Subject: Tobramycin Inhalation 1887-A SGM P2023
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tobramycin inhalation solution/TOBI
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TOBI Podhaler
(tobramycin inhalation powder)
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Bethkis
(tobramycin inhalation solution)
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Kitabis Pak
(tobramycin inhalation solution)
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Policy:
I. 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.
A. FDA-Approved Indication
Management of cystic fibrosis in patients with Pseudomonas
aeruginosa
B. Compendial Use
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.
II. CRITERIA FOR INITIAL APPROVAL
A. Cystic Fibrosis
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.
B. Bronchiectasis (Non-Cystic Fibrosis)
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.
III. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for continued
treatment in members requesting reauthorization for an
indication listed in Section II 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:
- Tobramycin inhalation solution [package insert]. Parsippany, NJ: Teva Pharmaceuticals USA; February 2020.
- TOBI [package insert]. Morgantown, WV: Mylan Specialty L.P.; June 2021.
- TOBI Podhaler [package insert]. Morgantown, WV: Mylan Specialty L.P.; October 2020.
- Bethkis [package insert]. Woodstock, IL: Chiesi USA, Inc.; May 2021.
- Kitabis Pak [package insert]. Midlothian, VA: PARI Respiratory Equipment, Inc.; August 2021.
- Micromedex® (electronic version). IBM Watson Health, Greenwood Village, Colorado. Available at https://www.micromedexsolutions.com. Accessed December 1, 2022.
- 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
- 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
- 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. Published 2017 Sep 9. doi:10.1183/13993003.00629-2017
- 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 11, 2023
