Laronidase (Aldurazyme)

Policy ID: I-54-017

Section: Injections

Effective Date: October 01, 2019

Revised Date: September 17, 2020

Revision Effective Date: October 01, 2020

Last Reviewed: September 21, 2020

Description

Laronidase (Aldurazyme®) is 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 ONE of the following forms of mucopolysaccharidosis type I:

Hurler; or
Hurler-Scheie; or
Scheie form with moderate to severe symptoms.

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

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.

Section: Injections

Effective Date: October 01, 2019

Revised Date: September 30, 2019

Archived Date: September 30, 2020

Description

Criteria

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

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

Diagnosis of ANY ONE of the following forms of mucopolysaccharidosis type I:

Hurler; or
Hurler-Scheie; or
Scheie form with moderate to severe symptoms.

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. Blue Cross and Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

Diagnosis Codes

Covered Diagnosis Codes for J1931

E76.01

E76.02

E76.03

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