II-199-004

Medical Policy:

II-199-004

Topic:

Bezlotoxumab

Section:

Medicine

Effective Date:

May 3, 2021

Issued Date:

May 3, 2021

Last Revision Date:

April 2021

Annual Review:

April 2021

This policy version was replaced May 30, 2022. To find the newest version, go to https://www.bluecrossmn.com/providers/medical-policy-and-utilization-management, read and accept the Blue Cross Medical Policy Statement, then select “Blue Cross and Blue Shield of Minnesota Medical Policies.” This will bring up the Medical Policy search screen. Enter the policy number without the version number (last 3 digits).

Bezlotoxumab is a human monoclonal antibody that binds to Clostridioides (formerly Clostridium) difficile toxin B and neutralizes its effects. Bezlotoxumab is administered by intravenous infusion.

The U.S. Food and Drug Administration has approved bezlotoxumab (Zinplava®) to reduce recurrence of Clostridioides (formerly Clostridium) difficile infection (CDI) in patients 18 years of age or older who are receiving antibacterial drug treatment of CDI and are at high risk for CDI recurrence. According to the prescribing information, bezlotoxumab is not indicated for treatment of CDI and is not an antibacterial drug. Bezlotoxumab should only be used in conjunction with antibacterial drug treatment of CDI.

Heart failure has occurred in bezlotoxumab-treated patients with a history of congestive heart failure. In patients with a history of congestive heart failure, bezlotoxumab should be reserved for use when the benefit outweighs the risk.

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Policy Position Coverage is subject to the specific terms of the member's benefit plan.

I. Bezlotoxumab may be considered MEDICALLY NECESSARY AND APPROPRIATE when ALL of the following criteria are met:

Age 18 years or older; AND
Confirmed Clostridioides (formerly Clostridium) difficile infection (CDI), including BOTH of the following:
- Passage of 3 or more loose stools within 24 hours or less; AND
- Positive stool test for toxigenic Clostridioides (formerly Clostridium) difficile from a stool sample collected no more than 7 days prior to treatment with bezlotoxumab; AND
Currently receiving antibacterial therapy (e.g., metronidazole, vancomycin, fidaxomicin) for CDI; AND
Patient is at high risk of CDI recurrence, as defined by at least ONE of the following:
- Age 65 years or older; OR
- One or more episodes of CDI within 6 months prior to the episode under treatment; OR
- Immunocompromised state; OR
- Severe CDI at presentation (CDI with abdominal distension, hypoalbuminemia [serum albumin <3 g/dL], and white blood cell count ≥15,000 cells/mm³); OR
- Clostridioides (formerly Clostridium) difficile ribotype 027; AND
No FDA labeled contraindications to bezlotoxumab (see table 1 below); AND
Bezlotoxumab will only be administered as a single dose per active CDI episode; AND
The dose is within the FDA labeled dose for the indication (see table 2 below).

II. Bezlotoxumab is considered EXPERIMENTAL/INVESTIGATIVE for all other indications due to the lack of clinical evidence demonstrating an impact on improved health outcomes.

J0565

Table 1. FDA Labeled Contraindications

Agent	FDA Labeled Contraindications
Bezlotoxumab	None

Table 2. Dosing

FDA Labeled Indications	Dosing
Reduce recurrence of Clostridioides (formerly Clostridium) difficile infection (CDI)	Single dose of 10 mg/kg

Denial Statements

No additional statements.

Links

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