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Coverage criteria policies

Bezlotoxumab (Zinplava™) – Minnesota Health Care Programs

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

Bezlotoxumab (Zinplava) requires prior authorization from HealthPartners Pharmacy Administration.

Approval Criteria

  1. Patient must be 18 years of age or older; and
  2. Patient must be prescribed Zinplava by, or in consultation with, a gastroenterologist or an infectious disease specialist; and,
  3. Patient must have a diagnosis of Clostridium difficile (C. difficile) infection (CDI) confirmed by documentation of positive Clostridium difficile toxin B test; and,
  4. Patient has had at least two episodes of CDI recurrence (i.e., three CDI episodes) in the previous 6 months; and,
  5. Patient has been treated with at least one of the following:
    1. Metronidazole:  500 mg orally three times per day for 10-14 days; or,
    2. Vancomycin:  125 mg orally four times per day for 10 days; and,
  6. Patient has been treated with one course of pulsed vancomycin (125 mg four times daily for 10 days, followed by 125 mg daily pulsed every 3 days for 10 doses); and,
  7. Patient will receive or is currently receiving concomitant antibiotic treatment for CDI; and,
  8. Patient’s weight must be submitted at time of request.

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

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

Codes

Description

J0565

Injection, bezlotoxumab, 10 mg

NDC Codes

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. https://mn.gov/dhs/partners-and-providers/policies-procedures/minnesota-health-care-programs/provider/types/rx/pa-criteria/zinplava.jsp

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Policy activity

  • 05/07/2018 - Date of origin
  • 10/01/2018 - Effective date
Review date
  • 02/2019

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