Olipudase alfa-rpcp (Xenpozyme) (Medicaid Expansion)

Policy ID: ME-I-9958-001-01

Section: Injections

Effective Date: August 01, 2023

Last Reviewed: July 26, 2023

Applies To: Medicaid Expansion Only

Description

Olipudase alfa-rpcp (Xenpozyme ^TM ) is a hydrolytic lysosomal sphingomyelin-specific enzyme indicated for treatment of non-central nervous system manifestations of acid sphingomyelinase deficiency (ASMD), a lysosomal storage disease. ASM is necessary to break down the fatty substance shingomyelin in the lysosomes. Buildup of sphingomyelin can occur in major organs such as the liver, lungs, and spleen which, over time, can cause serious health complications.

Criteria

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

Olipudase alfa-rpcp (Xenpozyme) may be considered medically necessary when an individual meets the following criteria:

The individual must meet FDA-approved label for use (e.g., use outside of studied population will be considered investigational); and
The requested medication must be prescribed by, or in consult with, a specialist in the individual's treated diagnosis; and
As applicable, documentation must be attached to confirm serum marker or pathogenic gene variants amenable to treatment.

The use of olipudase alfa-rpcp (Xenpozyme) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Code

J0218

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (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

E75.241

E75.244

E75.249

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 7-26-2023 - Effective August 01, 2023

Adopted Medicaid Expansion specific policy

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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