Subject: Arikayce 3150-A SGM P2023

Drug

ARIKAYCE  (amikacin liposome inhalation suspension)

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.

          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.

 
    II.  CRITERIA FOR INITIAL APPROVAL

          Mycobacterium avium complex (MAC) lung disease
          Authorization of 12 months may be granted for members with
          mycobacterium avium complex (MAC) lung disease when the
          following criteria is met:
          A.  The patient has refractory disease with limited or no other
               treatment options.
          B.  The requested medication will be used as part of a
               combination antibacterial drug regimen.
          C.  The patient has not achieved negative sputum cultures after
               being treated with a multidrug background regimen therapy
               for a minimum of 6 consecutive months.

 
  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 (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; October 2020.
2. Griffith, DE, Aksamit, T, Brown-Elliott, BA, et al. An Official ATS/IDSA Statement: Diagnosis, Treatment, and Prevention of Nontuberculous Mycobacterial Disease [published correction appears in Am J Respir Crit Care Med. 2007 Apr 1;175(7):744-5. Dosage error in article text]. Am J Respir Crit Care Med. 2007;175(4):367-416. doi:10.1164/rccm.200604-571ST
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. doi:10.1093/cid/ciaa241

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