CurrentMass General Brigham Health PlanPolicy N/A

Pulmicort Flexhaler (budesonide) — Coverage Criteria

This policy governs prior-authorization coverage for Pulmicort Flexhaler (budesonide) for maintenance/prophylactic treatment of asthma for members of Mass General Brigham Health Plan under the pharmacy benefit.

Policy Summary

PayerMass General Brigham Health Plan

PolicyPulmicort Flexhaler (budesonide) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2024

Next Review DateN/A

Key ActionObtain prior authorization and document patient is >6 years old, has an asthma diagnosis for maintenance/prophylactic therapy, and has trialed and had failure/intolerance/contraindication to both Arnuity Ellipta and Qvar.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

PharmacyBenefit

≥6Min age

2 productsPrior trials

12 moApproval duration

Coverage Criteria for Pulmicort Flexhaler

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Initial Therapy

Covered when ALL of the following are met:

Initial Authorization

Age: Member is > 6 years of age> 6 years
Diagnosis: Member has a diagnosis of maintenance and prophylactic treatment of asthma
Prior therapy: Member has had trial and failure, intolerance, or contraindication to BOTH: (a) Arnuity Ellipta and (b) Qvar
Documentation required

Continuation Therapy

Reauthorization when the following is met:

Reauthorization

Clinical response: Member achieves or maintains positive clinical response as evidenced by low disease activity or improvement in signs and symptoms
Approvals granted for 12 months
Approval duration: Initial approvals and reauthorizations will be granted for 12 months12 months

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization is required under the pharmacy benefit for Pulmicort Flexhaler. Requests will be reviewed for members new to the plan who are currently receiving the medication and for new starts; authorization is not required for samples or medication obtained via manufacturer patient assistance programs.

Benefit: Pharmacy Benefit
Contact: Pharmacy prior authorization phone 800-711-4555

Step Therapy

Step Therapy / Required Prior Trials

Step therapy: member must have trialed and had failure, intolerance, or contraindication to both Arnuity Ellipta and Qvar before Pulmicort Flexhaler will be authorized.

Required prior trials: Arnuity Ellipta and Qvar — documentation of trial and failure/intolerance/contraindication required

Documentation Required

Required Documentation

Documentation must include member age, diagnosis, and evidence of prior trials and outcomes. For step-therapy, provide dates, duration, and reason for discontinuation (failure, intolerance, or contraindication) for both Arnuity Ellipta and Qvar.

Minimum documentation: Member age (> 6 years)
Diagnosis: maintenance and prophylactic treatment of asthma
Evidence of prior trials: dates, duration, and reason for failure/intolerance/contraindication for Arnuity Ellipta and Qvar

Denial Risk

Denial Triggers / Risks

Denial will be considered if required criteria are not met or documentation is incomplete. Common denial triggers include member age ≤ 6 years, missing or non-supportive diagnosis, and lack of documented trial and failure/intolerance/contraindication to both required therapies.

Denial triggers: age ≤ 6 years; no diagnosis of maintenance/prophylactic asthma; missing or inadequate documentation of trials with Arnuity Ellipta and Qvar

Required prior trial	Notes
Arnuity Ellipta	Trial and failure, intolerance, or contraindication to Arnuity Ellipta is required before authorization.
Qvar	Trial and failure, intolerance, or contraindication to Qvar is required before authorization.

Background

Pulmicort Flexhaler (budesonide) is an inhaled corticosteroid indicated for the maintenance and prophylactic treatment of asthma in patients 6 years of age and older. It is intended for regular use to reduce airway inflammation and prevent asthma symptoms in patients requiring long‑term control therapy.

This policy applies to Pulmicort Flexhaler under the pharmacy benefit and requires prior authorization. Initial approval is contingent on documentation that the member is > 6 years old, has a diagnosis of maintenance/prophylactic asthma, and has had trial and failure, intolerance, or contraindication to both Arnuity Ellipta and Qvar; reauthorizations are granted when the member demonstrates a positive clinical response and approvals are issued for 12 months.

Policy Summary

PayerMass General Brigham Health Plan

PolicyPulmicort Flexhaler (budesonide) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2024

Next Review DateN/A

SourceLink

On This Page

OpenPayer

Pulmicort Flexhaler (budesonide) — Coverage Criteria

Coverage Criteria for Pulmicort Flexhaler

Initial Authorization Criteria

Continuation / Reauthorization Criteria

Provider Actions and Authorization Requirements

Step Therapy Requirements

Indication and Definitions

Background