Pharmacy Prior Authorization Criteria

Lantidra (donislecel-jujn)

Indications for Prior Authorization

Lantidra (donislecel-jujn)

• For diagnosis of Type 1 diabetes
  Indicated for the treatment of adults with Type 1 diabetes who are unable to approach target HbA1c because of current repeated episodes of severe hypoglycemia despite intensive diabetes management and education. Use Lantidra in conjunction with concomitant immunosuppression.

  Limitations of Use: When considering the risks associated with the infusion procedure and long-term immunosuppression, there is no evidence to show a benefit of administration of Lantidra in patients whose diabetes is well-controlled with insulin therapy or patients with hypoglycemic unawareness who are able to prevent current repeated severe hypoglycemic events (neuroglycopenia requiring active intervention from a third party) using intensive diabetes management (including insulin, devices, and education). Repeated intraportal islet infusions are not recommended in patients who have experienced prior portal thrombosis, unless the thrombosis was limited to second- or third-order portal vein branches. There is no evidence to support the safe and effective use of Lantidra in patients with liver disease, renal failure, or who have received a renal transplant.

Criteria

Lantidra

Prior Authorization (Initial Authorization)

Length of Approval: One Time Approval

• Diagnosis of Type 1 diabetes
AND
• Patient has been insulin dependent for 5 years
AND
• Patient is unable to approach target HbA1c because of repeated episodes of severe hypoglycemia despite adherence to intensive diabetes management and education
AND
• Patient has reduced awareness of hypoglycemia, as defined by the absence of adequate autonomic symptoms at glucose levels of less than 54 mg/dL
AND
• Patient has had at least one episode of severe hypoglycemia in the past 3 years with both of the following:
• Patient required assistance of another person
AND
• One of the following:
• Symptoms were associated with a blood glucose level less than 54 mg/dL
OR
• Prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration
AND
• Patient will be on concomitant immunosuppression (e.g., daclizumab, sirolimus, tacrolimus, etanercept, mycophenolate mofetil, etc.) [2]
AND
• Prescribed by or in consultation with an endocrinologist

Lantidra

*There are no data regarding the effectiveness or safety for patients receiving more than three infusions.

Prior Authorization (Reauthorization)

Length of Approval: One Time Approval

• Patient has not achieved independence from exogenous insulin within one year of infusion or within one year after losing independence from exogenous insulin after previous infusion
AND
• Patient has not had more than three infusions of Lantidra in their lifetime*

P & T Revisions

2024-11-04, 2024-07-16, 2023-11-20

References

1. Lantidra Prescribing Information. CellTrans Inc. Chicago, IL. June 2023.
2. Qi, Meirigeng, et al. “Five-Year Follow-up of Patients with Type 1 Diabetes Transplanted with Allogeneic Islets: The UIC Experience.” Acta Diabetologica, U.S. National Library of Medicine, Oct. 2014, www.ncbi.nlm.nih.gov/pmc/articles/PMC4801517/.

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Revision History

• 2024-11-04: Annual review: No criteria changes.
• 2024-07-16: Updating requirement for patient to be insulin dependent for 5 years and updating glucose level of less than 54 mg/dL.
• 2023-11-20: New Program for Lantidra

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