CurrentCignaPolicy N/A

Cystic Fibrosis - Bronchitol Prior Authorization Policy

Prior authorization policy describing medical necessity criteria, exclusions, prescribing specialist requirement, and approval duration for Bronchitol (mannitol inhalation) as add-on maintenance therapy in cystic fibrosis for Cigna-administered plans.

Policy Summary

PayerCigna

PolicyCystic Fibrosis - Bronchitol Prior Authorization Policy

Policy CodePolicy N/A

Change TypeAnnual revision — no criteria changes

Effective Date

Next Review Date

Key ActionObtain prior authorization and document specialist involvement, prior hypertonic saline trial, and a passed Bronchitol Tolerance Test before approving for 1 year.

POLICY UPDATE CHANGES

Annual Revision notes indicate 'No criteria changes.' for prior review dates including 2023, 2024, and 2025.

1Covered Indication (CF)

1 yrApproval Duration

Tolerance testSafety Restriction

Coverage Summary

Bronchitol (mannitol oral inhalation powder) is covered with criteria as an add-on maintenance therapy for cystic fibrosis in patients aged ≥ 18 years. Coverage is provided as covered with criteria and approvals are issued for 1 year. Because of safety considerations and the specialized care required, Bronchitol must be prescribed by or in consultation with a pulmonologist or a physician who specializes in cystic fibrosis, and a supervised Bronchitol Tolerance Test is required prior to prescribing.

Medical Necessity Criteria

FDA-Approved Indication — Cystic Fibrosis

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

Age requirement: Patient is ≥ 18 years of age
Prior therapy: Patient has tried hypertonic saline
Tolerance testing: Patient has passed the Bronchitol Tolerance Test
Bronchitol is contraindicated in individuals who fail to pass the Bronchitol Tolerance Test; the test must be administered under supervision of a practitioner able to manage acute bronchospasm.
Premedication: Patient will pre-medicate with a short-acting bronchodilator
A short-acting bronchodilator should be administered 5 to 15 minutes before every dose of Bronchitol.
Specialist involvement: Medication is prescribed by or in consultation with a pulmonologist or a physician who specializes in the treatment of cystic fibrosis
Approval requires prescription by or consultation with a specialist due to monitoring and evaluation needs.

Provider Actions & Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for prescription benefit coverage of Bronchitol. All approvals are provided for a duration of 1 year.

Documentation Required

Specialist prescription/consultation required

Bronchitol must be prescribed by or in consultation with a pulmonologist or a physician who specializes in the treatment of cystic fibrosis. Documentation of specialist involvement should be available at review.

Documentation Required

Bronchitol Tolerance Test required

Document that the patient passed the Bronchitol Tolerance Test. The test must be performed under the supervision of a practitioner able to manage acute bronchospasm; failure of the test is a contraindication.

Documentation Required

Prior trial of hypertonic saline

Document prior use or trial of hypertonic saline before approving Bronchitol.

Billing Rule

Dosing and premedication practice

Prescribe Bronchitol 400 mg twice daily by oral inhalation. A short-acting bronchodilator should be administered by oral inhalation 5 to 15 minutes before each Bronchitol dose per safety guidance.

Background & Evidence

Bronchitol is indicated as add-on maintenance therapy to improve pulmonary function in adults (≥ 18 years) with cystic fibrosis. It can cause bronchospasm, including severe bronchospasm in susceptible patients, so a supervised Bronchitol Tolerance Test must be performed before initiating therapy; failure to pass the tolerance test is a contraindication. For patients who pass, dosing guidance recommends 400 mg twice daily with a short-acting bronchodilator given 5 to 15 minutes before each dose. In terms of guideline context, Bronchitol is not addressed in US CF guidance, while the European CF Society (2024) recognizes inhaled dry powder mannitol as an alternative to hypertonic saline and recommends initial tolerance testing (often with bronchodilator premedication).

Evidence source	Brief descriptor
Prescribing information (Bronchitol oral inhalation powder, Oct 2020)	Indication: add‑on maintenance therapy to improve pulmonary function in patients ≥18 years with cystic fibrosis; safety: can cause bronchospasm, requires supervised Bronchitol Tolerance Test; dosing and premedication guidance included
Key trials (multiple RCTs and long‑term studies; refs 3–5)	Clinical trial evidence includes randomized controlled studies and long‑term trials evaluating efficacy and safety of inhaled dry‑powder mannitol in adults with CF

Definitions

TermBronchitol Tolerance Test

DefinitionA supervised test to identify patients suitable for Bronchitol maintenance therapy and to detect bronchospasm risk; failure is a contraindication.

Operational noteMust be performed under supervision of a practitioner able to manage acute bronchospasm; documentation of passing required prior to prescribing

Revision History

2023-02-08annual_review

Annual Revision — No criteria changes.

2024-02-07annual_review

Annual Revision — No criteria changes.

2025-02-05annual_reviewLatest

Annual Revision — No criteria changes.

Policy Summary

PayerCigna

PolicyCystic Fibrosis - Bronchitol Prior Authorization Policy

Policy CodePolicy N/A

Change TypeAnnual revision — no criteria changes

Effective Date

Next Review Date

Key ActionObtain prior authorization and document specialist involvement, prior hypertonic saline trial, and a passed Bronchitol Tolerance Test before approving for 1 year.

On This Page

OpenPayer

Cystic Fibrosis - Bronchitol Prior Authorization Policy

Coverage Summary

Medical Necessity Criteria

Provider Actions & Requirements

Coding

Background & Evidence

Revision History