CurrentCignaPolicy N/A

Lyfgenia and Casgevy gene therapy prior authorization for sickle cell disease

Authorizations and documentation requirements for gene therapy (Lyfgenia, Casgevy) for sickle cell disease patients, including eligibility, clinical documentation, and billing/coding details; intended for providers seeking coverage through Cigna.

Policy Summary

PayerCigna

PolicyLyfgenia and Casgevy gene therapy prior authorization for sickle cell disease

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionRequest prior authorization using the gene therapy fax form (fax 833-910-1625) or contact the Cigna Gene Therapy Program and include required clinical documentation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥12minimum patient age specified

≥4vaso-occlusive crises threshold

Hgb ≤11 / Sickle Hgb <30%hematologic target

6 monthsreproductive precaution duration

Coverage Criteria for Lyfgenia and Casgevy

Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met:

Primary eligibility: Patient is ≥ 12 years of age; patient has not previously received Lyfgenia or Casgevy for sickle cell disease; prescribing physician deems hematopoietic stem cell transplantation appropriate; either no HLA-matched donor exists or a matched donor is unwilling/unable to donate.

Genotype requirement: Genetic testing documents ONE of: βS/βS, βS/β0, or βS/β+ genotype.

Other genotypes will be reviewed case-by-case by the Medical Director

Prior pharmacologic therapy: Patient has tried at least one pharmacologic treatment for sickle cell disease (examples include hydroxyurea, L-glutamine, crizanlizumab [Adakveo], or voxelotor [Oxbryta]) — documentation required.

Policy Summary

PayerCigna

PolicyLyfgenia and Casgevy gene therapy prior authorization for sickle cell disease

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionRequest prior authorization using the gene therapy fax form (fax 833-910-1625) or contact the Cigna Gene Therapy Program and include required clinical documentation.

SourceLink

On This Page

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Clinical severity: While receiving appropriate standard treatment, patient had at least four severe vaso-occlusive crises/events in the previous 2 years OR has one of the listed severe complications (acute chest syndrome, acute hepatic sequestration, acute splenic sequestration, or priapism >2 hours requiring a medical facility visit).>=4 events in 2 years

Exclusions - infections and comorbidities: Patient screening is negative for HIV-1/2, Hepatitis B, Hepatitis C, and HTLV-1/2; patient does not have clinically significant active infection, more than two alpha-globin gene deletions, advanced liver disease, prior or current malignancy or myeloproliferative disorder, or significant immunodeficiency.

Treatment prerequisites & conditioning: Patient will undergo mobilization, apheresis, and myeloablative conditioning; a hematopoietic stem cell mobilizer (e.g., plerixafor) will be used; busulfan will be used for myeloablative conditioning; sickle hemoglobin < 30% of total and total hemoglobin concentration ≤ 11 g/dL at both specified timepoints; specified medications will be discontinued by the prescribing physician prior to mobilization as indicated.Sickle Hgb < 30% and Hgb ≤ 11 g/dL

Reproductive precautions: Negative serum pregnancy test prior to each mobilization cycle and prior to myeloablative conditioning; effective contraception from start of mobilization through at least 6 months after administration for females and for males of reproductive potential.6 months

Patients with advanced liver disease are excluded from coverage. Examples of advanced liver disease that trigger exclusion include alanine transaminase (ALT) > 3 times the upper limit of normal, direct bilirubin > 2.5 times the upper limit of normal, baseline prothrombin time (INR) > 1.5 times the upper limit of normal, or diagnoses such as cirrhosis, bridging fibrosis, or active hepatitis.

Requests will be considered not medically necessary or non‑covered when required documentation or eligibility elements are missing. This includes absence of genetic testing documenting one of the required genotypes (βS/βS, βS/β0, or βS/β+) or lack of documentation that the patient has tried at least one pharmacologic treatment for sickle cell disease. Requests are also non‑covered when the patient has active, clinically significant infection or other disqualifying conditions (for example, more than two α‑globin gene deletions, severe immunodeficiency, or prior/current malignancy) as noted in the criteria.

Billing, Codes, and Clinical Markers

Cell Collection CPT CodesCPTCovered

96372	Therapeutic, prophylactic, or diagnostic injection; subcutaneous or intramuscular
38206	Blood-derived hematopoietic progenitor cell harvesting for transplantation, per collection; autologous

G-CSF and Mobilizer HCPCS/NDCHCPCSCovered

J2562	Injection, plerixafor, 1 mg (Mozobil)
J1442	Injection, filgrastim (G-CSF), excludes biosimilar, 1 mcg
J1447	Injection, tbo-filgrastim, 1 mcg
Q5101	Injection, filgrastim-sndz, biosimilar (Zarxio), 1 mcg
Q5110	Injection, filgrastim-aafi, biosimilar (Nivestym), 1 mcg

Conditioning Regimen HCPCSHCPCSCovered

J0594

Injection, busulfan, 1 mg

Requested Medication Identifiersmixed

HCPCS Code	Place for requested gene therapy HCPCS code
NDC	Place for requested gene therapy NDC

inv-08: Sickle hemoglobin proportion and hemoglobin concentration — lab thresholds at specified timepoints

Required hematologic targetsSickle hemoglobin < 30% of total hemoglobin AND total hemoglobin concentration ≤ 11 g/dL

Timing - first timepointAt the first specified timepoint prior to mobilization (documented)

Timing - second timepointAt the second specified timepoint prior to conditioning (documented)

inv-09: Vaso-occlusive event frequency — minimum events threshold in prior 2 years

Minimum events in prior 2 yearsAt least 4 severe vaso-occlusive crises or events in the previous 2 years

Context for eventsEvents must have occurred while receiving appropriate standard treatment for sickle cell disease

Documentation requiredMedical records documenting facility visits and therapies delivered during each event (e.g., IV opioid and/or IV NSAID)

Provider Responsibilities, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Gene therapy prior authorization is required. Fax completed form to the designated gene therapy fax (833) 910-1625. For urgent requests, contact the Cigna Gene Therapy Program at (855) 678-0051 or email GeneTherapyProgram@Cignahealthcare.com. Provide the completed Medication Request Detail form including ICD-10, HCPCS code, NDC (if applicable), indication/diagnosis, and whether request is new start or continuation.

Fax: (833) 910-1625
Urgent phone: (855) 678-0051
Email: GeneTherapyProgram@Cignahealthcare.com
Include Medication Request Detail: ICD-10, HCPCS code, NDC, indication, new start vs continuation

Documentation Required

Required Supporting Documentation

Documentation is required for all gene therapy requests. Missing or incomplete documentation is a common reason for denial. All documentation must include patient identifiers. Clinical documentation should demonstrate eligibility criteria and support medical necessity.

Acceptable documentation: chart notes, laboratory results, medical test results, claims records, prescription receipts, genetic testing reports
All documents must include patient-specific identifying information
Ensure screening test results (HIV-1/2, Hepatitis B, Hepatitis C, HTLV-1/2) and pregnancy tests (when applicable) are included

Step Therapy

Prior Pharmacologic and Disease-Modifying Therapy Requirements

Prior pharmacologic and disease-modifying therapy requirements must be met and documented before approval. Provide records showing prior treatments, duration of therapy, and response. If requirements are not met, provide clinical justification and rationale for medical necessity.

Documentation that the patient has tried at least ONE pharmacologic treatment for sickle cell disease (examples: hydroxyurea, L-glutamine, crizanlizumab/Adakveo, voxelotor/Oxbryta)
Evidence of disease-modifying therapies for at least 2 months (examples: hydroxyurea, Adakveo, L-glutamine, Oxbryta)
If applicable, documentation of erythropoietin for ≥ 2 months, iron chelation for ≥ 7 days, and prophylactic antiretrovirals for ≥ 1 month

Denial Risk

Documentation and Eligibility-Related Denial Triggers

Documentation and eligibility-related denial triggers — items that frequently lead to denials if absent or not met. Review these before submission to avoid avoidable denials.

Missing genetic testing confirming one of the required sickle cell genotypes (βS/βS, βS/β0, or βS/β+)
Patient age not meeting requirement (e.g., < 12 years when ≥ 12 required)
Prior receipt of the same gene therapy (e.g., Lyfgenia or Casgevy) documented
Lack of documentation of prior pharmacologic or disease-modifying therapies or insufficient duration of those therapies
Absent documentation of severe vaso-occlusive crises/events (≥4 in the previous 2 years) while on appropriate standard treatment, if required
Missing lab or screening results (HIV-1/2, Hepatitis B, Hepatitis C, HTLV-1/2), pregnancy test results when applicable, or documentation of contraceptive use for reproductive potential patients
No documentation that required mobilization, apheresis, myeloablative conditioning plans, or use of hematopoietic stem cell mobilizer and conditioning agents (e.g., busulfan) are in place when indicated
Missing facility/provider administration details (facility name, state, tax ID, address) and where medication will be obtained/administration setting

Key Definitions

inv-15: Severe vaso-occlusive crisis or event — definition and required care settings/therapies

Definition of severe vaso-occlusive crisis/eventAn episode of acute pain resulting in a visit to a medical facility that required administration of an intravenous opioid and/or intravenous NSAID; includes acute chest syndrome, acute hepatic sequestration, acute splenic sequestration, or priapism >2 hours requiring a facility visit

Acute chest syndrome criteriaNew pulmonary infiltrate plus pneumonia-like symptoms (e.g., chest pain, fever >99.5°F, tachypnea, wheezing or cough, or abnormal lung exam)

Acute hepatic/splenic sequestration criteriaHepatic: sudden increase in liver size with RUQ pain, abnormal LFTs not due to biliary disease, and hemoglobin drop ≥2 g/dL; Splenic: enlarged spleen, LUQ pain, and hemoglobin drop ≥2 g/dL

inv-16: Advanced liver disease — examples and lab thresholds

Examples of advanced liver diseaseAlanine transaminase (ALT) > 3 times upper limit of normal; direct bilirubin > 2.5 times upper limit of normal; baseline INR > 1.5 times upper limit of normal; cirrhosis; bridging fibrosis; or active hepatitis

Documentation requiredClinical documentation confirming the specific lab abnormalities or diagnoses (e.g., cirrhosis) is required

Exclusion consequencePresence of advanced liver disease excludes the patient from eligibility for therapy

Background

This form governs evaluation for autologous gene therapy (Lyfgenia or Casgevy) in patients with sickle cell disease. It specifies eligibility requirements including age (patient is ≥ 12 years), genotype documentation of one of the listed sickle cell genotypes, trial of at least one pharmacologic therapy, and documented clinical severity such as at least 4 severe vaso‑occlusive crises/events in the prior 2 years. The form also outlines preparatory steps (mobilization, apheresis, and myeloablative conditioning) and required clinical documentation to support prior authorization.