Subject: Nuzyra PA with Limit 4363-C P01-2025

Drug

NUZYRA  (omadacycline)

Policy:

Indications

FDA-approved Indications

Community-Acquired Bacterial Pneumonia (CABP)

Nuzyra is indicated for the treatment of adult patients with community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae.

Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

Nuzyra is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by the following susceptible microorganisms: Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Staphylococcus lugdunensis, Streptococcus pyogenes, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Enterococcus faecalis, Enterobacter cloacae, and Klebsiella pneumoniae.

Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Nuzyra and other antibacterial drugs, Nuzyra 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.

Coverage Criteria

Authorization for the requested drug may be granted when the following criteria is met:

• The patient is being converted from intravenous (IV) omadacycline (Nuzyra) as prescribed by or in consultation with an Infectious Disease specialist.

Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

Authorization may be granted when the requested drug is being prescribed for the treatment of an adult patient with an acute bacterial skin and skin structure infection (ABSSSI) when ALL of the following criteria are met:

• The infection is caused by ANY of the following susceptible microorganisms: Staphylococcus aureus(methicillin-susceptible and -resistant isolates), Staphylococcus lugdunensis, Streptococcus pyogenes, Streptococcus anginosus  (includes S. anginosus, S. intermedius, and S. constellatus), Enterococcus faecalis, Enterobacter cloacae, Klebsiella pneumoniae.
• The infection is proven or strongly suspected to be caused by susceptible bacteria.
• The patient meets ONE of the following:
  • The patient has experienced an inadequate treatment response, intolerance, or contraindication to alternative therapies.
  • The bacteria are NOT susceptible to any other antibiotics.

Community-Acquired Bacterial Pneumonia (CABP)

Authorization may be granted when the requested drug is being prescribed for the treatment of an adult patient with community-acquired bacterial pneumonia (CABP) when ALL of the following criteria are met:

• The infection is caused by ANY of the following susceptible microorganisms: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, Chlamydophila pneumoniae.
• The infection is proven or strongly suspected to be caused by susceptible bacteria.
• The patient meets ONE of the following:
  • The patient has experienced an inadequate treatment response, intolerance, or contraindication to alternative therapies.
  • The bacteria are NOT susceptible to any other antibiotics.

Quantity Limits Apply

Quantity Limit

These drugs are for short-term acute use.

Drug	Limit
Nuzyra (omadacycline) 150 mg tablet	30 tablets / 14 days
Nuzyra (omadacycline) 100 mg vial	15 vials / 14 days

 

Duration of Approval (DOA)

• 4363-C: DOA: 14 days

Place of Service:

Outpatient

The above policy is based on the following references:

1. Nuzyra [package insert]. Boston, MA: Paratek Pharmaceuticals, Inc.; May 2021.
2. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2024. https://online.lexi.com. Accessed November 22, 2024.
3. Micromedex (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 11/22/2024).
4. Metlay JP, Waterer GW, Long AC, et al. Diagnosis and Treatment of Adults with Community-acquired Pneumonia. An Official Practice Guideline of the American Thoracic Society and Infectious Diseases Society of America. Am J Respir Crit Care Med. 2019;200(7):e45-67.
5. Stevens DL, Bisno AL, Chambers HF, et al. Practice Guidelines for the Diagnosis and Management of Skin and Soft Tissue Infections: 2014 Update by the Infectious Diseases Society of America. Clin Infect Dis. 2014;59(2):e10-52.

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.

June 06, 2025