ModifiedCentenePolicy CP.PMN.264

Viloxazine (Qelbree)

Centene clinical policy governing medical necessity criteria, dosing limits, and authorization requirements for viloxazine (Qelbree) for treatment of ADHD in members aged ≥6 years across Commercial, HIM/ICHRA, and Medicaid lines of business.

Policy Summary

PayerCentene

PolicyViloxazine (Qelbree)

Policy CodePolicy CP.PMN.264

Change TypeMaterial updates (step therapy IL HIM bypassapproval duration)

Effective Date06.01.21

Next Review Date

Key ActionSubmit prior authorization with documentation showing ADHD diagnosis, age ≥6, step therapy or documented exception, and dose within policy limits.

SourceLink

POLICY UPDATE CHANGES

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

Revised initial approval duration from 6 months to 12 months.

Added ICHRA (health insurance marketplace/ICHRA) line of business.

≥6minimum age for FDA indication

400 mgmax pediatric daily dose

600 mgmax adult daily dose

12 mocontinuation approval duration

100/150/200

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Coverage and Medical Necessity Criteria

Initial Therapy

Covered when ALL of the following are met

Initial ADHD criteria

Diagnosis and Age: Diagnosis of ADHD AND age ≥ 6 years
Step-therapy pathway A: Failure of atomoxetine at up to maximally indicated doses unless contraindicated or clinically significant adverse effects are experienced
Step-therapy pathway B: Documentation of inability to swallow capsules OR history of substance abuse OR both failures of amphetamine- and methylphenidate-based stimulants at up to maximally indicated doses unless contraindicated
If inability to swallow capsules is documented, this satisfies step requirement; IL HIM bypass applies per IL HB 5395
Dose limits: For pediatric members: maximum 400 mg/day AND maximum 2 capsules/day; For adults: maximum 600 mg/day AND maximum 3 capsules/dayPediatric ≤400 mg/day & ≤2 capsules/day; Adult ≤600 mg/day & ≤3 capsules/day

Dosing/titration reference: Typical titration: Age 6–11 start 100 mg, titrate by 100 mg weekly to 400 mg target; Age 12–17 start 200 mg, after 1 week may titrate by 200 mg to 400 mg target; Adults start 200 mg, titrate by 200 mg weekly to 600 mg target; capsules may be swallowed whole or contents sprinkled on applesauceMax pediatric 400 mg/day; Max adult 600 mg/day

Continuation Therapy

Covered when ALL of the following are met

Continuation criteria: 1) Member is currently receiving medication via Centene benefit or previously met initial approval criteria OR is receiving medication and covered under continuity of care; 2) Member is responding positively to therapy; 3) If request is for a dose increase, new dose does not exceed age-specific maximumsPediatric ≤400 mg/day & ≤2 capsules/day; Adult ≤600 mg/day & ≤3 capsules/day

Approval duration: 12 months

Non‑FDA approved indications for viloxazine (Qelbree) that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety consistent with the applicable off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace/ICHRA), or CP.PMN.53 (Medicaid). Prior authorization decisions for such uses will require submission of supporting clinical evidence per those referenced policies.

This clinical policy is the property of the Health Plan. Unauthorized copying, use, and distribution of this clinical policy or any information contained herein are strictly prohibited. Providers, members, and their representatives are bound by the terms and conditions set forth in their contracts with the Health Plan; where no contract exists, provision of services or submission of claims constitutes agreement to be bound by these terms.

Provider Responsibilities and Authorization Procedures

Prior Authorization

Prior Authorization Required

Prior authorization is required for viloxazine (Qelbree) before benefit coverage. Submit a PA request with supporting clinical documentation demonstrating the member meets the policy’s approval criteria (diagnosis of ADHD, age criteria, prior therapy or inability to swallow capsules as applicable, and dose limits). Approval durations and dose limits in the policy apply (initial and continuation therapy limits; see policy criteria).

Affected drug: viloxazine (Qelbree)
Approval duration: up to 12 months for continuation requests
Dose limits: pediatric ≤400 mg/day & ≤2 capsules/day; adult ≤600 mg/day & ≤3 capsules/day

Note

Medicaid Precedence for Coverage

For Medicaid members, state Medicaid coverage provisions supersede this clinical policy when conflicts exist. Refer to the applicable state Medicaid manual for any state-specific coverage rules or prior authorization processes.

Definitions and Policy Notes

Qelbree (viloxazine) — key facts

Drug nameQelbree (viloxazine)

Mechanism of actionSelective norepinephrine reuptake inhibitor

FDA indicationTreatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older

Minimum indicated age≥ 6 years

Policy vs. medical advice

Purpose of policyThis clinical policy does not constitute medical advice, medical treatment, or medical care and is not intended to dictate how providers practice medicine.

Pharmacotherapy and Treatment Details

Pharmacotherapy (Qelbree)

Dosing/titration: Pediatric 6–11: start 100 mg, titrate by 100 mg weekly to 400 mg target; 12–17: start 200 mg, after 1 week may titrate by 200 mg to 400 mg target; Adults: start 200 mg, titrate by 200 mg weekly to 600 mg targetMax pediatric 400 mg/day; Max adult 600 mg/day

Capsules may be swallowed whole or contents sprinkled on applesauce.

Background and Drug Information

Viloxazine (Qelbree) is a selective norepinephrine reuptake inhibitor approved by the FDA for the treatment of attention‑deficit/hyperactivity disorder (ADHD) in pediatric patients and adults. Recommended dosing varies by age: for children 6–11 years start at 100 mg daily with weekly titration by 100 mg to a target and maximum of 400 mg/day; for adolescents and adults initial and titration schedules differ with an adult maximum of 600 mg/day. Capsules may be swallowed whole or the contents sprinkled on applesauce per product dosing guidance.

Policy Summary

PayerCentene

PolicyViloxazine (Qelbree)

Policy CodePolicy CP.PMN.264

Change TypeMaterial updates (step therapy IL HIM bypassapproval duration)

Effective Date06.01.21

Next Review Date

Key ActionSubmit prior authorization with documentation showing ADHD diagnosis, age ≥6, step therapy or documented exception, and dose within policy limits.

SourceLink

On This Page

Step Therapy

Step Therapy and Illinois HIM Bypass

Step therapy requirements apply for initial approval (failure of atomoxetine and stimulant trials as specified), except where noted. Per Illinois HB 5395 (effective 1/1/2026), the step therapy requirements do not apply to Illinois HIM requests — providers should indicate IL HIM when submitting requests from Illinois HIM lines of business.

Step therapy: failure of atomoxetine at maximally indicated doses unless contraindicated, or inability to swallow capsules
Further requirements: failure of amphetamine- and methylphenidate-based stimulants unless contraindicated or adverse effects
IL HIM bypass effective 01/01/2026 per IL HB 5395

Documentation Required

Required Clinical Documentation

Providers must submit adequate clinical documentation to support approval requests. Acceptable documentation includes office chart notes, medication history, prior authorization history, laboratory results, and other relevant clinical records showing diagnosis, prior medication trials (or contraindications/intolerances), response to therapy, and dosing.

Examples: office chart notes, lab results, medication history, documentation of inability to swallow capsules, documentation of contraindications or adverse reactions to prior therapies

Denial Risk

Documentation & Indication-Related Denials

Failure to provide required documentation or to meet the documented indication criteria may result in denial of the prior authorization request. Ensure documentation clearly demonstrates that all policy criteria are met (diagnosis, age, prior therapy trials or exceptions, dosing limits, and response for continuation requests).

Note

Unauthorized Use and Submission Restrictions

This clinical policy is the property of the Health Plan. Unauthorized copying, use, distribution, or modification of this policy or its contents is strictly prohibited. By submitting claims or providing services to members, providers agree to be bound by the terms herein.

Note

Provider Expectations and Professional Judgment

Providers are expected to exercise professional medical judgment when using this policy and remain responsible for clinical decisions. Follow contractual obligations and submission requirements when requesting authorization; incomplete or misrouted submissions may delay review.

Providers are independent contractors and are responsible for care decisions
Adhere to provider contract terms and required submission processes

Provider responsibility

Providers are expected to exercise professional medical judgment and are solely responsible for the medical advice and treatment of members.

Patient adviceMembers should consult with their treating physician for diagnosis and treatment decisions.

Provider relationship to the Health Plan

Provider statusProviders referenced in this clinical policy are independent contractors who exercise independent judgment and are not controlled by the Health Plan.

Agency relationshipProviders are not agents or employees of the Health Plan.

Policy ownership and useThis clinical policy is the property of the Health Plan; unauthorized copying, use, and distribution are strictly prohibited.