CurrentAvMedPolicy N/A

Casgevy - β - Thalassemia (Medical)

Medical prior authorization form and clinical coverage criteria for one lifetime treatment of Casgevy (exagamglogene autotemcel) for members with β-thalassemia. Defines clinical eligibility requirements, dosing limits, required documentation, provider qualifications, and administration site options.

Policy Summary

PayerAvMed

PolicyCasgevy - β - Thalassemia (Medical)

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrescribing physician must sign and print name on the PA request and submit complete documentation including labs, diagnostics, and chart notes; incomplete or illegible information may delay authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes.

1Lifetime treatments allowed

≥12Minimum age

3e6/kgMinimum CD34+ cells/kg dose

2Transfusion-dependence options

Coverage Summary

Scope: This is a medical prior authorization form and clinical coverage criteria for one lifetime treatment of Casgevy (exagamglogene autotemcel) for members with β-thalassemia, defining clinical eligibility requirements, dosing limits, required documentation, provider qualifications, and administration site options.

Coverage stance: Covered with criteria — authorization is provided when all specified criteria are met and required documentation is submitted; one treatment per lifetime is allowed and the course may not be renewed.

Subject: Casgevy (exagamglogene autotemcel) for β-thalassemia.

Payer: AvMed (medical prior authorization/step-edit request; Medicare Part B guidance referenced where applicable).

Status: CURRENT.

One-sentence overview: This policy permits one lifetime administration of Casgevy when all clinical criteria are met and requires prior authorization with supporting documentation; prior authorization must be signed by the prescribing physician and necessary labs/diagnostics submitted.

Dosing and Eligibility Thresholds

Minimum recommended dose3 × 10^6 CD34+ cells per kg of body weight

Age≥ 12 years

HemoglobinTotal hemoglobin ≥ 11 g/dL prior to mobilization and ≥ 11 g/dL prior to myeloablative conditioning

Transfusion-dependence option AReceipt of ≥ 100 mL packed RBC per kg per year in the previous 2 years

Transfusion-dependence option BReceipt of ≥ 10 units packed RBC per year in the previous 2 years

Contraception durationUse effective contraception from start of mobilization through at least 6 months after Casgevy administration

Approval Criteria and Dosing Limits

Dosing Limits and Treatment Frequency

Limits on dosing and lifetime treatments.

ALL of the following

Casgevy is supplied in one or more vials; one carton contains a single lot consisting of 1 to 9 vials
NDC 51167-290-09
Minimum recommended dose is 3 × 10^6 CD34+ cells per kg of body weight3 × 10^6 CD34+ cells per kg
One treatment (dose) per lifetime

Relevant Codes

Drug HCPCS/J-codeHCPCSCovered

J3392

Exagamglogene autotemcel (Casgevy)

NDC listed in policyNDC

51167-290-09

Casgevy vial/carton NDC (frozen suspension of genome edited autologous CD34+ cells)

Actions for Providers (Prior Authorization, Documentation, Billing)

Prior Authorization

Prior authorization required with signed form

The prescribing physician must sign and clearly print their name on the prior authorization request (preprinted stamps not valid). All required documentation — including labs, diagnostics, and chart notes — must be submitted; incomplete, incorrect, or illegible information may delay authorization.

Documentation Required

Document genotype and transfusion history

Submit genetic testing confirming the member's β-thalassemia genotype and documentation supporting transfusion dependence (either ≥100 mL packed RBC/kg/year or ≥10 units packed RBC/year in the previous 2 years). Also submit cellular infectious disease screening results as part of the documentation package.

Documentation Required

Verify prior gene therapy

Verify that the member has not previously received a gene therapy for beta-thalassemia (Casgevy or Zynteglo) via medical paid claims; if claims are unavailable, the prescribing physician must attest that the member has not previously received these therapies.

Billing Rule

One lifetime administration

Benefit covers one treatment course per member lifetime and may not be renewed. Bill using HCPCS J3392 for Casgevy where applicable.

Documentation Required

Weight and hemoglobin documentation

Current body weight must be documented and obtained within 30 days. Total hemoglobin values of ≥ 11 g/dL must be documented prior to mobilization and prior to myeloablative conditioning.

Documentation Required

Iron overload assessment

Submit documentation that the member has been evaluated for the presence of severe iron overload and demonstrate absence of severe iron overload. Examples of severe iron overload include myocardial T2* < 10 msec, liver iron concentration ≥ 15 mg/g, abnormal liver biopsy, or clinical evidence of organ damage (e.g., endocrine comorbidities).

Documentation Required

Reproductive safety documentation

For females of reproductive potential, confirm a negative serum pregnancy test prior to the start of mobilization and re-confirm prior to myeloablative conditioning, and document use of effective contraception from the start of mobilization through at least 6 months after Casgevy administration. For males of reproductive potential, document use of effective contraception from the start of mobilization through at least 6 months after Casgevy administration.

Background and Product Information

Background: Casgevy (exagamglogene autotemcel) is supplied as an autologous, genome edited CD34+ cell gene therapy product for the treatment of β-thalassemia (HCPCS J3392; NDC listed for the frozen suspension vial/carton).

This document is a medical prior authorization/step-edit form outlining clinical eligibility criteria, required screening and infectious disease testing, conditioning and treatment logistics (mobilization, apheresis, myeloablative conditioning such as busulfan), administration site options or specialty pharmacy, and program-specific documentation and provider signature requirements.

Where applicable for Medicare members, outpatient (Part B) drug coverage guidance (Medicare Benefit Policy Manual, NCDs and LCDs) is referenced and must be followed in addition to this prior authorization process.

Defined Terms

Transfusion-dependent: Either ≥ 100 mL of packed red blood cells per kg per year in the previous 2 years OR ≥ 10 units of packed red blood cells per year in the previous 2 years.

Severe iron overload: Examples include myocardial T2* < 10 msec; liver iron concentration ≥ 15 mg/g; abnormal liver biopsy; or clinical evidence of organ damage such as endocrine comorbidities.

Policy Summary

PayerAvMed

PolicyCasgevy - β - Thalassemia (Medical)

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

SourceLink

On This Page

OpenPayer

Casgevy - β - Thalassemia (Medical)

Coverage Summary

Approval Criteria and Dosing Limits

Relevant Codes

Actions for Providers (Prior Authorization, Documentation, Billing)

Background and Product Information

Defined Terms

Revision History