Pharmacy Prior Authorization Criteria

Pulmozyme (dornase alfa inhalation solution)

For diagnosis of Cystic Fibrosis
Indicated, in conjunction with standard therapies, for the management of pediatric and adult patients with cystic fibrosis (CF) 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.

For initial authorization request, approve through 12/31/2039 For reauthorization request, bypass criteria review and approve through 12/31/2039

Prior Authorization

Length of Approval: When approved; no reauthorization required

2025-05-01, 2025-04-30, 2025-03-24, 2024-05-03, 2023-11-06, 2023-04-06, 2022-03-25, 2021-09-27, 2021-05-21, 2021-04-07, 2020-03-12

Pulmozyme Prescribing Information. Genentech, Inc. South San Francisco, CA. February 2024.
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(7):680-9.
Flume PA, O’Sullivan BP, Robinson KA et al. Cystic fibrosis pulmonary guidelines. Am J Respir Crit Care Med. 2007;176:957-969

2025-05-01: Approval length updated to "Approved- no reauthorization required"
2025-04-30: Note and approval lenght updated from 2099 to 2039.
2025-03-24: Removing reauthorization requirement as part of extended reauthorization program.
2024-05-03: Annual review: No criteria changes. Updated references.
2023-11-06: Program update to standard reauthorization language. No changes to clinical intent
2023-04-06: Annual review: No criteria changes.
2022-03-25: Annual review: No criteria changes. Updated references and indications to align with PI.
2021-09-27: Addition of EHB formulary to guideline, no changes to criteria
2021-05-21: Addition of EHB formulary to guideline, no changes to criteria
2021-04-07: 2021 Annual Review. No change to criteria.
2020-03-12: 2020 Annual Review, no changes to criteria.