Subject: Pulmozyme SGM 1886-A P2026

Drug

PULMOZYME  (dornase alfa)

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 Indication¹

Pulmozyme is indicated, in conjunction with standard therapies, for the management of pediatric and adult patients with cystic fibrosis (CF) patients to improve pulmonary function.

In CF patients with an FVC ≥ 40% of predicted, daily administration of Pulmozyme has also been shown to reduce the risk of respiratory tract infections requiring parenteral antibiotics.

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

Prescriber Specialties

This medication must be prescribed by or in consultation with a pulmonologist or a prescriber specialized in the treatment of cystic fibrosis.

Coverage Criteria

Cystic Fibrosis^1-3

Authorization of 12 months may be granted for treatment of cystic fibrosis when Pulmozyme will be used in conjunction with standard therapies for cystic fibrosis.

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 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.      Pulmozyme [package insert]. South San Francisco, CA: Genentech, Inc.; February 2024.

2.     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.doi: 10.1164/rccm.201207-1160oe

3.     Cohen-Cymberknoh M, Shoseyov D, Kerem E. Managing cystic fibrosis: strategies that increase life expectancy and improve quality of life. Am J Respir Crit Care Med. 2011;183:1463-1471. doi: 10.1164/rccm.201009-1478CI

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.

July 29, 2026