Bezlotoxumab (Zinplava)

Policy ID: I-165-007

Section: Injections

Effective Date: October 01, 2019

Revised Date: July 17, 2023

Revision Effective Date: September 01, 2023

Last Reviewed: July 26, 2023

Applies To: Commercial and Medicaid Expansion

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 one (1) year 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 (1) or more episodes of CDI within the six (6) 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.

The use of bezlotoxumab (Zinplava) not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Procedure Code

J0565

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the United States Food and Drug Administration (U.S. FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Diagnosis Codes

A04.71

A04.72

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 9-26-2019 Adopted policy

Internal Medical Policy Committee 9-21-2020 Annual review; no clinical content changed

Internal Medical Policy Committee 5-20-2021 No clinical content change

Internal Medical Policy Committee 5-24-2022 Annual review, no clinical content change

Internal Medical Policy Committee 7-21-2022 - Effective September 01, 2022

Added bezlotoxumab (Zinplava), J0565, to the precertification drug list
Updated the experimental/investigational statement

Internal Medical Policy Committee 7-26-2023- Effective September 01, 2023

Updated criteria age to one (1) year of age or older due to FDA labeling change, previously was 18 years of age or older

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

Policy ID: I-165-006

Section: Injections

Effective Date: October 01, 2019

Revised Date: July 05, 2022

Revision Effective Date: September 01, 2022

Last Reviewed: July 21, 2022

Archived Date: August 31, 2023

Applies To: Commercial and Medicaid Expansion

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 (1) or more episodes of CDI within the six (6) 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.

Procedure Codes

J0565

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.

Diagnosis Codes

Covered Diagnosis Codes for J0565

A04.71

A04.72

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 9-26-2019 Adopted policy

Internal Medical Policy Committee 9-21-2020 Annual review; no clinical content changed

Internal Medical Policy Committee 5-20-2021 No clinical content change

Internal Medical Policy Committee 5-24-2022 Annual review, no clinical content change

Internal Medical Policy Committee 7-21-2022 Added bezlotoxumab (Zinplava), J0565, to the precertification drug list effective September 1, 2022, updated the experimental/investigational statement

Links

References (PDF)

Disclaimer

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