CurrentAvMedPolicy N/A

Prior authorization and step-edit for LABA/ICS combination inhalers

Form and criteria to request pharmacy prior authorization or step-edit exception for long-acting beta2-agonist (LABA) plus inhaled corticosteroid (ICS) combination products for AvMed members; intended for prescribers and office staff submitting requests.

Policy Summary

PayerAvMed

PolicyPrior authorization and step-edit for LABA/ICS combination inhalers

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionPrescriber must complete and sign the prior authorization/step-edit request form and fax it to AvMed (1-305-671-0200) with required supporting documentation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5listed LABA/ICS product options

30drequired trial duration

faxsubmission fax

requireddocumentation

Coverage Criteria for LABA/ICS Products

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Advair/AirDuo criteria: Member must have tried and failed at least 30 days of therapy with ALL the following: Breo Ellipta; Breyna (AB-rated generic Symbicort) or budesonide-formoterol (ABA Symbicort); Dulera; Advair HFA.30 days per listed product

If requesting Advair Diskus, provider must submit clinical chart notes or a completed MedWatch form documenting intolerance or contraindication to fluticasone-salmeterol or Wixela Inhub (generic Advair Diskus).

Criteria for brand Symbicort

Covered when ALL of the following are met for brand Symbicort:

Brand Symbicort criteria: Member must have tried and failed at least 30 days of therapy with ALL the following: Breo Ellipta; Breyna (AB-rated generic Symbicort) or budesonide-formoterol (ABA Symbicort); Dulera; Advair HFA.30 days per listed product

Provider must submit clinical chart notes or a completed MedWatch form documenting intolerance or contraindication to Breyna or budesonide-formoterol (ABA Symbicort).

Criteria for fluticasone furoate-vilanterol

Covered when ALL of the following are met for fluticasone furoate-vilanterol:

Fluticasone furoate-vilanterol (Breo) criteria: Member must have tried and failed at least 30 days of therapy with ALL the following: Breo Ellipta; Breyna (AB-rated generic Symbicort) or budesonide-formoterol (ABA Symbicort); Dulera; Advair HFA.30 days per listed product

Provider must submit clinical chart notes or a completed MedWatch form documenting intolerance or contraindication to brand Breo Ellipta.

Coverage and medical necessity for requested long-acting beta2-agonist (LABA) plus inhaled corticosteroid (ICS) combination products are determined by meeting all product-specific step-therapy criteria and providing required documentation. For each requested branded product (for example, Advair Diskus, AirDuo Digihaler/RespiClick, brand Symbicort, or fluticasone furoate-vilanterol), the member must have documented trials and failures of the listed alternative LABA/ICS products for at least 30 days each. Providers must submit the completed and signed prior authorization/step-edit request form and supply supporting clinical documentation (clinical chart notes, lab results, diagnostics, and/or a completed MedWatch form) when documenting intolerance or contraindication to preferred or generic alternatives. Authorization may be delayed or denied if the form is incomplete, incorrect, or illegible, or if required supporting documentation is not provided. Approval is contingent on verification of prior therapies through pharmacy paid claims or submitted chart notes.

Initial Therapy and Step-Edit Requirements

Initial therapy / step-edit

Initial coverage requires documented trials of specified alternatives.

Initial step requirements: For requested brand product, member must have tried and failed at least 30 days each of specified alternative LABA/ICS products and provide documentation of intolerance/contraindication to generics or preferred brands when applicable.30 days per listed product

Use of samples to initiate therapy does not meet step edit/preauthorization criteria. Previous therapies will be verified through pharmacy paid claims or submitted chart notes. Provider must submit clinical chart notes or a completed MedWatch form documenting intolerance or contraindication to the specified alternatives when requesting the non-preferred brand.

Step Therapy Details

Requirement	Documentation
Member must have tried and failed at least 30 days of therapy with Breo Ellipta	Clinical chart notes or other records showing trial/failure (e.g., pharmacy claims)
Member must have tried and failed at least 30 days of therapy with Breyna (AB-rated generic Symbicort) or budesonide-formoterol (ABA Symbicort)	Clinical chart notes or other records showing trial/failure (e.g., pharmacy claims)
Member must have tried and failed at least 30 days of therapy with Dulera	Clinical chart notes or other records showing trial/failure (e.g., pharmacy claims)
Member must have tried and failed at least 30 days of therapy with Advair HFA	Clinical chart notes or other records showing trial/failure (e.g., pharmacy claims)
When requesting Advair Diskus: provider must document intolerance or contraindication to fluticasone-salmeterol or Wixela Inhub (generic Advair Diskus)	Clinical chart notes or a completed MedWatch form documenting intolerance or contraindication
When requesting Brand Symbicort: provider must document intolerance or contraindication to Breyna or budesonide-formoterol (ABA Symbicort)	Clinical chart notes or a completed MedWatch form documenting intolerance or contraindication
When requesting fluticasone furoate-vilanterol (Breo): provider must document intolerance or contraindication to brand Breo Ellipta	Clinical chart notes or a completed MedWatch form documenting intolerance or contraindication

Provider Instructions and Submission Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required using the pharmacy prior authorization/step-edit request form. The prescribing physician must sign and clearly print their name (preprinted stamps not valid). Fax completed form to 1-305-671-0200. Incomplete, incorrect, or illegible information (including missing contact phone/fax) may delay processing or result in denial.

Fax: 1-305-671-0200
Prescribing physician signature required (no preprinted stamps)

Documentation Required

Required supporting documentation

All supporting documentation must be provided with the request. Authorization may be delayed or denied if drug information, dosing schedule, length of therapy, diagnosis, ICD code (if applicable), weight, date, or clinical chart notes/lab results/diagnostics are missing or incomplete.

Provide Drug Form/Strength, Dosing Schedule, Length of Therapy, Diagnosis, ICD code (if applicable), Weight, Date
Attach relevant chart notes, lab results, diagnostics, or completed MedWatch forms as indicated

Step Therapy

Step therapy trial and failure requirement

Step-therapy (step-edit) requirements apply. For approval of Advair Diskus, AirDuo Digihaler, AirDuo RespiClick, Brand Symbicort, or fluticasone furoate-vilanterol the member must have tried and failed at least 30 days of therapy with all listed alternative products. Documentation of prior therapies will be verified via pharmacy paid claims or submitted chart notes. Use of samples to initiate therapy does not meet step-edit/preauthorization criteria.

Advair Diskus/AirDuo products: failure of Breo Ellipta; Breyna (generic Symbicort) or budesonide-formoterol; Dulera; Advair HFA. If requesting Advair Diskus, submit chart notes or MedWatch documenting intolerance/contraindication to fluticasone-salmeterol or Wixela Inhub.
Brand Symbicort: failure of Breo Ellipta; Breyna (generic Symbicort) or budesonide-formoterol; Dulera; Advair HFA. Submit chart notes or MedWatch if intolerant/contraindicated to Breyna or budesonide-formoterol.
Fluticasone furoate-vilanterol: failure of Breo Ellipta; Breyna (generic Symbicort) or budesonide-formoterol; Dulera; Advair HFA. Submit chart notes or MedWatch if intolerant/contraindicated to brand Breo Ellipta.

Denial Risk

Incomplete or missing documentation — potential delays or denial

If a drug is non-formulary under the member's plan, documentation of medical necessity is required. Failure to supply required supporting documentation or to demonstrate step-therapy failure/intolerance with appropriate chart notes or MedWatch forms can result in delays or denial of the authorization.

Non-formulary drugs require medical necessity documentation
Previous therapies will be verified through pharmacy paid claims or submitted chart notes
Samples do not satisfy step-edit/preauthorization requirements

Background

This form provides minimal clinical background and is intended as an administrative prior authorization/step-edit tool for prescribers and office staff requesting coverage of LABA/ICS combination inhalers. It assumes use of LABA/ICS maintenance therapy and emphasizes step-therapy requirements, documentation expectations, and administrative instructions for submission (including signature requirements and fax submission procedures). Use of samples to initiate therapy does not satisfy the step-edit or prior authorization requirements.