J3392 — Injection, exagamglogene autotemcel, per treatment
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Medicare Pricing
Work RVU
0.00
Facility
N/A
Non-Facility
N/A
Documentation Required
- Documentation demonstrating diagnosis of transfusion-dependent beta-thalassemia (TDT) for Casgevy or β-thalassemia requiring RBC transfusions for Zynteglo
- Documentation of patient age to confirm within indicated ranges (Casgevy: 12–65; Zynteglo: 4–65)
- Documentation confirming 'absence of limitations' (i.e., evidence patient is not pregnant or breastfeeding; not desiring pregnancy and will use effective contraception; no hepatic impairment; no renal impairment; no prior allogeneic or autologous HSC transplant for Casgevy; and appropriate viral serology negative as specified)
- Documentation of relevant laboratory/clinical testing as applicable (e.g., pregnancy test, hepatic and renal function tests, serology for HIV/HBV/HCV/HTLV as applicable)
Key Coverage Criteria
- Casgevy (exagamglogene autotemcel) (J3392) one-time, single dose will be considered medically reasonable and necessary when the following indications are met: Absence of limitations; AND Individual has diagnosis of TDT; AND Individual is 12 through 65 years of age
- Zynteglo (betibeglogene autotemcel) (J3393) one-time, single dose will be considered medically reasonable and necessary when the following indications are met: Absence of limitations; AND Individual has β-thalassemia, requires RBC transfusions; AND Individual is 4 through 65 years of age
- Requests for Casgevy (exagamglogene autotemcel) AND Zynteglo (betibeglogene autotemcel) require review by a medical director
- Inferred: Treatment of sickle cell disease (SCD) associated with abnormal hemoglobin S (HbS) — intended to address the underlying HbS pathology, reduce vaso-occlusive crises (VOCs), and prevent organ damage.
- The mainstays of treatment for SCD have been supportive care to manage complications and preventive measures to reduce the incidence of VOCs.
- Currently, the only potential cure is hematopoietic stem cell transplantation (HSCT) using cells from a healthy donor.
4 Active Policies
HUMANA-GENE-THERAPY-TREATMENTS-FOR-BETA-THALASSEMIA-MA — Gene Therapy Treatments for Beta Thalassemia - Medicare Advantage
HUMANA-GENE-THERAPY-TREATMENTS-FOR-SICKLE-CELL-DISEASE-MA — Gene Therapy Treatments for Sickle Cell Disease - Medicare Advantage
ANTHEM-MED.00140 — MED.00140 Gene Therapy for Beta Thalassemia
ANTHEM-MED.00146 — MED.00146 Gene Therapy for Sickle Cell Disease
Related Codes
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