CurrentColorado Rocky Mountain Health PlansPolicy 1 = 2026 P 3157-6

Bronchitol (mannitol) step therapy — coverage criteria

Defines step therapy requirements for coverage of Bronchitol (mannitol) as add-on maintenance therapy in adults with cystic fibrosis, requiring prior trial of inhaled hypertonic saline; applies to pharmacy benefits under the payer's clinical pharmacy programs.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyBronchitol (mannitol) step therapy — coverage criteria

Policy CodePolicy 1 = 2026 P 3157-6

Change TypeAnnual review (no material changes)

Effective Date6/1/2026

Next Review DateN/A

Key ActionObtain prior authorization and document a trial (date and reason) of inhaled hypertonic saline showing failure, contraindication, or intolerance before requesting Bronchitol.

SourceLink

POLICY UPDATE CHANGES

Annual review with no change to coverage criteria; updated reference in 3/2024, 3/2025, and 3/2026.

18+age requirement (adults)

1 prior agentrequired trial

12 moauthorization duration

6/2021–3/2026policy review dates

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Initial and reauthorization coverage criteria

Covered when ALL of the following are met

Eligibility and clinical prerequisites: Patient is an adult (>=18 years) with cystic fibrosis and has passed the Bronchitol Tolerance Test

from indication

Step therapy requirement: History of failure, contraindication, or intolerance to inhaled hypertonic saline (e.g., HyperSal) with documentation of trial date and reason

required prior agent

Authorization period: Authorization will be issued for 12 months

renewal per program rules

Use only in adults: Bronchitol is indicated as add‑on maintenance therapy to improve pulmonary function in patients with cystic fibrosis who are 18 years of age and older; it should be used only in adults who have passed the Bronchitol Tolerance Test.

Use of Bronchitol without a documented trial, contraindication, or intolerance to inhaled hypertonic saline (e.g., HyperSal) does not meet the program’s step therapy requirement. The policy requires documentation of the date of the hypertonic saline trial and the reason for therapeutic failure, contraindication, or intolerance before approval will be considered.

Initial Therapy

Initial approval conditions

Adult indication: Patient is 18 years or older with cystic fibrosis

Bronchitol indication

Tolerance test: Patient has passed the Bronchitol Tolerance Test

per product labeling

Step therapy failure: Documented history of failure, contraindication, or intolerance to inhaled hypertonic saline with date and reason

required prior agent before Bronchitol

Continuation Therapy

Renewal/continuation

Reauthorization: Authorization may be renewed; UnitedHealthcare may approve based on prior claim/medication history and diagnosis codes and automated processes may be used

Authorization issued for 12 months per approval

Step	Requirement	Notes
1	Trial of inhaled hypertonic saline (e.g., HyperSal) required prior to coverage of Bronchitol	Document date of trial and reason for therapeutic failure, contraindication, or intolerance; Bronchitol is indicated only for adults (≥18 years) who have passed the Bronchitol Tolerance Test

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Bronchitol. Approval will be issued for 12 months.

Prior authorization required
Approval duration: 12 months

Step Therapy

Step Therapy Requirement

Member must try inhaled hypertonic saline (e.g., HyperSal) before Bronchitol. Approval is granted only with documented failure, contraindication, or intolerance to inhaled hypertonic saline.

Step therapy: trial of inhaled hypertonic saline required prior to Bronchitol

Documentation Required

Required Documentation of Prior Trial

Document the date of the hypertonic saline trial and the specific reason for therapeutic failure, contraindication, or intolerance. Failure to document a prior trial, intolerance, or contraindication may result in denial of coverage.

Record trial date
State reason for failure, contraindication, or intolerance

Denial Risk

Prior Hypertonic Saline Required

If the member does not have a documented history of trial, intolerance, or contraindication to inhaled hypertonic saline (e.g., HyperSal), the request may be denied.

Lack of documented prior hypertonic saline trial = denial risk

Definitions

Bronchitol Tolerance Test (definition and requirement)

DefinitionBronchitol Tolerance Test: a tolerance assessment required before using Bronchitol as referenced in the indication.

PurposeTo confirm patient can tolerate inhaled Bronchitol (mannitol) prior to initiating therapy.

PopulationRequired for adult patients (age 18 years and older) prior to Bronchitol use.

Action requiredPatient must have passed the Bronchitol Tolerance Test before Bronchitol will be considered for coverage.

Supporting policy noteBronchitol is indicated as add-on maintenance therapy in adults with cystic fibrosis and use is limited to those who have passed this tolerance assessment.

Background

Background: Bronchitol (mannitol) is a sugar alcohol indicated as add‑on maintenance therapy to improve pulmonary function in adults (age 18+) with cystic fibrosis. The program requires patients to have passed a Bronchitol Tolerance Test and to follow the step therapy requirement of prior use of hypertonic saline before Bronchitol will be approved.