Galsulfase (Naglazyme) is a human enzyme produced by recombinant DNA technology in a Chinese hamster ovary. Galsulfase (Naglazyme) is an orphan drug used to treat the inherited metabolic disorder mucopolysaccharidosis VI (MPS VI or Maroteaux-Lamy Syndrome). Mucopolysaccharidosis VI is caused by a lack of the enzyme arylsulfatase B that normally breaks down certain carbohydrates known as glycosaminoglycans. MPS VI causes widespread cumulative organ and tissue damage.
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.
Food and Drug Administration (FDA) Indication
Galsulfase (Naglazyme) may be considered medically necessary for the treatment of mucopolysaccharidosis VI (MPS VI, Maroteaux-Lamy syndrome).
The use of galsulfase (Naglazyme) for any other indication, is considered experimental/investigational and therefore, non-covered, due to lack of supporting published peer reviewed literature.
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 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.
Covered Diagnosis Codes for Procedure Code J1458