Pharmacy Prior Authorization Criteria

Bronchitol (mannitol) inhalation powder

Indications for Prior Authorization

Bronchitol (mannitol) inhalation powder

• For diagnosis of Cystic Fibrosis (CF)
  Indicated as add-on maintenance therapy to improve pulmonary function in adult patients 18 years and older with cystic fibrosis. Use only in adults who have passed the Bronchitol Tolerance Test.

Criteria

Bronchitol

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)

• Diagnosis of cystic fibrosis (CF)
AND
• Patient is 18 years of age or older
AND
• Patient has passed the Bronchitol Tolerance Test (BTT)
AND
• One of the following:
• Patient is currently receiving Pulmozyme (dornase alfa)
OR
• Patient has a contraindication, intolerance, or is not a candidate for continued Pulmozyme therapy
AND
• Trial and failure, contraindication, or intolerance to inhaled hypertonic saline
AND
• Prescribed by or in consultation with one of the following:
• Pulmonologist
• Specialist affiliated with a CF care center

Bronchitol

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates positive clinical response to therapy (e.g., improvement in lung function [forced expiratory volume in one second {FEV1}])
AND
• One of the following:
• Patient is currently receiving Pulmozyme (dornase alfa)
OR
• Patient has a contraindication, intolerance, or is not a candidate for continued Pulmozyme therapy
AND
• Trial and failure, contraindication, or intolerance to inhaled hypertonic saline

P & T Revisions

2024-03-27, 2023-09-13, 2023-03-09, 2022-03-25, 2021-04-07

References

1. Bronchitol Prescribing Information. Chiesi USA, Inc. Cary, NC. January 2024.
2. Per clinical consult with specialist, March 24, 2021.
3. Simon, RH. Cystic fibrosis: Overview of the treatment of lung disease. In: Post T, ed. UpToDate. UpToDate; 2021. Accessed March 24, 2021. www.uptodate.com
4. Micromedex Healthcare Series [database on the Internet]. Greenwood Village (CO): IBM Corporation.; Updated periodically. Available by subscription at: https://www.micromedexsolutions.com/. Accessed February 11, 2021.

---

Revision History

• 2024-03-27: 2024 UM Annual Review. Added in embedded step of t/f of Pulmozyme and hypertonic saline into reauth criteria. Background updates
• 2023-09-13: Program update to standard reauthorization language. No changes to clinical intent.
• 2023-03-09: 2023 UM Annual Review. No criteria changes.
• 2022-03-25: Annual review: no criteria changes
• 2021-04-07: New Program

---