CurrentCentenePolicy CP.MP.250

Clinical Policy: Lantidra (donislecel): Allogeneic Pancreatic Islet Cellular Therapy

Defines medical necessity criteria for coverage of Lantidra (donislecel) for treatment of type 1 diabetes in members unable to reach target HbA1c due to recurrent severe hypoglycemia despite intensive management; includes limits (age, number of infusions) and contraindications related to concomitant diseases and pregnancy and requires concomitant immunosuppression.

Policy Summary

PayerCentene

PolicyClinical Policy: Lantidra (donislecel): Allogeneic Pancreatic Islet Cellular Therapy

Policy CodePolicy CP.MP.250

Change TypeRemoved maximum age requirement

Effective DateJul 1, 2025

Next Review Date

Key ActionProvider must document attempts at intensive diabetes management and education and persistent recurrent severe hypoglycemia that prevents reaching target HbA1c despite these efforts.

POLICY UPDATE CHANGES

Removed maximum age requirement from criteria in prior revisions.

≤3Maximum infusions covered

≥18Minimum age for coverage

Type 1 diabetesIndication covered

J3590Referenced billing code

Coverage Summary

CP.MP.250: Lantidra (donislecel) is covered with criteria for adult patients with type 1 diabetes who cannot reach target HbA1c because of recurrent severe hypoglycemic episodes despite intensive management. Effective date: 2025-07-01. The policy requires concomitant immunosuppression and documents limits including a minimum age of ≥ 18 years and a maximum of ≤ 3 infusions.

Supporting evidence: Two non-randomized, single-arm clinical studies with a total of 30 enrollees showed that 21 participants were insulin-independent for ≥1 year, with additional participants insulin-independent 1–5 years and >5 years, while five participants continued to require insulin.

Quick Facts / Thresholds

Maximum number of infusions≤ 3

Minimum age for coverage≥ 18 years

Indication coveredType 1 diabetes

Provider Actions & Documentation Requirements

Prior Authorization

Prior authorization required for medical necessity

Coverage requires prior authorization. All medical necessity criteria must be met and documented prior to authorization. Providers must follow the Health Plan prior authorization process for Lantidra (donislecel).

Documentation Required

Document prior intensive diabetes management and education

Document that intensive diabetes management and education were attempted prior to Lantidra, per the policy definition of intensive diabetes management (coordinating frequent blood glucose monitoring and insulin replacement with meals and activity).

Documentation Required

Document contraindications/pregnancy status

Document absence of contraindications including confirmation the member is not pregnant and has no conditions that would contraindicate the infusion or required immunosuppression.

Billing Rule

Limit on number of infusions

Claims should not exceed three Lantidra infusions per member; the policy limit is no more than three infusions. This applies to services billed under HCPCS code J3590 (Unclassified biologics).

Background & Evidence

Lantidra (donislecel) is an FDA-approved (June 2023) allogeneic pancreatic islet cellular therapy produced from deceased donor pancreatic islet cells and intended for adults with type 1 diabetes who cannot reach target HbA1c due to recurrent severe hypoglycemia despite intensive management.

The product is administered by infusion into the hepatic portal vein and requires peri-procedural and ongoing immunosuppression to maintain viability of the transplanted islet cells.

Clinical evidence comprises two non-randomized, single-arm studies including a total of 30 enrollees with type 1 diabetes and hypoglycemic unawareness who received between one and three infusions. Outcomes reported: 21 participants achieved insulin-independence for ≥1 year; 1 participant for 1–5 years; 10 participants for >5 years; and 5 participants continued to require insulin.

Intensive diabetes management: coordinating frequent blood glucose monitoring and insulin replacement with meals and activity, plus education; documentation that this approach was attempted is required prior to Lantidra.

Policy Summary

PayerCentene

PolicyClinical Policy: Lantidra (donislecel): Allogeneic Pancreatic Islet Cellular Therapy

Policy CodePolicy CP.MP.250

Change TypeRemoved maximum age requirement

Effective DateJul 1, 2025

Next Review Date

Key ActionProvider must document attempts at intensive diabetes management and education and persistent recurrent severe hypoglycemia that prevents reaching target HbA1c despite these efforts.

On This Page

OpenPayer

Clinical Policy: Lantidra (donislecel): Allogeneic Pancreatic Islet Cellular Therapy

Coverage Summary

Medically Necessary Criteria

Provider Actions & Documentation Requirements

Coding

Background & Evidence

Medicare Determinations

Revision History