BRONCHITOL (mannitol)

BRONCHITOL (mannitol)

Self Administration - Inhalation

Diagnosis considered for coverage:

• 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.

Coverage Criteria:

For diagnosis of Cystic Fibrosis:

• Dose does not exceed 800 mg (20 capsules) per day via oral inhalation, AND
• Patient is 18 years of age or older, AND
• Prescribed by or in consultation with a pulmonologist or specialist affiliated with a cystic fibrosis care center, AND
• Patient has passed the Bronchitol Tolerance Test (BTT), AND
• Tried and failed, contraindicated, or intolerant to inhaled hypertonic saline, AND
• One of the following:
  • Patient is currently receiving Pulmozyme (dornase alfa).
  • Patient has a contraindication, intolerance, or is not a candidate for continued Pulmozyme therapy.

Reauthorization Criteria:

For diagnosis of Cystic Fibrosis:

• Dose does not exceed 800 mg (20 capsules) per day via oral inhalation, AND
• Documentation of positive clinical response to therapy (e.g., improvement in lung function [forced expiratory volume in one second {FEV1}]).

Coverage Duration:

• Initial: up to 6 months.
• Reauthorization: up to 12 months.

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:

• Bronchitol is the only mannitol product approved to treat CF.
• The BTT must be performed under the supervision of a healthcare practitioner before starting Bronchitol to identify patients who experience bronchospasm, a decrease in FEV1, or decreased oxygen saturation with the administration of mannitol.
• The recommended dose is 400 mg (contents of 10 inhalation capsules containing 40 mg mannitol/capsule) via oral inhalation twice daily (morning and evening - at least 2 to 3 hours before bedtime). Administer an inhaled short-acting bronchodilator 5 to 15 minutes before every mannitol dose. Each capsule is inhaled individually using the provided inhaler device.

Policy Updates:

• 06/15/2021 – New policy approved by P&T.

References:

• Aitken ML, Bellon G, De Boeck K, et al; CF302 Investigators. Long-term inhaled dry powder mannitol in cystic fibrosis: an international randomized study. Am J Respir Crit Care Med. 2012;185(6):645-652. doi: 10.1164/rccm.201109-1666OC.
• Bilton D, Bellon G, Charlton B, et al; CF301 and CF302 Investigators. Pooled analysis of two large randomised phase III inhaled mannitol studies in cystic fibrosis. J Cyst Fibros. 2013;12(4):367-376. doi: 10.1016/j.jcf.2012.11.002.
• Bilton D, Robinson P, Cooper P, et al; CF301 Study Investigators. Inhaled dry powder mannitol in cystic fibrosis: an efficacy and safety study. Eur Respir J. 2011;38(5):1071-1080. doi: 10.1183/09031936.00187510.
• Bronchitol [package insert], Cary, NC: Chiesi USA, Inc.; October 2020.
• ClinicalTrials.gov Web site. https://clinicaltrials.gov. Identifiers: NCT02134353, NCT00446680, NCT00630812. Accessed March 15, 2021.
• Flume PA, Amelina E, Daines CL, et al. Efficacy and safety of inhaled dry-powder mannitol in adults with cystic fibrosis: an international, randomized controlled study. J Cyst Fibros. 2021:S1569-1993(21)00046-1. doi: 10.1016/j.jcf.2021.02.011.
• Medscape medical news [press release]. FDA panel recommends mannitol inhalation powder for CF. https://www.medscape.com/viewarticle/912853 May 9, 2019. Accessed March 19, 2021.
• Mogayzel PJ, Naureckas ET, Robinson KA, et al; Pulmonary Clinical Practice Guidelines Committee. Cystic fibrosis pulmonary guidelines: chronic medications for maintenance of lung health. Am J Respir Crit Care Med. 2013;187(7):680-689.
• Nevitt SJ, Thornton J, Murray CS, Dwyer T. Inhaled mannitol for cystic fibrosis. Cochrane Database Syst Rev. 2020;5(5):CD008649. doi: 10.1002/14651858.CD008649.pub4.
• Tam J, Nash EF, Ratjen F, Tullis E, Stephenson A. Nebulized and oral thiol derivatives for pulmonary disease in cystic fibrosis. Cochrane Database Syst Rev. 2013;(7):CD007168. doi: 10.1002/14651858.CD007168.pub3.
• Wark P, McDonald VM. Nebulised hypertonic saline for cystic fibrosis. Cochrane Database Syst Rev. 2018;9(9):CD001506. doi: 10.1002/14651858.CD001506.pub4.
• Yang C, Montgomery M. Dornase alfa for cystic fibrosis. Cochrane Database Syst Rev. 2021;3:CD001127. doi: 10.1002/14651858.CD001127.pub5