Donislecel-jujn (Lantidra) — Hepatic Portal Vein Islet Transplantation Coverage Criteria
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Defines medical necessity, approval criteria, and utilization limits for donislecel-jujn (Lantidra) hepatic portal vein islet transplantation for adults with type 1 diabetes with recurrent severe hypoglycemia; applies to Blue Cross NC members and providers.
Added applicable revenue codes 0891 and 0892 associated with policy HCPCS code(s).
Minor formatting updates to criteria throughout the policy.
Coverage and Medical Necessity Criteria
Initial Therapy — Covered when ALL of the following are met for initial infusion:
Covered when ALL of the following are met for initial infusion:
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Continuation Therapy / Subsequent Infusions — Covered when ALL of the following are met for continuation/subsequent infusion:
Covered when ALL of the following are met for continuation/subsequent infusion:
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Donislecel-jujn (Lantidra) administration is not recommended for patients who have active liver disease, renal failure, or a history of prior portal vein thrombosis (unless thrombosis was limited to second- or third-order portal vein branches). The policy also excludes patients with abnormal kidney or liver function as defined by any one of the following: creatinine clearance < 80 mL/min/1.73 m2, serum creatinine > 1.5 mg/dL, macroalbuminuria (>300 mg/24 hr), or baseline liver function tests > 1.5 times the upper limit of normal. Additional exclusionary conditions include increased bleeding risk, active infection (HBV, HCV, HIV, or tuberculosis), recent or active malignancy (except adequately treated basal/squamous skin cancer), pregnancy, and other concomitant diseases or conditions that contraindicate the transplant procedure or long-term immunosuppression.
Administration is not supported for patients whose diabetes is well-controlled with insulin therapy or for patients with hypoglycemia unawareness who are able to prevent repeated severe hypoglycemic events using intensive diabetes management (including insulin, devices, and education). The FDA labeling explicitly states there is no evidence of benefit for these populations when weighing the infusion and long-term immunosuppression risks.
Applicable Billing Codes and Clinical Thresholds
| 0891 | Revenue code - Special Processed Drugs - FDA Approved Cell Therapy |
| 0892 | Revenue code - Special Processed Drugs - FDA Approved Gene Therapy |
Prior Authorization, Documentation, and Denial Triggers
Prior authorization required; one infusion per authorization (365-day duration)
Prior authorization is required for donislecel-jujn (Lantidra). Authorizations are issued for one transplant infusion per authorization with a duration of 365 days; the policy limits a total maximum of 3 transplant infusions per patient lifetime. Documentation of the planned EIN dosing (minimum and maximum per infusion) is required with the authorization request.
- One transplant infusion authorized per authorization (Duration of Approval: 365 days).
- Total maximum of 3 transplant infusions per lifetime.
- Documentation of planned EIN dose required (initial ≥5,000 EIN/kg; subsequent ≥4,500 EIN/kg; not >1 x 10^6 EIN per infusion).
Prior intensive diabetes management required and documented
Before consideration for therapy, the patient must have attempted intensive diabetes management and education, including either continuous subcutaneous insulin infusion (insulin pump) or multiple daily injections plus intensive blood glucose monitoring (CGM or pump), documented in the medical record.
- Intensive insulin management: insulin pump or multiple daily injections of basal and mealtime insulin.
- Intensive blood glucose monitoring: continuous glucose monitor (CGM) or use of an insulin pump with monitoring.
- Documentation of prior education and management is required.
Required medical record documentation to support authorization
Medical record documentation must accompany the prior authorization and include: duration of Type 1 diabetes (>5 years), evidence of intensive insulin management and intensive glucose monitoring, history of severe hypoglycemia and reduced awareness, planned concomitant immunosuppression regimen, negative T- and B-cell crossmatch, and documentation of planned EIN dosing.
- Confirmed Type 1 diabetes duration >5 years.
- Evidence of intensive insulin management and intensive blood glucose monitoring (CGM or pump).
- At least one severe hypoglycemia episode in past 3 years and reduced awareness of hypoglycemia.
- Planned concomitant immunosuppression regimen.
- Negative T- and B-cell crossmatch assay results.
- Planned EIN dosing (initial ≥5,000 EIN/kg; subsequent ≥4,500 EIN/kg; maximum 1 x 10^6 EIN per infusion).
Denial triggers — exclusionary criteria and unmet eligibility
Requests will be denied if the member does not meet key eligibility criteria or has any exclusionary conditions, including age <18, insufficient duration of diagnosis or inadequate intensive management/monitoring, absence of qualifying severe hypoglycemia or reduced awareness, positive crossmatch or high PRA, dosing or lifetime infusion limits exceeded, or specified clinical exclusions (infection, abnormal liver/kidney function, high BMI, high insulin requirement, contraindicating comorbidities).
- Age under 18 years or diagnosis duration ≤5 years.
- No documentation of prior intensive insulin management or intensive glucose monitoring.
- No qualifying severe hypoglycemia episode in past 3 years and/or no reduced awareness of hypoglycemia.
- Positive T- or B-cell crossmatch or PRA >80%.
- C-peptide >0.3 ng/mL, insulin requirement >0.7 IU/kg/day with HbA1c >12%, or BMI >27 kg/m2.
- Abnormal kidney (CrCl <80 mL/min/1.73 m2 or serum creatinine >1.5 mg/dL) or liver function, active infection (HBV/HCV/HIV/TB), increased bleeding risk, recent malignancy (except treated basal/squamous skin cancer), pregnancy, inability to adhere, or other contraindicating comorbidities.
- Requested dose or number of infusions exceeding FDA labeled limits (e.g., >1 x 10^6 EIN per infusion or more than 3 infusions lifetime).
Clinical Definitions and Dosing Metrics
Clinical Background
Donislecel-jujn (Lantidra) is an allogeneic pancreatic islet cellular suspension intended for hepatic portal vein infusion in adults with type 1 diabetes who have recurrent severe hypoglycemia despite intensive diabetes management and require concomitant immunosuppression. Use carries procedural risks related to intraportal infusion and risks associated with long-term immunosuppression; repeated infusions are limited and not recommended for patients with prior portal thrombosis except in limited branch involvement.
Policy Revision History and Changes
Added applicable revenue codes 0891 (Special Processed Drugs - FDA Approved Cell Therapy) and 0892 (Special Processed Drugs - FDA Approved Gene Therapy); policy notification given 2026-02-01 for this effective date.
Minor formatting updates made to criteria throughout the policy for clarity.
Original medical policy criteria issued.
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