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HealthPartners

Coverage criteria policies

Bezlotoxumab (Zinplava)

These services may or may not be covered by your HealthPartners plan. Please see your plan documents for your specific coverage information. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage.

Administrative Process

Prior authorization is required.

Coverage

Zinplava is generally covered subject to the indications listed below and per your plan documents.

Indications that are covered

Zinplava is reserved for:

  1. FDA-approved indications.1 Zinplava is indicated to reduce recurrence of Clostridium difficile infection (CDI) in patients 18 years of age or older who are receiving antibacterial drug treatment and are at a high risk for CDI recurrence.
  2. Previous therapies. Zinplava is reserved after oral antibiotics (metronidazole and vancomycin), and after Fecal Microbiota Transplant (FMT).
  3. Medical necessity. Zinplava is reserved for patients with recurrent Clostridium difficile infections.

Definitions

ZINPLAVA is a human monoclonal antibody that binds to Clostridium difficile toxin B, indicated to reduce recurrence of Clostridium difficile infection (CDI) in patients 18 years of age or older who are receiving antibacterial drug treatment of CDI and are at a high risk for CDI recurrence.

Fecal Microbiota Transplant (FMT). is a procedure in which fecal matter, or stool, is collected from a tested donor, mixed with a saline or other solution, strained, and placed in a patient, by colonoscopy, endoscopy, sigmoidoscopy, or enema

If available, codes are listed below for informational purposes only, and do not guarantee member coverage or provider reimbursement. The list may not be all-inclusive.

The services associated with these codes require prior authorization:
HCPCS

Codes

Description

C9399

Unclassified drugs or biologicals 

J3590

Unclassified biologics

NDC

Codes

Description

00006-3025-00

Zinplava 1000 MG/40ML SOLN

CPT Copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

Products

This information is for most, but not all, HealthPartners plans. Please read your plan documents to see if your plan has limits or will not cover some items. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage. These coverage criteria may not apply to Medicare Products if Medicare requires different coverage. For more information regarding Medicare coverage criteria or for a copy of a Medicare coverage policy, contact Member Services at 952-883-7979 or 1-800-233-9645.

References

  1. Zinplava prescribing information. Merck & Co,. Inc., Whitehouse Station, NJ. October, 2016.

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Policy activity

  • 03/13/2017 - Date of origin
  • 05/03/2017 - Effective date

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