Subject: Arikayce SGM 3150-A P2025

Drug

ARIKAYCE  (amikacin liposome inhalation suspension)

Policy:

Indications¹

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

Arikayce is indicated in adults who have limited or no alternative treatment options, for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen in patients who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy.

Limitation of Use

Arikayce has only been studied in patients with refractory MAC lung disease defined as patients who did not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. The use of Arikayce is not recommended for patients with non-refractory MAC lung disease.

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

Coverage Criteria

Mycobacterium avium complex (MAC) lung disease^1,3

Authorization of 12 months may be granted for members with mycobacterium avium complex (MAC) lung disease when all of the following criteria are met:

• The patient has refractory disease with limited or no other treatment options.
• The requested medication will be used as part of a combination antibacterial drug regimen.
• The patient has not achieved negative sputum cultures after being treated with a multidrug background regimen therapy for a minimum of 6 consecutive months.

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 (e.g., achievement and maintenance of negative sputum cultures).

Place of Service:

Outpatient

The above policy is based on the following references:

1. Arikayce [package insert]. Bridgewater, NJ: Insmed Incorporated; February 2023.
2. Griffith, DE, Aksamit, T, Brown-Elliott, BA, et al. An Official ATS/IDSA Statement: Diagnosis, Treatment, and Prevention of Nontuberculous Mycobacterial Disease Am J Respir Crit Care Med. 2007;175(4):367-416.
3. Daley, CL, Iaccarino, JM, Lange, C, et al. Treatment of Nontuberculous Mycobacterial Pulmonary Disease: An Official ATS/ERS/ESCMID/IDSA Clinical Practice Guideline [published correction appears in Clin Infect Dis. 2020 Dec 31;71(11):3023]. Clin Infect Dis. 2020;71(4):e1-e36.

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