CurrentAvMedPolicy Pub. 100-2

Lantidra (donislecel) IV prior authorization

Defines prior authorization and step-edit requirements for Lantidra (donislecel) IV infusion for AvMed members, including clinical criteria, dosing limits, and documentation needed from prescribers and facilities.

Policy Summary

PayerAvMed

PolicyLantidra (donislecel) IV prior authorization

Policy CodePolicy Pub. 100-2

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionPrescribing physician must sign the prior authorization request and submit required clinical documentation including chart notes, labs, and crossmatch results.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1/yearinitial authorization dosing frequency

Max 3lifetime/plan limit

≥5000 EIN/kgmin initial dose

≥18min member age

Coverage Criteria for Lantidra (donislecel)

Initial Authorization Criteria

Covered when ALL of the following are met for initial authorization (12 months, 1 infusion bag yearly):

Prescriber and age: Prescribed by or in consultation with an endocrinologist AND member is 18 years of age or older

Diagnosis duration and treatment: Confirmed diagnosis of type 1 diabetes mellitus for >5 years complicated by disease despite intensive insulin management AND intensive glucose monitoring

Intensive insulin management includes coordination of diet/activity with physiologic insulin replacement (multiple daily injections or continuous subcutaneous insulin infusion); intensive monitoring includes use of a continuous glucose monitor (CGM) or insulin pump; must submit chart notes and labs.

Severe hypoglycemia criteria: One or more episodes of severe hypoglycemia in the past 3 years requiring assistance and associated with either blood glucose <50 mg/dL or prompt recovery after oral carbohydrate/IV glucose/glucagon OR reduced awareness of hypoglycemia defined by absence of autonomic symptoms at plasma glucose <54 mg/dL

Policy Summary

PayerAvMed

PolicyLantidra (donislecel) IV prior authorization

Policy CodePolicy Pub. 100-2

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionPrescribing physician must sign the prior authorization request and submit required clinical documentation including chart notes, labs, and crossmatch results.

SourceLink

On This Page

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Immunosuppression and crossmatch: Lantidra will be prescribed in combination with immunosuppressive therapy AND member is T- and B-cell crossmatch assay negative

Verify immunosuppressive therapy by chart notes and/or pharmacy paid claims; note that positive T- and B-cell crossmatch may increase risk for graft infections.

Transplant risk and contraindications: No prior transplant or evidence of sensitization on Panel Reactive Antibody (PRA) indicating high transplant rejection risk; no concomitant disease or condition (including pregnancy) that contraindicates infusion or immunosuppression; no history of prior portal vein thrombosis (excluding 2nd/3rd order branch thrombosis); no history of liver disease or renal failure; no active infection; member will not receive live vaccines during immunosuppression

Product administration may elevate PRA and affect renal transplant candidacy; provide chart notes and labs.

Reauthorization Criteria

Reauthorization (12 months; 1 infusion bag yearly; maximum of 3 infusions) criteria — all must be met:

Continuation of initial criteria: Member continues to meet all initial authorization criteria

All supporting documentation (labs, diagnostics, chart notes) must be provided.

Prior approval by other plan: Member has received authorization/reauthorization for the requested agent previously approved by another health plan in the past 2 years

Must submit documentation of a health plan paid claim during the last 2 years and clinical chart notes.

Tolerability and outcomes: Member has not experienced unacceptable toxicity from the drug (e.g., severe infections, portal vein thrombosis, portal hypertension, islet graft rejection) AND member has not achieved or has lost independence from exogenous insulin and continues to experience severe hypoglycemia requiring intervention or hospitalization

Must submit chart notes and labs.

Adherence: Member is adherent to prescribed immunosuppressive therapy

Verify adherence via chart notes or pharmacy paid claims.

Second or third infusion rationale: Second infusion may be requested for failure to achieve insulin independence within 1 year; third infusion may be requested using the same criteria as the second; no evidence supports >3 infusions

If applicable, provider must check request for second or third infusion and provide supporting documentation.

Patients with a positive T- and B-cell crossmatch between recipient serum and donor lymphocytes are considered at increased risk for graft-related complications, including graft infection and sensitization that may jeopardize future transplant candidacy. The policy therefore requires a negative T- and B-cell crossmatch/PRA and absence of prior sensitization (high PRA) as part of eligibility for Lantidra administration; documentation of these results must be submitted with the prior authorization request.

The use of manufacturer or office samples to initiate Lantidra therapy does not meet AvMed's step-edit or preauthorization criteria. Prior authorization requests must reflect actual prior therapies and exposures, which will be verified through pharmacy paid claims or submitted chart notes.

Coding and Dose Limits

Affected HCPCSHCPCS

J3590

Unclassified biologics (used here for Lantidra)

inv-06: Minimum initial islet dose — >= 5000 EIN/kg

Minimum initial islet dose>= 5000 EIN/kg (recommended minimum for initial infusion)

ContextApplies to initial infusion (transplant) as the recommended minimum dose

Documentation requirementDose and clinical indications must be supported by chart notes and labs for prior authorization

inv-07: Subsequent infusion dose — >= 4500 EIN/kg

Subsequent infusion dose>= 4500 EIN/kg (recommended minimum for subsequent infusions)

ContextUsed for second or third infusion when criteria for reauthorization are met

Limit on number of infusionsPolicy allows up to 3 infusion bags total (1 infusion bag yearly)

inv-08: Maximum EIN per bag per year — <= 1 x 10^6 EIN

Maximum EIN per bag per year<= 1 x 10^6 EIN per infusion bag per year

Annual and lifetime limitsMaximum 1 infusion bag yearly; up to 3 infusions total per policy

Packaging noteLantidra supplied as two infusion bags; one contains up to 1x10^6 EIN in 400 mL transplant media

Provider Responsibilities and Authorization Process

Prior Authorization

Prior Authorization Required

Prior Authorization Required — The prescribing physician must sign and clearly print their name on the prior authorization/step-edit request (preprinted stamps are not valid). Fax the completed form to 1-844-668-1550. If information provided is incomplete, incorrect, or illegible, authorization can be delayed or denied.

Drug requested: Lantidra (donislecel) IV (J3590) (Medical)
Fax number for submission: 1-844-668-1550

Documentation Required

Required Documentation and Signatures

Required documentation must be submitted with the request. To support each criterion checked on the form, provide clinical documentation including chart notes, laboratory results, diagnostics, and pharmacy paid claims when applicable. For reauthorization, include documentation of prior health-plan paid claims if the agent was previously approved by another plan within the past 2 years.

Submit chart notes demonstrating diagnosis and previous intensive insulin management
Provide lab results (e.g., HbA1c, infection screening, T- and B-cell crossmatch assays)
Provide pharmacy paid claims to verify prior therapies and immunosuppressive regimen when applicable
For reauthorization after prior plan approval, include proof of a health plan paid claim within the last 2 years

Documentation Required

Samples and Verification

Samples do not meet preauthorization/step-edit criteria. Initiation of therapy with sample medication will not satisfy the requirement for prior authorization. The plan will verify previous therapies through pharmacy paid claims or submitted chart notes.

Samples cannot be used to fulfill prior authorization or step-edit requirements
Previous therapies will be verified via pharmacy paid claims or chart notes

Background

Lantidra (donislecel) is an allogeneic islet cell product supplied in infusion bags and administered via infusion into the hepatic portal vein for adults with complicated type 1 diabetes. It is given in combination with immunosuppressive therapy and must be performed by experienced interventional teams. The policy defines dosing and administration requirements (including minimum islet doses per kilogram and limits per bag/year), requires that patients be managed with appropriate monitoring and immunosuppression, and sets prior authorization and documentation requirements for prescribers and facilities.

Definitions

inv-14: Equivalent Islet Number (EIN) — Unit used to express islet dose; policy specifies minimum and maximum EIN per kg and per bag.

DefinitionEquivalent Islet Number (EIN) — unit used to express islet dose

Dose usePolicy specifies EIN-based dosing thresholds: minimums per kg for initial and subsequent infusions and a maximum EIN per bag per year

Product packagingLantidra is supplied as infusion bags containing up to 1x10^6 EIN in 400 mL transplant media

Administration siteEIN-based product must be infused into the hepatic portal vein by experienced interventional teams