Medical Policy
Effective Date:10/01/2023 Title:Zinplava (bezlotoxumab)
Revision Date: Document:BI725:00
CPT Code(s):J0565
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Zinplava (bezlotoxumab) requires prior authorization.

2)    Zinplava is indicated to reduce the recurrence of Clostridium difficile infection (CDI) in patients 18 years of age or older.

3)    Zinplava is covered under the medical benefit.
Medical Statement

I. Initial Approval Criteria

A. Clostridium difficile Infection (must meet all):

1. Diagnosis of CDI confirmed by documentation of positive Clostridium difficile test;

2. Age ≥ 18 years;

3. Member will receive or is currently receiving concomitant antibacterial drug treatment for CDI (e.g., vancomycin, fidaxomicin);

4. Member has had at least one episode of CDI recurrence (total 2 episodes) in the previous 6 months and has been treated with appropriate treatment for CDI (e.g., metronidazole, vancomycin, fidaxomicin), including a pulsed vancomycin regimen;

*Treatment failure for CDI may be declared in as little as 48 hours in patients with severe disease who fail to improve.

5. Dose does not exceed 10 mg/kg once.

 

Approval duration: 3 months (1 dose only)

 

 

II. Continued Therapy

A. Clostridium difficile Infection

1. Re-authorization is not permitted. Members must meet the initial approval criteria.

 

Approval duration: Not applicable

 

 

Codes Used In This BI:

 

J0565 – Injection, bezlotoxumab, 10mg
Limits
Intentially left empty
Reference

1. Zinplava Prescribing Information. Whitehouse Station, NJ: Merck & Co., Inc; October 2016. Available at: https://www.merck.com/product/usa/pi_circulars/z/zinplava/zinplava_pi.pdf. Accessed October 12, 2022.

 

2. Antimicrobial Drugs Advisory Committee. Bezlotoxumab injection briefing document (BLA 761046). Published June 9, 2016. Available at http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/anti-infectivedrugsadvisorycommittee/ucm505291.pdf. Accessed October 12, 2022.

 

3. Surawicz CM, Brandt LJ, Binion DG et al. Guidelines for diagnosis, treatment, and prevention of Clostridium difficile infections. Am J Gastroenterol. 2013 Apr;108(4):478-98; quiz 499. doi: 10.1038/ajg.2013.4. Epub 2013 Feb 26.

 

4. Zar FA, Bakkanagari SR, Moorthi KM, Davis MB. A comparison of vancomycin and metronidazole for the treatment of Clostridium difficile-associated diarrhea, stratified by disease severity. Clin Infect Dis 2007;45(3):302-7.

 

5. Lessa FC, Mu Y, Bamber WM et al. Burden of Clostridium difficile infection in the United States. N Engl J Med. 2015 Feb 26;372(9):825-34. doi: 10.1056/NEJMoa1408913

 

6. McDonald LC, Gerding DN, Johnson S, et al. Clinical practice guidelines for Clostridium difficile infection in adults and children: 2017 updated by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA). Clin Infect Dis. March 2018;66(7):987-994.

 

7. Johnson S, Lavergne V, Skinner AM, et al. Clinical Practice Guideline by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA): 2021 Focused Update Guidelines on Management of Clostridioides difficile Infection in Adults. CID 2021; 73 (1 September): e1029-1044.

 

8. Kelly CR, Fischer M, Allegretti JR, et al. ACG Clinical Guidelines: Prevention, Diagnosis, and Treatment of Clostridioides difficile Infections. Am J Gastroenterol 2021;116:1124 - 1147.

Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.