Description

Bezlotoxumab (Zinplava^TM) is a human monoclonal antibody used to decrease the risk of Clostridium difficile infection (CDI) from coming back in adult individuals who are at high risk of CDI recurrence.

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.

Bezlotoxumab (Zinplava) may be considered medically necessary to reduce the recurrence of CDI in individuals who meet ALL of the following:

• Individual is 18 years of age or older; and
• Has a confirmed diagnosis of CDI, defined as:
  • Having passed three (3) or more loose bowel movements in 24 or fewer hours); and
  • A positive stool test for toxigenic C. difficile from a stool sample collected no more than 10 days before treatment with Zinplava; and
• Currently receiving the standard of care antibacterial drugs for CDI such as metronidazole, vancomycin, or fidaxomycin; and
• Individual is at high risk of CDI recurrence when ANY ONE of the following is present:
  • Individual is 65 years of age or older; or
  • Has had one or more episodes of CDI within the (6) six months prior to the episode under treatment; or
  • Are immunocompromised; or
• Has clinically severe CDI (CDI with abdominal distension, hypoalbuminemia (serum albumin less than 3g /dl) and a white blood cell (WBC) count greater than or equal to 15,000 cells/ mm 3); and Zinplava will only be approved for one dose per active CDI. Zinplava will not be approved for any repeat doses for recurrence of the same active infection.

Bezlotoxumab (Zinplava) is considered experimental/investigational for any other indication, and, therefore, non-covered.  Scientific evidence does not support its use for any other indications.

Procedure Codes

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

Covered Diagnosis Codes for J0565

Links