Subject: Pulmozyme 1886-A SGM P2023

Drug

PULMOZYME  (dornase alfa)

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
          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.

 
    II.  CRITERIA FOR INITIAL APPROVAL

          Cystic Fibrosis
          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.

  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. Pulmozyme [package insert]. South San Francisco, CA: Genentech, Inc.; July 2021.
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.
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.

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