Currentculinary health fundPolicy N/A

Lyfgenia (lovotibeglogene autotemcel) gene therapy — coverage criteria

Governs prior authorization, coverage criteria, dosing, and exclusions for Lyfgenia (autologous HSC-based gene therapy) for treatment of sickle cell disease patients age ≥12 years within the payer's medical benefit.

Policy Summary

Payerculinary health fund

PolicyLyfgenia (lovotibeglogene autotemcel) gene therapy — coverage criteria

Policy CodePolicy N/A

Change TypeClarified/revised verification, screening, and dosing

Effective DateN/A

Next Review DateFeb 11, 2026

Key ActionObtain prior authorization; approvals are one-time (per lifetime) for a single IV dose and provided for 1 year to allow preparation and administration.

SourceLink

POLICY UPDATE CHANGES

If claims history is available, verification is required for certain criteria; if not available the prescribing physician must confirm no prior gene therapy.

Viral/cellular screening language was revised to require negative screening for HIV-1 and -2 and HTLV-1 and -2 (changed from 'or').

Dosing language clarified to a minimum of 3 x 10^6 CD34+ cells/kg (one-time per lifetime).

≥12minimum eligible patient age

one-timelifetime dosing frequency

3 x 10^6 CD34+/kgrecommended minimum dose

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required severe VOEs prior

94%trial VOE resolution

Coverage Criteria

Prior hematopoietic stem cell transplantation is an explicit exclusion for Lyfgenia. Per policy, Lyfgenia has not been studied in patients who have received a prior allogeneic or autologous hematopoietic stem cell transplant, and treatment following any prior HSCT is therefore not recommended. The prescribing physician must confirm that the patient has not received a prior hematopoietic stem cell transplantation when requesting authorization.

Prior receipt of another gene therapy is also an explicit exclusion. The policy states that Lyfgenia has not been studied in patients who previously received gene therapy (for example, Casgevy/exagamglogene autotemcel), and treatment after prior gene therapy is not recommended. Requests outside the recommended authorization criteria, including these prior‑therapy situations, are subject to denial.

Use of Lyfgenia following a prior allogeneic or autologous hematopoietic stem cell transplant is considered not medically necessary. The document specifies that because Lyfgenia has not been studied in patients with prior HSCT, treatment in this context is not recommended and the prescribing physician must confirm absence of prior transplant when claims do not document it.

Coding and Dose Parameters

Codes referencedmixed

N/A	No explicit CPT/HCPCS/ICD codes listed in document

inv-05: Minimum CD34+ dose

Minimum CD34+ cellular doseOne-time (per lifetime) intravenous dose containing a minimum of 3 x 10^6 CD34+ cells per kg of body weight

Dose compositionA single dose may be composed of one or more infusion bag(s)

Dosing timingAdministered after patient undergoes mobilization, apheresis, and myeloablative conditioning

inv-06: Sickle hemoglobin threshold

Sickle hemoglobin targetSickle hemoglobin < 30% of total with total hemoglobin ≤ 11 g/dL at two timepoints (prior to mobilization and until initiation of conditioning)

Measurement timingThreshold must be confirmed at two separate timepoints as specified in criteria

PurposeRequirement to reduce circulating sickle hemoglobin prior to mobilization and conditioning

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior authorization required; one-time approval valid 1 year

Prior authorization is required for Lyfgenia; approvals are one-time (per lifetime) as a single IV dose. The approval duration is 1 year to allow adequate time to prepare and administer the one dose. If claims history is available, verification of certain criteria (including prior gene therapy) is required; verification of weight-based dosing is performed by a Medical Director as noted.

Approval is one-time (per lifetime) for a single IV dose.
Approval duration: 1 year to allow preparation and administration.
Verification in claims history required when available; Medical Director verifies weight-based dosing.

Step Therapy

Trial of ≥1 pharmacologic SCD therapy required

Patient must have tried at least one pharmacologic treatment for sickle cell disease prior to approval. Examples provided in the policy include hydroxyurea, L-glutamine, Adakveo (crizanlizumab-tmca), and Oxbryta (voxelotor).

Definitions

inv-12: VOE / severe VOE

VOE definitionA vaso-occlusive event (VOE) is an episode requiring evaluation at a medical facility: acute pain >2 hours without another cause; acute chest syndrome; acute hepatic sequestration; or acute splenic sequestration

Severe VOE — hospitalization criteriaSevere VOE is a VOE requiring hospitalization

Severe VOE — repeated visits criteriaOr multiple emergency department/urgent care visits over 72 hours requiring IV medications at each visit, or priapism requiring medical attention

Clinical documentationAt least four severe VOEs in the previous 2 years while on standard treatment are required for eligibility

Background

Lyfgenia (lovotibeglogene autotemcel) is an autologous, CD34+ hematopoietic stem cell gene therapy that uses a BB305 lentiviral vector to introduce a modified β‑globin (HbA T87Q) transgene into the patient’s own hematopoietic stem cells. The therapy is administered as a single intravenous dose following mobilization and apheresis of CD34+ cells and myeloablative conditioning (busulfan), with the goal of producing anti‑sickling hemoglobin to reduce vaso‑occlusive events.

Policy Summary

Payerculinary health fund

PolicyLyfgenia (lovotibeglogene autotemcel) gene therapy — coverage criteria

Policy CodePolicy N/A

Change TypeClarified/revised verification, screening, and dosing

Effective DateN/A

Next Review DateFeb 11, 2026

Key ActionObtain prior authorization; approvals are one-time (per lifetime) for a single IV dose and provided for 1 year to allow preparation and administration.

SourceLink

On This Page

Examples: hydroxyurea; L-glutamine; Adakveo (crizanlizumab-tmca infusion); Oxbryta (voxelotor).

Documentation Required

Provide chart notes, labs, genotype, weight, and prior treatment history

Required documentation may include chart notes, laboratory and medical test results, genetic testing confirming sickle cell genotype, prior treatment history, and current body weight obtained within 30 days. Documentation must also support infectious disease screening results and contraception/medication discontinuation as specified in the criteria.

Genetic testing documenting βS/βS, βS/β0, or βS/β+ genotype [documentation required].
Lab/test results: infectious disease screening (HIV‑1 and -2; Hepatitis B; Hepatitis C; HTLV‑1 and -2) and other labs as noted.
Current body weight obtained within 30 days [documentation required].
Prior treatment history, including trial of pharmacologic therapies and VOE history.

Denial Risk

Do not approve requests outside criteria (prior HSCT or prior gene therapy excluded)

Requests outside the Recommended Authorization Criteria are not recommended for approval. Specifically, patients with prior hematopoietic stem cell transplantation or prior receipt of gene therapy (e.g., Casgevy/exagamglogene autotemcel) are not recommended for treatment with Lyfgenia and may be denied.

Prior allogeneic or autologous HSCT: treatment with Lyfgenia is not recommended.
Prior receipt of gene therapy (e.g., Casgevy/exagamglogene autotemcel): treatment with Lyfgenia is not recommended.
Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria.