Elosulfase alfa (Vimizim)

Section: Injections
Effective Date: October 01, 2019
Revised Date: September 30, 2019

Description

Elosulfase alfa (VimizimTM) 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.

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.

Elosulfase alfa (Vimizim) may be considered medically necessary for individuals five (5) years of age or older with a documented diagnosis of mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome) defined as meeting BOTH of the following criteria:

  • Documented clinical signs and symptoms of the disease (e.g., kyphoscoliosis, corneal opacity, genu valgum, pectus carinatum, gait disturbance, growth deficiency, etc.); and
  • Documented reduced fibroblast or leukocyte GALNS enzyme activity or molecular genetic testing confirming diagnosis of MPS IVA.

The use of elosulfase alfa (Vimizim) for any other indications not listed above is considered experimental/investigational and therefore, non-covered. Scientific evidence of safety and efficacy has not been proven for any other indications.

Procedure Codes 

J1322

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.

Diagnosis Codes 

E76.210

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