CurrentUnitedHealthcarePolicy 2025 P 3071-14

Dulera® (mometasone furoate/formoterol fumarate) - Step Therapy - UnitedHealthcare Commercial Plansopen_in_new

UnitedHealthcare step therapy program requiring trial of specified preferred inhaled combination therapies (Symbicort and either fluticasone/salmeterol or Breo Ellipta) prior to coverage authorization for Dulera for asthma in patients aged ≥5. Authorization issued for 12 months; program effective 2026-02-15.

Policy Summary

PayerUnitedHealthcare

PolicyDulera® (mometasone furoate/formoterol fumarate) - Step Therapy - UnitedHealthcare Commercial Plansopen_in_new

Policy CodePolicy 2025 P 3071-14

Change TypeAnnual review (no material changes)

Effective DateFeb 15, 2026

Next Review Date

Key ActionPrior authorization required for Dulera; ensure members have documented failure, contraindication, or intolerance to Symbicort and to either fluticasone/salmeterol or Breo Ellipta before requesting authorization (authorization issued for 12 months).

SourceLink

POLICY UPDATE CHANGES

Annual review 11/2025 recorded with 'No changes.'

12Authorization Duration

≥5Minimum Age (years)

2Required alternatives

Summary of Change Bulletin

Background: Dulera (mometasone furoate/formoterol fumarate) is indicated for the treatment of asthma in patients aged 5 years and older. It should be used in patients not adequately controlled on a long-term asthma-control medication (such as an inhaled corticosteroid) or when initiation of both an ICS and a long-acting beta2-adrenergic agonist is warranted.

Scope summary: UnitedHealthcare’s step therapy program requires trial of specified preferred inhaled combination therapies (Symbicort and either fluticasone/salmeterol — e.g., AirDuo RespiClick, generic Advair Diskus, or Advair HFA — or Breo Ellipta) prior to coverage authorization for Dulera for asthma in patients aged ≥5. The program effective date is 2026-02-15, and prior authorization approvals are issued for 12 months. The 11/2025 annual review recorded No changes.

Authorization Criteria

Initial Authorization Criteria

Dulera will be approved based on the following criteria:

ALL of the following

History of failure, contraindication, or intolerance to Symbicort (budesonide/formoterol)
AND one of the following
- History of failure, contraindication, or intolerance to fluticasone/salmeterol (AirDuo RespiClick, generic Advair Diskus, or Advair HFA)
- History of failure, contraindication, or intolerance to Breo Ellipta (fluticasone/vilanterol)

Preferred Alternatives and Product Coding

Preferred / Required Step Therapy Alternatives (mentioned)mixedCovered

Symbicort	budesonide/formoterol (preferred first step)
fluticasone/salmeterol	AirDuo RespiClick, generic Advair Diskus, Advair HFA (one of the required alternatives)
Breo Ellipta	fluticasone/vilanterol (one of the required alternatives)

Dulera (subject drug)NDC|mixed

Dulera

mometasone furoate/formoterol fumarate (requires step therapy)

Typically Excluded Products (per policy note)mixedNot Covered

budesonide/formoterol	Breyna (generic Symbicort) - typically excluded
AirDuo RespiClick	brand AirDuo RespiClick - typically excluded
Advair Diskus	brand Advair Diskus - typically excluded
Dulera	Dulera - typically excluded from coverage (subject to step therapy exceptions)
Fluticasone/Salmeterol HFA	authorized brand alternative for Advair HFA - typically excluded
Fluticasone/Vilanterol Ellipta	authorized brand alternative for Breo Ellipta - typically excluded

What Providers Must Do

Prior Authorization

Step therapy prior authorization required

Prior authorization required for Dulera; member must have history of failure, contraindication, or intolerance to Symbicort and to either fluticasone/salmeterol (AirDuo RespiClick/generic Advair Diskus/Advair HFA) or Breo Ellipta. Authorization will be issued for 12 months.

Affected codes: Dulera
Authorization duration: 12 months
Effective date: 2026-02-15

Documentation Required

Allow automated approval based on claims history

UnitedHealthcare may approve initial and reauthorization based solely on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic. Use of automated approval and re-approval processes varies by program and/or therapeutic class.

Automated approval may be based on prior claims/medication history, diagnosis codes (ICD-10), and claim logic; availability varies by program.

Billing Rule

Supply limits may apply

Supply limits may be in place per plan or program; state mandates and member-specific benefit plan coverage may impact coverage.

Supply limits and state or member-specific plan mandates may affect coverage.

Definitions and Evidence

Step Therapy: A utilization management program requiring trial of specified preferred medications prior to coverage of a non-preferred agent; this program requires a member to try Symbicort and either fluticasone/salmeterol (AirDuo RespiClick or Advair formulations) or Breo Ellipta before providing coverage for Dulera.

P&T approval historyApprovals documented from 2/2016 through 11/2025

Change Log

2/2016policy review

Change Control: New Program (Step Therapy - Dulera)

7/2016policy review

Change Control: Added Indiana and West Virginia coverage information

11/2016policy review

Change Control: Administrative change; Added California coverage information

2/2017policy review

Annual Review: References updated

11/2017policy review

Annual Review: Added brand and generic AirDuo RespiClick and noted Dulera typically excluded from coverage; updated mandate language and references

11/2018policy review

Annual Review: Updated background section and references

11/2019policy review

Annual Review: Updated background section and references

10/2020policy review

Annual Review: Updated references

11/2021policy review

Annual Review: Updated references

11/2022policy review

Annual Review: Updated references

11/2023policy review

Annual Review: Updated list of excluded products and references

11/2024policy review

Annual Review: Updated covered fluticasone/salmeterol products and references

11/01/2025policy reviewLatest

Annual review 11/2025 recorded with "No changes."

Policy Summary

PayerUnitedHealthcare

PolicyDulera® (mometasone furoate/formoterol fumarate) - Step Therapy - UnitedHealthcare Commercial Plansopen_in_new

Policy CodePolicy 2025 P 3071-14

Change TypeAnnual review (no material changes)

Effective DateFeb 15, 2026

Next Review Date

SourceLink

On This Page