CurrentUnitedHealthcarePolicy 2025 P 1353-5

Bronchitol (mannitol) prior authorization

Prior authorization policy for Bronchitol (mannitol) as add-on maintenance therapy for adults with cystic fibrosis, governing initial and reauthorization criteria, approval durations, and program operation for UnitedHealthcare Pharmacy Clinical Pharmacy Programs.

Policy Summary

PayerUnitedHealthcare

PolicyBronchitol (mannitol) prior authorization

Policy CodePolicy 2025 P 1353-5

Change TypeClarified / annual review

Effective DateJun 1, 2025

Next Review Date

Key ActionObtain prior authorization with documentation of CF diagnosis, concomitant standard CF therapies, and passed Bronchitol Tolerance Test; authorizations are issued for 12 months.

POLICY UPDATE CHANGES

Annual review in 3/2025 with no change to coverage criteria; updated reference.

1Covered Indications

12 moAuthorization Duration

>=18Age Restriction

Coverage Summary

Coverage stance: covered_with_criteria. Scope: Prior authorization policy for Bronchitol (mannitol) as add-on maintenance therapy for adults with cystic fibrosis, governing initial and reauthorization criteria, approval durations, and program operation for UnitedHealthcare Pharmacy Clinical Pharmacy Programs. Age threshold: >= 18 years. Effective date: 2025-06-01. Last review: 2025-03-01.

Initial Authorization

Bronchitol will be approved based on all of the following criteria:

Diagnosis of cystic fibrosis (CF)
Concomitant therapies: Used in conjunction with standard CF therapies (e.g., chest physiotherapy, bronchodilators, antibiotics, anti-inflammatory therapy [e.g., ibuprofen, oral/inhaled corticosteroids])
Standard CF therapies must be concomitantly used
Tolerance test: Patient has passed the Bronchitol Tolerance Test
Bronchitol is indicated only in adults who have passed the Bronchitol Tolerance Test

Continuation / Reauthorization Criteria

Reauthorization

Bronchitol will be approved based on the following criteria:

Clinical response: Documentation of positive clinical response to Bronchitol therapy
Documentation required at reauthorization demonstrating clinical benefit

Program Operational Exceptions

Additional pathways that may permit approval regardless of above clinical criteria:

Automated approvals: UnitedHealthcare may approve initial and re-authorization based solely on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic
Use of automated approval and re-approval processes varies by program
Supply limitations may be in place
Quantity/supply limits can be applied

Provider Actions & Authorization Details

Prior Authorization

Prior authorization required

Prior authorization is required for Bronchitol. Initial authorization requires documentation of a diagnosis of cystic fibrosis, use in conjunction with standard CF therapies, and documentation that the patient has passed the Bronchitol Tolerance Test.

Authorization duration: 12 months
Required documentation elements: CF diagnosis; concomitant standard CF therapies; passed Bronchitol Tolerance Test

Prior Authorization

Reauthorization requirements

Reauthorization requires documentation of a positive clinical response to Bronchitol therapy.

Reauthorization duration: 12 months
Must document positive clinical response

Documentation Required

Tolerance test documentation

Document that the patient passed the Bronchitol Tolerance Test prior to initiation. See Definitions for the Bronchitol Tolerance Test requirement.

Refer to Definitions entry: Bronchitol Tolerance Test

Billing Rule

Supply/quantity limits may apply

Supply or quantity limitations may be applied by the program. UnitedHealthcare may use automated approval and re-approval processes based on prior claim/medication history, diagnosis codes, and/or claim logic.

Automated approvals based on claims history and claim logic may be used

Quick Reference

Authorization duration (initial)12 months

Authorization duration (reauthorization)12 months

Age restriction>= 18 years

Policy number2025 P 1353-5

Effective date2025-06-01

Last review2025-03-01

Background & Definitions

Bronchitol (mannitol) is indicated as add-on maintenance therapy to improve pulmonary function in adult patients 18 years and older with cystic fibrosis and should be used only in adults who have passed the Bronchitol Tolerance Test. Initial authorization requires a diagnosis of cystic fibrosis, use in conjunction with standard CF therapies, and documentation that the patient passed the Bronchitol Tolerance Test; authorization is issued for 12 months. Reauthorization requires documentation of a positive clinical response and is issued for 12 months. Federal regulatory requirements and member-specific benefit plans may also impact coverage, and UnitedHealthcare program operational processes (including automated approvals and supply limitations) may affect approval and quantity limits.

Term	Definition
Bronchitol Tolerance Test
A tolerance test required prior to Bronchitol initiation; documentation that the patient passed the test is required for coverage.
Positive clinical response
Documentation required at reauthorization demonstrating clinical benefit from Bronchitol therapy (unspecified measure per clinical documentation).