CurrentAvMedPolicy N/A

Qelbree (viloxazine) pharmacy prior authorization and step-edit

Form and criteria governing prior authorization and step-therapy requirements for Qelbree (viloxazine) for AvMed members; applies to prescribers requesting coverage for members starting or continuing Qelbree.

Policy Summary

PayerAvMed

PolicyQelbree (viloxazine) pharmacy prior authorization and step-edit

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionComplete the AvMed Pharmacy Prior Authorization/Step-Edit Request form with required documentation and fax to 1-305-671-0200.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6min age

30-daytrial length

2 stimulants + atomoxetine + 1 non-stimulantrequired failures

1-305-671-0200fax

Coverage Criteria

Initial Authorization Criteria

Covered when ALL of the following are met

Age: Member is 6 years of age or older>=6 years

From form checkbox requirement

Diagnosis: Member must have a diagnosis of Attention Deficit Hyperactivity Disorder (ADHD)

Required diagnosis on form

Stimulant trials: Member must have a 30-day trial and failure with BOTH of the following (verified by pharmacy paid claims; documentation of intolerance or treatment failure must be submitted): amphetamine-based stimulant at up to maximally indicated doses, AND methylphenidate-based stimulant at up to maximally indicated doses, unless clinically significant adverse effects are experienced or contraindicated

Policy Summary

PayerAvMed

PolicyQelbree (viloxazine) pharmacy prior authorization and step-edit

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionComplete the AvMed Pharmacy Prior Authorization/Step-Edit Request form with required documentation and fax to 1-305-671-0200.

SourceLink

On This Page

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Initial Therapy Requirements

Initial therapy requirements for Qelbree

Initial authorization requires documented prior therapy trials and failures

Age and diagnosis: Member is >=6 years and has a diagnosis of ADHD>=6 years

Stimulant failures: 30-day trials and failures of BOTH an amphetamine-based stimulant and a methylphenidate-based stimulant at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced30 days each

Verified by pharmacy paid claims or chart notes

Atomoxetine failure: 30-day trial and failure of atomoxetine (Strattera) at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced30 days

Verified by pharmacy paid claims or chart notes

ER alpha-2 agonist: Trial and failure of guanfacine ER (Intuniv) OR clonidine ER (Kapvay) at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced30 days

Verified by pharmacy paid claims or chart notes

Step Therapy Requirements

Step	Required trial (duration)	Agent(s) to trial and fail	Notes / verification
{"text":"1","status":""},{"text":"30 days","status":""},{"text":"Amphetamine-based stimulant (at up to maximally indicated doses)","status":""},{"text":"Failure or intolerance required; verified by pharmacy paid claims or documentation of intolerance/treatment failure","status":""}
{"text":"2","status":""},{"text":"30 days","status":""},{"text":"Methylphenidate-based stimulant (at up to maximally indicated doses)","status":""},{"text":"Failure or intolerance required; verified by pharmacy paid claims or documentation of intolerance/treatment failure","status":""}
{"text":"3","status":""},{"text":"30 days","status":""},{"text":"Atomoxetine (Strattera) at up to maximally indicated doses","status":""},{"text":"Failure or intolerance required unless contraindicated; verified by pharmacy paid claims or documentation","status":""}
{"text":"4","status":""},{"text":"30 days","status":""},{"text":"One ER alpha-2 agonist: guanfacine ER (Intuniv) OR clonidine ER (Kapvay)","status":""},{"text":"Failure or intolerance of one agent required unless contraindicated; verified by pharmacy paid claims or documentation","status":""}
{"text":"Authorization condition","status":""},{"text":"N/A","status":""},{"text":"Qelbree (viloxazine) may be authorized only after completion of the above step therapy sequence/combination","status":""},{"text":"All checked criteria must be met and supporting documentation (pharmacy claims or chart notes) provided or request may be denied","status":""}

Provider Actions and Submission Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Qelbree (viloxazine). Complete the AvMed Pharmacy Prior Authorization/Step-Edit Request form and provide all required supporting documentation. Fax the completed form to 1-305-671-0200. If the form is incomplete, incorrect, illegible, or missing required documentation (including prescriber signature, member identifiers, or clinical records), the authorization process may be delayed or the request may be denied.

Fax completed form to 1-305-671-0200
Prescriber signature required (preprinted stamps not valid)
Include member name and AvMed ID, date of birth, prescriber name, office contact, phone and fax numbers, and DEA or NPI
Ensure form is legible and all fields complete to avoid delays or denial

Step Therapy

Step-Therapy Requirements

AvMed requires step therapy trials before approving Qelbree. Approvals require verification (pharmacy paid claims or submitted chart notes) of 30-day trials and failures as specified below. Documentation of intolerance or treatment failure must be submitted when applicable. Use of samples to initiate therapy does not satisfy step therapy or prior authorization requirements.

30-day trial and failure with an amphetamine-based stimulant at up to maximally indicated doses, unless clinically significant adverse effects or contraindication
30-day trial and failure with a methylphenidate-based stimulant at up to maximally indicated doses, unless clinically significant adverse effects or contraindication
30-day trial and failure of atomoxetine (Strattera) at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects
AND one of the following (30-day trial and failure unless contraindicated): guanfacine ER (Intuniv) or clonidine ER (Kapvay) at up to maximally indicated doses

Documentation Required

Supporting Documentation for Prior Therapies

Provide supporting documentation for all prior therapies and clinical criteria. To support each checked criterion, submit pharmacy paid-claim histories and/or chart notes that document medication name, dose, dates of therapy, duration (e.g., 30 days), and reason for discontinuation (treatment failure or intolerance). Include relevant diagnostics, lab results, and clinical notes verifying the ADHD diagnosis and member age. If a required drug is non-formulary on the member's plan, include medical necessity justification.

Pharmacy paid claims verifying prior fills (preferred) or detailed chart notes if claims are unavailable
Documentation of trial length (minimum 30 days where specified) and dosing (up to maximally indicated doses)
Clinical notes describing treatment failure or intolerance, including adverse effects when claimed
Diagnostics or assessment supporting ADHD diagnosis and member’s age (must be ≥ 6 years)
Medical necessity statement when requesting a non-formulary product

Documentation Required

Administrative Submission Requirements

Administrative submission requirements: ensure all required form fields are completed and legible. The prescriber must sign and print their name (preprinted stamps are not valid). Provide prescriber contact details, member identifiers, and complete drug information (form/strength, dosing schedule, length of therapy, diagnosis, ICD code, weight, and date). Incomplete or missing administrative information may result in delays or denial.

Prescriber signature and printed name (no preprinted stamps)
Member AvMed number, full name, and date of birth
Prescriber name, DEA or NPI, office contact, phone and fax numbers
Drug form/strength, dosing schedule, length of therapy, diagnosis, and ICD code
Weight and date of documentation

Denial Risk

Incomplete or Missing Documentation

Incomplete or missing documentation — caution: requests submitted without the completed form, required prescriber signature, member identifiers, verification of prior therapies (claims or chart notes), or clinical documentation (diagnosis, trial lengths, intolerance reasons) may be delayed or denied. Use of medication samples does not satisfy prior-therapy requirements.

Missing prescriber signature or illegible signature invalidates the request
Absent pharmacy paid-claim verification or adequate chart notes for step failures may result in denial
Insufficient detail about trial duration, dosing, or reason for discontinuation (e.g., intolerance) can delay processing
Ensure contact phone/fax numbers are correct to avoid additional follow-up

Definitions

Step-edit / prior therapy failure - required documented trials

Required trial length30-day trials for each required agent/class (stimulants, atomoxetine, ER alpha-2 agonist)

Stimulant classes requiredDocumented 30-day trial and failure of BOTH an amphetamine-based stimulant AND a methylphenidate-based stimulant at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects

Atomoxetine requirementDocumented 30-day trial and failure of atomoxetine (Strattera) at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects

ER alpha-2 agonist requirementDocumented 30-day trial and failure of one ER alpha-2 agonist: guanfacine ER (Intuniv) OR clonidine ER (Kapvay) at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects

Verification of trialsTrials must be verified by pharmacy paid claims or submitted chart notes; documentation of intolerance or treatment failure must be provided

OpenPayer

Qelbree (viloxazine) pharmacy prior authorization and step-edit

Coverage Criteria

Initial Therapy Requirements

Step Therapy Requirements

Provider Actions and Submission Requirements

Definitions

Background