Neighborhood Health Plan RI Casgevy Coverage

Coverage Criteria for Casgevy (exagamglogene autotemcel)

Initial Approval Criteria

Covered when ALL of the following are met for Initial Approval:

Age and general prerequisites: Member is between 12 and 35 years of age; provider has considered prophylactic seizure therapy prior to initiating myeloablative conditioning; member screened negative for HBV, HCV, and HIV‑1/HIV‑2 prior to leukapheresis; Casgevy will not be given concurrently with live vaccines while immunosuppressed; no history of hypersensitivity to dimethyl sulfoxide (DMSO) or dextran 40; treatment will occur at a manufacturer‑approved Authorized Treatment Center (ATC); Casgevy prescribed by or in consultation with a hematology specialist.

Prior gene therapy and concomitant therapy exclusions: Member has not received other gene therapies (e.g., lovotibeglogene autotemcel, betibeglogene autotemcel); member will not receive iron chelators for 7 days prior to mobilization and for 6 months post‑treatment (3 months post‑treatment for non‑myelosuppressive chelators); disease‑modifying agents (e.g., hydroxyurea or crizanlizumab) are held for at least 8 weeks prior to mobilization and conditioning.

Transplant candidacy and device/procedure fitness: Member does not have a known 10/10 HLA matched related donor willing to undergo allogeneic HSCT; member is a candidate for autologous HSCT (no significant bone marrow, lung, heart, or liver dysfunction); member has no prior hematopoietic stem cell transplant (HSCT); member has no contraindication to products/procedures required for gene therapy (including plerixafor, busulfan, and red blood cell infusion).

Disease-specific criteria - Sickle Cell Disease: Member has confirmed sickle cell disease (e.g., genotypes βS/βS, βS/β0, βS/β+ by hemoglobin assay or biallelic HBB pathogenic variants with at least one p.Glu6Val allele); symptomatic disease despite hydroxyurea and formulary add‑on therapy; member experienced ≥2 vaso‑occlusive events/crises (VOE/VOC) per year in each of the prior 2 years while adherent to therapy; member will be transfused prior to apheresis to total Hb ≤11 g/dL and HbS <30% and transfused at least 8 weeks before myeloablative conditioning; member will not receive G‑CSF for HSC mobilization.

VOE/VOC is defined in policy as an event requiring a medical facility visit with documentation of acute pain, acute chest syndrome, splenic/hepatic sequestration, priapism >2 hours, and need for interventions (e.g., opioids, NSAIDs, RBC transfusion).

Disease-specific criteria - Beta Thalassemia: Member has documented homozygous or compound heterozygous beta thalassemia confirmed by HBB sequencing or consistent severe phenotype; transfusion‑dependent disease defined as history of ≥100 mL/kg/year or ≥10 units/year of packed RBCs in the 2 years prior to therapy; member will be transfused prior to apheresis to total Hb ≥11 g/dL for 60 days prior to myeloablative conditioning; member does not have severely elevated cardiac iron (cardiac T2* <10 msec), LVEF <45%, or advanced liver disease (AST/ALT >3× ULN, direct bilirubin >2.5× ULN, or biopsy showing bridging fibrosis/cirrhosis).

Renewal/Continuation

Renewal restriction: Coverage is limited to a single treatment course (one dose of Casgevy) and coverage cannot be renewed.

Plan clinical coverage criteria

Covered when ALL of the following are met per plan P&T-adopted criteria (and no overriding NCD/LCD exist for Medicare members):

Plan criteria: Use of Casgevy aligns with FDA‑approved labeling and relevant clinical literature; prescriber submits necessary clinical information and medical records for review; the plan will consider more cost‑effective options first when appropriate.

For Medicare members, applicable NCD/LCD/LCA take precedence.

Members considered for Casgevy for the transfusion-dependent beta thalassemia indication must not have evidence of advanced organ iron-related injury. Specifically, the policy excludes members with cardiac T2* < 10 msec on MRI or left ventricular ejection fraction (LVEF) < 45%. Advanced liver disease is also an exclusion, defined as AST or ALT > 3× upper limit of normal (ULN), or direct bilirubin > 2.5× ULN, or liver biopsy demonstrating bridging fibrosis or cirrhosis.

Casgevy must not be administered concurrently with live vaccines while the member is immunosuppressed. Treatment is contraindicated in members with a documented history of hypersensitivity to dimethyl sulfoxide (DMSO) or dextran 40.

For Medicare members, applicable Centers for Medicare & Medicaid Services policies take precedence. Where a relevant National Coverage Determination (NCD), Local Coverage Determination (LCD), or Local Coverage Article (LCA) exists, compliance with that CMS document governs Part B coverage and claims payment rather than the plan criteria.

Use of Casgevy outside the policy's specified eligibility window or without meeting disease-specific requirements will generally be considered not medically necessary. The policy requires members to be between 12 and 35 years of age, and disease-specific thresholds must be met (for example, documented transfusion dependence for beta thalassemia or required VOE/VOC frequency and pre-apheresis transfusion targets for sickle cell disease). Members with contraindicating organ dysfunction are also excluded.

Requests for indications that are not consistent with FDA labeling or the relevant clinical literature, or submissions in which prescriber-supplied clinical information does not support medical necessity per the plan's adopted criteria, may be denied as not medically necessary. The plan will give individual consideration based on the clinical information submitted, but adherence to FDA-approved indications and supporting literature is expected.

Billing and Coding

HCPCSHCPCSCovered

J3392

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

NDCNDCCovered

51167-0290-xx

NDC for Casgevy containing a minimum of 3.0 × 10^6 CD34+ cells/kg, multiple vials

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

D57.00	Hb-SS disease with crisis unspecified
D57.01	Hb-SS disease with acute chest syndrome
D57.02	Hb-SS disease with splenic sequestration
D57.03	Hb-SS disease with cerebral vascular involvement
D57.04	Hb-SS disease with crisis with other specified complication
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

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Medicare Part B Covered Diagnosis CodesICD-10

N/A	Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCA/LCD): N/A

Medicare Part B Administrative Contractor (MAC) Jurisdictionsmixed

Jurisdictions E (1)	Applicable State/US Territory = CA, HI, NV, AS, GU, CNMI; Contractor = Noridian Healthcare Solutions, LLC
Jurisdictions F (2 & 3)	Applicable State/US Territory = AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ; Contractor = Noridian Healthcare Solutions, LLC
Jurisdiction 5	Applicable State/US Territory = KS, NE, IA, MO; Contractor = Wisconsin Physicians Service Insurance Corp (WPS)
Jurisdiction 6	Applicable State/US Territory = MN, WI, IL; Contractor = National Government Services, Inc. (NGS)
Jurisdictions H (4 & 7)	Applicable State/US Territory = LA, AR, MS, TX, OK, CO, NM; Contractor = Novitas Solutions, Inc.
Jurisdiction 8	Applicable State/US Territory = MI, IN; Contractor = Wisconsin Physicians Service Insurance Corp (WPS)
Jurisdiction N (9)	Applicable State/US Territory = FL, PR, VI; Contractor = First Coast Service Options, Inc.
Jurisdiction (10)	Applicable State/US Territory = TN, GA, AL; Contractor = Palmetto GBA, LLC
Jurisdiction M (11)	Applicable State/US Territory = NC, SC, WV, VA (excluding below); Contractor = Palmetto GBA, LLC
Jurisdiction L (12)	Applicable State/US Territory = DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA); Contractor = Novitas Solutions, Inc.

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Minimum CD34+ cell dose

Minimum per-dose cellular content>= 3.0 x 10^6 CD34+ cells/kg (minimum recommended dose per single intravenous infusion)

Dose formulationProvided as a suspension of CD34+ cells in one or more vials; administer all vials to achieve member-specific dose

Single treatment courseCasgevy is provided as a single dose (one treatment course) containing the minimum CD34+ cell dose

Transfusion dependence (beta thalassemia)

Transfusion-dependence definitionHistory of transfusions of at least 100 mL/kg/year or >=10 units/year of packed red blood cells in the 2 years preceding therapy

Provider Requirements and Authorization Workflow

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests will be reviewed against the plan clinical coverage criteria adopted by Neighborhood Health Plan of Rhode Island (as reviewed by P&T). Coverage is provided only when the clinical criteria are met; individual consideration may be given based on prescriber-submitted clinical information and supporting documentation.

Submit requests via the PA web portal or fax with required documentation.

Denial Risk

Denial Risk if Criteria or Documentation Not Met

Requests may be denied or delayed if the required clinical information and medical records are not submitted or if the request does not meet the plan's adopted clinical coverage criteria. Individual consideration is available but does not guarantee approval.

Failure to submit chart notes, diagnostic test results, genetic/mutational testing, or documentation of prior/concomitant therapies may result in denial.

Background and Therapy Overview

Casgevy (exagamglogene autotemcel) is an autologous, CRISPR-based gene‑editing hematopoietic stem cell therapy approved for treatment of certain patients with sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT). The plan's clinical criteria require confirmation of diagnosis by appropriate laboratory or genetic testing, evidence of symptomatic or transfusion‑dependent disease despite standard therapies, and suitability for autologous hematopoietic stem cell transplant. Treatment is supplied as a single course (one dose) and must be delivered at a manufacturer‑approved Authorized Treatment Center with appropriate pre-treatment screening (e.g., HBV, HCV, HIV) and management of concomitant therapies as specified in the policy.

Definitions and Key Terms

VOE/VOC (vaso-occlusive event/crisis)

VOE/VOC definitionAn event requiring a visit to a medical facility for evaluation that results in documentation of acute pain, acute chest syndrome, acute splenic or hepatic sequestration, or priapism >2 hours

Required interventions documentedEvent must have necessitated interventions such as opioid pain management, NSAIDs, or RBC transfusion

Temporal requirement for criteriaFrequency of VOE/VOC is measured as >=2 events per year in the previous 2 years while adherent to therapy (per SCD coverage criteria)

CMS coverage documents (NCD / LCD / LCA)

NCD (National Coverage Determination)A CMS-issued national policy that may govern Medicare Part B coverage for specific services or drugs

LCD (Local Coverage Determination)

OpenPayer

Casgevy (exagamglogene autotemcel) — Single-course gene therapy coverage criteria

Coverage Criteria for Casgevy (exagamglogene autotemcel)

Billing and Coding

Provider Requirements and Authorization Workflow

Background and Therapy Overview

Definitions and Key Terms