Criteria
Coverage is subject to the specific terms of the member's benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the
www.fepblue.org
website.
Exagamglogene autotemcel (Casgevy) may be approved when
ALL
of the following criteria are met:
-
The individual is at least 12 years of age;
and
-
Provider has considered use of prophylaxis therapy for seizures prior to initiating myeloablative conditioning;
and
-
The individual has been screened and found negative for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus 1 &2 (HIV-1/HIV-2) in accordance with clinical guidelines prior to collection of cells (leukapheresis);
and
-
Must not be administered concurrently with live vaccines while immunosuppressed;
and
-
The individual does not have a history of hypersensitivity to dimethyl sulfoxide (DMSO) or dextran 40;
and
-
The individual has not received other gene therapies [e.g., lovotibeglogene autotemcel (Lyfgenia), betibeglogene autotemcel (Zynteglo), etc.]
†
;
and
-
The individual will not receive therapy concomitantly with any of the following:
-
Iron chelators for seven (7) days prior to mobilization and six (6) months post-treatment (three (3) months post-treatment for non-myelosuppressive iron chelators);
and
-
Disease-modifying agents (e.g., vexelotor or crizanlizumab) for at least eight (8)-weeks prior to mobilization;
and
-
Hydroxyurea for at least two (2) months prior to mobilization;
and
-
The individual is a candidate for autologous hematopoietic stem cell transplant (HSCT);
and
-
ONE of the following:
-
ALL of the following:
-
The individual has a confirmed diagnosis of sickle-cell disease with one of the following genotypes βS/βS or βS/β0 or βS/β+
(Note: Additional genotypes will be considered on a case-by-case basis based on disease severity)
as determined by one of the following:
-
Identification of significant quantities of HbS with or without an additional abnormal β-globin chain variant by hemoglobin assay;
or
-
Identification of biallelic
HBB
pathogenic variants where at least one allele is the p.Glu6Val pathogenic variant on molecular genetic testing;
and
-
The individual will not receive granulocyte-colony stimulating factor (G-CSF) for the mobilization of hematopoietic stem cells (HSC);
and
-
The individual experienced at least two vaso-occlusive events/crises (VOE/VOC)* in the previous 12 months
(Note: Patients experiencing four events/crises in the previous 24 months will also have met this requirement);or
-
ALL of the following:
-
The individual has a documented diagnosis of homozygous beta thalassemia or compound heterozygous beta thalassemia including β-thalassemia/hemoglobin E (HbE) as outlined by the following:
-
The individual's diagnosis is confirmed by
HBB
sequence gene analysis showing biallelic pathogenic variants;
or
-
The individual has severe microcytic hypochromic anemia, absence of iron deficiency, anisopoikilocytosis with nucleated red blood cells on peripheral blood smear, and hemoglobin analysis that reveals decreased amounts or complete absence of hemoglobin A (HbA) and increased HbA
2
with or without increased amounts of hemoglobin F (HbF);
and
-
The individual has transfusion-dependent disease defined as a history of transfusions of at least 100 mL/kg/year or greater than or equal to 10 units/year of packed red blood cells (pRBCs) in the two (2) years preceding therapy;
and
-
The individual will be transfused prior to apheresis to a total Hb greater than or equal to 11 g/dL for 60 days prior to myeloablative conditioning;
and
-
The individual does not have any of the following:
-
Severely elevated iron in the heart (i.e., patients with cardiac T2* less than 10 msec by magnetic resonance imaging [MRI] or left ventricular ejection fraction [LVEF] less than 45% by echocardiogram);
and
- Advanced liver disease [i.e., AST or ALT greater than three (3) times the upper limit of normal (ULN), or direct bilirubin value greater than 2.5 times the ULN, or if a liver biopsy demonstrated bridging fibrosis or cirrhosis].
*VOE/VOC is defined as an event requiring a visit to a medical facility for evaluation which results in a diagnosis of such being documented due to one (or more) of the following: acute pain, acute chest syndrome, acute splenic sequestration, acute hepatic sequestration, priapism lasting greater than two (2) hours AND necessitating subsequent interventions such as opioid pain management, non-steroidal anti-inflammatory drugs, RBC transfusion, etc.
†Requests for subsequent use of exagamglogene after receipt of other gene therapies will be evaluated on a case-by-case basis
Length of Approval:
Once per lifetime
The use of exagamglogene autotemcel (Casgevy) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.
Procedure Code
