Medical Drug Criteria (MDC)

MDC Num:       P01.001.001
MDC Name:     Adakveo
MDC ID:          [P01.001.001] [Ac /B / M / P ]   [0.00.00]

Last Review:       July 8, 2022
Next Review:      July 8, 2023
Issue:                   7:2022

Related MDC: None

Adakveo

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.

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

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

a.    Member 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:

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

DOSAGE/ADMINISTRATION

5 mg/kg given as an intravenous infusion over 30 minutes on Weeks 0, 2 then every 4 weeks.

REQUIRED MEDICAL INFORMATION

Initial Approval Criteria

a)    Diagnosis: to reduce the frequency of vasoocclusive crises (VOCs) in patients with sickle cell disease, 
b)    Document: Patient’s actual body weight (recommended dose is 5 mg/kg).

Renewal Approval Criteria 

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

BlueCard/National Account Issues

OTHER CRITERIA

a.    Validate if intravenous infusion drugs are covered under the Pharmacy benefit. 

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.
 

Text

Codes

Applicable Modifiers

N/A

Policy History