Medical Drug Criteria (MDC)

Policy Num:       P1.001.001
Policy Name:     Adakveo
Policy ID:          [P1.001.001] [Ac /L / M+/ P+ ][0.00.00]

Last Review:       September 17, 2024
Next Review:      September 20, 2025
 

Related Policies: 

None

ADAKVEO^® (crizanlizumab-tmca)

Summary

ADAKVEO is a prescription medicine used to treat the symptoms of Sickle Cell Disease. Adakveo may be used alone or with other medications. Adakveo belongs to a class of drugs called P-Selectin Inhibitor. Safety and efficacy for Adakveo has not been established in children younger than 16 years of age. Crizanlizumab-tcma, a humanized IgG2 kappa monoclonal antibody, inhibits adhesion of sickled red blood cells by binding to P-selectin and preventing interaction with P-selectin glycoprotein ligand 1. Binding P-selectin on the surface of activated endothelium and platelets blocks interactions between endothelial cells, platelets, red blood cells, and leukocytes.

Policy Statements

Adakveo may be considered medically necessary in patients 16 years of age or older with vasoocclusive crises associated with sickle cell disease (SCD) and if the conditions indicated below are met. Adakveo is considered investigational in patients less than 16 years of age and for all other indications.
 

Policy Guidelines

Coverage of Adakveo is available when the following criteria have been met:

• In patients 16 years of age or older with vasoocclusive crises associated with sickle cell disease (SCD) and if the conditions indicated below are met

DOSAGE/ADMINISTRATION

Injection: 100 mg/10 mL (10 mg/mL) solution in a single-dose vial

Administer 5 mg/kg by intravenous infusion over a period of 30 minutes on Week 0, Week 2, and every 4 weeks thereafter. 

REQUIRED MEDICAL INFORMATION

Initial Approval Criteria

a)    Diagnosis: to reduce the frequency of vasoocclusive crises (VOCs) in patients with sickle cell disease, and patient is at least 16 years of age AND
b.    Medication is prescribed by a physician specializing in sickle cell disease (e.g., hematologist) AND
c.    Member has been diagnosed with sickle cell disease (any genotype, including HbSS, HbSC, HbS/beta0-thalassemia, HbS/beta+-thalassemia, etc) AND
d.    Member has experienced at least 2 painful episodes of vaso-occlusive crises (VOCs) in the previous 12 months as determined by medical documentation AND
e.    One of the following applies:

• Member will be receiving hydroxyurea concomitantly with Adakveo OR
• Member has had an inadequate treatment response to at least a 3-month trial with a maximum tolerated dose of hydroxyurea
• Member is not a candidate for hydroxyurea treatment due to previously experienced hematologic toxicity reactions with this medication.

b)    Document: Patient’s actual body weight (recommended dose is 5 mg/kg).

Renewal Criteria for Approval

a)    The patient has disease improvement while using the requested agent, as demonstrated by a decrease in the frequency of vasoocclusive crisis (VOC) events [medical record documentation required]; AND
b)    The patient will NOT be using crizanlizumab-tmca (Adakveo® ) in combination with voxelotor (Oxbryta™) [medical record documentation required]; AND
c)    The prescriber is a specialist in the area of the patient’s diagnosis (e.g., hematologist, SCD specialist) or has consulted with a specialist in the area of the patient’s diagnosis [medical record documentation required]

EXCLUSION CRITERIA

N/A

BENEFIT APPLICATION

Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered. Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage.

OTHER CRITERIA

N/A

Population Reference No. 1 Policy Statement

References

1.    Product Information: ADAKVEO(R) intravenous injection, crizanlizumab-tmca intravenous injection. Novartis Pharmaceuticals Corporation (per FDA), East Hanover, NJ, 2021.
2.    Crizanlizumab-tmca. In: DRUGDEX [database on the Internet]. Greenwood Village (CO): IBM Corporation; 2022 [cited 2022 Apr 16]. Available from: www.micromedexsolutions.com. Subscription required to view.
3.    Ataga KI, Kutlar A, Kanter J, et al. Crizanlizumab for the prevention of pain crises in sickle cell disease. N Engl J Med. 2017;376:429-39.
 

Codes

Applicable Modifiers

N/A

Policy History