CurrentCareSourcePolicy N/A

Bronchitol (mannitol) pharmacy coverage for cystic fibrosis

Defines pharmacy benefit coverage, prior authorization, quantity limits, and clinical criteria for Bronchitol (mannitol) for CareSource members in Arkansas (PASSE). Applies to providers submitting pharmacy claims and prior authorizations.

Policy Summary

PayerCareSource

PolicyBronchitol (mannitol) pharmacy coverage for cystic fibrosis

Policy CodePolicy N/A

Change TypeNew policyremoved prescriber specialty requirement

Effective Date01/01/2022

Next Review Date

Key ActionObtain prior authorization and document diagnosis, age ≥18, passed Bronchitol tolerance test, and prior trial or intolerance to nebulized hypertonic saline (7%)

SourceLink

POLICY UPDATE CHANGES

New policy for Bronchitol created.

Removed prescriber specialty requirement.

580quantity limit per 28 days

400mg BIDdose (inhaled)

12 moinitial approval

12 moreauthorization

Coverage Criteria for Bronchitol (mannitol)

inv-01: Initial Therapy

Covered when ALL of the following are met for initial authorization:

Initial Authorization - Cystic Fibrosis: 1) Member is 18 years old or older; AND 2) Member has a diagnosis of cystic fibrosis; AND 3) Documentation showing member has passed the Bronchitol tolerance test (BTT); AND 4) Member had an inadequate response, intolerance, or contraindication to documented prior therapy with nebulized hypertonic saline (7%); AND 5) Dosage allowed: 400 mg (10 capsules) twice daily, inhaled;

If all criteria met, medication approved for 12 months.

inv-02: Continuation Therapy / Reauthorization

Covered when ALL of the following are met for reauthorization:

Reauthorization: 1) Member must be in compliance with all other initial criteria; AND 2) Evidence of disease stability or disease improvement, evidenced by chart notes such as improved FEV1 or other lung function tests; decrease in pulmonary exacerbations; decrease in pulmonary infections; decrease in hospitalizations; increase in weight-gain;

Policy Summary

PayerCareSource

PolicyBronchitol (mannitol) pharmacy coverage for cystic fibrosis

Policy CodePolicy N/A

Change TypeNew policyremoved prescriber specialty requirement

Effective Date01/01/2022

Next Review Date

Key ActionObtain prior authorization and document diagnosis, age ≥18, passed Bronchitol tolerance test, and prior trial or intolerance to nebulized hypertonic saline (7%)

SourceLink

On This Page

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If reauthorization criteria met, medication approved for additional 12 months.

Bronchitol (mannitol) is considered not medically necessary for the treatment of any disease states that are not specifically listed in this policy. Coverage is limited to the indications and clinical criteria detailed in this document; therapies for unlisted diagnoses will not be approved.

Use of Bronchitol (mannitol) for indications other than cystic fibrosis (as described in this policy) is considered not medically necessary. The pharmacy benefit applies only when the member meets the documented clinical criteria for cystic fibrosis and other policy requirements (e.g., prior authorization and quantity limits); requests for other indications will be denied.

Initial Authorization Requirements

inv-13: Initial Therapy

Initial authorization requirements and dosing

Initial: Age >=18; diagnosis of cystic fibrosis; documented passed Bronchitol tolerance test (BTT); prior inadequate response, intolerance, or contraindication to nebulized hypertonic saline (7%); dosage: 400 mg (10 capsules) twice daily, inhaled;

Approve for 12 months if all initial criteria met.

Step	Requirement
1	Trial of nebulized hypertonic saline (7%) required unless inadequate response, intolerance, or contraindication to hypertonic saline is documented prior to approval.

Reauthorization Criteria

inv-14: Reauthorization

Reauthorization criteria and evidence required for continued coverage.

Reauthorization: Member in compliance with initial criteria AND evidence of disease stability or improvement (e.g., improved FEV1 or other lung function tests; decreased pulmonary exacerbations; decreased pulmonary infections; decreased hospitalizations; increased weight);

Approve for additional 12 months if criteria met.

Billing, Codes, and Quantity Limits

Billing requirementsNDC

NDC required

Must use valid NDC code

Quantity limit

Quantity limit580 capsules per 28 days

Unitcapsules

Limit period28 days

Bronchitol (mannitol)

DrugBronchitol (mannitol)

Approved dosage400 mg (10 capsules) twice daily, inhaled

IndicationCystic fibrosis (adult members ≥18 years)

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for non-preferred Bronchitol (mannitol) under the pharmacy benefit. Claims for non-preferred product submitted without an approved prior authorization will be denied. Approval, when granted, is for up to 12 months.

Benefit type: Pharmacy
Site of service allowed: Home
Quantity limit: 580 capsules per 28 days
Billing: Must use valid NDC code

Step Therapy

Step Therapy Requirement

Member must have tried and had an inadequate response to, intolerance of, or a contraindication to nebulized hypertonic saline (7%) prior to approval of Bronchitol.

Documentation Required

Documentation Requirements

Documentation submitted with the prior authorization must include: diagnosis of cystic fibrosis, evidence the member is ≥18 years old, documentation that the member passed the Bronchitol tolerance test (BTT), evidence of prior therapy with nebulized hypertonic saline (7%) (or documentation of intolerance/contraindication), and the requested dosage (400 mg twice daily, inhaled). For reauthorization include evidence of disease stability or improvement (examples: improved FEV1 or other lung function tests, decrease in pulmonary exacerbations or infections, decreased hospitalizations, weight gain) and continued compliance with initial criteria.

Denial Risk

Failure to obtain required prior authorization for non-preferred Bronchitol will result in claim denial.

Definitions and Tests

Bronchitol tolerance test (BTT)

DefinitionBronchitol tolerance test (BTT): documented test demonstrating the member has passed the tolerance assessment prior to initiating therapy.

TimingMust be documented prior to initiating therapy

RequirementPassing the BTT is required for initial authorization

Background

Bronchitol (inhaled mannitol) is an osmotic inhaled mucolytic agent used to improve airway mucus clearance in members with cystic fibrosis. This policy restricts use to adult members (≥18 years) with a documented diagnosis of cystic fibrosis who have passed a Bronchitol tolerance test (BTT) and who have had an inadequate response, intolerance, or contraindication to prior therapy with nebulized hypertonic saline (7%). Prior authorization is required for the non-preferred product under the pharmacy benefit; when initial criteria are met, approval is granted for 12 months. The medication is allowed to be administered in the home setting and is subject to a quantity limit of 580 capsules per 28 days.

Quantity Limit Details

Bronchitol (mannitol)

DrugBronchitol (mannitol)

Quantity limit580 capsules per 28 days

Site of serviceHome allowed

Quantity limit

Quantity limit580 capsules per 28 days

Applies toBronchitol (mannitol)

Benefit typePharmacy

Permitted Site of Care

Note

Home setting allowed

Bronchitol (mannitol) is permitted to be administered or used in the home setting; site of service is allowed: home.

Policy Revision History

2021-01-13creation

Policy created for Bronchitol (mannitol) establishing coverage criteria for cystic fibrosis, including initial authorization requirements and 12-month approval duration.

2021-12-21administrative_updateLatest

Administrative removal of a prescriber specialty requirement (non-clinical change).