Subject: Tobramycin Inhalation SGM 1887-A P2025

Drug

TOBI  (tobramycin inhalation solution)

TOBI  (tobramycin inhalation powder)

BETHKIS  (tobramycin inhalation solution)

KITABIS PAK  (tobramycin inhalation solution)

Policy:

Indications

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

FDA-approved Indication^1-5

Management of cystic fibrosis in patients with Pseudomonas aeruginosa.

Compendial Use^6,8,9

Pseudomonas aeruginosa lower respiratory tract infection in patients with non-cystic fibrosis bronchiectasis.

All other indications are considered experimental/investigational and are not medically necessary.

Coverage Criteria

Cystic Fibrosis^1-5,7,10

Authorization of 12 months may be granted for members 2 years of age and older with cystic fibrosis when Pseudomonas aeruginosa is present in airway cultures OR the member has a history of Pseudomonas aeruginosa infection or colonization in the airways.

Bronchiectasis (Non-Cystic Fibrosis)^6,8,9

Authorization of 12 months may be granted for members with non-cystic fibrosis bronchiectasis when Pseudomonas aeruginosa is present in airway cultures OR the member has a history of Pseudomonas aeruginosa infection or colonization in the airways.

Continuation of Therapy

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication listed in the coverage criteria section who are experiencing benefit from therapy as evidenced by disease stability or disease improvement.

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Tobramycin inhalation solution [package insert]. Princeton, NJ: Dr. Reddy’s Laboratories Inc.; February 2023.
2. TOBI [package insert]. Morgantown, WV: Mylan Specialty L.P.; February 2023.
3. TOBI Podhaler [package insert]. Morgantown, WV: Mylan Specialty L.P.; February 2023.
4. Bethkis [package insert]. Woodstock, IL: Chiesi USA, Inc.; February 2023.
5. Kitabis Pak [package insert]. Midlothian, VA: PARI Respiratory Equipment, Inc.; August 2023.
6. Lexicomp Online. Waltham, MA: UpToDate, Inc.. Available at: http://online.lexi.com. Accessed December 18, 2024.
7. Mogayzel PJ, Naureckas ET, Robinson KA, et al. Cystic fibrosis pulmonary guidelines. chronic medications for maintenance of lung health. Am J Respir Crit Care Med. 2013;187(7):680-689. doi:10.1164/rccm.201207-1160oe
8. Rosen, MJ. Chronic cough due to bronchiectasis: ACCP evidence-based clinical practice guidelines. Chest. 2006;129(1 Suppl):122S-131S. doi:10.1378/chest.129.1_suppl.122S
9. Polverino E, Goeminne PC, McDonnell MJ, et al. European Respiratory Society guidelines for the management of adult bronchiectasis. Eur Respir J 2017;50(3):1700629. doi:10.1183/13993003.00629-2017
10. Lahiri T, Hempstead SE, Brady C, et al. Clinical practice guidelines from the Cystic Fibrosis Foundation for preschoolers with cystic fibrosis. Pediatrics. 2016;137(4):e20151784. doi:10.1542/peds.2015-1784

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 07, 2025