ZINPLAVA™

(bezlotoxumab) injection

Professional Resources

Possible relevant diagnosis codes for CDI

Patients with Clostridium difficile infections may experience repeat episodes, and the risk of a recurrence increases with each episode.1 Between 25% and 30% of patients develop recurrence within days or weeks of an initial infection.2 Recurrence is associated with greater morbidity, and practice guidelines provide distinct recommendations for the management of recurrence.2

These were some of the factors considered when the CDC recommended, and CMS adopted, new codes effective fiscal year 2018 (starting October 1, 2017).3

The potentially relevant codes, now available for use (effective October 1, 2017), are4:

Diagnosis
A04.71 Enterocolitis due to Clostridium difficile, recurrent
A04.72 Enterocolitis due to Clostridium difficile, not specified as recurrent

Providers are now able to more easily identify patients who have had previous CDI episodes, and can thus aid in decision-making about appropriate treatment options.

The above codes may be potentially relevant when billing for ZINPLAVA and its administration. Consult the relevant manual and/or other guidelines for a description of each code to determine the appropriateness of its use and for information on additional codes. Diagnosis codes should be selected only by a health care professional. Please consult with the applicable payer to understand the payer’s specific billing requirements. This information is subject to change.

You are solely responsible for determining the appropriate codes and for any action you take in billing. The information provided here is not intended to be definitive or exhaustive, and is not intended to replace the guidance of a qualified professional advisor. Merck and its agents make no warranties or guarantees, expressed or implied, concerning the accuracy or appropriateness of this information for your particular use given the frequent changes in public and private payer billing. The use of this information does not guarantee payment or that any payment received will cover your costs.

Definitions

CDC = Centers for Disease Control and Prevention 

CDI = Clostridium difficile infection 

CMS = Centers for Medicare and Medicaid Services

References

1. Cohen SH, Gerding DN, Johnson S, et al. Clinical practice guidelines for Clostridium difficile infection in adults: 2010 update by the Society for Healthcare Epidemiology of America (SHEA) and the Infectious Diseases Society of America (IDSA). Infect Control Hosp Epidemiol. 2010;31(5):431–455. doi:10.1086/651706. 

2. Department of Health and Human Services. Centers for Medicare and Medicaid Services. Document CMS-1677-F. Published in the Federal Register August 14, 2017. https://federalregister.gov/d/2017-16434. Accessed August 9, 2017. 

3. ICD-10 code lookup. Centers for Medicare and Medicaid Services website. https://www.cms.gov/medicare-coverage-database/staticpages/icd-10-code-lookup.aspx?KeyWord=clostridium%20difficile&bc=AAAAAAAAAAAQAA%3d%3d&. Accessed August 30, 2017. 

4. Clostridium difficile. ICD-10 coordination and maintenance committee meeting. Centers for Disease Control and Prevention. March 9–10, 2016.

Indication

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 high risk for CDI recurrence.

ZINPLAVA is not indicated for the treatment of CDI. ZINPLAVA is not an antibacterial drug. ZINPLAVA should only be used in conjunction with antibacterial drug treatment of CDI.

Selected Safety Information

  • In patients with a history of congestive heart failure (CHF), ZINPLAVA should be used when the benefit outweighs the risk. Heart failure was reported more commonly in the two Phase 3 clinical trials in ZINPLAVA-treated patients compared to placebo-treated patients. In patients with a history of CHF, 12.7% (n=15/118) of ZINPLAVA-treated patients and 4.8% (n=5/104) of placebo-treated patients had the serious adverse reaction of heart failure during the 12-week study period. During the same period, for patients with a history of CHF, there were more deaths in ZINPLAVA-treated patients 19.5% (n=23/118) than in placebo-treated patients 12.5% (n=13/104). The causes of death varied and included cardiac failure, infections, and respiratory failure.
  • The most common adverse reactions occurring within 4 weeks of infusion with a frequency greater than placebo and reported in ≥4% of patients treated with ZINPLAVA and Standard of Care (SoC) antibacterial drug therapy vs placebo and SoC antibacterial drug therapy were nausea (7% vs 5%), pyrexia (5% vs 3%), and headache (4% vs 3%).
  • Serious adverse reactions occurring within 12 weeks following infusion were reported in 29% of ZINPLAVA-treated patients and 33% of placebo-treated patients. Heart failure was reported as a serious adverse reaction in 2.3% of the ZINPLAVA-treated patients and 1.0% of placebo-treated patients.
  • In ZINPLAVA-treated patients, 10% experienced one or more infusion specific adverse reactions compared to 8% of placebo-treated patients, on the day of or the day after, the infusion. Infusion specific adverse reactions reported in ≥0.5% of patients receiving ZINPLAVA and at a frequency greater than placebo were nausea (3%), fatigue (1%), pyrexia (1%), dizziness (1%), headache (2%), dyspnea (1%), and hypertension (1%). Of these patients, 78% experienced mild adverse reactions, and 20% experienced moderate adverse reactions. These reactions resolved within 24 hours following onset.
  • As with all therapeutic proteins, there is a potential for immunogenicity following administration of ZINPLAVA. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Comparison of the incidence of antibodies to bezlotoxumab in the two Phase 3 studies (MODIFY I and II) with the incidence of antibodies in other studies or to other products may be misleading. In MODIFY I and II, none of the 710 evaluable ZINPLAVA-treated patients tested positive for treatment-emergent anti-bezlotoxumab antibodies.

Before prescribing ZINPLAVATM (bezlotoxumab), please read the Prescribing Information. The Patient Information is also available.

AINF-1245982-000007/18