Humana Lantidra Form

. Related Medical/Pharmacy Coverage Policies Solid Organ Transplants Description Lantidra (donislecel) is an allogenic (deceased donor) pancreatic islet cellular therapy for the treatment of type 1 diabetes (T1D). It is composed of single donor pancreatic islet cells and is believed to function through the secretion of insulin from the donor islet beta cells. It is indicated for adults with T1D who are unable to approach target glycated hemoglobin (average blood glucose levels) because of current repeated episodes of severe hypoglycemia (low blood sugar) despite intensive diabetes management and education.5 The recommended minimum dose is 5,000 equivalent islet number (EIN)/kg for initial infusion and 4,500 EIN/kg for subsequent infusion in the same recipient. The maximum dose per infusion is dictated by the estimated tissue volume, which should not exceed 10 cc per infusion, and the total EIN present in the infusion bag (up to a maximum of 1 x 106 EIN per bag).3 Lantidra cell therapy is given as a single infusion into the hepatic portal vein, which may be repeated* if the initial dose is inadequate. Repeat intraportal Lantidra (donislecel) Page: 2 of 5 islet infusions are not recommended in an individual who has experienced prior portal vein thrombosis unless limited to second- or third-order portal vein branches. Diabetes mellitus (DM) is a complex endocrine disorder characterized by hyperglycemia (eg, abnormally high levels of glucose). DM usually occurs when the body does not produce enough insulin or cannot respond to the insulin in the body. T1D or insulin-dependent diabetes is an autoimmune disease that affects around 8 million people in the world. These individuals are prone to immediate life-threatening complications, including hypoglycemia and diabetic ketoacidosis (DKA).1 Conventional therapy for T1D includes exogenous insulin administered through several subcutaneous injections per day or via an insulin pump as well as self-monitoring or continuous monitoring of blood glucose with automatic monitoring technologies. Some individuals with T1D have difficulty controlling their blood glucose levels and may have episodes of severe hypoglycemia without feeling or having an awareness of symptoms. These episodes can negatively impact quality of life, require hospitalization and lead to death. Requests for Lantidra (donislecel) require review by a medical director. Coverage Determination Refer all requests or questions regarding Lantidra to the Corporate Transplant Department. Phone 866-421-5663 Fax 502-508-9300 Email transplant@humana.com Humana members may be eligible under the Plan for Lantidra (donislecel) when the following criteria are met: • Individual has T1D and is unable to approach target hemoglobin A1c due to one of the following despite intensive diabetes management and education: o Current repeated episodes of severe hypoglycemia; OR o Hypoglycemic unawareness (individual is unable to prevent repeated severe hypoglycemic events without intervention of a third party); AND • Individual is 18 through 65 years of age; AND • Absence of contraindications; AND • Individual will receive Lantidra at a certified treatment center; AND • Use Lantidra in conjunction with concomitant immunosuppression Lantidra (donislecel) Page: 3 of 5 *Infusion may be repeated when the individual meets all initial approval criteria AND has not achieved independence from exogenous insulin within one year of infusion OR within one year after losing independence from exogenous insulin after a previous infusion. Administration has not exceeded a maximum of 3 infusions (transplants). Note: The criteria for Lantidra (donislecel) are not consistent with the Medicare National Coverage Policy and therefore may not be applicable to Medicare members. Refer to the CMS website for additional information. If treatment is part of a clinical trial, please refer to Clinical Trials Medical Coverage Policy. Coverage Limitations Humana members may NOT be eligible under the Plan for Lantidra (donislecel) for any indications other than those listed above including, but may not be limited to: • Individual for whom immunosuppression is contraindicated; OR • Individual has desire to become pregnant/reproduce OR unwilling to use effective contraception; OR • Individual is pregnant or breastfeeding; OR • Liver disease (any condition that causes impaired function of the liver, such as hepatitis B or C); OR • Prior renal transplant; OR • Renal failure These are considered experimental/investigational as they are not identified as widely used and generally accepted for any other proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.