CurrentMass General Brigham Health PlanPolicy N/A

Bronchitol (mannitol) pharmacy coverage

Defines prior authorization and coverage criteria for Bronchitol (mannitol) as a specialty pharmacy benefit for Mass General Brigham Health Plan Commercial/Exchange members aged 18+ with cystic fibrosis.

Policy Summary

PayerMass General Brigham Health Plan

PolicyBronchitol (mannitol) pharmacy coverage

Policy CodePolicy N/A

Change TypeAdministrative updates (no clinical changes)

Effective DateJul 1, 2021

Next Review Date

Key ActionSubmit prior authorization with documentation of cystic fibrosis diagnosis, Bronchitol Tolerance Test results showing no bronchospasm, no decrease in FEV1, and no decrease in oxygen saturation, and confirm patient is age 18 or older.

SourceLink

POLICY UPDATE CHANGES

Policy created and effective 07/01/2021.

09/21/2022 review - separated out Commercial/Exchange vs MassHealth; no clinical changes.

24Initial and reauthorization approval length

600Quantity limit for Bronchitol 40 mg capsules

18+Minimum patient age for coverage

Authorization Criteria for Bronchitol (mannitol)

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ALL of the following

Continuation for current members
- Member is currently receiving treatment with Bronchitol (excluding product obtained only as samples or via manufacturer's patient assistance programs).
Member has a diagnosis of Cystic Fibrosis.
- ANY of the following
  - Bronchospasm
    Authorization requires that these events did NOT occur during tolerance test.
  - Decrease in FEV1
    Authorization requires that these events did NOT occur during tolerance test.
  - Decrease in oxygen saturation
    Authorization requires that these events did NOT occur during tolerance test.
Member is at least 18 years of age.

Required Provider Actions and Documentation

Prior Authorization

Prior authorization required

Prior authorization is required for Bronchitol under the pharmacy benefit for Commercial/Exchange members; specialty pharmacy fill is required.

Pharmacy benefit for Commercial/Exchange members
Designated specialty medication — must be filled at a contracted specialty pharmacy

Documentation Required

Documentation of tolerance test and diagnosis

Provider must document diagnosis of cystic fibrosis, results of the Bronchitol Tolerance Test showing no bronchospasm, no decrease in FEV1, and no decrease in oxygen saturation, and patient age >=18 for initial authorization.

Diagnosis of Cystic Fibrosis
Bronchitol Tolerance Test results showing no bronchospasm
Bronchitol Tolerance Test results showing no decrease in FEV1
Bronchitol Tolerance Test results showing no decrease in oxygen saturation
Patient is at least 18 years of age for initial authorization

Documentation Required

Reauthorization documentation

For reauthorization, submit documentation demonstrating clinical benefit (disease stability or improvement, e.g., FEV1 improvement from baseline).

Demonstrate clinical benefit (disease stability or improvement, e.g., FEV1 improvement from baseline)

Denial Risk

Exclusion for samples or PAP-provided product

Authorization will not be granted for members only obtaining Bronchitol through samples or manufacturer's patient assistance programs.

Do not authorize if member's Bronchitol supply is only from samples or the manufacturer's patient assistance program

Contact information for prior authorization and appeals routing

Pharmacy benefit phone800-711-4555

Pharmacy benefit fax844-403-1029

Medical benefit phone833-895-2611

Medical benefit fax888-656-6671

Clinical and Administrative Background

Bronchitol (mannitol) is an inhaled sugar alcohol indicated as an add-on maintenance therapy to improve pulmonary function in adults with cystic fibrosis. Prior to initiating therapy, a Bronchitol Tolerance Test must be performed to screen for airway reactivity; the tolerance test is used to identify any occurrence of bronchospasm, a decrease in FEV1, or a decrease in oxygen saturation that would preclude safe initiation of therapy.

Designated specialty medication — must be filled at a contracted specialty pharmacy.

This policy applies to the pharmacy benefit for Mass General Brigham Health Plan Commercial/Exchange members aged 18 years and older with a diagnosis of cystic fibrosis and documents requirements for prior authorization and specialty pharmacy dispensing.

Policy Summary

PayerMass General Brigham Health Plan

PolicyBronchitol (mannitol) pharmacy coverage

Policy CodePolicy N/A

Change TypeAdministrative updates (no clinical changes)

Effective DateJul 1, 2021

Next Review Date

SourceLink

On This Page

OpenPayer

Bronchitol (mannitol) pharmacy coverage

Authorization Criteria for Bronchitol (mannitol)

Drug and Billing Codes

Required Provider Actions and Documentation

Clinical and Administrative Background

Defined Terms

Policy Review and Revision History

Bronchitol (mannitol) pharmacy coverage

Authorization Criteria for Bronchitol (mannitol)

Drug and Billing Codes

Required Provider Actions and Documentation

Clinical and Administrative Background

Defined Terms

References and Related Policies

Policy Review and Revision History