CurrentCignaPolicy IP0126

Cystic Fibrosis - Bronchitol

Defines medical necessity criteria for coverage of Bronchitol (mannitol oral inhalation powder) as add-on maintenance therapy for adults with cystic fibrosis and states noncoverage for other uses including concomitant use with hypertonic saline.

Policy Summary

PayerCigna

PolicyCystic Fibrosis - Bronchitol

Policy CodePolicy IP0126

Change TypeAnnual Revision (No criteria changes)

Effective Date

Next Review Date

Key ActionWhen criteria are met, approve Bronchitol for 1 year; renewal requires meeting coverage criteria again.

POLICY UPDATE CHANGES

Annual Revision dated 05/01/2025 with summary: No criteria changes.

1Covered Indication (CF in adults)

5Required criteria count

1Yearly approval duration

Coverage Summary

This policy defines medical necessity criteria for coverage of Bronchitol (mannitol oral inhalation powder) as an add-on maintenance therapy for adults with cystic fibrosis. The policy stance is covered with criteria — approvals are granted when specified requirements are met and other uses are considered not medically necessary. Key thresholds include age ≥ 18 years, documented trial of hypertonic saline, completion of a supervised Bronchitol Tolerance Test, and pre‑medication with a short-acting bronchodilator prior to each dose.

Medical-Necessity Criteria

FDA-Approved Indication - Cystic Fibrosis (Approve for 1 year)

Approve for 1 year if the patient meets ALL of the following (A, B, C, D, and E):

Age: Patient is ≥ 18 years of age≥ 18 years
Prior therapy: Patient has tried hypertonic saline
Tolerance test: Patient has passed the Bronchitol Tolerance Test
Test must be administered and performed under supervision able to manage acute bronchospasm
Bronchodilator pre-medication: Patient will pre-medicate with a short-acting bronchodilatoradministered 5 to 15 minutes before every dose
Prescriber specialty: The medication is prescribed by or in consultation with a pulmonologist or a physician who specializes in the treatment of cystic fibrosis

Not Medically Necessary / Exclusions

Bronchitol for any other use is considered not medically necessary, including but not limited to:

Not Medically Necessary / Exclusions: Concomitant use with hypertonic saline (Bronchitol has not been studied in combination with hypertonic saline)

Provider Actions & Authorization

Prior Authorization

Coverage duration and approval

Approve Bronchitol for a duration of 1 year when the patient meets all coverage criteria. Renewal or continuation beyond the initial approval requires documentation that the patient continues to meet the policy criteria.

Documentation Required

Bronchitol Tolerance Test required

Document that the patient passed the Bronchitol Tolerance Test administered under the supervision of a practitioner able to manage acute bronchospasm prior to prescribing Bronchitol. The Bronchitol Tolerance Test is a supervised test to identify patients who may have bronchospasm with Bronchitol and must be performed under supervision able to manage acute bronchospasm.

Documentation Required

Bronchodilator pre-medication requirement

Document that the patient will pre-medicate with a short-acting bronchodilator 5 to 15 minutes before every dose of Bronchitol.

Documentation Required

Prior therapy requirement

Document a trial of hypertonic saline prior to initiating Bronchitol.

Documentation Required

Prescriber specialty

Document that the medication is prescribed by or in consultation with a pulmonologist or a physician who specializes in the treatment of cystic fibrosis.

Denial Risk

Not covered indications

Claims for Bronchitol for indications other than the FDA‑approved cystic fibrosis indication in adults, including concomitant use with hypertonic saline, are considered not medically necessary and may be denied.

Billing Rule

Use appropriate codes

When billing, use the most appropriate diagnosis and procedure/drug codes as of the effective date. Claims submitted without covered codes under this policy will be denied as not covered.

Background & Evidence

Bronchitol is indicated as add‑on maintenance therapy to improve pulmonary function in patients ≥ 18 years with cystic fibrosis. The agent can cause bronchospasm, which may be severe in susceptible patients; therefore a supervised Bronchitol Tolerance Test is required prior to prescribing to identify patients who tolerate the medication. For patients who pass tolerance testing, a short‑acting bronchodilator should be administered by inhalation 5 to 15 minutes before every dose to reduce bronchospasm risk.

Prescribing information: Bronchitol oral inhalation powder prescribing information (Pharmaxis/Chiesi; October 2020) provides the approved indication, safety information about bronchospasm, dosing guidance, and the requirement for a supervised Bronchitol Tolerance Test.

Evidence and guidelines: Randomized controlled studies (including pivotal RCTs from 2011, 2012, and 2020) evaluated inhaled dry‑powder mannitol in adults with cystic fibrosis. The European Cystic Fibrosis Society (2024) recognizes inhaled dry powder mannitol as an alternative to hypertonic saline and specifically recommends initial tolerance testing and consideration of bronchodilator premedication because both agents can irritate the airways.

Definitions

Definition:

Bronchitol Tolerance Test: A supervised test to identify patients who may have bronchospasm with Bronchitol; required prior to prescribing and must be performed under supervision able to manage acute bronchospasm.

Contraindicated in individuals who fail to pass the test.

OpenPayer

Cystic Fibrosis - Bronchitol

Coverage Summary

Medical-Necessity Criteria

Provider Actions & Authorization

Coding

Background & Evidence

Revision History