CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Casgevy (exagamglogene autotemcel) (Intravenous)

Policy governs coverage, clinical criteria, administration, coding, and prior-authorization requirements for a single-course intravenous gene therapy Casgevy for Medicaid, Commercial, and Medicare-Medicaid Plan (MMP) members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCasgevy (exagamglogene autotemcel) (Intravenous)

Policy CodePolicy N/A

Change Typeclarified

Effective DateMay 1, 2024

Next Review Date

Key ActionSubmission of medical records (chart notes) related to medical necessity criteria is REQUIRED on all authorization requests and must document diagnosis, prior therapies, and relevant testing.

POLICY UPDATE CHANGES

Policy includes detailed initial approval criteria, administration guidance, and coding (HCPCS J3392 and NDC 51167-0290-xx).

1Allowed treatment courses per patient

12-35Allowed patient age range (years)

3.0e6Minimum CD34+ cells per kg

J3392Primary billing HCPCS

Coverage Summary

Coverage stance: covered with criteria. Policy provides coverage for a single-course (one dose) treatment of Casgevy for Medicaid, Commercial, and Medicare‑Medicaid Plan (MMP) members, subject to detailed clinical criteria and prior authorization. Coverage requires meeting the indication‑specific eligibility and all listed initial approval criteria (age, infection screening, contraindications, specialist prescribing and treatment at an Authorized Treatment Center).

Quick facts & thresholds

Allowed treatment courses per patient1

Allowed patient age range12-35 years

Minimum CD34+ cells per kg3.0 x 10^6 CD34+ cells/kg

Primary billing HCPCSJ3392 (Injection, exagamglogene autotemcel, 1 mg; 1 billable unit = treatment)

Minimum CD34+ cell dose thresholdMinimum recommended dose: 3.0 x 10^6 CD34+ cells/kg (single dose)

Sickle cell pre-conditioning Hb targetsTransfuse prior to apheresis to total Hb < 11 g/dL and HbS < 30%; transfuse at least 8 weeks prior to initiation of myeloablative conditioning

Beta thalassemia pre-conditioning Hb targetTransfuse prior to apheresis to total Hb > 11 g/dL for 60 days prior to myeloablative conditioning

Transfusion-dependent beta thalassemia definitionHistory of transfusions ≥100 mL/kg/year or ≥10 units/year of RBCs in the 2 years preceding treatment

Initial Therapy Criteria

Initial Approval Criteria

Coverage is provided when ALL of the following are met:

ALL of the following

Patient eligibility and safety prerequisites
- Age: Patient is at least 12-35 years of age
- Seizure prophylaxis consideration: Provider has considered use of prophylaxis for seizures when initiating myeloablative conditioning
- Infectious disease screening: Patient 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)
- Live vaccine restriction: Must not be administered concurrently with live vaccines while immunosuppressed
- Hypersensitivity exclusion: Patient does not have a history of hypersensitivity to dimethyl sulfoxide (DMSO) or dextran 40
- Contraindications to required procedures/products: Patient will not have a contraindication to necessary products or procedures required for successful gene therapy (examples listed include plerixafor, busulfan, red blood cell infusion)
- Authorized treatment center: Patient will undergo treatment at a manufacturer-approved Authorized Treatment Center (ATC)
- Specialist prescribing: Casgevy is prescribed by, or in consultation with, a hematology specialist
Indication: Sickle Cell Disease OR Beta Thalassemia
- Sickle Cell Disease (SCD) criteria
  - Diagnosis confirmation: Patient has a confirmed diagnosis of sickle-cell disease (includes genotypes HbS/HbS or HbS/β0 or HbS/β+) by either identification of significant quantities of HbS on hemoglobin assay or identification of biallelic HBB pathogenic variants where at least one allele is p.Glu6Val on molecular genetic testing
  - Refractory disease: Patient has symptomatic disease despite treatment with hydroxyurea and formulary add-on therapy (example: crizanlizumab)
  - Vaso-occlusive events: Patient experienced two or more vaso-occlusive events (VOE/VOC) per year in the previous two years while adhering to the above therapy
    VOE/VOC defined as event requiring medical facility visit resulting in diagnosis and necessitating interventions such as opioid management, NSAIDs, or RBC transfusion
Transplant candidacy and prior HSCT
- Donor exclusion: Patient does not have a known 10/10 HLA-matched related donor willing to participate in an allogeneic HSCT
- Autologous HSCT candidacy: Patient is a candidate for autologous hematopoietic stem cell transplant (HSCT) (i.e., no significant marrow, cardiac, pulmonary, or liver dysfunction precluding transplant)
- No prior HSCT: Patient does not have a history of prior hematopoietic stem cell transplant (HSCT)
Concomitant therapy restrictions
- Iron chelator timing: Patient will not receive therapy concomitantly with iron chelators for 7 days prior to mobilization and for 6 months post-treatment (3 months post-treatment for non-myelosuppressive iron chelators)7 days pre-mobilization; 6 months post-treatment (3 months for non-myelosuppressive)
- Stop disease-modifying agents: Disease-modifying agents (hydroxyurea or crizanlizumab/Adakveo) must be stopped at least 8 weeks prior to mobilization and conditioning≥8 weeks prior to mobilization and conditioning

Applicable Codes

HCPCS (billing unit)HCPCSCovered

J3392

Injection, exagamglogene autotemcel, 1 mg; 1 billable unit = treatment

NDC (product identifier)NDCCovered

51167-0290-xx

Casgevy containing minimum of 3.0 X 10^6 CD34+ cells/kg; supplied in vial(s)

Covered Diagnosis Codes (ICD-10)ICD-10Covered

D57.0	Hb-SS disease with crisis unspecified
D57.01	Hb-SS disease with crisis unspecified
D57.02	Hb-SS disease with acute chest syndrome
D57.03	Hb-SS disease with splenic sequestration
D57.04	Hb-SS disease with cerebral vascular involvement
D57.1	Sickle-cell disease without crisis
D57.20	Sickle-cell/Hb-C disease without crisis
D57.211	Sickle-cell, Hb-C disease with acute chest syndrome
D57.212	Sickle-cell, Hb-C disease with splenic sequestration
D57.213	Sickle-cell, Hb-C disease with cerebral vascular involvement

1–10 of 36

1/4

Billing: HCPCS code J3392 corresponds to injection, exagamglogene autotemcel, 1 mg; 1 billable unit = treatment. Requests must follow the one‑time dose billing rule and submit required medical records with authorization requests.

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization and medical records submission required

Submission of medical records (chart notes) related to medical necessity is REQUIRED on all authorization requests. Records will be reviewed at time of submission and must document the diagnosis, prior therapies (including genetic testing when applicable), and relevant testing needed to support initiation of therapy.

Documentation Required

Pre-treatment infectious disease screening

Document negative screening 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 leukapheresis.

Documentation Required

Specialist prescribing/consult

Casgevy must be prescribed by, or in consultation with, a hematology specialist and the patient must undergo treatment at a manufacturer‑approved Authorized Treatment Center (ATC).

Billing Rule

One-time dose billing (J3392)

Coverage is limited to a single treatment course (one dose) of Casgevy; claims should use HCPCS code J3392.

J3392
Coverage limited to a single treatment course (one dose)
HCPCS J3392 = 1 billable unit = treatment

Documentation Required

Concomitant therapy restrictions

Manage concomitant therapies per policy: stop hydroxyurea and crizanlizumab at least 8 weeks prior to mobilization/conditioning; do not use G-CSF for mobilization in sickle cell disease; avoid administering live vaccines while the patient is immunosuppressed; and restrict iron chelators around mobilization/treatment per policy.

Stop hydroxyurea/crizanlizumab: at least 8 weeks prior to mobilization
Do not use G-CSF for mobilization in SCD: (prohibited for SCD mobilization)
Avoid live vaccines while immunosuppressed: do not administer concurrently
Iron chelators: stop for 7 days prior to mobilization and avoid for 6 months post-treatment (3 months for non‑myelosuppressive chelators)

Denial Risk

Age and prior HSCT exclusions

Requests will be denied if the patient is outside the 12–35 year age range, has a history of prior hematopoietic stem cell transplant (HSCT), or has a known 10/10 HLA‑matched related donor willing to proceed to allogeneic HSCT.

Background & Definitions

Indication and mechanism: Casgevy (exagamglogene autotemcel) is an autologous ex vivo CRISPR‑Cas9 gene‑edited hematopoietic stem cell (CD34+) therapy indicated for treatment of sickle cell disease and transfusion‑dependent beta thalassemia.

Trial design and efficacy: The therapy was evaluated in ongoing single‑arm, multicenter phase 1/2/3 trials demonstrating high response rates (e.g., VF12 response 29/31 [93.5%]; HF12 30/30 [100%] among evaluable patients).

Administration and common adverse events: Casgevy is given as a single intravenous dose (minimum recommended dose 3.0 x 10^6 CD34+ cells/kg) supplied in one or more vials for infusion; common adverse reactions and laboratory abnormalities include mucositis, febrile neutropenia, neutropenia, thrombocytopenia, leukopenia, anemia, and lymphopenia.

Term	Definition
VOE/VOC
Vaso-occlusive event/crisis defined as event requiring medical facility visit resulting in diagnosis (acute pain, acute chest syndrome, splenic/hepatic sequestration, priapism) and necessitating interventions such as opioids, NSAIDs, or RBC transfusion.
Authorized Treatment Center (ATC)
Manufacturer-approved treatment center where Casgevy administration and required procedures are performed.

Transfusion-dependent Beta Thalassemia (TDT) criteria

Diagnosis confirmation: Patient has documented diagnosis of homozygous beta thalassemia or compound heterozygous beta thalassemia including β-thalassemia/hemoglobin E (HbE) confirmed by HBB sequence gene analysis showing biallelic pathogenic variants OR by clinical/laboratory phenotype consistent with severe disease
Transfusion dependence: Patient has transfusion-dependent disease defined as history of transfusions of at least 100 mL/kg/year or ≥10 units/year of red blood cells in the 2 years preceding treatment≥100 mL/kg/year or ≥10 units/year (in prior 2 years)
Pre-apheresis transfusion target: Patient will be transfused prior to apheresis to a total hemoglobin (Hb) > 11 g/dL for 60 days prior to myeloablative conditioningHb > 11 g/dL for 60 days prior to conditioning
Cardiac exclusion: Patients with severely elevated cardiac iron (cardiac T2* < 10 msec by MRI) or left ventricular ejection fraction (LVEF) ≤ 45% are excludedcardiac T2* < 10 msec or LVEF ≤ 45%
Advanced liver disease exclusion: Patient does not have advanced liver disease (AST or ALT > 3×ULN, direct bilirubin ≥ 2.5×ULN, or biopsy-demonstrated bridging fibrosis or cirrhosis)AST or ALT > 3×ULN; direct bilirubin ≥ 2.5×ULN

OpenPayer

Casgevy (exagamglogene autotemcel) (Intravenous)

Coverage Summary

Initial Therapy Criteria

Length of Authorization

Renewal Criteria

Applicable Codes

Provider Actions & Prior Authorization

Clinical Evidence

Background & Definitions

Revision History