Neighborhood Health Plan Lyfgenia Coverage

Coverage Criteria for Lyfgenia (lovotibeglogene autotemcel)

Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met:

Age: Patient is at least 12-50 years of age

Documentation: Submission of medical records (chart notes) related to diagnosis, step therapy, and genetic/mutational testing is REQUIRED

Provide documentation via PA web portal or fax

Pre-treatment evaluation and monitoring: Provider has considered prophylactic seizure therapy prior to myeloablative conditioning; patient will be monitored periodically for hematologic malignancies after treatment; avoid live vaccines while immunosuppressed; patient is HIV negative by non-PCR test prior to mobilization

PCR-based HIV assays may give false-positive results after Lyfgenia due to integrated proviral DNA

Contraindications and concurrent therapy: No history of hypersensitivity to dimethyl sulfoxide (DMSO) or dextran 40; patient will not receive specified concomitant therapies (hydroxyurea within 2 months prior to mobilization and until apheresis complete; myelosuppressive iron chelators 7 days prior to mobilization through 6 months post-treatment; disease-modifying agents for 2 months prior to mobilization; prophylactic ART stopped ≥1 month prior to mobilization; G-CSF mobilization; erythropoietin for 2 months prior to mobilization)

List of prohibited concomitant therapies is explicit in policy

Prior gene therapy and transplant eligibility: Patient has not received other gene therapy (e.g., Casgevy); is candidate for autologous HSCT with adequate organ function; does not have a known 10/10 HLA matched related donor willing to proceed with allogeneic HSCT; no prior HSCT

Requests for subsequent use after exagamglogene will be evaluated case-by-case

Transfusion and product compatibility: Patient will be transfused at least twice (once each month) prior to mobilization to reach target hemoglobin 8–10 g/dL (and <30% HbS); no contraindication to required products/procedures including plerixafor, busulfan, and red blood cell infusionHb 8-10 g/dL; <30% HbS

Treatment setting and prescriber: Treatment will occur at a manufacturer‑approved Qualified Treatment Center (QTC) and Lyfgenia is prescribed by or in consultation with a hematology specialist

Sickle cell diagnosis specifics: Confirmed diagnosis of sickle‑cell disease (includes genotypes βS/βS, βS/β0, or βS/β+) by hemoglobin assay or identification of biallelic HBB pathogenic variants with at least one p.Glu6Val allele; patient does NOT have disease with more than two alpha‑globin gene deletions

Disease severity: Patient has symptomatic disease despite treatment with hydroxyurea and formulary add‑on therapy and experienced ≥4 vaso‑occlusive events/crises (VOE/VOC) in the previous 24 months while adhering to therapy>=4 VOEs in prior 24 months

VOE/VOC defined as event requiring medical facility visit for evaluation resulting in diagnosis (acute pain, acute chest syndrome, splenic/hepatic sequestration, priapism >2 hours) and necessitating interventions such as opioids, NSAIDs, or RBC transfusion

Casgevy consideration: Patient has a contraindication to or is not indicated for Casgevy (exagamglogene autotemcel); subsequent use after exagamglogene will be evaluated on a case‑by‑case basis

MMP members who received this medication within past 365 days are not subject to Step Therapy requirements

General coverage criteria — follow FDA labeling, literature, prescriber supporting information

Covered when use follows FDA-approved labeling, relevant clinical literature, and prescriber provides supporting clinical information:

General coverage conditions: Use conforms to FDA‑approved labeling or relevant clinical literature

Criteria adopted by P&T committee; Neighborhood will give individual consideration to prescriber‑submitted information

Medicare‑Medicaid Plan exception: For INTEGRITY (Medicare‑Medicaid Plan) members, these criteria apply only in the absence of an applicable National Coverage Determination (NCD) or Local Coverage Determination (LCD)

Compliance with NCD/LCD overrides these criteria

Coverage exclusions include patients with a documented history of hypersensitivity to dimethyl sulfoxide (DMSO) or dextran 40. In addition, patients who have previously received another gene therapy (for example, Casgevy™ (exagamglogene autotemcel)) are excluded from standard approval; requests for subsequent use following prior gene therapy will be evaluated on a case‑by‑case basis.

Medicare-specific coverage may differ. National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), or Local Coverage Articles (LCAs) issued by CMS supersede these non‑Medicare coverage determinations where applicable. For INTEGRITY (Medicare‑Medicaid Plan) members, the plan’s criteria apply only in the absence of an applicable NCD or LCD; reviewers must comply with and refer to CMS coverage guidance as required.

Renewal is not applicable for this therapy. Lyfgenia is provided as a single treatment course and coverage cannot be renewed.

Use that is inconsistent with Food and Drug Administration (FDA)–approved labeling or the relevant clinical literature, or requests that lack supportive prescriber‑submitted clinical information, may be considered not medically necessary by the plan. Individual consideration will be given based on documentation provided by the prescriber and other information available to the plan.

Coding and Billing

Covered HCPCS CodesHCPCSCovered

J3394

injection, lovotibeglogene autotemcel, per treatment

NDCNDC

73554-1111xx

Lyfgenia NDC (20 mL infusion bag, frozen suspension)

Covered ICD-10 Diagnosis CodesICD-10Covered

D57.00	Hb-SS disease with crisis unspecified
D57.01	Hb-SS disease with acute chest syndrome
D57.02	Hb-SS disease with splenic sequestration
D57.03	Hb-SS disease with cerebral vascular involvement
D57.04	Hb-SS disease with crisis with other specified complication
D57.1	Sickle-cell disease without crisis
D57.20	Sickle-cell/Hb-C disease without crisis
D57.211	Sickle-cell/Hb-C disease with acute chest syndrome
D57.212	Sickle-cell/Hb-C disease with splenic sequestration
D57.213	Sickle-cell/Hb-C disease with cerebral vascular involvement

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Covered Diagnosis CodesICD-10Covered

D57.814	Other sickle-cell disorders with crisis with other specified complication
D57.819	Other sickle-cell disorders with crisis, unspecified

Medicare Part B Covered Diagnosis Codesmixed

No codes listed

Minimum CD34+ cells/kg

Minimum cellular doseMinimum recommended dose = 3 × 10^6 CD34+ cells/kg

Dose formSingle dose for infusion in one to four infusion bags containing CD34+ cell suspension

Indication contextDose specified for sickle-cell disease treatment with Lyfgenia

Provider Responsibilities and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required. Submission of medical records (chart notes) related to the medical necessity criteria is REQUIRED on all requests for authorizations. Records will be reviewed at the time of submission. Please provide documentation related to diagnosis, step therapy, and clinical markers (e.g., genetic and mutational testing) supporting initiation when applicable. Provide documentation via direct upload through the PA web portal or by fax.

Affected requests: all prior authorization submissions for this therapy
Required documentation: chart notes, diagnosis, prior therapy records (including hydroxyurea and formulary add‑on therapies), VOE/VOC event documentation, genetic/molecular testing, transplant candidacy evaluation

Documentation Required

Documentation Required for Review

Documentation submission required — medical records/chart notes are required on all authorization requests and will be reviewed with the initial request. Neighborhood will give individual consideration to each request based on the information submitted by the prescriber and other information available to the plan.

Background

Lyfgenia (lovotibeglogene autotemcel) is an autologous, CD34+ cell–enriched, lentiviral vector gene therapy indicated for patients with sickle cell disease and a history of vaso‑occlusive events. Approval and the plan’s coverage criteria are intended to align use with FDA‑approved labeling and relevant clinical literature; treatment is provided as a single infusion course administered at a manufacturer‑approved Qualified Treatment Center and prescribed by or in consultation with a hematology specialist. Key safety and programmatic considerations include pre‑treatment evaluation (e.g., consideration of seizure prophylaxis prior to myeloablative conditioning), requirement for transfusion management to achieve target hemoglobin and <30% HbS prior to mobilization, verification of HIV status by a non‑PCR test prior to mobilization (PCR assays may yield false positives after treatment), and monitoring for hematologic malignancies after infusion.

Definitions

VOE/VOC definition

DefinitionVOE/VOC = event requiring a visit to a medical facility for evaluation resulting in documented acute pain, acute chest syndrome, acute splenic or hepatic sequestration, or priapism lasting >2 hours

Required interventionsEvents necessitating subsequent interventions such as opioid pain management, non‑steroidal anti‑inflammatory drugs (NSAIDs), or red blood cell (RBC) transfusion

Setting for countVOEs counted toward eligibility must have occurred while the patient was adhering to hydroxyurea and formulary add‑on therapy (if applicable) in the prior 2 years

OpenPayer

Lyfgenia (lovotibeglogene autotemcel) — Coverage Criteria

Coverage Criteria for Lyfgenia (lovotibeglogene autotemcel)

Coding and Billing

Provider Responsibilities and Authorization Requirements

Background

Definitions