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

Clinical Policy: Lantidra (donislecel): Allogeneic Pancreatic Islet Cellular Therapy
Reference Number: CP.MP.250
Date of Last Revision: 07/24
Coding Implications
Revision Log

See Important Reminder at the end of this policy for important regulatory and legal
information.

Description
This policy describes the medical necessity criteria for Lantidra (donislecel), an allogeneic
pancreatic islet cellular therapy, used for the treatment of type 1 diabetes in those who are unable
to reach target hemoglobin A1c (HbA1c).¹

Note: For criteria applicable to Medicare plans, please see MC.CP.MP.250 Lantidra
(donislecel): Allogeneic pancreatic islet cellular therapy.



Background
Type 1 diabetes is a chronic autoimmune disease, characterized by the destruction of pancreatic
beta cells, causing insulin deficiency.²,³ Intensive diabetes management is the standard of care
for type 1 diabetes, and includes coordinating frequent blood glucose monitoring and insulin
replacement with meals and activity.³ Type 1 diabetes requires lifelong insulin treatment, but
some people have difficulty managing hyperglycemia without causing hypoglycemia, especially
in those who develop hypoglycemia unawareness.² Insulin dosing becomes challenging in these
situations, but Lantidra is a possible treatment option.²

In June 2023, the U.S. Food and Drug Administration (FDA) approved Lantidra, an allogeneic
pancreatic islet cellular therapy.² Lantidra is produced from deceased donor pancreatic islet cells
that include beta cells, which have the ability to produce and secrete insulin.¹ Lantidra is infused
in the hepatic portal vein so that the infused cells are able to produce enough insulin to regulate
blood glucose levels, eliminating the need for additional insulin administration.² The product is
intended to be used in adult patients with type 1 diabetes who cannot reach target HbA1c due to
having recurrent severe hypoglycemic episodes, despite intensive diabetes management and
education.¹,² Additionally, immunosuppressive medicine is required to be taken before receiving
Lantidra and needs to be continued after the infusion to keep the transplanted islet cells viable.¹

Page 1 of 4
CLINICAL POLICY
Lantidra (donislecel): Allogeneic Pancreatic Islet Cellular Therapy
Two non-randomized, single-arm studies evaluated the safety and effectiveness of Lantidra and
included a total of 30 enrollees with type 1 diabetes and hypoglycemic unawareness who
received a minimum of one infusion and a maximum of three infusions. The studies found that
21 participants did not require insulin administration for one year or longer, 11 participants did
not require insulin administration for one to five years, and 10 participants did not require
insulin administration for over five years. Additionally, five of the total participants continued to require
insulin administration without any resulting days of insulin independence.²

Coding Implications
This clinical policy references Current Procedural Terminology (CPT®). CPT® is a registered
trademark of the American Medical Association. All CPT codes and descriptions are copyrighted
2023, American Medical Association. All rights reserved. CPT codes and CPT descriptions are
from the current manuals and those included herein are not intended to be all-inclusive and are
included for informational purposes only. Codes referenced in this clinical policy are for
informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage.
Providers should reference the most up-to-date sources of professional coding guidance prior to
the submission of claims for reimbursement of covered services.

| HCPCS Codes | Description |
|-------------|-------------|
| J3590       | Unclassified biologics |

| Reviews, Revisions, and Approvals | Review Date | Approval Date |
|---------------------------------|-------------|---------------|
| Policy developed.                | 08/23       | 08/23         |
| Added note to description regarding Medicare policy version. | 02/24 | 02/24 |
| Removed maximum age requirement from Criteria IA. |  |  |
| Annual review. References reviewed and updated. Reviewed by external specialist. | 07/24 | 07/24 |



Important Reminder
This clinical policy has been developed by appropriately experienced and licensed health care
professionals based on a review and consideration of currently available generally accepted
standards of medical practice; peer-reviewed medical literature; government agency/program
approval status; evidence-based guidelines and positions of leading national health professional

Page 2 of 4
CLINICAL POLICY
Lantidra (donislecel): Allogeneic Pancreatic Islet Cellular Therapy
organizations; views of physicians practicing in relevant clinical areas affected by this clinical
policy; and other available clinical information. The Health Plan makes no representations and
accepts no liability with respect to the content of any external information used or relied upon in
developing this clinical policy. This clinical policy is consistent with standards of medical
practice current at the time that this clinical policy was approved. “Health Plan” means a health
plan that has adopted this clinical policy and that is operated or administered, in whole or in part,
by Centene Management Company, LLC, or any of such health plan’s affiliates, as applicable.

The purpose of this clinical policy is to provide a guide to medical necessity, which is a
component of the guidelines used to assist in making coverage decisions and administering
benefits. It does not constitute a contract or guarantee regarding payment or results. Coverage
decisions and the administration of benefits are subject to all terms, conditions, exclusions and
limitations of the coverage documents (e.g., evidence of coverage, certificate of coverage, policy,
contract of insurance, etc.), as well as to state and federal requirements and applicable Health
Plan-level administrative policies and procedures.

This clinical policy is effective as of the date determined by the Health Plan. The date of posting
may not be the effective date of this clinical policy. This clinical policy may be subject to
applicable legal and regulatory requirements relating to provider notification. If there is
a discrepancy between the effective date of this clinical policy and any applicable legal or
regulatory requirement, the requirements of law and regulation shall govern. The Health Plan
retains the right to change, amend or withdraw this clinical policy, and additional clinical
policies may be developed and adopted as needed, at any time.

This clinical policy does not constitute medical advice, medical treatment or medical care. It is
not intended to dictate to providers how to practice medicine. Providers are expected to exercise
professional medical judgment in providing the most appropriate care, and are solely responsible
for the medical advice and treatment of members/enrollees. This clinical policy is not intended
to recommend treatment for members/enrollees. Members/enrollees should consult with their
treating physician in connection with diagnosis and treatment decisions.

Providers referred to in this clinical policy are independent contractors who exercise independent
judgment and over to whom the Health Plan has no control or right of control. Providers are not
agents or employees of the Health Plan.

This clinical policy is the property of the Health Plan. Unauthorized copying, use, and
distribution of this clinical policy or any information contained herein are strictly prohibited.
Providers, members/enrollees and their representatives are bound to the terms and conditions
expressed herein through the terms of their contracts. Where no such contract exists, providers,
members/enrollees and their representatives agree to be bound by such terms and conditions by
providing services to members/enrollees and/or submitting claims for payment for such services.

Note: For Medicaid members/enrollees, when state Medicaid coverage provisions conflict
with the coverage provisions in this clinical policy, state Medicaid coverage provisions take
precedence. Please refer to the state Medicaid manual for any coverage provisions pertaining to
this clinical policy.

Page 3 of 4
CLINICAL POLICY
Lantidra (donislecel): Allogeneic Pancreatic Islet Cellular Therapy

Note: For Medicare members/enrollees, to ensure consistency with the Medicare National
Coverage Determinations (NCD) and Local Coverage Determinations (LCD), all applicable
NCDs, LCDs, and Medicare Coverage Articles should be reviewed prior to applying the criteria
set forth in this clinical policy. Refer to the CMS website at http://www.cms.gov for additional
information.



Page 4 of 4