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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

Zinplava requires prior authorization from HealthPartners Pharmacy Administration.

Coverage

Zinplava is generally covered subject to the indications listed below when all of the following criteria are met, and per your plan documents:

Initial Authorizations:

  1. Prescribed for patients with recurrent Clostridium difficile infections; and,
  2. Patient is 18 years of age or older; and,
  3. Patient is receiving antibacterial drug treatment and is at a high risk for CDI recurrence; and,
  4. Patient has tried and failed oral antibiotics (metronidazole and vancomycin); and,
  5. Patient has had a Fecal Microbiota Transplant (FMT); and,
  6. Zinplava is prescribed within the FDA-approved dosing regimen.

Approvals are limited to a single dose of 10mg/kg, and cannot be renewed.

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

J0565

Injection, bezlotoxumab, 10 mg

NDC

Codes

Description

00006302500

Zinplava 1000 MG/40ML SOLN

00006302501

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
  • 04/01/2019 - Effective date
Review date
  • 02/2019
Revision date
  • 02/04/2019

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