Viloxazine (Qelbree) Form

Viloxazine (Qelbree™) is a selective norepinephrine reuptake inhibitor. FDA Approved Indication(s) Qelbree is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Qelbree is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Attention Deficit Hyperactivity Disorder (must meet all):

1. Diagnosis of ADHD;
   2. Age ≥ 6 years;
   3. Member meets one of the following (a or b): a. Failure of atomoxetine at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced; b. Documentation supports inability to swallow capsules;
2. Member meets one of the following (a or b): a. Member or parent/guardian of member has a history of substance abuse;
   b. Both of the following (i and ii): 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; 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;

3. Dose does not exceed one of the following (a or b): a. Pediatric members: 400 mg per day; b. Adults: 600 mg per day. Approval duration: 6 months Page 1 of 6

   CLINICAL POLICY Viloxazine B. Other diagnoses/indications (must meet 1 or 2):

4. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
5. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. Attention Deficit Hyperactivity Disorder (must meet all):
6. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
   2. Member is responding positively to therapy;
   3. If request is for a dose increase, new dose does not exceed one of the following (a or b): a. Pediatric members: 400 mg per day; b. Adults: 600 mg per day. Approval duration: 12 months B. Other diagnoses/indications (must meet 1 or 2):

7. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or Page 2 of 6

   CLINICAL POLICY Viloxazine

8. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   III. Diagnoses/Indications for which coverage is NOT authorized:
   A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid or evidence of coverage documents.
   IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key ADHD: attention-deficit and hyperactivity disorder FDA: Food and Drug Administration Appendix B: Therapeutic Alternatives
   This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
   Drug Name Dosing Regimen Dose Limit/ Maximum Dose ≤ 70 kg: 1.4 mg/kg/day

   70 kg: 100 mg/day 60 mg/day 60 mg/day 40 mg/day 25 mg/day 6 to 12 years: 18.8 mg/day
   13 to 17 years, Adults: 12.5 mg/day 20 mg/day 20 mg/day (20-30 mg/day if ≥ 6 years) 40 mg/day atomoxetine (Strattera®) ≤ 70 kg: 1.2 mg/kg/day PO 70 kg: 80 mg/day PO Refer to prescribing information Refer to prescribing information Short-Acting Amphetamines Evekeo® (amphetamine) amphetamine/dextroamphetamine salts (Adderall®) dextroamphetamine (Dexedrine®, Procentra®, Zenzedi®) methamphetamine (Desoxyn®) Long-Acting Amphetamines Adzenys XR ODT™ (amphetamine ER)
   Dyanavel® XR (amphetamine ER)
   amphetamine/ dextroamphetamine salts ER (Adderall® XR) dextroamphetamine ER (Dexedrine Spansule®) Page 3 of 6

   CLINICAL POLICY Viloxazine Drug Name Dosing Regimen Dose Limit/ Maximum Dose Short-Acting Methylphenidates dexmethylphenidate (Focalin®) methylphenidate (Methylin®, Ritalin®) Long-Acting Methylphenidates dexmethylphenidate ER (Focalin XR®) methylphenidate ER (Aptensio XRTM, Metadate CD®, QuilliChew ER®, Quillivant XR®, Ritalin LA®) methylphenidate ER (Concerta®) Daytrana® (methylphenidate transdermal) Cotempla XR-ODT® (methylphenidate ER) Adhansia XR® (methylphenidate) Refer to prescribing information 20 mg/day 60 mg/day Refer to prescribing information 40 mg/day (30 mg/day if 6-17 years) 60 mg/day
   72 mg/day One 30 mg/9-hour patch/day 51.8 mg/day 6 to 17 years: 70 mg Adults: 85 mg Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Appendix C: Contraindications/Boxed Warnings • Contraindication(s) o Concomitant administration of monoamine oxidase inhibitors (MAOI), or dosing within 14 days after discontinuing an MAOI o Concomitant administration of sensitive CYP1A2 substrates or CYP1A2 substrates with a narrow therapeutic range • Boxed warning(s): suicidal thoughts and behaviors V. Dosage and Administration
   Indication Dosing Regimen ADHD Age 6 to 11 years of age: Initial daily dose: 100 mg. May titrate in increments of 100 mg weekly to the target daily dosage of 400 mg
   Maximum Dose Pediatric members: 400 mg/day Age 12 to 17 years of age: Initial daily dose: 200 mg. After 1 week, may titrate by an increment of 200 mg to target daily dose of 400 mg
   Adults: 600 mg/day Adults: Initial daily dose: 200 mg. May titrate by an increment of 200mg weekly to target daily dose of 600 mg Page 4 of 6

   CLINICAL POLICY Viloxazine Indication Dosing Regimen Maximum Dose Capsules may be swallowed whole or opened and the entire contents sprinkled onto applesauce VI. Product Availability
   Extended-release capsules: 100 mg, 150 mg and 200 mg VII.