CurrentAmbetter NevadaPolicy CP.MP.250

Lantidra (donislecel): Allogeneic Pancreatic Islet Cellular Therapy

Defines medical necessity criteria and coverage considerations for Lantidra (donislecel) for treating adults with type 1 diabetes who cannot reach target HbA1c due to recurrent severe hypoglycemia; applies to Ambetter Nevada (Centene-affiliated) health plans.

Policy Summary

PayerAmbetter Nevada

PolicyLantidra (donislecel): Allogeneic Pancreatic Islet Cellular Therapy

Policy CodePolicy CP.MP.250

Change TypeNo material change

Effective Date

Next Review DateJul 25, 2025

Key ActionObtain prior authorization documenting that all medical necessity criteria are met before approval of Lantidra infusions.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥18minimum eligible age

up to 3maximum infusions allowed

30total enrollees (studies)

21insulin-independent ≥1 yr

J3590HCPCS referenced

Coverage / Medical Necessity Criteria

Medical Necessity Criteria

Covered when ALL of the following are met:

Initial coverage criteria for Lantidra: Member/enrollee is ≥ 18 years of age; diagnosis of type 1 diabetes; member is unable to approach target HbA1c due to current repeated episodes of severe hypoglycemia despite intensive diabetes management and education; therapy will be used in conjunction with concomitant immunosuppression; no more than three infusions will be given; member/enrollee does not have concomitant diseases or conditions, including pregnancy, that contraindicate the procedure for Lantidra infusion or immunosuppression.

Members with concomitant diseases or conditions that would contraindicate Lantidra infusion or the required concomitant immunosuppression are excluded from coverage. This includes, but is not limited to, pregnancy and any other medical condition that prevents safe administration of intrahepatic portal infusion or long‑term immunosuppressive therapy. Prior authorization will require documentation that no contraindicating comorbid condition or pregnancy is present before approval.

If the medical necessity criteria are not met, the request should be considered not medically necessary and routed accordingly. Examples include when the member is younger than 18 years, does not have a documented diagnosis of type 1 diabetes, is not experiencing repeated episodes of severe hypoglycemia despite intensive diabetes management and education, will not receive the required concomitant immunosuppression, or the request is for > three infusions. In these situations, deny coverage for Lantidra and direct the provider to continue or optimize intensive diabetes management and education; alternative referrals (endocrinology, diabetes education programs) should be used as appropriate.

Policy Summary

PayerAmbetter Nevada

PolicyLantidra (donislecel): Allogeneic Pancreatic Islet Cellular Therapy

Policy CodePolicy CP.MP.250

Change TypeNo material change

Effective Date

Next Review DateJul 25, 2025

Key ActionObtain prior authorization documenting that all medical necessity criteria are met before approval of Lantidra infusions.

SourceLink

On This Page

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Provider Requirements, Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests must document that all medical necessity criteria are met before approval.

Prior authorization required prior to scheduling infusion
Include documentation addressing each medical necessity criterion (age, diagnosis, hypoglycemia history, prior management, planned immunosuppression, infusion number limit)

Documentation Required

Prior Management Requirement

Member must have failed or be unable to achieve target HbA1c due to recurrent severe hypoglycemia despite intensive diabetes management and education. The member must be ≥ 18 years of age, have a diagnosis of type 1 diabetes, and be unable to reach target HbA1c because of repeated episodes of severe hypoglycemia. Therapy is intended to be used with concomitant immunosuppression and is limited to no more than three infusions.

Age ≥ 18 years
Documented diagnosis of type 1 diabetes
Documented intensive diabetes management and education attempts
Evidence that recurrent severe hypoglycemia prevents achieving target HbA1c
Plan for concomitant immunosuppression
Infusion limit: ≤ 3 total infusions

Denial Risk

Triggers for Denial

Common reasons for denial include missing or inadequate documentation of prior management and hypoglycemia history, ineligible age or diagnosis, lack of plan for immunosuppression, exceeding infusion limits, or contraindicating comorbid conditions (including pregnancy). Provide clear, dated clinical notes and relevant objective data to avoid denial.

Age < 18 years — not eligible
Diagnosis other than type 1 diabetes — not eligible
Insufficient documentation of recurrent severe hypoglycemia (e.g., unspecified episodes, no dates or clinical details)
No evidence of prior intensive diabetes management or education
No plan for concomitant immunosuppression
Request for > 3 infusions
Presence of contraindicating conditions (e.g., pregnancy, active infection, other contraindications to infusion or immunosuppression)

Key Definitions

Lantidra (donislecel) — product description

Product name (generic)Lantidra (donislecel)

DefinitionAn FDA‑approved allogeneic pancreatic islet cellular therapy produced from deceased donor pancreatic islet cells (including beta cells) intended to restore insulin production in adults with type 1 diabetes who have recurrent severe hypoglycemia and cannot achieve target HbA1c.

AdministrationInfused into the hepatic portal vein so infused islet cells can produce insulin and regulate blood glucose.

Adjunct therapy requirementMust be used in conjunction with concomitant immunosuppression to maintain graft viability.

Intensive diabetes management — definition and components

DefinitionCoordinated frequent blood glucose monitoring and insulin replacement tailored to meals and activity, combined with diabetes education.

Role in policyConsidered the standard of care for type 1 diabetes; Lantidra is considered only after intensive diabetes management fails to prevent recurrent severe hypoglycemia.

Clinical challenge addressedUsed when patients cannot manage hyperglycemia without causing hypoglycemia or have hypoglycemia unawareness despite intensive management and education.

OpenPayer

Lantidra (donislecel): Allogeneic Pancreatic Islet Cellular Therapy

Coverage / Medical Necessity Criteria

Coding and Quantity Limits

Provider Requirements, Authorization & Documentation

Key Definitions

Background and Clinical Context