Subject: Tobramycin Inhalation 1887-A SGM P2022

Drug

tobramycin inhalation solution/TOBI

TOBI Podhaler  (tobramycin inhalation powder)

Bethkis  (tobramycin inhalation solution)

Kitabis Pak  (tobramycin inhalation solution)

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 Indications
      Management of cystic fibrosis in patients with Pseudomonas aeruginosa 

B.   Compendial Uses
      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 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:

1. Tobramycin inhalation solution [package insert]. Sellersville, PA: Teva Pharmaceuticals USA; April 2020.
2. TOBI [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; October 2018.
3. TOBI Podhaler [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; July 2020.
4. Bethkis [package insert]. Woodstock, IL: Chiesi USA, Inc.; May 2021.
5. Kitabis Pak [package insert]. Midlothian, VA: PARI Respiratory Equipment, Inc.; July 2021.
6. Micromedex® (electronic version). IBM Watson Health, Greenwood Village, Colorado. Available at https://www.micromedexsolutions.com Accessed December 10, 2021.
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;187:680-689.
8. Rosen, MJ. Chronic cough due to bronchiectasis: ACCP Evidence-Based Clinical Practice Guidelines. Chest. 2006;129:122S-131S.
9. Polverino E, Goeminne PC, McDonnell MJ, et al. European Respiratory Society guidelines for the management of adult bronchiectasis. Eur Respir J 2017; 50: 1700629.

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 26, 2022