Adakveo (crizanlizumab-tmca) prior authorization
Customize your policy alerts
Sign up for AvMed Policy Pub. 100-2 alerts
Get alerted when Policy Pub. 100-2 changes without checking for updates manually.
Monitor payer policy activity
Requirements and clinical criteria for AvMed medical prior authorization of Adakveo (crizanlizumab-tmca) for reducing vaso-occlusive crises in patients with sickle cell disease; applies to providers requesting coverage for the medication.
No material clinical or coverage changes in this revision.
Coverage Criteria for Adakveo (crizanlizumab-tmca)
Initial Therapy — Adakveo
Adakveo is medically necessary for reduction of VOC frequency when ALL of the following are met:
Initial Authorization
- VOC frequency: Member has experienced at least 2 vaso-occlusive crises within the preceding 12 months as documented by medical records and ICD diagnosis codes (VOC defined in Part A)>=2 VOCs in 12 months
Section C
- Hydroxyurea requirement: Either insufficient response to at least 90 consecutive days of hydroxyurea (defined as >2 VOCs while compliant) OR documented contraindication to hydroxyurea (severe bone marrow depression: leukopenia <2,500/mm3, thrombocytopenia <100,000/mm3, or severe anemia requiring transfusion with labs within 30 days)
Section C hydroxyurea requirements
- Specialist involvement and safety criteria: Provider is or has consulted a hematologist/sickle cell specialist; hemoglobin >4.0 g/dL; member is not planning exchange transfusion or on a chronic transfusion program; member is not on chronic anticoagulation other than aspirin; no cancer diagnosis (except non-melanoma skin or in situ cervical) within 5 years; no history of stroke within past 2 years; member is not concomitantly receiving Oxbryta (voxelotor) or Endari (L-glutamine)
Section B clinical and safety requirements
Continuation Therapy — Adakveo
Continuation approved for 12 months when ALL of the following are met:
Section C reauthorization requirements
Not Covered / Investigational
Section C note
Use of Adakveo (crizanlizumab-tmca) for any indication other than reduction of vaso-occlusive crisis (VOC) frequency in sickle cell disease is considered investigational.
Concurrent use of Adakveo (crizanlizumab-tmca) with Oxbryta (voxelotor) or Endari (L-glutamine) will be denied.
Coding and Clinical Inputs
| J0791 | Adakveo (crizanlizumab-tmca) Injection |
| C9053 | Adakveo (crizanlizumab-tmca) Injection HCPCS |
| 282.42 | Sickle cell crisis code listed |
| 282.62 | Sickle cell crisis code listed |
| 282.64 | Sickle cell crisis code listed |
| 282.69 | Sickle cell crisis code listed |
| D57.0 | Sickle-cell anaemia with crisis |
| D57.00 | Sickle-cell anaemia without crisis |
| D57.01 | Sickle-cell anaemia with acute chest syndrome |
| D57.02 | Sickle-cell anaemia with splenic sequestration |
| D57.21 | HbSC disease with crisis |
| D57.211 | HbSC disease with acute chest syndrome |
Provider Requirements and Submission
Prior authorization required for Adakveo (J0791/C9053)
Prior authorization is required for Adakveo (crizanlizumab-tmca) Injection (J0791/C9053). The prescribing physician must complete and sign the medical prior authorization/step-edit request and provide all required clinical documentation on the form; incomplete or illegible submissions may delay authorization.
- Drug Requested: Adakveo (crizanlizumab-tmca) Injection (J0791/C9053)
- Prescribing physician must sign and clearly print name on the request (preprinted stamps not valid)
- Complete authorization form including dosing, diagnosis, and required supporting documentation
Hydroxyurea trial (≥90 days) or documented contraindication required
Member must have had an insufficient response to at least 90 consecutive days of hydroxyurea prior to approval, or have a documented contraindication to hydroxyurea (severe bone marrow depression such as leukopenia <2,500/mm3, thrombocytopenia <100,000/mm3, or severe anemia requiring transfusion). Paid pharmacy claims will be verified.
- Insufficient response defined as >2 VOCs while compliant on hydroxyurea/Droxia during the 90-day trial
- If contraindication claimed, submit labs within the last 30 days documenting leukopenia, thrombocytopenia, or severe anemia
- Paid pharmacy claims for hydroxyurea/Droxia within the last 12 months will be verified
Required submission documents and clinical evidence
Prescriber must sign the prior authorization form and submit member and prescriber information plus supporting clinical documentation, including ICD codes and progress notes documenting VOC events in the last 12 months, relevant lab results, and pharmacy claims to verify prior therapies.
- Completed and signed medical prior authorization/step-edit request (physician signature required)
- ICD codes and progress notes documenting VOC events (as defined in Part A) within the prior 12 months
- Relevant lab results (e.g., hemoglobin, platelet counts) — labs for contraindication claims must be within 30 days
- Paid pharmacy claims to verify hydroxyurea/Droxia use in the last 12 months
Incomplete or insufficient documentation may delay or deny authorization
Authorization may be delayed or denied if the information provided is incomplete, incorrect, or illegible, or if supporting documentation (e.g., VOC documentation, labs, pharmacy claims) is missing.
- Incomplete, incorrect, or illegible submissions can delay authorization
- Missing documentation of VOC events, labs, or pharmacy claims may result in denial
Background Information
Adakveo (crizanlizumab-tmca) is indicated to reduce the frequency of vaso-occlusive crises (VOCs) in patients with sickle cell disease aged 16 years and older. The policy requires documentation of a confirmed sickle cell genotype and at least 2 VOCs in the prior 12 months (as defined by Part A and verified by ICD codes and chart notes). Prior trial of hydroxyurea for at least 90 consecutive days with insufficient response, or a documented contraindication to hydroxyurea, is required. Reauthorization is granted for 12 months when the member continues to meet criteria and shows a documented decrease in VOCs from baseline without unacceptable toxicity. Other uses outside this indication are investigational.
Definitions and Code Use
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.