CurrentCommunity Health Plan WashingtonPolicy 82.80.40-1

Hematopoietic Agents – Sickle Cell Disease Cell and Gene Therapies

Defines medical necessity criteria, dosing/quantity limits, coding, and authorization rules for the two one-time gene therapies (Casgevy and Lyfgenia) for sickle cell disease with recurrent vaso-occlusive crises/events for Apple Health (Community Health Plan Washington). Also requires treatment centers to be CIBMTR-enrolled per CMS CMMI model.

Policy Summary

PayerCommunity Health Plan Washington

PolicyHematopoietic Agents – Sickle Cell Disease Cell and Gene Therapies

Policy CodePolicy 82.80.40-1

Change TypeNew policy created

Effective DateJan 1, 2026

Next Review DateN/A

Key ActionRequests for Exagamglogene autotemcel or Lovotibeglogene autotemcel must meet the clinical criteria and non-preferred new-to-market agents are subject to prior authorization requiring inadequate response/intolerance to preferred agents.

SourceLink

POLICY UPDATE CHANGES

New policy created

2Gene therapies covered under policy

1One-time dose requirement

>=12Minimum patient age (years)

3.0×10^6Minimum CD34+ cells/kg

Coverage Summary

Coverage stance: covered_with_criteria for two one-time gene therapies: Exagamglogene autotemcel (Casgevy) and Lovotibeglogene autotemcel (Lyfgenia). Policy defines medical necessity criteria, dosing/quantity limits, coding, and authorization rules for these therapies and specifies that both are single, one-time doses.

Scope summary: Defines medical necessity criteria, dosing/quantity limits, coding, and authorization rules for the two one-time gene therapies (Casgevy and Lyfgenia) for sickle cell disease with recurrent vaso-occlusive crises/events for Apple Health (Community Health Plan Washington). Treatment centers must be enrolled in the CIBMTR registry per the CMS CMMI Cell and Gene Therapy Access Model before administering gene therapies to Apple Health clients.

Policy number: 82.80.40-1. Effective date: 01/01/2026. Status: CURRENT.

Minimum CD34+ cell dose threshold: minimum dose of 3.0 × 10^6 CD34+ cells/kg.

Key thresholds

Age requirement>= 12 years at expected time of gene therapy administration

Casgevy VOC frequency>= 2 VOCs per year in prior 24 months (provider attestation)

Lyfgenia VOE frequency>= 4 VOEs in prior 24 months (provider attestation)

Minimum CD34+ cells/kgminimum dose of 3.0 × 10^6 CD34+ cells/kg

One-time dose requirementSingle, one-time gene therapy dose; reauthorization not appropriate unless prior auth expired and therapy not received

Number of gene therapies covered2

Exagamglogene autotemcel (Casgevy) - Initial Therapy (Medical Necessity)

Covered when ALL of the following are met:

ALL of the following

Patient is 12 years of age or older at expected time of gene therapy administration
Prescribed by, or in consultation with a board-certified hematologist with SCD experience at a qualified treatment center
Treatment centers must be enrolled in CIBMTR per CMS CMMI model (policy requirement)
Diagnosis of sickle cell disease as confirmed by genetic testing
Prescriber attests that the patient is clinically stable and fit for hematopoietic stem cell transplantation
Patient is not a prior recipient of gene therapy or an allogenic hematopoietic stem cell transplant
Patient has prior use of hydroxyurea and, per health care professional judgment, hydroxyurea resulted in treatment failure, is contraindicated, or patient is intolerant
ONE of the following (evidence of recurrent VOCs)
- Patient has experienced recurrent VOCs, defined as greater than or equal to two (2) documented VOCs per year in the previous twenty-four (24) months, based on provider attestation
- Patient is currently receiving chronic transfusion therapy for recurrent VOCs, based on provider attestation

Exagamglogene autotemcel (Casgevy) - Reauthorization

Reauthorization rules:

ALL of the following

Casgevy is a one-time gene therapy and should not receive reauthorization unless the previous prior authorization has expired AND the patient did not receive the gene therapy

Lovotibeglogene autotemcel (Lyfgenia) - Reauthorization

Reauthorization rules:

ALL of the following

Lyfgenia is a one-time gene therapy and should not receive reauthorization unless the previous prior authorization has expired AND the patient did not receive the gene therapy

Provider Actions and Billing Rules

Prior Authorization

Prior Authorization required for non-preferred agents and gene therapies

Requests for Exagamglogene autotemcel (Casgevy) or Lovotibeglogene autotemcel (Lyfgenia) must meet the clinical criteria in this policy. New-to-market, non-preferred agents in this class are subject to prior authorization and require documentation of inadequate response or intolerance to preferred agents (two preferred agents, or one if only one preferred exists).

J3392
J3394

Documentation Required

Attestation and documentation requirements

Provider attestation and documentation are required. The prescriber must attest the patient is clinically stable and fit for hematopoietic stem cell transplantation, provide genetic testing confirming a diagnosis of sickle cell disease, document prior use of hydroxyurea and that it resulted in treatment failure or is contraindicated or not tolerated, and document VOC/VOE frequency or chronic transfusion status based on provider attestation (see numeric thresholds for VOC/VOE in policy).

Age: patient ≥ 12 years at expected time of gene therapy administration
Hydroxyurea: prior use with treatment failure, contraindication, or intolerance (provider attestation)
VOC threshold for Casgevy: ≥ 2 documented VOCs per year in the prior 24 months (provider attestation)
VOE threshold for Lyfgenia: ≥ 4 VOEs requiring medical treatment in the prior 24 months (provider attestation)
Or current chronic transfusion therapy for recurrent VOCs/VOEs (provider attestation)

Documentation Required

Qualified treatment center and registry enrollment

Treatment centers administering gene therapies for Apple Health clients must be enrolled in the Center for International Blood and Marrow Transplant Research (CIBMTR) and be members of the CMS Designated Registry as required under the CMS CMMI Cell and Gene Therapy Access Model.

Apple Health participates in the CMS CMMI Cell and Gene Therapy Access Model; participating centers must be enrolled in CIBMTR and be CMS Designated Registry members prior to administration.

Billing Rule

One-time therapy billing constraint

Both Casgevy (Exagamglogene autotemcel) and Lyfgenia (Lovotibeglogene autotemcel) are single, one-time gene therapy doses. Reauthorization is not appropriate unless a prior authorization has expired and the patient did not receive the therapy.

J3392
J3394

Definitions

Vaso-occlusive crises (VOC) / vaso-occlusive event (VOE): An episode of sickle cell disease exacerbation that may manifest as acute pain crises, acute chest syndrome, acute splenic sequestration, priapism, or splenic sequestration; diagnosed by a qualified medical professional within their scope of practice; and requires treatment at a medical facility (e.g., emergency department, hospital).

Background

Background: This policy addresses the use of recently available gene therapies that aim to replace the deficient gene responsible for producing hemoglobin in sickle cell disease, enabling production of normal, functioning hemoglobin.

Apple Health participation: Apple Health participates in the CMS CMMI Cell and Gene Therapy Access Model. Under this model, treatment centers that provide gene therapies for sickle cell disease must be members of the CMS Designated Registry through CIBMTR and must be enrolled in CIBMTR before administering gene therapies to Apple Health clients.

Policy metadata

Policy number82.80.40-1

Effective date2026-01-01

Last review2025-11-19

StatusCURRENT

SubjectHematopoietic cell and gene therapies for sickle cell disease (Exagamglogene autotemcel Casgevy; Lovotibeglogene autotemcel Lyfgenia)

Scope summaryDefines medical necessity criteria, dosing/quantity limits, coding, and authorization rules for the two one-time gene therapies (Casgevy and Lyfgenia) for sickle cell disease with recurrent vaso-occlusive crises/events for Apple Health; requires treatment centers to be CIBMTR-enrolled per CMS CMMI model.

Policy Summary

PayerCommunity Health Plan Washington

PolicyHematopoietic Agents – Sickle Cell Disease Cell and Gene Therapies

Policy CodePolicy 82.80.40-1

Change TypeNew policy created

Effective DateJan 1, 2026

Next Review DateN/A

SourceLink

On This Page

OpenPayer

Hematopoietic Agents – Sickle Cell Disease Cell and Gene Therapies

Coverage Summary

Exagamglogene autotemcel (Casgevy) - Initial Therapy (Medical Necessity)

Exagamglogene autotemcel (Casgevy) - Reauthorization

Lovotibeglogene autotemcel (Lyfgenia) - Initial Therapy (Medical Necessity)

Lovotibeglogene autotemcel (Lyfgenia) - Reauthorization

Applicable Codes

Provider Actions and Billing Rules

Definitions

Background

Clinical Evidence

Revision History

J3392	Injection, exagamglogene autotemcel, per treatment
J3394	Injection, lovotibeglogene autotemcel, per treatment