Elosulfase alfa (Vimizim) (Medicaid Expansion)

Policy ID: ME-I-138-008-04

Section: Injections

Effective Date: January 01, 2022

Revised Date: March 09, 2025

Revision Effective Date: May 01, 2025

Last Reviewed: March 11, 2025

Applies To: Medicaid Expansion Only

Description

Elosulfase alfa (Vimizim ^TM ) is a purified human enzyme produced by recombinant DNA for the treatment of Mucopolysaccharidosis type IVA (MPS IVA) or Morquio A syndrome which causes a deficiency in N-acetylgalactosamine-6-sulfatase (GALNS). Elosulfase alfa (Vimizim) replaces the missing enzyme GALNS.

Policy Application

All claims submitted under this policy's section will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.

Criteria

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

The use of elosulfase alfa (Vimizim) may be considered medically necessary when ALL of the following criteria are met:

The individual must meet FDA-approved label for use (e.g., use outside of studied population will be considered investigational); and
Documentation of the member's diagnosis must be submitted, as evidenced by the following:
- Genetic testing confirming biallelic pathogenic mutations in the GALNS gene; and
- Deficiency in activity of the N-acetylgalactosamine 6-sulfatase (GALNS) enzyme; and
Elosulfase alfa (Vimizim) must be prescribed by, or in consult with, a geneticist, metabolic specialist, or specialist in mucopolysaccharidoses (MPS); and
The individual must not have had a hematopoietic stem cell transplant; and
If 3 years of age or older, must be able to walk without support; and
Baseline Urine Keratan Sulfate (KS) levels must be submitted; and
Documentation of one of the following must be submitted:
- Forced Vital Capacity (FVC) via Pulmonary Function Test; or
- Six (6)-minute walk test (6MWT); or
- Three (3)-minute stair claim test (3-MSCT).

Initial Authorization: Six (6) months

Reauthorization Criteria

Continuation of therapy with elosulfase alfa (Vimizim) may be considered medically necessary when the following is met:

The individual must have experienced and maintained clinical benefit since starting treatment with the requested medication, as evidenced by medical documentation (e.g., chart notes) attached to the request (subject to clinical review) by one of the following scores:
- Forced Vital Capacity (FVC) via Pulmonary Function Test; or
- Six (6)-minute walk test (6MWT); or
- Three (3)-minute stair claim test (3-MSCT); or
- Reduced Urine Keratan Sulfate (KS) levels.

The use of elosulfase alfa (Vimizim) 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

J1322

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 Code

E76.3

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 11-23-2021 Adopted Medicaid Expansion specific policy effective 1-1-2022

Internal Medical Policy Committee 11-29-2022 - Effective January 01, 2023

Updated initial criteria, and
Updated reauthorization criteria, and
Updated experimental/investigational statement

Internal Medical Policy Committee 11-15-2023 Annual Review-no changes in criteria

Internal Medical Policy Committee 11-19-2024 - Effective January 01, 2025

Annual review no clinical content change;and
AddedPolicy Application

Internal Medical Policy Committee 03-11-2025 Effective May 01, 2025

Updated initial and reauthorization criteria required based on the DHHS PDL Version 2025.3

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.

Policy ID: ME-I-138-008-03

Section: Injections

Effective Date: January 01, 2022

Revised Date: October 16, 2024

Revision Effective Date: January 01, 2025

Last Reviewed: November 19, 2024

Archived Date: April 30, 2025

Applies To: Medicaid Expansion Only

Description

Policy Application

All claims submitted under this policy's section will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.

Criteria

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

The use of elosulfase alfa (Vimizim) may be considered medically necessary when ALL of the following criteria are met:

The individual must meet FDA-approved label for use (e.g., use outside of studied population will be considered investigational); and
Documentation of the member's diagnosis must be submitted, as evidenced by the following:
- Genetic testing confirming biallelic pathogenic mutations in the GALNS gene; and
- Deficiency in activity of the N-acetylgalactosamine 6-sulfatase (GALNS) enzyme; and
Elosulfase alfa (Vimizim) must be prescribed by, or in consult with, a geneticist, metabolic specialist, or specialist in mucopolysaccharidoses (MPS); and
The individual is experiencing musculoskeletal signs and symptoms of MSP-IVA such as knee deformity, kyphosis, hip dysplasia, arthralgia, etc.; and
Documentation of one of the following must be submitted:
- Forced Vital Capacity (FVC) via Pulmonary Function Test; or
- Six (6)-minute walk test (6MWT); or
- Three (3)-minute stair claim test (3-MSCT).

Initial Authorization: Six (6) months

Reauthorization Criteria

Continuation of therapy with elosulfase alfa (Vimizim) may be considered medically necessary when the following is met:

The individual must have experienced and maintained clinical benefit since starting treatment with the requested medication, as evidenced by medical documentation (e.g., chart notes) attached to the request (subject to clinical review) by one of the following scores:
- Forced Vital Capacity (FVC) via Pulmonary Function Test; or
- Six (6)-minute walk test (6MWT); or
- Three (3)-minute stair claim test (3-MSCT); or
- Reduced Urine Keratan Sulfate (KS) levels.

Procedure Code

J1322

Diagnosis Code

E76.3

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 11-23-2021 Adopted Medicaid Expansion specific policy effective 1-1-2022

Internal Medical Policy Committee 11-29-2022 - Effective January 01, 2023

Updated initial criteria, and
Updated reauthorization criteria, and
Updated experimental/investigational statement

Internal Medical Policy Committee 11-15-2023 Annual Review-no changes in criteria

Internal Medical Policy Committee 11-19-2024 - Effective January 01, 2025

Annual review no clinical content change; and
Added Policy Application

Medical Policies Quick Search

Elosulfase alfa (Vimizim) (Medicaid Expansion)

Description

Policy Application

Criteria

Procedure Code

Diagnosis Code

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer

Description

Policy Application

Criteria

Procedure Code

Diagnosis Code

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer