Lantidra (donislecel): Allogeneic Pancreatic Islet Cellular Therapy
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Defines medical necessity criteria and coverage considerations for Lantidra (donislecel) for treating adults with type 1 diabetes who cannot reach target HbA1c because of recurrent severe hypoglycemia; applies to health plans affiliated with Centene Corporation / Arizona Complete Health.
Removed maximum age requirement from Criteria I.A.
Added note to description regarding Medicare policy version.
Coverage Criteria for Lantidra (donislecel)
Initial Therapy
Covered when ALL of the following are met:
Members/enrollees who have concomitant diseases or conditions that would contraindicate infusion of Lantidra or the required peri‑procedural immunosuppression are excluded from coverage. The policy specifically lists pregnancy as a contraindicating condition. Prior authorization must establish the absence of such contraindications before approval for Lantidra infusion.
Use of Lantidra when any of the specified medical necessity criteria are not met is considered not medically necessary. Examples include when the member is not diagnosed with type 1 diabetes, is younger than 18 years, lacks documentation that repeated severe hypoglycemia persists despite intensive diabetes management and education, a plan for concomitant immunosuppression is not in place, or more than the allowed number of infusions would be given. Requests missing these required elements may be denied.
Coding and Quantity Limits
| J3590 | Unclassified biologics |
Provider Actions, Prior Authorization, and Documentation
Prior Authorization Required
Prior authorization is required before scheduling Lantidra (donislecel) infusion. Submit prior authorization requests with clinical documentation demonstrating that the member meets all medical necessity criteria.
- Prior authorization required for Lantidra (donislecel) infusion
- Relevant billing code: HCPCS J3590 — Unclassified biologics (use per payer billing guidance)
Requirement to Attempt Intensive Diabetes Management
Documented evidence that the member has attempted and failed intensive diabetes management is required. Intensive diabetes management includes frequent blood glucose monitoring, coordinated insulin dosing with meals and activity, and diabetes education. The member must have recurrent severe hypoglycemia despite these intensive management efforts.
- Must document failure of or inability to achieve target HbA1c due to recurrent severe hypoglycemia
- Include description of prior intensive diabetes management strategies attempted (eg, insulin regimen adjustments, CGM use, education sessions)
Required Clinical Documentation
Clinical documentation submitted with the prior authorization must support all required criteria: age (≥ 18 years), diagnosis of type 1 diabetes, history of repeated severe hypoglycemia despite intensive diabetes management and education, planned concomitant immunosuppression, and that no more than three infusions are planned. Also document absence of contraindicating conditions (including pregnancy).
- Include medical records, HbA1c history, hypoglycemia event documentation, diabetes education records, and treatment plans for immunosuppression
Failure to Meet Listed Criteria May Result in Denial
Requests that do not meet all listed medical necessity criteria will be denied. Failure to provide required documentation of intensive diabetes management attempts, recurrent severe hypoglycemia, appropriate diagnosis, age, immunosuppression plan, or documentation of contraindication screening may result in denial.
- Denial risk if any criterion from the policy is not met or not documented
- Claims billed without prior authorization or without correct use of billing codes (eg, HCPCS J3590 as applicable) may be rejected
Definitions
Background
Type 1 diabetes is an autoimmune condition characterized by loss of pancreatic beta cells leading to absolute insulin deficiency. For most patients, intensive diabetes management—including frequent blood glucose monitoring, individualized insulin replacement timed to meals and activity, and structured diabetes education—is the first‑line approach to minimize hypoglycemia and achieve target glycemic control. Lantidra (donislecel) is an allogeneic pancreatic islet cellular therapy intended for adults with type 1 diabetes who remain unable to approach target HbA1c because of recurrent severe hypoglycemia despite such intensive management; its use requires planned concomitant immunosuppression and adherence to the policy limits (for example, no more than three infusions and recipients ≥ 18 years of age).
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