Subject: Vancomycin Oral Limit 2559-H P12-2024

Drug

FIRVANQ  (vancomycin)

VANCOCIN  (vancomycin)

Policy:

Indications

FDA-approved Indications

Vancocin

Vancocin is indicated for the treatment of Clostridioides difficile-associated diarrhea. Vancocin is also used for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adult and pediatric patients less than 18 years of age.

Limitations of Use

• Parenteral administration of vancomycin is not effective for the above infections; therefore, Vancocin must be given orally for these infections.
• Orally administered Vancocin is not effective for other types of infections.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancocin and other antibacterial drugs, Vancocin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Firvanq

Firvanq is indicated for the treatment of Clostridium difficile-associated diarrhea in adults and pediatric patients less than 18 years of age. Firvanq is also indicated for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adults and pediatric patients less than 18 years of age.

Important Limitations of Use

• Parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin must be given orally for these infections.
• Orally administered vancomycin hydrochloride is not effective for treatment of other types of infections.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Firvanq and other antibacterial drugs, Firvanq should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Initial Limit Quantity

Limits should accumulate across all drugs and strengths up to highest quantity listed depending on the order the claims are processed. Accumulation does not apply if limit is coded for daily dose.

This drug is indicated for short-term acute use.

Drug	Limit
Firvanq (vancomycin) powder for oral solution (all strengths)	450 mL / 10 days
Vancocin (vancomycin) capsules (all strengths)	80 capsules / 10 days

Place of Service:

Outpatient

The above policy is based on the following references:

1. Firvanq [package insert]. Wilmington, MA: Azurity Pharmaceuticals; February 2022.
2. Vancocin [package insert]. Baudette, MN: ANI Pharmaceuticals, Inc.; December 2021.
3. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2024. https://online.lexi.com. Accessed November 4, 2024.
4. Micromedex (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 11/04/2024).
5. McDonald L, Gerding D, Johnson S, et al. Clinical Practice Guidelines for Clostridium difficile Infection in Adults and Children: 2017 Update by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA). Clinical Infectious Diseases 2018:66 (7): e1-e48. https://doi.org/10.1093/cid/cix1085. Accessed November 4, 2024.
6. Johnson S, Lavergne V, Skinner A 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, Clinical Infectious Diseases 2021;73 (5): e1029–e1044. https://doi.org/10.1093/cid/ciab549 . Accessed November 4, 2024.
7. Kelly CR, Fischer M, Allegretti JR, LaPlante K, et al. ACG Clinical Guidelines: Prevention, Diagnosis, and Treatment of Clostridioides difficile Infections. Am J Gastroenterol. 2021 Jun 1;116(6):1124-1147.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

April 23, 2025