CurrentColorado Rocky Mountain Health PlansPolicy 2026 P 1353-6

Bronchitol (mannitol) prior authorization

Prior authorization policy for Bronchitol (mannitol) as add-on maintenance therapy in adult patients with cystic fibrosis, including initial and reauthorization clinical criteria and authorization durations. Applies to the payer's clinical pharmacy program and may be subject to state mandates and member benefit plan specifics.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyBronchitol (mannitol) prior authorization

Policy CodePolicy 2026 P 1353-6

Change TypeAnnual review (no change)

Effective DateJun 1, 2026

Next Review Date

Key ActionSubmit prior authorization with documentation of CF diagnosis, concomitant standard CF therapies, and passing the Bronchitol Tolerance Test; approvals issued for 12 months.

POLICY UPDATE CHANGES

Annual review. No changes to coverage criteria. Updated reference.

18+Minimum age for coverage (years)

12 moAuthorization duration (initial & renewal)

1Required tolerance test

Coverage Summary

Bronchitol (mannitol) is indicated as add-on maintenance therapy to improve pulmonary function in adults 18 years and older with cystic fibrosis; use is restricted to adults who have passed the Bronchitol Tolerance Test. Prior authorization is required and authorizations are issued for 12 months. State mandates and member-specific benefit plans may affect coverage. This policy is designated as covered with criteria under Program 2026 P 1353-6 (effective 2026-06-01).

Initial Therapy Criteria

Initial Authorization

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

Initial Authorization criteria

Diagnosis of cystic fibrosis (CF)
Concomitant therapies: Used in conjunction with standard CF therapies (e.g., chest physiotherapy, bronchodilators, antibiotics, anti-inflammatory therapy such as ibuprofen, oral/inhaled corticosteroids)
Standard CF therapies definition: Examples include chest physiotherapy, bronchodilators, antibiotics, anti-inflammatory therapy (e.g., ibuprofen, oral/inhaled corticosteroids).
Tolerability requirement: Patient has passed the Bronchitol Tolerance Test
Bronchitol Tolerance Test: A test to assess patient tolerability to Bronchitol prior to initiating therapy (policy requires patient to have passed this test).

Continuation / Reauthorization Criteria

Reauthorization

Bronchitol will be approved for reauthorization based on the following criterion:

Reauthorization criterion: Documentation of positive clinical response to Bronchitol therapy

Reauthorizations issued for 12 months.

Limitations and Exclusions

Coverage is limited to adult patients (minimum age 18) and is contingent on the patient having passed the Bronchitol Tolerance Test prior to initiation. Prior authorization requires documentation of CF diagnosis, concomitant use with standard CF therapies, and passing the tolerance test. State mandates and member benefit plan specifics may further restrict coverage or apply alternate requirements.

Provider Actions & Authorization Process

Prior Authorization

Prior authorization required

Prior authorization/notification is required for Bronchitol. Initial approvals require documentation of a diagnosis of cystic fibrosis, use in conjunction with standard CF therapies, and that the patient has passed the Bronchitol Tolerance Test. Authorizations are issued for 12 months.

Documentation Required

Reauthorization documentation

For reauthorization, providers must document a positive clinical response to Bronchitol therapy. Reauthorizations are issued for 12 months.

Documentation Required

Tolerability requirement

Patients must have passed the Bronchitol Tolerance Test prior to use; the policy requires tolerability testing before initiating therapy.

Billing Rule

Automated approvals may apply

UnitedHealthcare may grant initial and reauthorizations automatically based on previous claim/medication history, diagnosis codes, and/or claim logic. Use of automated approval processes varies by program, and supply limitations may be in place.

Clinical Evidence & References

Bronchitol [package insert], Chiesi USA, Inc.; October 2024.

Clinical note: Bronchitol is indicated as add-on maintenance therapy to improve pulmonary function in adult patients 18 years of age and older with cystic fibrosis; use only in adults who have passed the Bronchitol Tolerance Test.

Definitions & Background

Bronchitol Tolerance Test: A test to assess patient tolerability to Bronchitol prior to initiating therapy (policy requires the patient to have passed this test).

Standard CF therapies: Examples include chest physiotherapy, bronchodilators, antibiotics, and anti-inflammatory therapy (e.g., ibuprofen, oral/inhaled corticosteroids).

Background: Bronchitol is indicated as add-on maintenance therapy for improving pulmonary function in adults aged 18 and older with cystic fibrosis; use is restricted to those who have passed the Bronchitol Tolerance Test.