CurrentCommunity Health Plan WashingtonPolicy MC.CP.MP.250

Lantidra (donislecel) Allogeneic Pancreatic Islet Cellular Therapy

Defines medical necessity criteria for Lantidra (donislecel) for treatment of adults with type 1 diabetes who cannot reach target HbA1c due to recurrent severe hypoglycemia, including limits on number of infusions and requirement for concomitant immunosuppression. Includes coding guidance and background; references FDA approval and clinical studies.

Policy Summary

PayerCommunity Health Plan Washington

PolicyLantidra (donislecel) Allogeneic Pancreatic Islet Cellular Therapy

Policy CodePolicy MC.CP.MP.250

Change TypeClarified; Revised (administrative)

Effective Date

Next Review DateJul 25, 202650d

Key ActionProviders must document that all medical necessity criteria are met (age ≥18, type 1 diabetes diagnosis, recurrent severe hypoglycemia despite intensive diabetes management and education, plan for concomitant immunosuppression, absence of contraindicating conditions including pregnancy) to support coverage and prior authorization.

SourceLink

POLICY UPDATE CHANGES

Updated description to note the absence of coverage criteria from CMS.

Review and references updated on 12/25; approval date 12/25.

≥18Minimum age for coverage

3Maximum infusions covered

30Pivotal study enrollees

Coverage Summary

Scope: Defines medical necessity criteria for Lantidra (donislecel), an allogeneic pancreatic islet cellular therapy for adults with type 1 diabetes who cannot reach target HbA1c because of recurrent severe hypoglycemia. The policy includes requirements for concomitant immunosuppression and a limit of no more than three infusions per member, and provides coding and background information. FDA approval and clinical study results are referenced in the background and evidence sections.

Coverage stance: Covered with criteria when all specified medical necessity requirements are met (age ≥18, diagnosis of type 1 diabetes, inability to approach target HbA1c due to repeated severe hypoglycemia despite intensive diabetes management and education, use with concomitant immunosuppression, absence of contraindicating conditions, and a limit of no more than three infusions). Immunosuppression is required before and after infusion to maintain transplanted islet viability. The FDA approval was based on two non-randomized single-arm studies totaling 30 participants, which demonstrated periods of insulin independence for many participants.

Key thresholds and evidence metrics

Age threshold>= 18 years

Maximum infusions covered3

Participants with >=1 year insulin independence21 of 30

Participants with 1–5 years insulin independence11 of 30

Participants with >5 years insulin independence10 of 30

Medical Necessity — Criteria for Coverage

Medically Necessary

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

Medically Necessary Criteria

Age: Member/enrollee is ≥ 18 years of age>= 18 years
Diagnosis of type 1 diabetes
Hypoglycemia: 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
Immunosuppressive medicine is required before and continued after infusion to maintain viability of transplanted islet cells
Infusion Limit: No more than three infusions will be givenMaximum of 3 total infusions per member
Contraindications: Member/enrollee does not have concomitant diseases or conditions, including pregnancy, that contraindicate the procedure for Lantidra infusion or immunosuppression
Contraindications to infusion or to immunosuppression should be assessed (e.g., pregnancy)

Provider Requirements & Billing Guidance

Prior Authorization

Medical necessity documentation required for Lantidra

Providers must submit documentation that all medical necessity criteria are met to support coverage and prior authorization for Lantidra. Required documentation should confirm: patient age ≥ 18, diagnosis of type 1 diabetes, inability to reach target HbA1c due to repeated severe hypoglycemia despite intensive diabetes management and education, planned concomitant immunosuppression, and absence of contraindicating conditions (e.g., pregnancy).

J3590

Documentation Required

Limit on number of infusions

Document the total number of prior Lantidra (donislecel) infusions in the medical record. Coverage is limited to no more than three total infusions per member; include prior infusion counts when requesting authorization or claim review.

Billing Rule

Use appropriate unclassified biologics code

Lantidra may be reported using the unclassified biologics HCPCS code J3590 for informational coding reference. Providers should confirm current, up-to-date coding guidance and applicable payer requirements prior to submitting claims.

J3590

Background, Evidence & Definitions

In June 2023, the U.S. Food and Drug Administration (FDA) approved Lantidra (donislecel), an allogeneic pancreatic islet cellular therapy produced from deceased donor pancreatic islet cells, for adult patients with type 1 diabetes who cannot reach target HbA1c due to recurrent severe hypoglycemic episodes. The product is infused into the hepatic portal vein so infused beta cells can produce insulin and potentially eliminate the need for exogenous insulin.

Immunosuppressive therapy is required to be started before receiving Lantidra and continued after infusion to maintain the viability of the transplanted islet cells; concomitant immunosuppression is an explicit criterion for medically necessary use.

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. Participants received between one and three infusions; study results showed that 21 of 30 participants achieved at least one year of insulin independence, with 11 participants insulin-independent for 1–5 years and 10 participants insulin-independent for over 5 years.

Outcome	Participants
Participants with ≥1 year insulin independence
21 of 30
{"text":"Participants with 1 6 years insulin independence","status":""}
11 of 30
Participants with >5 years insulin independence
10 of 30

Intensive diabetes management: Coordinating frequent blood glucose monitoring and insulin replacement with meals and activity, together with diabetes education, as the standard of care for type 1 diabetes.

Repeated episodes of severe hypoglycemia: Recurrent severe hypoglycemic events that prevent approaching target HbA1c despite adequate intensive diabetes management and education (package insert–derived criterion used to determine eligibility for Lantidra).