ModifiedPartners Insurance Company dba Jefferson Health PlansPolicy DR.021.C

Lyfgenia (lovotibeglogene autotemcel) for Sickle Cell Disease

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Coverage and prior authorization for one-time Lyfgenia gene therapy in eligible patients with sickle cell disease across Jefferson Health Plans lines of business; gene therapy is excluded for Individual and Family ACA products.

Policy Summary

PayerPartners Insurance Company dba Jefferson Health Plans

PolicyLyfgenia (lovotibeglogene autotemcel) for Sickle Cell Disease

Policy CodePolicy DR.021.C

Change TypeModified

Effective DateN/A

Last ReviewDec 17, 2025

Next Review DateN/A

Key ActionObtain prior authorization before administering Lyfgenia; approved requests allow 1 infusion over 18 months.

SourceLink

POLICY UPDATE CHANGES

The December 2025 version revised the prior authorization criteria, dosage and administration requirements, and monitoring sections.

The prior version added ICD-10 codes and additions to the FDA-approved indications and dosage and administration sections.

References were updated in the December 2025 ad-hoc review.

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ModifiedPartners Insurance Company dba Jefferson Health PlansPolicy DR.021.C

Lyfgenia (lovotibeglogene autotemcel) for Sickle Cell Disease

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Sign up for partners_insurance_company_dba_jefferson_health_plans Policy DR.021.C alerts

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Policy Summary

PayerPartners Insurance Company dba Jefferson Health Plans

PolicyLyfgenia (lovotibeglogene autotemcel) for Sickle Cell Disease

Policy CodePolicy DR.021.C

Change TypeModified

Effective DateN/A

Last ReviewDec 17, 2025

Next Review DateN/A

Key ActionObtain prior authorization before administering Lyfgenia; approved requests allow 1 infusion over 18 months.

SourceLink

POLICY UPDATE CHANGES

The December 2025 version revised the prior authorization criteria, dosage and administration requirements, and monitoring sections.

The prior version added ICD-10 codes and additions to the FDA-approved indications and dosage and administration sections.

References were updated in the December 2025 ad-hoc review.

12+ yearsFDA-labeled minimum age

1 infusionAuthorization quantity

18 monthsAuthorization approval period

3 × 10^6 cells/kgMinimum recommended dose

ExcludedACA gene therapy benefit status

28/32Study VOE resolution

Coverage Criteria

General initial therapy

Covered as medically necessary when ALL of the following apply:

General coverage requirements

Required criteria
- Lyfgenia (lovotibeglogene autotemcel) is prescribed for an indication included in the U.S. Food and Drug Administration (FDA)-approved package labeling.
- The member is within the age range specified in FDA-approved package labeling.
- The prescribed dose and number of treatments are consistent with FDA-approved package labeling.
- Lyfgenia is prescribed by a specialist at a qualified Lyfgenia treatment center.
- The member does not have a contraindication to the prescribed medication.
- The member is clinically stable for transplantation based on the prescriber's assessment.

Sickle cell disease-specific criteria

For sickle cell disease, ALL of the following apply:

Sickle cell disease requirements

The member has sickle cell disease confirmed by genetic testing.
ONE of
- The member has a history of vaso-occlusive episodes, such as pain crises, acute chest syndrome, splenic sequestration, or priapism, that required a medical facility visit, including an emergency department or hospital visit.
- The member is currently receiving chronic transfusion therapy for recurrent vaso-occlusive episodes.

Gene therapy is excluded and non-covered for Individual and Family (ACA) product lines. This exclusion applies even when other policy criteria may be met.

Off-label use is not applicable under this policy. Coverage is limited to FDA-approved indications and FDA labeling.

Billing and Coding

HCPCS codeHCPCS

J3394

Injection, lovotibeglogene autotemcel, per treatment

ICD-10 diagnosis codesICD-10

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 dactylitis
D57.09	Hb-SS disease with crisis with other specified complication

Minimum Lyfgenia Dose

Dose basisBased on the number of CD34+ cells in the infusion bag(s) per kg of body weight.

Minimum recommended dose3 × 10^6 CD34+ cells/kg.

Cell typeCD34+ cells.

Neutrophil Engraftment

ANC thresholdAbsolute neutrophil count (ANC) ≥ 0.5 × 10^9 cells/L.

Consecutive resultsThree consecutive ANC values are required.

Timing

Provider Requirements and Authorization

Prior Authorization

Prior Authorization and Approval Duration

Prior authorization is required for Lyfgenia (lovotibeglogene autotemcel). Approved requests are authorized for one infusion within an 18-month approval period.

Approval duration: 18 months
Approved quantity: 1 infusion

Documentation Required

Specialist and Qualified Treatment Center

Lyfgenia must be prescribed by a specialist and administered at a qualified treatment center. The prescriber must also assess that the member is clinically stable for transplantation and does not have a contraindication to the medication.

Specialist prescribing is required.
Administration must occur at a qualified Lyfgenia treatment center.

Clinical Background

Sickle cell disease is an inherited hemoglobin disorder in which sickled red blood cells can obstruct blood flow, causing vaso-occlusive events, pain, organ injury, and other serious complications. Lyfgenia is a one-time autologous gene therapy that modifies the patient's hematopoietic stem cells to add functional βA-T87Q-globin, with the goal of reducing hemoglobin S polymerization and red blood cell sickling. Treatment includes stem cell mobilization and apheresis, myeloablative conditioning, and intravenous infusion of the manufactured cells.

Key Definitions

Gene Therapy

DefinitionIntroduction, removal, or change in the content of a person's genetic code with the goal of treating or curing a disease.

Included mechanismGene transfer.

Included mechanismsGene-modified cell therapy and gene editing.

Vaso-Occlusive Event (VOE)

Operational definitionAn event requiring evaluation at a medical facility.

Acute pain criterionAcute pain with no medically determined cause other than vaso-occlusion, lasting more than 2 hours.

Other qualifying events

Initial Therapy

Initial therapy

Initial treatment may be considered medically necessary when ALL of the following criteria are met:

Initial Lyfgenia treatment requirements

Lyfgenia is used for an indication included in FDA-approved package labeling.
The member is age-appropriate according to FDA-approved package labeling.
The prescribed dose and number of treatments are consistent with FDA-approved package labeling.
Lyfgenia is prescribed by a specialist at a qualified Lyfgenia treatment center.
The member does not have a contraindication to the prescribed medication.

Quantity and Duration Limits

Quantity Limit

ProductLyfgenia (lovotibeglogene autotemcel).

Quantity1 infusion.

Approval periodApproved for 18 months.

Administration Site

Billing Rule

Administer through a qualified treatment center

For hospital outpatient administration, Lyfgenia must be prescribed by a specialist and administered through a qualified Lyfgenia treatment center.

Policy Summary

PayerPartners Insurance Company dba Jefferson Health Plans

PolicyLyfgenia (lovotibeglogene autotemcel) for Sickle Cell Disease

Policy CodePolicy DR.021.C

Change TypeModified

Effective DateN/A

Last ReviewDec 17, 2025

Next Review DateN/A

Key ActionObtain prior authorization before administering Lyfgenia; approved requests allow 1 infusion over 18 months.

SourceLink

On This Page

Values must be obtained on different days by Day 43 after infusion.

The member must be clinically stable for transplantation based on the prescriber's assessment.

The member must not have a contraindication to the prescribed medication.

Documentation Required

Required Clinical Documentation

Submit clinical documentation supporting the requested indication and demonstrating that the request meets FDA-approved labeling and provider requirements.

FDA-approved indication
Age appropriateness under FDA-approved labeling
Dose and number of treatments consistent with FDA-approved labeling
Prescribing specialist and qualified treatment-center qualifications

Documentation Required

Sickle Cell Disease Documentation

For treatment of sickle cell disease, document confirmatory genetic testing and qualifying disease history.

Sickle cell disease confirmed by genetic testing
A history of vaso-occlusive episodes requiring a medical facility visit, such as for pain crises, acute chest syndrome, splenic sequestration, or priapism; or current chronic transfusion therapy for recurrent vaso-occlusive episodes

Unsupported block type: denial_risk子тоoolong?

Denial Risk

Failure to Meet Prior Authorization Criteria

Prior authorization may be denied when the request does not satisfy the applicable clinical criteria, including the required indication, age, dose, treatment count, provider, treatment-center, safety, stability, or sickle cell disease documentation requirements. If the criteria are not met, a physician reviewer may nevertheless approve the request when, in the reviewer's professional judgment, the service is medically necessary to meet the beneficiary's medical needs.

Indication is not included in FDA-approved labeling
Age, dose, or number of treatments is inconsistent with FDA-approved labeling
Prescriber is not a specialist or the treatment center is not qualified
The member has a contraindication or is not clinically stable for transplantation
Required sickle cell disease genetic confirmation or qualifying vaso-occlusive episode/transfusion history is not documented
A physician reviewer may approve an otherwise nonqualifying request when the service is judged medically necessary for the beneficiary

Denial Risk

Off-Label Indication Not Covered

Coverage is limited to use consistent with Lyfgenia's FDA-approved package labeling. Off-label indications are not supported for coverage.

Use must be for an FDA-approved indication.
Off-label use is not supported.

Acute chest syndrome, acute hepatic sequestration, or acute splenic sequestration.

Severe Vaso-Occlusive Event (sVOE)

Hospitalization criterionA VOE requiring hospitalization.

Acute-care criterionMultiple emergency department or urgent-care visits over 72 hours, with intravenous medication received at each visit.

Priapism criterionPriapism requiring any level of medical attention.

The member is clinically stable for transplantation based on the prescriber's assessment.

For sickle cell disease

The member has sickle cell disease with confirmatory genetic testing.
ONE of the following
- The member has a history of vaso-occlusive episodes, such as pain crises, acute chest syndrome, splenic sequestration, or priapism, that required a medical facility visit, including an emergency department or hospital visit.
- The member is currently receiving chronic transfusion therapy for recurrent vaso-occlusive episodes.