CurrentBlue Cross Blue Shield - IowaPolicy 05.05.35

Lyfgenia (lovotibeglogene autotemcel) for sickle cell disease

Defines coverage and prior authorization criteria for Lyfgenia (gene therapy) for treatment of sickle cell disease patients, including required documentation, prescribing specialties, dosing limits, and eligibility criteria for Wellmark members.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyLyfgenia (lovotibeglogene autotemcel) for sickle cell disease

Policy CodePolicy 05.05.35

Change TypeNo material changes

Effective DateMay 30, 2024

Next Review Date

Key ActionObtain prior authorization with genotype confirmation, documentation of ≥4 severe VOEs in the prior 24 months, and prescriber specialty (hematologist or transplant specialist).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

one lifetimetreatment courses allowed per member

>=12 yrsminimum FDA-indicated age

3 x 10^6 CD34+/kgrecommended dose

>=4/24 morequired history of VOEs

hematologist/transplantrequired prescriber specialty

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Coverage and Medical Necessity Criteria

Initial Therapy — Eligibility Criteria

Covered when ALL of the following are met

Age: Member is ≥ 12 years and < 50 years old12-49 years

supported by FDA indication

Diagnosis confirmation: Diagnosis of sickle cell disease confirmed by molecular or genetic testinggenotype documented

genotype results required; submit molecular/genetic testing

Genotype: Documented genotypes Bs/Bs or Bs/+; additional genotypes will be considered on a case-by-case basis based on disease severity

specific genotypes listed in policy

Hydroxyurea trial: Member has experienced hydroxyurea (HU) failure or has intolerance or inability to tolerate HU

Vaso-occlusive events: Documented history of ≥ 4 severe vaso-occlusive events (VOEs) within the previous 24 months despite appropriate supportive care>=4 VOEs in 24 months

chart notes or medical records documenting VOEs required

HIV serology: Negative serologic test for HIV infection

Prescriber specialty: Medication prescribed by or in consultation with a hematologist or transplant specialist

prescriber specialty must be documented

Baseline labs and counts: Adequate baseline blood counts: white blood cell count ≥ 3 x 10^9/L and platelet count ≥ 100 x 10^9/L (not due to hypersplenism); baseline eGFR >= 70 mL/min/1.73 m2

No advanced liver disease or severe iron overload: No advanced liver disease as defined by PT/PTT >1.5x ULN, persistent AST/ALT >3x ULN, MRI evidence of cirrhosis, liver biopsy showing cirrhosis/bridging fibrosis, or other clinician-documented cirrhosis; no severe iron overload (e.g., myocardial T2* <10 msec) as applicable

No significant comorbidities or contraindications: No clinically significant pulmonary hypertension, no current malignancy (except basal or squamous cell carcinoma of the skin), no significant immunodeficiency, no uncontrolled active infection (including active/uncontrolled HBV or HCV), and no contraindication to required conditioning agents (e.g., plerixafor, busulfan)

No prior gene therapy or allogeneic HSCT: No history of prior gene therapy or allogeneic hematopoietic stem cell transplant

No severe cerebral vasculopathy: Absence of severe cerebral vasculopathy defined by one or more of: >=50% stenosis or occlusion of the circle of Willis, presence of Moyamoya disease, or any history of overt ischemic or hemorrhagic stroke

Continuation Therapy

Repeat treatment rules

Repeat therapy: Repeat treatment of Lyfgenia for any indication is considered investigational; approval is limited to one treatment course per lifetime

Coverage is denied for members with genetic or clinical features that meet the policy's exclusion criteria. Specifically, Lyfgenia is not covered for members with genetic mutations resulting in inactivation of two or more alpha-globin genes (e.g., a two-gene deletion), a history of prior gene therapy or prior allogeneic hematopoietic stem cell transplant, or severe cerebral vasculopathy such as Moyamoya disease or ≥50% stenosis/occlusion of the circle of Willis. Members with advanced liver disease (laboratory, imaging, or biopsy evidence as described in policy), clinically significant pulmonary hypertension, current malignancy (except basal or squamous cell carcinoma of the skin), significant immunodeficiency, uncontrolled active infections (including HBV/HCV), contraindication to conditioning agents (e.g., plerixafor, busulfan), or inadequate baseline blood counts (WBC < 3 x 10^9/L or platelets < 100 x 10^9/L) are also excluded from coverage.

Lyfgenia is considered not medically necessary for members who do not meet the coverage criteria outlined in this policy.

Billing and Dosing Information

Billing codes for LyfgeniaHCPCS

J3490	Unclassified drugs (when specified as [Lyfgenia] (lovotibeglogene autotemcel))
J3394	Injection, lovotibeglogene autotemcel, per treatment (effective 7/1/2024)
J3590	Unclassified biologics (when specified as [Lyfgenia] (lovotibeglogene autotemcel))
C9399	Unclassified drugs or biologics (when specified as [Lyfgenia] (lovotibeglogene autotemcel))

HCPCS codes (alternate view)HCPCS

J3490	Unclassified drugs (when specified as [Lyfgenia] (lovotibeglogene autotemcel))
J3394	Injection, lovotibeglogene autotemcel, per treatment (effective 7/1/2024)
J3590	Unclassified biologics (when specified as [Lyfgenia] (lovotibeglogene autotemcel))
C9399	Unclassified drugs or biologics (when specified as [Lyfgenia] (lovotibeglogene autotemcel))

Recommended CD34+ cell dose

Recommended CD34+ cell dose3 x 10^6 CD34+ cells per kg

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Lyfgenia. Submit prior authorization request with documentation confirming sickle cell disease genotype and evidence of vaso-occlusive episodes (VOEs). Requests lacking required documentation or clinical criteria may be denied.

Submit molecular or genetic testing results confirming sickle cell disease genotype.
Include chart notes or medical records documenting history of severe vaso-occlusive episodes (VOEs).
Specify prescriber specialty: must be prescribed by or in consultation with a hematologist or transplant specialist.

Prior Authorization

Hydroxyurea Failure/Intolerance Requirement

Member must have documented hydroxyurea (HU) failure, intolerance, or inability to tolerate HU prior to approval. If HU has not been tried or intolerance not documented, authorization may be denied.

Document trial of hydroxyurea with reason for discontinuation (lack of efficacy or intolerance), OR clinical rationale why HU cannot be used.

Key Definitions

Severe vaso-occlusive event (VOE) - components

Acute chest syndromeIncluded as an example of a severe vaso-occlusive event (VOE)

Acute pain event requiring medical facility visitPain event requiring a visit to a medical facility and administration of pain medications (opioids or IV NSAIDs) or red blood cell transfusion

Priapism >2 hours requiring medical facility visitPriapism lasting greater than 2 hours that requires a visit to a medical facility

Hepatic sequestrationListed as an example of a severe VOE

Splenic sequestrationListed as an example of a severe VOE

Background and Indication

Lyfgenia (lovotibeglogene autotemcel) is an autologous gene therapy for the treatment of sickle cell disease in appropriately selected patients. The policy aligns coverage with the FDA-indicated population and clinical evidence, restricts administration to a single lifetime treatment course, and notes that safety and efficacy beyond one dose have not been studied.