| Medical Drug Policy Name | Revised Criteria |
|---|---|
| Exagamglogene autotemcel (Casgevy®) “Notification” (PDF) | For SCD indication: Added diagnostic confirmation criteria of either presence of significant quantities of HbS with or without an additional abnormal β-globin chain variant on hemoglobin assay OR molecular genetic testing showing biallelic HBB pathogenic variants with at least one allele as the p.Glu6Val pathogenic variant. Updated genotype-specific requirement to allow for prescriber submission of adequate written clinical rationale to support use of the requested agent for the patient's genotype and disease severity. Adjusted required trial and failure of hydroxyurea (HU) to specify uncontrolled disease despite treatment with HU or crizanlizumab at any point in the past. Added required discontinuation of any disease-modifying therapies for SCD at least 8 weeks prior to mobilization and conditioning. For TDT indication: Added diagnostic confirmation criteria of either sequence gene analysis showing biallelic HBB pathogenic variants OR presence of severe microcytic hypochromic anemia, absence of iron deficiency, anisopoikilocytosis with nucleated red blood cells on peripheral blood smear, and hemoglobin analysis that reveals decreased amounts or complete absence of HbA and increased HbA2 with or without increased amounts of HbF. Reformatted criteria for no history of iron overload to only apply to TDT indication and added LVEF < 45% as additional indication of iron overload. For all indications: Removed Karnofsky/Lansky performance status defining ability to undergo autologous HSCT. Adjusted formatting of criteria for no associated alpha-thalassemia and > 1 alpha chain deletion for clarity. Removed requirement of no CKD and added required assessment for renal impairment to ensure HSCT is appropriate (i.e., eGFR > 60 mL/min/1.73m2). Removed requirement of no pulmonary hypertension. Adjusted no cerebral vasculopathy requirement to only indicate no history or presence of Moyamoya disease putting patient at risk of bleeding. Adjusted no HBV criteria for clarity to allow for vaccinated patients (HBV surface antibody-positive) who are negative for other HBV markers (HBV core antibody-negative) and for past HBV exposure if patient is negative for HBV DNA. Adjusted HCV antibody-positive criteria with negative HCV RNA to undetectable viral load for clarity. Adjusted criteria for no immediate family members with a known or suspected Familial Cancer Syndrome to no history of Familial Cancer Syndrome. Added that no previous gene therapy requirement is for the requested and/or approved indications. Other minor updates made throughout policy for clarity. Policy notification given 10/15/2025 for effective date 12/15/2025. |
| Lovotibeglogene autotemcel (Lyfgenia®) “Notification” (PDF) | Added diagnostic confirmation criteria of either presence of significant quantities of HbS with or without an additional abnormal β-globin chain variant on hemoglobin assay OR molecular genetic testing showing biallelic HBB pathogenic variants with at least one allele as the p.Glu6Val pathogenic variant. Updated genotype-specific requirement to allow for prescriber submission of adequate written clinical rationale to support use of the requested agent for the patient's genotype and disease severity. Adjusted required trial and failure of hydroxyurea (HU) to specify uncontrolled disease despite treatment with HU or crizanlizumab at any point in the past. Added required discontinuation of any disease-modifying therapies for SCD at least 8 weeks prior to mobilization and conditioning. Removed Karnofsky/Lansky performance status defining ability to undergo autologous HSCT. Adjusted criteria to only apply to patients less than 18 years old for allogeneic HSCT candidate but no available suitable and willing 10/10 HLA-matched sibling hematopoietic-cell donor. Reformatted criteria for no history of iron overload to add LVEF < 45% as additional indication of iron overload. Adjusted no HBV criteria for clarity to allow for vaccinated patients (HBV surface antibody-positive) who are negative for other HBV markers (HBV core antibody-negative) and for past HBV exposure if patient is negative for HBV DNA. Adjusted HCV antibody-positive criteria with negative HCV RNA to undetectable viral load for clarity. Added that no previous gene therapy requirement is for the requested and/or approved indications. Other minor updates made throughout policy for clarity. Policy notification given 10/15/2025 for effective date 12/15/2025. |
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