Omidubicel as Adjunct Treatment for Hematologic Malignancies

Policy ID: Y-5068-001

Section: Therapy

Effective Date: January 01, 2024

Last Reviewed: November 15, 2023

Applies To: Commercial Only

Description

Hematologic malignancies are a heterogeneous group of diseases characterized by distinct biological subtypes, marked by cellular, immunophenotypic, and genetic profile variations. Therapeutic approaches may involve hematopoietic cell transplantation, and in cases where a suitable matched donor is unavailable, umbilical cord blood may serve as a source of hematopoietic stem and progenitor cells for transplantation. Ex vivo expansion strategies using nicotinamide have been investigated to expedite hematopoietic recovery and enhance cell volume without inducing differentiation or cellular stress commonly associated with culturing hematopoietic progenitor cells outside their natural environment. Omidubicel is a modified allogeneic hematopoietic progenitor cell therapy derived from cord blood utilizing a proprietary nicotinamide enrichment technology.

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

Omidubicel is considered experimental/investigational in individuals with hematologic malignancies planning myeloablative allogenic umbilical cord transplantation.

Procedure Code

J3590

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the United States Food and Drug Administration (U.S. FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Diagnosis Codes

Not Applicable for this policy

Professional Statements and Societal Positions Guidelines

The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.

Practice Guidelines and Position Statements

Guidelines or position statements will be considered for inclusion in 'Supplemental Information' if they were issued by, or jointly by, a US professional society, an international society with US representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.

American Academy of Pediatrics

The American Academy of Pediatrics issued a position statement in 2017 concerning cord blood banking and selection, but the statement contained no discussion of ex vivo expansion.

National Comprehensive Cancer Network

Current National Comprehensive Cancer Network (NCCN) guidelines on acute lymphoblastic leukemia (v1.2023), acute myeloid leukemia (v3.2023), B-cell lymphomas (v4.2023), chronic myeloid leukemia (v2.2023), myelodysplastic syndromes (v1.2023), Hodgkin lymphoma (v2.2023), or guidance on hematopoietic stem cell transplantation (v1.2023) do not provide recommendations on the use of omidubicel or ex vivo expansion of cord blood more generally.

American Society for Transplantation and Cellular Therapy

The American Society for Transplantation and Cellular Therapy published guidelines on the indications for hematopoietic cell transplantation and immune effector cell therapy in 2020; these guidelines did not provide recommendations on the use of omidubicel or ex vivo expansion of cord blood.

Ongoing and Unpublished Clinical Trials

Some currently unpublished trials that might influence this review are listed in Table 10.

Table 10. Summary of Key Trials

NCT No.

Trial Name

Planned Enrollment

Completion Date

Ongoing

NCT04260698 ^a

Expanded Access of Omidubicel, for Allogeneic Transplantation in Patients With Hematological Malignancies ^a

May 2025

NCT02039557 ^a

Long Term Follow Up Protocol for NiCord(R)/CordIn (Omidubicel) Patients ^a

Jul 2023

NCT02730299 ^a

Stem Cell Transplantation With NiCord(R) (Omidubicel) vs Standard UCB in Patients With Leukemia, Lymphoma, and MDS ^a

125

Apr 2024

NCT03173937

Unrelated Umbilical Cord Blood Transplantation for Severe Aplastic Anemia and Hypo-plastic MDS Using CordIn(TM), Umbilical Cord Blood-Derived Ex Vivo Expanded Stem and Progenitor Cells to Expedite Engraftment and Improve Transplant Outcome

Mar 2028

                 NCT: national clinical trial.
^aDenotes industry-sponsored or cosponsored trial.

ND Committee Review

Internal Medical Policy Committee 11-15-2023 Effective January 1, 2024

Adopted policy - Policy created with literature review through June 23, 2023.

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

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