Medical Drug Criteria (MDC)

Policy Num:       P1.002.018
Policy Name:     LANTIDRA (Donislecel)
Policy ID:          [P1.002.018] [Ac/ L / M / P+ ]

Last Review:       September 22, 2025
Next Review:      September 20, 2026
 

Related MDC: NONE

LANTIDRA (Donislecel)

Summary

Lantidra (donislecel-jujn) is an allogeneic pancreatic islet cell therapy approved by the FDA in June 2023. It is indicated for the treatment of adults with type 1 diabetes who are unable to achieve target HbA1c due to recurrent severe hypoglycemia and who have hypoglycemia unawareness despite intensive insulin therapy. It is the first FDA-approved allogeneic islet cell product. Therapy involves one or more infusions of islet cells into the hepatic portal vein, requiring lifelong immunosuppression.

Policy Statements

Initiation of LANTIDRA (Donislecel) meets the definition of medical necessity when all the criteria below are met.

Covered for adult patients with type 1 diabetes mellitus who meet FDA-approved indication criteria. 

Limited to specialized islet transplantation centers with expertise in cellular therapy and transplant immunology.

Requires prior authorization and medical necessity documentation.

Not intended for routine type 1 diabetes management or patients controlled on insulin therapy.

Policy Guidelines

1. Member is 18 years of age or older

2. Diagnosis of type 1 diabetes mellitus

3. Unable to achieve target HbA1C goal despite both of the following (“a” and “b”): – documentation from the medical record and/or lab tests must be provided

a. Intensive insulin management that includes coordination of diet and activity with physiologic insulin replacement (i.e., multiple daily injections of prandial and basal insulin or continuous subcutaneous insulin infusion)

b. Intensive monitoring of blood glucose with either use of a continuous glucose monitor (CGM) or insulin pump

4. History of severe hypoglycemia as defined by both of the following (“a” and “b”): - documentation from the medical record and/or lab tests must be provided

a. Reduced awareness of hypoglycemia, defined by the absence of adequate autonomic symptoms (e.g., palpitations, anxiety, sweating, confusion, sensation of warmth, weakness or fatigue, severe cognitive failure) at a plasma glucose levels of less than 54 mg/dL

b. One or more episodes of severe hypoglycemia in the past 3 years which necessitated assistance from another person and was associated with either a blood glucose level less than 50 mg/dL or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration

5. Member does not have ANY of the following:

a. Previous renal transplant

b. Positive T- and B-cell crossmatch between recipient serum and donor lymphocytes that indicates high risk for transplant rejection

c. Renal disease defined as recent (within the last 30 days) creatinine clearance less than 80 mL/min/1.73 m2, serum creatinine greater than 1.5 mg/dL, or macroalbuminuria (urinary albumin excretion rate greater than 300 mg/24 hours)

d. Recent (within the last 30 days) liver function test panel with any value > 1.5 times normal upper limits

e. Increased risk of bleeding as defined by recent (within the last 30 days) hemoglobin (Hb) less than 12 gm/dL in women or less than 13 gm/dL in men, uncorrectable bleeding diathesis, use of coumadin or other antiplatelet or anticoagulant therapy, prothrombin time (PT) international normalized ratio (INR) > 1.5, or history of Factor V deficiency

f. History of prior portal vein thrombosis, excluding thrombosis of 2nd or 3rd order portal vein branches

g. Active infection such as hepatitis C, hepatitis B, HIV, or tuberculosis

h. Malignancies (with the exception of adequately treated basal or squamous cell carcinoma of the skin)

6. Donislecel (Lantidra) will be prescribed in combination with immunosuppressive therapy

7. Prescribed by a specialist who conducts islet cell transplantation such as an endocrinologist,hematologist, or hepatologist

8. The initial infusion of donislecel (Lantidra) will not exceed 5,000 equivalent islet number (EIN) per kg patient body weight.

DOSAGE/ADMINISTRATION

The recommended minimum dose is 5,000 equivalent islet number (EIN) per kg patient body weight for the initial infusion (transplant) and 4,500 EIN/kg for subsequent infusions, and the estimated tissue volume should not exceed 10 cc per transplant infusion.

Route: Intraportal infusion of allogeneic pancreatic islet cells.

Dosing: Variable – patients may require one or more infusions to achieve adequate glycemic control.

Concomitant therapy: Lifelong immunosuppression is required to maintain graft survival and function.

Infusion performed by interventional radiology into the hepatic portal vein.

Monitoring includes blood glucose, HbA1c, and C-peptide levels, as well as immunosuppressive drug levels.

REQUIRED MEDICAL INFORMATION

Diagnosis of type 1 diabetes.

Documentation of recurrent severe hypoglycemia (events requiring third-party assistance) or hypoglycemia unawareness.

Records of inadequate response to optimized insulin therapy (including pump and/or CGM use).

Screening results for infectious disease, hepatic function, and immune system evaluation.

Patient informed consent regarding risks of immunosuppression and transplant procedures.

EXCLUSION CRITERIA

Patients with type 2 diabetes or secondary diabetes.

Patients with adequate glycemic control on insulin therapy. 

Contraindications to long-term immunosuppressive therapy.

Significant active infection, malignancy, or severe comorbidities.

Hepatic disease preventing safe portal vein infusion.

BENEFIT APPLICATION

OTHER CRITERIA

None

Practice Guidelines and Position Statements

FDA: Approved Lantidra based on clinical trials demonstrating reduction in severe hypoglycemia events and insulin independence in some patients.

American Diabetes Association (ADA) and Endocrine Society recognize islet transplantation as an option for select patients with life-threatening hypoglycemia unawareness.

International Pancreas and Islet Transplant Association (IPITA) supports islet allotransplantation for brittle diabetes unresponsive to standard therapy.

Medicare National Coverage

As of 2024, no formal National Coverage Determination (NCD) specific for Lantidra. 

References

1. FDA Press Release – Approval of Lantidra (June 28, 2023).

2. Lantidra Prescribing Information (CellTrans, Inc.).

3. ClinicalTrials.gov – Islet cell transplantation trials in type 1 diabetes.

4. American Diabetes Association – Standards of Care in Diabetes 2024.

5. Endocrine Society Clinical Practice Guidelines on hypoglycemia.

6. IPITA Consensus Statement on islet transplantation.

Codes

Applicable Modifiers

Policy History