Laronidase (Aldurazyme)

Policy ID: I-54-019

Section: Injections

Effective Date: October 01, 2019

Revised Date: February 25, 2021

Revision Effective Date: May 03, 2021

Last Reviewed: March 17, 2021

Description

Laronidase (Aldurazyme®) is a hydrolytic lysosomal glycosaminoglycan (GAG)-specific enzyme used to treat mucopolysaccharidosis I (MPS I), an autosomal recessive disorder which causes a deficiency of alpha-L-iduronidase, an enzyme required to break down glycosaminoglycans.

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.

Laronidase (Aldurazyme) may be considered medically necessary for individuals with the following:

Diagnosis of ANY of the following forms of mucopolysaccharidosis type I confirmed by genetic testing or abnormal enzymology on cultured fibroblasts:
- Hurler; or
- Hurler-Scheie; or
- Scheie form with moderate to severe symptoms; and
Baseline predicted forced vital capacity (FVC); or
Baseline distance walked in six (6) minutes.

Reauthorization Criteria

Reauthorization of laronidase (Aldurazyme) may be considered medically necessary when the following criteria are met:

Individual diagnosed with MPS I (Hurler, Hurler-Scheie or Scheie form as listed above); and
Documentation of stability or improvement from baseline in FVC or distance walked in six (6) minutes.

The use of laronidase (Aldurazyme) is considered experimental/investigational and therefore are non-covered for all other indications. Scientific evidence does not support the use of laronidase (Aldurazyme) for any other indication.

Procedure Codes

J1931

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

Covered Diagnosis Codes for J1931

E76.01

E76.02

E76.03

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 9-26-2019 Adopted policy

Internal Medical Policy Committee 9-21-2020 Annual review, no clinical content changed

Internal Medical Policy Committee 1-19-2021 Added additional description language

Internal Medical Policy Committee 3-17-2021 Laronidase (Aldurazyme) will require precertification as of May 1, 2021. Added the following to the criteria "mucopolysaccharidosis type I confirmed by genetic testing or abnormal enzymology on cultured fibroblasts, baseline predicted forced vital capacity (FVC), or baseline distance walked in six (6) minutes". Also added reauthorization criteria.

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: I-54-018