QELBREE (viloxazine extended-release)

QELBREE (viloxazine extended-release)

Self Administration - Oral capsules

Indications for Prior Authorization:

Attention Deficit Hyperactivity Disorder (ADHD): Indicated for the treatment of ADHD in adults and pediatric patients 6 years and older.

Coverage Criteria:

For diagnosis of ADHD:

• Dose does not exceed 400 mg daily; AND
• Member is 6 years of age or older; AND
• Inadequate response, intolerance, or contraindication to one of the following:
  • atomoxetine
  • guanfacine ER
  • clonidine ER

Reauthorization Criteria:

For diagnosis of ADHD:

• Dose does not exceed 400 mg daily; AND
• Documentation of a positive clinical response to therapy.

Coverage Duration:

• Initial: 12 months
• Reauthorization: 12 months

Dosing:

• 6 to 11 years of age - Initial: 100 mg once daily (maximum: 400 mg once daily)
• 12 to 17 years of age - Initial: 200 mg once daily (maximum: 400 mg once daily)

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:

• In clinical trials, higher rates of suicidal thoughts and behavior were reported in patients treated with Qelbree than in patients treated with placebo. Closely monitor for worsening and emergence of suicidal thoughts and behaviors

Policy Updates:

• 11/16/2021 – New policy approved by P&T.
• 08/16/2022 - Coverage expanded to adults for treatment of ADHD (4/2022) 

References:

• Qelbree Prescribing Information. Supernus Pharmaceuticals, Inc. Rockville, MD. April 2022