CurrentCentenePolicy CP.MP.250

Lantidra (donislecel): Allogeneic Pancreatic Islet Cellular Therapy

Defines medical necessity criteria for coverage of Lantidra (donislecel) for treatment of adults with type 1 diabetes who are unable to reach target HbA1c due to recurrent severe hypoglycemia, including restrictions on age, diagnosis, concomitant immunosuppression, infusion limits, and contraindications.

Policy Summary

PayerCentene

PolicyLantidra (donislecel): Allogeneic Pancreatic Islet Cellular Therapy

Policy CodePolicy CP.MP.250

Change TypeAdministrative updates; removal of maximum age requirement

Effective Date

Next Review Date

Key ActionProvider must document diagnosis of type 1 diabetes, repeated episodes of severe hypoglycemia despite intensive diabetes management and education, and a plan for concomitant immunosuppression.

SourceLink

POLICY UPDATE CHANGES

Removed maximum age requirement from Criteria I.A.

Annual reviews with references updated; external specialist reviewed

Adults ≥18Covered Population Age

Type 1 diabetesCovered Indication

Max 3Infusion Limit

Coverage Summary

Defines medical necessity criteria for Lantidra (donislecel) for adults (≥ 18 years) with type 1 diabetes who are unable to reach target HbA1c because of recurrent severe hypoglycemia despite intensive diabetes management and education. Therapy must be used with concomitant immunosuppression, and coverage is limited to a maximum of three infusions. The criteria also require absence of conditions (including pregnancy) that would contraindicate infusion or immunosuppression.

Summary Coverage Stats

Covered IndicationType 1 diabetes

Infusion LimitMaximum of 3 infusions per member

Medical-Necessity Criteria

Medically Necessary Criteria

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

Age: Member/enrollee is ≥ 18 years of age
Diagnosis of type 1 diabetes
Hypoglycemia and prior management: Member/enrollee is unable to approach target HbA1c due to current repeated episodes of severe hypoglycemia, despite intensive diabetes management and education
Immunosuppression: Therapy will be used in conjunction with concomitant immunosuppression
Infusion limit: No more than three infusions will be given
Maximum of 3 infusions per member
Contraindications: Member/enrollee does not have concomitant diseases or conditions, including pregnancy, that contraindicate the procedure for Lantidra infusion or immunosuppression
Includes pregnancy and other contraindicating conditions

Provider Actions & Billing Rules

Documentation Required

Document severe hypoglycemia and prior intensive management

Document the diagnosis of type 1 diabetes, repeated severe hypoglycemia despite intensive diabetes management and education that prevents approaching target HbA1c, and the plan to use Lantidra with concomitant immunosuppression.

Diagnosis of type 1 diabetes
Repeated episodes of severe hypoglycemia despite intensive diabetes management and education
Plan for concomitant immunosuppression before and after infusion

Billing Rule

Limit on number of infusions

No more than three Lantidra (donislecel) infusions will be covered per member.

Max 3 infusions

Background & Evidence

Lantidra (donislecel) is an FDA-approved allogeneic pancreatic islet cellular therapy produced from deceased donor pancreatic islet cells and intended for adult patients with type 1 diabetes who cannot reach target HbA1c due to recurrent severe hypoglycemic episodes despite intensive diabetes management and education. The product is infused into the hepatic portal vein so transplanted islet cells can produce insulin; immunosuppressive medicine is required before and continued after infusion to maintain viability of the transplanted islet cells.

Definitions / Evidence

Evidence Metrics

Revision History

08/23policy_developed

Policy developed; policy developed and approved on 08/23. Added note to description regarding Medicare policy version.

02/24revised

Removed maximum age requirement from Criteria I.A.; added note to description regarding Medicare policy version. Review and approval dates referenced as 02/24.

07/24annual_reviewLatest

Annual review; references reviewed and updated; external specialist reviewed. Review and approval dates referenced as 07/24 (Date of Last Revision: 07/24).