Hematopoietic Agents – Sickle Cell Disease Cell and Gene Therapies
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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.
New policy created
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.
Exagamglogene autotemcel (Casgevy) - Initial Therapy (Medical Necessity)
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
Lovotibeglogene autotemcel (Lyfgenia) - Initial Therapy (Medical Necessity)
Applicable Codes
Provider Actions and Billing Rules
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).
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)
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.
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.
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.
Clinical Evidence
Evidence: No structured evidence entries are included in the brief. Populate clinical trial identifiers, study summaries, and outcome metrics (e.g., VOC/VOE reduction, transfusion independence, survival, treatment-related adverse events) here if available.
Revision History
Policy created and approved by HCA; New policy created
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