CurrentFidelis CarePolicy MC.CP.MP.250

Lantidra (donislecel): Allogeneic pancreatic islet cellular therapy

Medical necessity criteria for coverage of Lantidra (donislecel) for adults with type 1 diabetes who cannot reach target HbA1c due to recurrent severe hypoglycemia despite intensive diabetes management; governs health plans affiliated with Centene Corporation.

Policy Summary

PayerFidelis Care

PolicyLantidra (donislecel): Allogeneic pancreatic islet cellular therapy

Policy CodePolicy MC.CP.MP.250

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document that the member has recurrent severe hypoglycemia despite intensive diabetes management and that an immunosuppression plan and contraindication assessment are in place.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥18Minimum age for coverage

≤3Maximum number of infusions allowed

30Total subjects in studies cited

Medical Necessity Criteria for Lantidra (donislecel)

Medically necessary

Lantidra (donislecel) is medically necessary when ALL of the following are met:

Policy Summary

PayerFidelis Care

PolicyLantidra (donislecel): Allogeneic pancreatic islet cellular therapy

Policy CodePolicy MC.CP.MP.250

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

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ALL of the following

Member/enrollee is ≥ 18 years of age>= 18 years
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
Requires documented history of recurrent severe hypoglycemia and prior intensive diabetes management and education
Therapy will be used in conjunction with concomitant immunosuppression
Immunosuppressive medication must be taken prior to and continued after infusion
No more than three infusions will be given<= 3 infusions
Member/enrollee does not have concomitant diseases or conditions, including pregnancy, that contraindicate the procedure for Lantidra infusion or immunosuppression
Contraindications include pregnancy and other conditions making infusion or immunosuppression unsafe

Documentation, Prior Authorization, and Administrative Requirements

Documentation Required

Document failure of intensive diabetes management

Provider must document that the member has recurrent severe hypoglycemia and has undergone intensive diabetes management and education without achieving target HbA1c.

Documentation of repeated episodes of severe hypoglycemia requiring assistance or preventing target HbA1c
Records of prior intensive diabetes management and education efforts

Documentation Required

Document immunosuppression plan

Provider must document that Lantidra will be used with concomitant immunosuppression and that immunosuppressive therapy will be started prior to infusion and continued after the infusion to maintain viability of implanted islet cells.

Plan showing immunosuppressive medication initiation prior to Lantidra infusion
Plan showing scheduled continuation of immunosuppression post-infusion

Prior Authorization

Prior authorization implied by policy

Prior authorization should be obtained and the provider must supply evidence demonstrating that all medical necessity criteria are met.

Member is ≥ 18 years of age
Diagnosis of type 1 diabetes
Documented recurrent severe hypoglycemia despite intensive diabetes management and education
Documented plan for concomitant immunosuppression (start prior to infusion and continued post-infusion)
Assessment that no concomitant diseases or conditions (including pregnancy) contraindicate infusion or immunosuppression
Number of infusions to be no more than three

Clinical and Evidence Summary

Lantidra (donislecel) is an FDA-approved allogeneic pancreatic islet cellular therapy produced from deceased donor pancreatic islet cells that contain insulin-secreting beta cells. The therapy is intended for adults with type 1 diabetes who are unable to reach target HbA1c because of recurrent severe hypoglycemia despite intensive diabetes management and education. (FDA approval and intended use are described in the product information and supporting materials.)

Lantidra is delivered by infusion into the hepatic portal vein so that the transplanted islet cells can engraft in the liver and produce insulin sufficient to regulate blood glucose, potentially eliminating or reducing the need for exogenous insulin. Use of Lantidra requires concomitant immunosuppression: immunosuppressive medications must be started prior to infusion and continued after the procedure to maintain viability of the implanted islet cells.

The primary safety and effectiveness evidence supporting approval comes from two non-randomized, single-arm studies that together enrolled a total of 30 participants with type 1 diabetes and hypoglycemic unawareness who received between one and three infusions. These studies demonstrated periods of insulin independence in many participants and formed the basis for the FDA review and the policy criteria for medical necessity.

Scope, Status, and Review Dates

Policy Details

Policy numberMC.CP.MP.250

SubjectLantidra (donislecel) allogeneic pancreatic islet cellular therapy

Scope summaryMedical necessity criteria for coverage of Lantidra (donislecel) for adults with type 1 diabetes who cannot reach target HbA1c due to recurrent severe hypoglycemia despite intensive diabetes management; governs health plans affiliated with Centene Corporation.

StatusCURRENT

Date last review2024-07-24

Effective dateN/A

Next review dateN/A

≥ 18Minimum age for coverage

≤ 3Maximum number of infusions allowed

30Total subjects across supporting studies

OpenPayer

Lantidra (donislecel): Allogeneic pancreatic islet cellular therapy

Medical Necessity Criteria for Lantidra (donislecel)

Relevant Billing and Coding Guidance

Documentation, Prior Authorization, and Administrative Requirements

Clinical and Evidence Summary

Key Defined Terms

Scope, Status, and Review Dates

Lantidra (donislecel): Allogeneic pancreatic islet cellular therapy

Medical Necessity Criteria for Lantidra (donislecel)

Relevant Billing and Coding Guidance

Documentation, Prior Authorization, and Administrative Requirements

Clinical and Evidence Summary

Key Defined Terms

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Scope, Status, and Review Dates