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Sickle Cell Disease Gene Therapy Coverage Information

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This article has been updated. To read the updated information, see "Update to 'Sickle Cell Disease Gene Therapy Coverage Information.'”

Procedure codes for exagamglogene autotemcel (Casgevy) (procedure code J3392) and lovotibeglogene autotemcel (Lyfgenia) (procedure code J3394) are benefits of Texas Medicaid.

Exagamglogene autotemcel (Casgevy) is an autologous genome-edited hematopoietic stem cell-based gene therapy indicated for the treatment of clients who are 12 years of age or older with one of the following:

  • Sickle cell disease with recurrent vaso-occlusive crises
  • Transfusion-dependent ß-thalassemia

Exagamglogene autotemcel (Casgevy) (procedure code J3392) will be limited to one transfusion treatment per lifetime.

Lovotibeglogene autotemcel (Lyfgenia) is an autologous hematopoietic stem cell-based gene therapy indicated for the treatment of clients who are 12 years of age or older with sickle cell disease and a history of vaso-occlusive events.

Lovotibeglogene autotemcel (Lyfgenia) (procedure code J3394) will be limited to one transfusion treatment per lifetime.

Note: New benefits that are adopted by Texas Medicaid must be presented at a rate hearing to receive public comment on proposed Texas Medicaid reimbursement rates. After the rate hearing, expenditures must be approved before the rates are adopted by Texas Medicaid. Providers will be notified in a future article if a proposed reimbursement rate will change or a procedure code will not be reimbursed because the expenditures are not approved.

Prior Authorization Requirements

Prior authorization will be required for exagamglogene autotemcel (Casgevy) (procedure code J3392) and lovotibeglogene autotemcel (Lyfgenia) (procedure code J3394).

Prior authorization requests for exagamglogene autotemcel (Casgevy) (procedure code J3392) and lovotibeglogene autotemcel (Lyfgenia) (procedure code J3394) must be submitted using the Special Medical Prior Authorization (SMPA) Request Form.

Exagamglogene Autotemcel (Casgevy)

Exagamglogene autotemcel (Casgevy) is a one-time infusion therapy for the treatment of clients for whom autologous hematopoietic stem cell transplantation is appropriate and who meet all the following criteria:

  • The client is 12 years of age or older and has been diagnosed with sickle cell disease or transfusion-dependent ß-thalassemia.
  • The client has not previously received allogeneic or autologous hematopoietic stem cell transplantation and does not have a matched related donor to participate in an allogenic stem hematopoietic stem cell transplant.
  • The client has not previously received exagamglogene autotemcel (Casgevy) or any other gene therapy.
  • The client has a confirmed negative serum pregnancy test.
  • The client does not have active HIV-1, HIV-2, hepatitis B virus, or hepatitis C virus infection.
  • The client does not have advanced liver or chronic kidney disease.

Additional Requirements for Clients with Sickle Cell Disease

Clients with sickle cell disease must meet the following additional criteria:

  • The client has inadequate response to hydroxyurea or crizanlizumab.
  • Genetic testing confirms the client’s diagnosis of sickle cell disease.
  • The client has a history of recurrent vaso-occlusive crises and at least two vaso-occlusive crisis events per year in the past two years, as documented with one of the following diagnosis codes:
Diagnosis Codes
D5700D5701D5702D5703D5704D5709D571
D5720D57211D57212D57213D57214D57218D57219
D5740D57411D57412D57413D57414D57418D57419
D5742D57431D57432D57433D57434D57438D57439
D5744D57451D57452D57453D57454D57458D57459
D5780D57811D57812D57813D57814D57818D57819

Prescriber attestation will be required and must document the following:

  • Hydroxyurea will be discontinued at least eight weeks before mobilization and conditioning.
  • Crizanlizumab will be discontinued at least eight weeks before mobilization or conditioning.
  • Iron chelators will be discontinued at least seven days before initiation of myeloablative conditioning.

Additional Requirements for Clients with Transfusion-Dependent ß-Thalassemia

Clients with transfusion-dependent ß-thalassemia must meet the following additional criteria:

  • The client has a history of requiring at least 100 mL/kg/year or ten units/year of red blood cell transfusions in the past 24 months.
  • Genetic testing confirms the client’s diagnosis of transfusion-dependent ß-thalassemia, as documented with diagnosis code D561 or D565.

Prescribers must attest and document that iron chelators will be discontinued at least seven days before initiation of myeloablative conditioning.

Lovotibeglogene Autotemcel (Lyfgenia)

Lovotibeglogene autotemcel (Lyfgenia) is a one-time infusion therapy for the treatment of clients for whom autologous hematopoietic stem cell transplantation is appropriate and who meet the following requirements:

  • The client is 12 years of age or older.
  • The client has not previously received allogeneic or autologous hematopoietic stem cell transplantation and does not have a matched related donor to participate in an allogenic stem hematopoietic stem cell transplant.
  • The client has inadequate response or contraindication to hydroxyurea.
  • The client has not previously received lovotibeglogene autotemcel (Lyfgenia) or any other gene therapy.
  • The client has a confirmed negative serum pregnancy test and is not breastfeeding.
  • The client has a confirmed negative serology test for HIV-1 or HIV-2.
  • The client does not have advanced liver or chronic kidney disease.
  • The client has a diagnosis of sickle cell disease that has been confirmed by genetic testing.
  • The client has a history of vaso-occlusive events, with at least four vaso-occlusive events in the past 24 months, as documented with one of the following diagnosis codes:
Diagnosis Codes
D5700D5701D5702D5703D5704D5709D571
D5720D57211D57212D57213D57214D57218D57219
D5740D57411D57412D57413D57414D57418D57419
D5742D57431D57432D57433D57434D57438D57439
D5744D57451D57452D57453D57454D57458D57459
D5780D57811D57812D57813D57814D57818D57819

Prescribers must attest and document the following:

  • Hydroxyurea will be discontinued two months before mobilization and two days before conditioning.
  • Anti-retroviral medication will be discontinued at least one month before mobilization and until all cycles of apheresis are completed.
  • Iron chelators will be discontinued at least seven days before initiation of myeloablative conditioning.

Required Monitoring Parameters

Monitoring parameters for exagamglogene autotemcel (Casgevy) are as follows:

  • Monitor for bleeding and conduct frequent platelet counts until platelet engraftment and platelet recovery are achieved.
  • Monitor absolute neutrophil counts until engraftment has been achieved.

Monitoring parameters for lovotibeglogene autotemcel (Lyfgenia) are as follows:

  • Monitor for evidence of malignancy through complete blood counts at least every six months and through integration site analysis at month 6, month 12, and as warranted.
  • Monitor for thrombocytopenia and bleeding.
  • Monitor neutrophil counts until engraftment has been achieved.

Providers should call the TMHP Contact Center at 800-925-9126 with any questions related to prior authorization for fee-for-service clients. Providers should contact the client’s MCO for managed care clients.