Lantidra (donislecel): Allogeneic Pancreatic Islet Cellular Therapy

This policy covers Lantidra (donislecel), an allogeneic pancreatic islet cellular therapy for adults (≥18) with type 1 diabetes who cannot reach target HbA1c despite intensive management and education and who experience recurrent severe hypoglycemia or hypoglycemia unawareness and require lifelong insulin. Coverage is limited to one to three infusions (maximum three), requires initiation and continuation of concomitant immunosuppression, excludes patients with contraindicating conditions (including pregnancy), is supported by only two single-arm studies totaling 30 participants, and is subject to member benefit terms and applicable state/Medicaid rules.

"Lantidra (donislecel) for treatment of type 1 diabetes in patients who are unable to reach target hemoglobin A1c (HbA1c) despite standard therapy"

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