CurrentmhnPolicy CP.PHAR.518

Mannitol (Bronchitol) — Clinical Policy

Defines medical necessity and prior authorization criteria for inhaled dry powder mannitol (Bronchitol) as add-on maintenance therapy in adults with cystic fibrosis, and describes required documentation and durations of approval for initial and continued therapy.

Policy Summary

Payermhn

PolicyMannitol (Bronchitol) — Clinical Policy

Policy CodePolicy CP.PHAR.518

Change TypeNo material changes

Effective Date03.01.21

Next Review Date

Key ActionSubmit prior authorization with documentation confirming CF diagnosis, prescriber specialty, age ≥18, prior inadequate response to alternatives or contraindications, successful BTT when required, and dosing within limits.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥18min age

800 mg/daymax dose

RequiredBTT

6 moInitial approval

12 moContinued approval

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Initial Therapy — Cystic Fibrosis

Covered when ALL of the following are met

Initial CF criteria: 1. Diagnosis of cystic fibrosis; 2. Prescribed by or in consultation with a pulmonologist; 3. Age >= 18 years; 4. Documentation of inadequate response to hypertonic saline and Pulmozyme (dornase alfa) unless both are contraindicated or clinically significant adverse events are experienced; 5. If request is for the 7-day or 4-week treatment pack, member meets both of the following: (a) documentation that member has successfully completed the Bronchitol tolerance test (BTT); (b) Bronchitol is prescribed concurrently with a short-acting bronchodilator; 6. Dose does not exceed one of the following: (a) For BTT: i. 400 mg once; ii. 10 capsules once; (b) For 7-day or 4-week treatment pack: i. 800 mg per day; ii. 20 capsules per day.see node 6

Approval duration: BTT: 4 weeks; 7-day/4-week treatment pack: 6 months.

Continued Therapy — Cystic Fibrosis

Covered when ALL of the following are met

Continued CF criteria: 1. Member meets one of the following: (a) currently receiving medication via Centene benefit or member has previously met initial approval criteria; or (b) member is currently receiving medication and is enrolled in a state and product with continuity of care regulations; 2. Member is responding positively to therapy; 3. If request is for BTT, re-authorization is not permitted; 4. If this is the first authorization for the 7-day or 4-week treatment pack, member meets both of the following: (a) documentation that member has successfully completed the BTT; (b) Bronchitol is prescribed concurrently with a short-acting bronchodilator; 5. If request is for a dose increase, new dose does not exceed both: (a) 800 mg per day; (b) 20 capsules per day.800 mg/day

Approval duration: 12 months.

Other Indications / Label Changes

For uses not specified under initial/continued criteria

Other indications logic: 1. If this drug has recently (within the last 6 months) undergone a label change that is not yet reflected in this policy, refer to the applicable formulary/non-formulary policy for the relevant line of business (see policy references listed in document); 2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 does not apply, refer to the off-label use policy for the relevant line of business (see CP.CPA.09, HIM.PA.154, CP.PMN.53).

See referenced policies for process.

Contraindications: hypersensitivity to mannitol or to any capsule components and failure to pass the Bronchitol tolerance test (BTT) preclude use. The policy also specifies that members younger than 18 years are not covered for this therapy.

Summary coverage note: Use of inhaled dry powder mannitol (Bronchitol) is not authorized for individuals who meet the contraindications above or who are < 18 years. Successful completion of the BTT is required before initiating therapy; failure of the BTT (e.g., bronchospasm) contraindicates treatment.

Off‑label/non‑FDA uses: Requests for uses that are not FDA‑approved and are not addressed in this policy are not authorized unless there is sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 (commercial), HIM.PA.154 (health insurance marketplace), or CP.PMN.53 (Medicaid).

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must submit documentation supporting that the member meets all approval criteria, including diagnosis, specialist involvement, age, prior therapies, and dose limits. Prior authorization may be required for Pulmozyme.

A completed prior authorization request documenting diagnosis of cystic fibrosis (CF)
Prescribed by or in consultation with a pulmonologist
Member age ≥ 18 years
Documentation of inadequate response to hypertonic saline and Pulmozyme unless both are contraindicated or have significant adverse events
If requesting 7-day or 4-week treatment pack: documentation of successful completion of the Bronchitol tolerance test (BTT) and concurrent prescription of a short-acting bronchodilator
Requested dose does not exceed approved limits (BTT: 400 mg once / 10 capsules once; 7-day/4-week pack: 800 mg per day / 20 capsules per day)
For continuation: evidence of positive response to therapy; BTT course is not re-authorized; first authorization for 7-day/4-week pack requires prior successful BTT

Step Therapy

Step Therapy / Therapeutic Alternatives

Step therapy applies for initial therapy. Documentation must show inadequate response to hypertonic saline and Pulmozyme prior to approval, unless both are contraindicated or clinically significant adverse events occurred.

Record of trials and inadequate response to hypertonic saline and Pulmozyme, or documentation of contraindication/adverse events
Note: Pulmozyme may itself require prior authorization

Documentation Required

Required Documentation

Provider must submit supporting clinical documentation such as office chart notes, lab results, or other clinical information to demonstrate the member meets all approval criteria.

Office notes showing diagnosis and specialist involvement
Documentation of prior therapies tried (hypertonic saline, Pulmozyme) and outcomes
BTT documentation when applicable (see Appendix D)
Medication dosing and quantity to confirm dose limits

Denial Risk

Unauthorized Indications / Age Restrictions

Requests for non‑FDA indications or for members under 18 years are not authorized under this policy and may be denied unless off‑label coverage policies or state continuity rules apply.

Non‑FDA approved indications require separate off‑label justification per CP.CPA.09 (commercial), HIM.PA.154 (marketplace), or CP.PMN.53 (Medicaid)
Members < 18 years: not authorized (see Appendix D); may be considered only under applicable off‑label or state-specific continuity provisions

Coding and Dosage Information

Codesmixed

N/A	No specific CPT/HCPCS/ICD codes listed in document

Drug Dosing / Product Availability (informational)mixed

400 mg	Mannitol (Bronchitol) dosing regimen: 400 mg (10 capsules) twice a day by oral inhalation; maximum 800 mg/day (20 capsules/day)
400 mg (BTT)	Mannitol (Bronchitol) Tolerance Test: 400 mg (10 capsules) once by oral inhalation under supervision (tolerance test: 1 inhaler, 10 capsules)
4-week pack	4-week treatment pack: 4 inhalers, 560 capsules
7-day pack	7-day treatment pack: 1 inhaler, 140 capsules

Maximum daily dose

Maximum daily dose800 mg/day (Mannitol/Bronchitol maximum maintenance dose)

Equivalent capsule limit20 capsules per day (corresponds to 800 mg/day)

Typical dosing frequency400 mg (10 capsules) twice daily (morning and evening)

BTT dose (tolerance test)

BTT single dose400 mg (10 capsules) administered once by oral inhalation under supervision

Purpose of administrationGiven as the Bronchitol tolerance test to screen for bronchospasm prior to initiating therapy

Supervision requirementMust be administered under a healthcare practitioner able to manage acute bronchospasm

Revision History

03.01.21policy_effective

Policy became effective (Clinical Policy: Mannitol, CP.PHAR.518).

10.22.21annual_review

1Q 2022 annual review: references reviewed and updated; no significant clinical changes.

02.22.22p&t_approval

P&T approval documented for 1Q 2022 annual review updates.

10.03.22template_change

Template changes applied to other diagnoses/indications and continued therapy section.

10.07.22annual_review

1Q 2023 annual review: Appendix D updated and references reviewed; no significant clinical changes.

02.23p&t_approval

P&T approval documented for 1Q 2023 annual review updates.

05.08.23annual_review

3Q 2023 annual review: references reviewed and updated; no significant clinical changes.

08.23p&t_approval

P&T approval documented for 3Q 2023 annual review updates.

05.09.24annual_review

3Q 2024 annual review: Appendix D defined FEV1 and ppFEV1; references reviewed and updated.

08.24p&t_approval

P&T approval documented for 3Q 2024 annual review updates.

04.10.25annual_reviewLatest

3Q 2025 annual review: Appendix D updated (removed supplemental information on hypertonic saline and dornase alfa); references reviewed and updated.

OpenPayer

Mannitol (Bronchitol) — Clinical Policy

Coverage Criteria for Inhaled Mannitol (Bronchitol)

Provider Requirements, Prior Authorization, and Documentation

Coding and Dosage Information

Definitions and Test Criteria

Background

Revision History