ModifiedmhnPolicy CP.PMN.264

Viloxazine (Qelbree) for ADHD

This policy governs prior authorization criteria, dosing limits, and coverage conditions for viloxazine (Qelbree) for treatment of ADHD in adults and pediatric patients 6 years and older for the payer's lines of business.

Policy Summary

Payermhn

PolicyViloxazine (Qelbree) for ADHD

Policy CodePolicy CP.PMN.264

Change TypeStep therapy bypass (IL HIM)capsule quantity limits added

Effective DateJun 1, 2021

Next Review Date

Key ActionSubmit prior authorization with supporting documentation (office notes, labs or other clinical information) showing the member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

Added step therapy bypass for Illinois HIM per IL HB 5395.

Added criteria limiting maximum capsule quantities based on maximum dosing.

Age ≥ 6minimum age for coverage

400 mg/daymaximum pediatric dose

600 mg/daymaximum adult dose

12 monthsauthorization period

Centene

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage and Medical Necessity Criteria

Initial Therapy

Initial Approval — ADHD (must meet ALL):

Initial ADHD criteria: 1. Diagnosis of ADHD; 2. Age ≥ 6 years; 3. Member meets ONE of the following (step therapy requirement unless IL HIM exception applies): (a) Failure of atomoxetine at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced; OR (b) Documentation supports inability to swallow capsules; 4. Member meets ONE of the following: (a) Member or parent/guardian has a history of substance abuse; OR (b) BOTH: (i) Failure of an amphetamine-based stimulant at up to maximally indicated doses, unless clinically significant adverse effects are experienced to any amphetamine product or all are contraindicated; AND (ii) Failure of a methylphenidate-based stimulant at up to maximally indicated doses, unless clinically significant adverse effects are experienced to any methylphenidate product or all are contraindicated; 5. Dose does not exceed limits: For pediatric members both (i) 400 mg per day AND (ii) 2 capsules per day; For adults both (i) 600 mg per day AND (ii) 3 capsules per day.see node text

Illinois HIM step therapy exception per IL HB 5395 applies (step therapy requirements do not apply for Illinois HIM requests as of 1/1/2026).

Continuation Therapy

Continuation/Modification (must meet ALL):

Continuation criteria: 1. Member currently receiving medication via Centene benefit or previously met initial approval criteria OR member is currently receiving medication and is enrolled in a state/product with continuity of care regulations; 2. Member is responding positively to therapy; 3. If request is for a dose increase, new dose must NOT exceed: For pediatric members both (i) 400 mg per day AND (ii) 2 capsules per day; For adults both (i) 600 mg per day AND (ii) 3 capsules per day.see node text

Approval duration: 12 months.

Non‑FDA approved uses of viloxazine (Qelbree) that are not specifically addressed in this policy are not authorized unless the request is supported by sufficient documentation of efficacy and safety per the applicable off‑label use policies or by an Evidence of Coverage document. Refer to off‑label policies CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid) for criteria and required documentation when seeking coverage for off‑label indications.

Coverage determinations and the administration of benefits for viloxazine are governed by the member's coverage documents and applicable law. This policy is intended only as a guide to medical necessity and does not supersede the terms, conditions, exclusions, and limitations of the Evidence of Coverage, Certificate of Coverage, policy, or contract of insurance. Failure to meet those contractual or plan‑level requirements may result in a denial of coverage.

Use of viloxazine (Qelbree) for indications that are not FDA‑approved is not authorized under this policy unless the request includes supporting documentation consistent with the referenced off‑label use policies or is allowed by the member's Evidence of Coverage. Providers should include clinical evidence demonstrating efficacy and safety per the cited off‑label policies when requesting prior authorization for such indications.

Coding and Dosing Limits

Codes referencedmixed

N/A	No specific CPT/HCPCS/ICD-10 or NDC codes listed in this part of the document.

Maximum daily dose by age — viloxazine (Qelbree)

Pediatric maximum daily dose400 mg/day (also limited to 2 capsules per day)

Adult maximum daily dose600 mg/day (also limited to 3 capsules per day)

Pediatric titration schedule (summary)Age 6–11: start 100 mg daily, may increase by 100 mg weekly to target 400 mg/day

Adolescent titration schedule (summary)Age 12–17: start 200 mg daily, after 1 week may increase by 200 mg to target 400 mg/day

Adult titration schedule (summary)Adults: start 200 mg daily, may titrate by 200 mg weekly to target 600 mg/day

Provider Requirements, Prior Authorization, and Denial Risks

Prior Authorization

Prior Authorization Required

Prior authorization (PA) is required and approval is contingent on medical necessity criteria being met. The provider must document that the member meets all approval criteria in this policy (diagnosis of ADHD, age criteria, prior therapy/step therapy where applicable, dosing limits, and response to therapy). For Illinois HIM requests, the step therapy requirements do not apply as of 1/1/2026 per IL HB 5395 — include this when applicable.

PA required when approval criteria are met (diagnosis, age, prior therapy, dosing limits, response to therapy).
Step therapy requirements apply except for Illinois HIM requests effective 1/1/2026 per IL HB 5395 (step therapy bypass for IL HIM).
Approval duration for continuation therapy: 12 months.

Documentation Required

Providers must submit supporting documentation with PA requests. Acceptable documentation includes office chart notes, recent lab results (if applicable), prior medication history showing trials and failures or contraindications, and documentation of clinical response if continuation is requested.

Background and Drug Information

Viloxazine (Qelbree) is a selective norepinephrine reuptake inhibitor approved by the FDA for treatment of attention‑deficit/hyperactivity disorder (ADHD) in adults and pediatric patients aged 6 years and older. The product is available as extended‑release capsules and dosing recommendations vary by age group with defined titration schedules and maximum daily doses. The policy includes age‑based dosing thresholds and safety considerations (including boxed warnings and contraindications) to guide appropriate use.

Definitions and Policy Concepts

Qelbree (viloxazine) — drug definition, mechanism, indication, formulation

Drug definitionViloxazine (Qelbree) — a selective norepinephrine reuptake inhibitor indicated for treatment of ADHD in adults and pediatric patients 6 years and older.

Mechanism of actionSelective norepinephrine reuptake inhibitor (NRI).

IndicationTreatment of attention deficit hyperactivity disorder (ADHD) in patients age ≥ 6 years.

Formulation strengthsExtended-release capsules available in 100 mg, 150 mg, and 200 mg strengths (capsules may be swallowed whole or opened and contents sprinkled onto applesauce).

Dosing notesAge-based titration schedules with maximum daily doses: pediatric ≤400 mg/day, adults ≤600 mg/day; capsule count limits apply (2 capsules/day pediatric, 3 capsules/day adult).

Medication-specific Treatment Modalities

Medication (viloxazine/Qelbree)

Medication (viloxazine/Qelbree): Dosing and administration: Age 6–11 years initial 100 mg daily, titrate by 100 mg weekly to target 400 mg/day; Age 12–17 years initial 200 mg daily, after 1 week may titrate by 200 mg to target 400 mg/day; Adults initial 200 mg daily, may titrate by 200 mg weekly to target 600 mg/day. Capsules may be swallowed whole or opened and the contents sprinkled onto applesauce. Maximum doses: pediatric 400 mg/day (≤2 capsules/day); adult 600 mg/day (≤3 capsules/day).max pediatric 400 mg/day; max adult 600 mg/day

Policy Summary

Payermhn

PolicyViloxazine (Qelbree) for ADHD

Policy CodePolicy CP.PMN.264

Change TypeStep therapy bypass (IL HIM)capsule quantity limits added

Effective DateJun 1, 2021

Next Review Date

Key ActionSubmit prior authorization with supporting documentation (office notes, labs or other clinical information) showing the member meets all approval criteria.

SourceLink

On This Page

Submit office chart notes demonstrating ADHD diagnosis and clinical assessment.
Provide prior medication history (e.g., atomoxetine, amphetamine- and methylphenidate-based stimulants) including doses and reasons for failure or contraindication.
If requesting a dose increase, document current response to therapy and that new dose does not exceed policy maximums (pediatric ≤400 mg/day and ≤2 capsules/day; adult ≤600 mg/day and ≤3 capsules/day).

Denial Risk

Denial Risk from Coverage Document Limits

Failure to provide complete or adequate documentation, or failure to meet the policy's medical necessity criteria and coverage document terms, may result in denial of the PA request. Coverage is subject to the member's evidence of coverage and plan contract terms.

Denial triggers include missing office notes, absent prior therapy documentation, insufficient evidence of treatment response, or requested dose exceeding policy limits.
Non-FDA approved indications are not authorized unless supported by off-label policies and evidence of coverage documents (see CP.CPA.09, HIM.PA.154, CP.PMN.53).
Coverage decisions are subject to all terms, conditions, exclusions and limitations of the member's coverage documents.

Note

Provider Obligations and Submission Notes

Providers are obligated to follow plan submission rules and attestations when requesting PA and submitting claims. This policy is a guide to medical necessity used to assist coverage decisions but does not guarantee payment; contractual and plan-level administrative rules apply.

By submitting a PA request, the provider attests that documentation is accurate and that services meet the policy criteria.
Providers should refer to state-specific continuity of care or addendum requirements (e.g., for members enrolled in states/products with continuity of care regulations).
Ensure claims submission aligns with plan billing requirements and that proprietary policy terms are followed; unauthorized copying or use of this clinical policy is prohibited.

Clinical policy — definition and scope

PurposeA clinical policy provides a guide to medical necessity to assist in making coverage decisions and administering benefits.

Not a contract or guaranteeThis clinical policy does not constitute a contract or guarantee of payment or results and is not intended as medical advice.

Scope and developmentDeveloped by licensed health care professionals using peer-reviewed literature, guidelines, and other clinical information to reflect standards of medical practice at approval time.

Provider responsibilityProviders retain independent clinical judgment; the policy is not intended to dictate clinical care and providers are responsible for member treatment decisions.