clinical trial contextSUSTAIN trial enrolled patients with 2–10 vaso-occlusive crises in the prior 12 months; Adakveo reduced annual pain crisis rate and hospitalized days