CurrentFidelis CarePolicy CP.MP.250

Lantidra (donislecel): Allogeneic Pancreatic Islet Cellular Therapy

Medical necessity criteria and coverage guidance for Lantidra (donislecel) for adult patients with type 1 diabetes who cannot reach target HbA1c due to recurrent severe hypoglycemia; intended for providers and payers within Fidelis Care/Centene-affiliated plans.

Policy Summary

PayerFidelis Care

PolicyLantidra (donislecel): Allogeneic Pancreatic Islet Cellular Therapy

Policy CodePolicy CP.MP.250

Change TypeRoutine review — no material change

Effective Date

Next Review DateJul 25, 2025

Key ActionObtain prior authorization and submit documentation supporting age, confirmed type 1 diabetes diagnosis, intensive management attempts, repeated severe hypoglycemia, planned immunosuppression, and intended infusion count (≤3).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥18minimum age for coverage

≤3max infusions allowed

30total pivotal enrollees

21insulin-free ≥1yr

Coverage and Medical Necessity Criteria

Initial Therapy

Covered when ALL of the following are met:

Initial coverage criteria

Member/enrollee is ≥ 18 years of age;
Diagnosis of type 1 diabetes;
Member/enrollee 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;

Policy Summary

PayerFidelis Care

PolicyLantidra (donislecel): Allogeneic Pancreatic Islet Cellular Therapy

Policy CodePolicy CP.MP.250

Change TypeRoutine review — no material change

Effective Date

Next Review DateJul 25, 2025

SourceLink

On This Page

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Provider Requirements, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Lantidra (donislecel) prior to administration. Submit authorization requests with clinical documentation supporting the medical necessity criteria and include appropriate billing guidance for unclassified biologics (e.g., HCPCS J3590) when applicable.

Prior authorization required before infusion
If billing with unclassified biologic code, consider HCPCS J3590 per payer billing instructions

Denial Risk

Denial/Coverage Risk if Criteria Not Met

Requests that do not meet all of the listed medical necessity criteria should be denied or considered not covered. All of the following must be documented and met for approval: age ≥ 18 years, confirmed diagnosis of type 1 diabetes, inability to achieve target HbA1c due to repeated severe hypoglycemia despite intensive diabetes management and education, plan for concomitant immunosuppression, no contraindicating comorbid conditions (including pregnancy), and limitation to no more than three infusions.

Denial recommended if any single criterion from I.A.–I.F. is not met
Maximum of three infusions — requests exceeding this should be denied

Documentation Required

Documentation Requirements for Authorization

Document and submit the following with the authorization request: patient age (≥18 years), confirmed diagnosis of type 1 diabetes (medical records or problem list), detailed history of recurrent severe hypoglycemia episodes despite intensive diabetes management, records of diabetes education and management efforts, evidence of the planned immunosuppression regimen to be used with the infusion, and relevant prior records to support safety (pregnancy status, comorbid conditions).

Age and diagnosis documentation
Detailed clinical history of recurrent severe hypoglycemia and failed intensive management
Records of diabetes education and management interventions
Planned immunosuppression regimen and safety assessments (pregnancy status, contraindications)
Previous treatment records as applicable

Step Therapy

Step Therapy Not Applicable

Step therapy is not applicable to this policy. Coverage decisions are based on meeting the specific medical necessity criteria enumerated in the policy rather than on a step therapy pathway.

Key Definitions

Lantidra (donislecel)

Therapy nameLantidra (donislecel)

Regulatory statusFDA-approved allogeneic pancreatic islet cellular therapy (approved June 2023)

Source materialProduced from deceased donor pancreatic islet cells (including beta cells)

AdministrationInfused into the hepatic portal vein

Intended useFor adult patients with type 1 diabetes unable to reach target HbA1c due to recurrent severe hypoglycemia

Severe hypoglycemia

DefinitionRecurrent episodes of severe hypoglycemia or hypoglycemia unawareness that prevent attainment of target HbA1c despite intensive diabetes management and education

Clinical relevanceUsed as a criterion for Lantidra when repeated severe hypoglycemia prevents safe insulin titration

Relation to managementIndicates failure to achieve glycemic targets despite intensive diabetes management and education

Clinical Background

Type 1 diabetes is characterized by insulin deficiency due to loss of pancreatic beta cells; intensive diabetes management including frequent glucose monitoring and education is standard care. Lantidra (donislecel) is an allogeneic pancreatic islet cell therapy intended for adult patients who, despite intensive management and education, experience repeated severe hypoglycemic episodes that prevent attainment of target HbA1c. The therapy is delivered by islet infusion and must be given with concomitant immunosuppression, with a limit of no more than three infusions per member.

Policy Revision History

2025-07-25Annual review / ApprovalLatest

Annual review: references reviewed and updated; policy approved on 07/25.

2024-07Annual review / Approval

Annual review: references reviewed and updated; reviewed and approved by external specialist (07/24 review and approval entries indicate activity in July 2024).

2024-02Criteria update / Approval

Removed maximum age requirement from Criteria I.A.; note about Medicare policy version added; approved in 02/24.

2023-08Policy development / Approval

Policy developed and approved in 08/23; initial policy development noted.

2023-06-28Regulatory milestone

FDA approved Lantidra (donislecel), the first cellular therapy to treat patients with type 1 diabetes (FDA announcement dated June 28, 2023).

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