CurrentCareSourcePolicy N/A

Casgevy (exagamglogene autotemcel) — Medical benefit prior authorization

Medical benefit prior authorization policy for Casgevy (exagamglogene autotemcel) for treatment of transfusion-dependent beta-thalassemia and severe sickle cell disease in members age 12 and older; applies to Arkansas PASSE members under the CareSource medical benefit.

Policy Summary

PayerCareSource

PolicyCasgevy (exagamglogene autotemcel) — Medical benefit prior authorization

Policy CodePolicy N/A

Change TypeNew policy

Effective DateJul 1, 2024

Next Review DateN/A

Key ActionSubmit prior authorization for a one-time Casgevy infusion with required documentation (diagnosis/genetic confirmation, transfusion or VOC history, HIV/hepatitis testing, and treatment timeline).

SourceLink

POLICY UPDATE CHANGES

New policy for Casgevy created.

>=12min patient age

3 x 10^6 CD34+ cells/kgmin infusion dose

3 monthsinitial approval

one-timereauthorization

>=2/yrSCD VOC requirement

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Coverage Criteria for Casgevy (exagamglogene autotemcel)

Initial Therapy - Sickle Cell Disease

Covered when ALL of the following are met

SCD initial: 1) Member is >= 12 years of age; AND 2) Medication prescribed by or in consultation with a hematologist; AND 3) Diagnosis of severe sickle cell disease with documented genotype (e.g., BS/BS or BS/B0); AND 4) Member has had at least two severe vaso-occlusive crises (VOCs) per year within the past two years (severe VOC defined as acute pain event requiring a medical facility visit with administration of medications or RBC transfusion, acute chest syndrome, priapism >2 hours requiring medical visit, or splenic sequestration); AND 5) Screening for HIV-1, HIV-2, hepatitis B and hepatitis C is completed or scheduled; AND 6) Member has had a 6-month trial of hydroxyurea without sufficient relief from VOCs; AND 7) Disease-modifying therapies for SCD (e.g., hydroxyurea, crizanlizumab, voxelotor) will be discontinued prior to Casgevy infusion; AND 8) Member does NOT have exclusionary conditions (prior HSCT, prior gene therapy, advanced liver disease, or other listed exclusions); AND 9) Dosage: minimum 3 x 10^6 CD34+ cells/kg as a single infusion.

If all requirements are met, approved for 3 months; provider must submit timeline for administration.

Initial Therapy - Transfusion-Dependent Beta-Thalassemia

Covered when ALL of the following are met

TDT initial: 1) Member is >= 12 years of age; AND 2) Medication prescribed by or in consultation with a hematologist or transplant specialist; AND 3) Diagnosis of beta-thalassemia confirmed by genetic testing; AND 4) Member is transfusion-dependent, defined as requiring >=100 mL/kg/year OR >=10 units/year of pRBC transfusions in the prior 2 years; AND 5) Member is clinically stable and eligible for HSCT but does NOT have a 10/10 HLA matched sibling/family donor; AND 6) Negative testing for hepatitis B, hepatitis C, HIV-1 and HIV-2 before cell collection; AND 7) Member does NOT have exclusionary conditions (prior or current malignancy, prior HSCT, prior gene therapy, advanced liver disease, severe cardiac iron overload such as cardiac T2* <10 ms); AND 8) Dosage: minimum 3 x 10^6 CD34+ cells/kg as a one-time IV infusion.

If all requirements are met, approved for 3 months; provider must submit timeline for administration.

Reauthorization / Continuation

Reauthorization: Casgevy is a one-time infusion and will not be reauthorized.

CareSource considers Casgevy (exagamglogene autotemcel) not medically necessary for the treatment of any condition that is not listed in this policy. Providers seeking use of Casgevy for indications outside those explicitly described should consult the payer's Off-Label policy prior to submitting a request.

Any indication for Casgevy that is not explicitly listed in this document is considered not medically necessary. Requests for treatment of off‑label or unlisted conditions will not meet coverage criteria under this policy.

Initial Authorization Requirements

Initial Therapy Requirements

Initial authorization criteria

SCD initial: See Initial Therapy - Sickle Cell Disease for full initial authorization criteria.

Initial approval duration when criteria met: 3 months; provider must submit timeline for administration with request.

TDT initial: See Initial Therapy - Transfusion-Dependent Beta-Thalassemia for full initial authorization criteria.

Initial approval duration when criteria met: 3 months; provider must submit timeline for administration with request.

Continuation / Reauthorization Criteria

Continuation Therapy

Reauthorization

One-time infusion: Casgevy is a one-time infusion and will not be reauthorized.

Clinical Definitions & Coding-related Thresholds

inv-06: Transfusion dependence

Threshold>=100 mL/kg/year OR >=10 units/year of pRBC transfusions (prior 2 years)

TimeframeMeasured over the prior 2 years

Applies toTransfusion-dependent beta-thalassemia initial authorization

inv-07: SCD VOC frequency

Required frequencyAt least two severe VOCs per year within the past two years (document lists 'TWQ' interpreted as two)

TimeframeDocumented over the prior 2 years

Applies toSickle cell disease initial authorization

Provider Requirements, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior Authorization Required — Casgevy (exagamglogene autotemcel) is a medical benefit that requires prior authorization. Approval is for a one-time IV infusion; initial authorization will be granted for up to 3 months. Provider must submit an anticipated timeline for cell collection and infusion with the request.

One-time IV infusion; minimum recommended dose: 3 x 10^6 CD34+ cells/kg
Initial authorization duration: up to 3 months
Provider must submit timeline for administration with prior authorization request

Step Therapy

Therapy Trial and Discontinuation Requirements

Therapy trial and discontinuation requirements — For SCD, members must have trialed hydroxyurea for at least 6 months without sufficient relief of vaso-occlusive crises (VOCs). Members must also have trialed (and discontinue prior to Casgevy infusion) other disease-modifying therapies as appropriate (examples: crizanlizumab, voxelotor). For TDT, member must be transfusion dependent as defined in policy.

SCD: ≥6-month trial of hydroxyurea without adequate VOC control
SCD: Trial of disease-modifying therapies (e.g., crizanlizumab, voxelotor) — these must be discontinued prior to infusion
TDT: Transfusion dependence defined as ≥100 mL/kg/year OR ≥10 units/year of pRBC transfusions in prior 2 years

Documentation Required

Required Documentation

Required documentation — Providers must submit documentation confirming diagnosis/genotype (SCD genotype BS1/BS or BS/BO or genetic confirmation for beta-thalassemia), age eligibility, hematology/transplant specialist involvement, and testing results. Evidence of disease severity must be provided (VOC frequency for SCD or transfusion history for TDT). Infection screening (HIV-1/2, hepatitis B and C) must be completed prior to cell collection.

Diagnosis confirmation and genotype/genetic testing results
Documentation of hematologist or transplant specialist prescription/consultation
For SCD: documentation of ≥2 severe VOCs per year in the past 2 years (examples: ED/medical visits with medication or transfusion, acute chest syndrome, prolonged priapism, splenic sequestration)
For TDT: transfusion history meeting dependence definition (≥100 mL/kg/year OR ≥10 units/year in prior 2 years)
Screening results: negative or completed testing for HIV-1, HIV-2, hepatitis B and hepatitis C prior to cell collection
Planned timeline for cell collection and infusion

Denial Risk

Denial Triggers

Denial Triggers — Requests will be denied if the member does not meet age or diagnostic criteria, lacks genotype or genetic confirmation, has not completed required infection testing, has not met prior therapy or transfusion dependence requirements, or has any absolute exclusions. Exclusions include prior HSCT, prior gene therapy, advanced liver disease, current/prior malignancy (for TDT), or a 10/10 HLA matched sibling/family donor available.

Age <12 years
SCD without required genotype confirmation (e.g., not BS/BS or BS/BO) or insufficient VOC frequency documentation
Failure to complete HIV/hepatitis B/hepatitis C testing before collection
No documented ≥6-month hydroxyurea trial for SCD when required, or failure to trial/discontinue other disease-modifying therapies as specified
TDT: not meeting transfusion dependence definition or presence of 10/10 HLA matched sibling/family donor
Any of the following exclusions: prior HSCT, prior gene therapy, advanced liver disease, prior or current malignancy (TDT), severe cardiac iron overload (e.g., cardiac T2* <10 ms)

Step Therapy Requirements

Step	Requirement	Notes
{"text":"1","status":""},{"text":"Member is at least 12 years of age","status":""},{"text":"Age requirement for SCD initial authorization","status":""}
{"text":"2","status":""},{"text":"Medication prescribed by or in consultation with a hematologist","status":""},{"text":"Specialist involvement required","status":""}
{"text":"3","status":""},{"text":"Diagnosis of severe sickle cell disease with genotype (BS/BS or BS/B0)","status":""},{"text":"Genotype confirmation required","status":""}
{"text":"4","status":""},{"text":"At least two severe vaso‑occlusive crises (VOCs) per year within the past two years","status":""},{"text":"Severe VOC defined as event requiring medical facility visit and meds or transfusion, acute chest syndrome, prolonged priapism, or splenic sequestration","status":""}
{"text":"5","status":""},{"text":"Screening completed or scheduled for HIV‑1, HIV‑2, hepatitis B and C","status":""},{"text":"Required prior to cell collection/infusion","status":""}
{"text":"6","status":""},{"text":"6‑month trial of hydroxyurea without relief from VOCs","status":""},{"text":"Trial and inadequate response to hydroxyurea required prior to Casgevy for SCD","status":""}
{"text":"7","status":""},{"text":"Disease‑modifying therapies (e.g., hydroxyurea, crizanlizumab, voxelotor) will be discontinued prior to Casgevy infusion","status":""},{"text":"Therapies must be stopped before infusion","status":""}
{"text":"8","status":""},{"text":"Member does NOT have exclusionary conditions (prior HSCT, prior gene therapy, advanced liver disease, etc.)","status":""},{"text":"See exclusions for full list","status":""}
{"text":"9","status":""},{"text":"Dosage: minimum 3 x 10^6 CD34+ cells/kg as a single infusion","status":""},{"text":"If all requirements met, approved for 3 months; provider must submit timeline for administration","status":""}

Definitions

inv-13: Transfusion-dependent definition

Definition>=100 mL/kg/year OR 10 units/year of packed RBC transfusions in the prior 2 years

Measurement periodPrior 2 years

Intended useEligibility criterion for Casgevy in transfusion-dependent beta-thalassemia

inv-14: Severe VOC definition

DefinitionAcute pain event requiring a visit to a medical facility with administration of medications or red blood cell transfusions (also includes acute chest syndrome, priapism >2 hours requiring medical visit, or splenic sequestration)

ContextUsed to define severe vaso-occlusive crises (VOCs) for SCD eligibility

DocumentationProvider must document medical-facility visits and treatments for each VOC

Quantity / Dose Information

inv-18: Casgevy (exagamglogene autotemcel)

Minimum doseMinimum 3 x 10^6 CD34+ cells/kg per course

AdministrationOne-time IV infusion when used for beta-thalassemia or as single infusion for SCD

Approval durationInitial approval up to 3 months when criteria met

Site of Care and Administration

Billing Rule

Hospital outpatient — medical benefit infusion; submit administration timeline

Casgevy is billed as a medical-benefit infusion in the hospital outpatient setting; include the planned timeline for cell collection and administration when submitting the authorization request.

Indicate hospital outpatient setting for the infusion
Attach timeline for cell collection and infusion with the prior authorization request

Background

Casgevy is an autologous, genome‑edited hematopoietic stem cell–based gene therapy in which CD34+ cells are edited to reduce BCL11A expression with the intent to prevent sickling and correct ineffective erythropoiesis. It is indicated in this policy for select patients with severe sickle cell disease with recurrent vaso‑occlusive crises and for transfusion‑dependent beta‑thalassemia; clinical use is restricted to the specific criteria listed in this document.