CurrentBlue Cross Blue Shield - IowaPolicy 05.04. 30

Bronchitol (mannitol) — Coverage Criteria for Cystic Fibrosis

Defines prior authorization, clinical criteria, and coverage conditions for Bronchitol (mannitol) as add-on maintenance therapy to improve pulmonary function in adults with cystic fibrosis in Wellmark members.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyBronchitol (mannitol) — Coverage Criteria for Cystic Fibrosis

Policy CodePolicy 05.04. 30

Change TypeNo material changes

Effective DateJun 5, 2021

Next Review DateApr 1, 2025

Key ActionObtain prior authorization with Bronchitol Tolerance Test (BTT) results and baseline ppFEV1 to support initial approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+age requirement (years)

ppFEV1 ≥30–<90%baseline lung function

Initial 6m; Renewal 12mauth duration

4 inhalers / 560 caps/28dquantity limit

Coverage and Medical Necessity Criteria

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Initial Therapy

Covered when ALL of the following are met:

Initial Therapy: 1. Patient is 18 years of age or older; 2. Baseline percent of predicted FEV1 (ppFEV1) is ≥ 30% to < 90%; 3. Patient has taken and passed the Bronchitol Tolerance Test (BTT) under supervision of a healthcare practitioner able to manage acute bronchospasm and did not experience bronchospasm, a decrease in FEV1, or a decrease in oxygen saturation during the test; 4. Patient has experienced inadequate response to a maximally tolerated dose OR has documented intolerance, FDA-labeled contraindication, or hypersensitivity to hypertonic saline inhalation solution; 5. Patient will perform airway clearance techniques (ACTs) while receiving Bronchitol; 6. Patient will use a short-acting bronchodilator by inhalation 5–15 minutes before each dose of Bronchitol; 7. Patient will NOT use Bronchitol and hypertonic saline inhalation solution concomitantly.initial approval 6 months

Initial approval duration: 6 months.

Continuation Therapy

Authorization for continued treatment may be granted when ALL of the following are met:

Continuation Therapy: 1. Patient continues to meet all initial criteria for approval; AND 2. Patient is experiencing benefit from therapy as evidenced by disease improvement (e.g., improvement in FEV1 from baseline).authorization up to 12 months

Continuation authorization: 12 months.

Coverage under this policy is conditional on the member having a benefit for Bronchitol (mannitol) and no contract exclusions that would bar the prescribed therapy. The policy criteria are the basis for medical necessity determinations; members must meet the specified clinical requirements (for example, age, baseline ppFEV1 range, passed Bronchitol Tolerance Test, prior use/intolerance to hypertonic saline, airway clearance technique use, bronchodilator use, and nonconcomitant use with hypertonic saline) in order for therapy to be considered a covered benefit. If the member’s benefits do not include the therapy or a contract exclusion applies, this policy does not provide coverage.

Coding and Clinical Thresholds

No applicable codesmixed

No codes listed

No applicable codesmixed

No codes listed

inv-08: Baseline ppFEV1 — initiation threshold

Baseline ppFEV1 range>= 30% to < 90% (percent of predicted FEV1)

Purpose of thresholdRequired baseline lung function for eligibility for initial Bronchitol therapy

Assessment timingBaseline ppFEV1 measured prior to initiation of therapy

Prior Authorization, Documentation, and Billing Guidance

Prior Authorization

Prior Authorization Required

Prior authorization is required for Bronchitol (mannitol). Initial approvals are granted for up to 6 months; continuation (re-authorization) may be granted for up to 12 months when continuation criteria are met and benefit is documented.

Initial approval: 6 months
Continuation approval: up to 12 months

Documentation Required

Required Documentation for Review

Providers must submit the Bronchitol Tolerance Test (BTT) results and the patient's percent predicted FEV1 (ppFEV1) with the prior authorization request. These documents are required to initiate review.

Bronchitol Tolerance Test (BTT) results
Percent predicted FEV1 (ppFEV1)

Step Therapy

Formulary Alternative Requirement

Bronchitol coverage requires prior use of hypertonic saline or documented intolerance/contraindication to hypertonic saline before approval (step-therapy/therapeutic alternative). Documentation of prior treatment failure, adverse effects, dose and duration, or contraindication to formulary alternatives must be provided for non-formulary exception requests.

Member must have had inadequate response to, or documented intolerance/contraindication to, hypertonic saline inhalation solution
For non-formulary exceptions: include chart notes documenting prior treatment failure, adverse events, dosage and duration, or contraindication

Billing Rule

Billing and Coding Guidance

To report provider services, use the appropriate CPT, HCPCS (Alpha Numeric), Revenue, and/or ICD-10 diagnosis codes as applicable. If no specific procedure or drug billing codes apply, report the service using the appropriate evaluation/management or facility revenue codes per usual billing practice.

Use applicable CPT, HCPCS Level II, Revenue, and ICD-10 codes
If no specific Bronchitol code exists, bill using appropriate provider service or facility codes

Denial Risk

Quantity Limits and Denial Triggers

Quantity limits apply and should be observed when submitting claims. Therapy that does not meet initiation or continuation criteria (including lack of required documentation or failure to meet formulary/step criteria) is considered not medically necessary and may be denied.

Quantity limit: 4 inhalers / 560 capsules per 28 days
Denial triggers include missing BTT or ppFEV1 documentation, failure to meet age or ppFEV1 thresholds, lack of documented intolerance to hypertonic saline, or lack of demonstrated benefit on reauthorization

Background and Indication

Bronchitol (mannitol) is an inhaled osmotic agent indicated as an add‑on maintenance therapy to improve pulmonary function in adults with cystic fibrosis. The policy is intended to ensure appropriate patient selection consistent with the product labeling, clinical guidelines, and clinical studies supporting its use.

Key Definitions

inv-18: Bronchitol Tolerance Test (BTT) — definition & role

DefinitionBronchitol Tolerance Test (BTT): a supervised test to assess tolerance to inhaled mannitol; patient must pass the BTT to be eligible for Bronchitol therapy due to risk of bronchospasm.

Who must supervisePerformed under the supervision of a healthcare practitioner able to manage acute bronchospasm

Failure criteria during testBronchospasm, decrease in FEV1, or decrease in oxygen saturation (test must be passed without these events)

DocumentationBTT results are required for prior authorization review

inv-19: Bronchitol (mannitol) — product definition & evidence

Product identityBronchitol (mannitol) inhalation powder — an inhaled osmotic agent used as add-on maintenance therapy to improve pulmonary function in adults with cystic fibrosis.

Regulatory & reference materialsPackage insert: Bronchitol [package insert]. Cary, NC: Chiesi USA, Inc; October 2020; clinical trial evidence cited in policy references (Aitken et al. 2012; Bilton et al. 2011; Phase 3 study 2018).

Indication limitationUse only in adults who have passed the Bronchitol Tolerance Test (BTT)

Comparative therapy notePolicy requires prior use or intolerance/contraindication to hypertonic saline before initiating Bronchitol in eligible patients.