Pharmacy Prior Authorization Criteria

NonStimulant ADHD Agents Step Therapy - ST, NF

Indications for Prior Authorization

Qelbree (viloxazine extended-release)

• For diagnosis of Attention Deficit Hyperactivity Disorder (ADHD)
  Selective norepinephrine reuptake inhibitor indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years of age and older.

Intuniv (guanfacine extended-release)

• For diagnosis of Attention Deficit Hyperactivity Disorder (ADHD)
  Central alpha 2A-adrenergic receptor agonist indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications.

Kapvay (clonidine hydrochloride extended-release)

• For diagnosis of Attention Deficit Hyperactivity Disorder (ADHD)
  Central alpha 2A-adrenergic receptor agonist indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications.

Strattera (atomoxetine)

• For diagnosis of Attention Deficit Hyperactivity Disorder (ADHD)
  Selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder.

Onyda XR (clonidine hydrochloride extended - release oral suspension)

• For diagnosis of Attention Deficit Hyperactivity Disorder (ADHD)
  Indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy or as adjunctive therapy to central nervous system (CNS) stimulant medications in pediatric patients 6 years of age and older.

Criteria

Brand Intuniv, Brand Kapvay, Brand Onyda XR, Qelbree, Brand Strattera

*Intent is to accept immediate release and/or extended release generic preparation of the listed prerequisites when available

Step Therapy

Length of Approval: 12 Month(s)

• Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
AND
• Trial and failure of a minimum 30 day supply, contraindication, or intolerance to TWO of the following:
• generic atomoxetine
• generic guanfacine ER
• generic clonidine ER
AND
• One of the following:
• Trial and failure of a minimum 30 day supply, contraindication, or intolerance to BOTH of the following:* [A-B, D]
• a generic methylphenidate class stimulant (e.g., methylphenidate)
• a generic amphetamine class stimulant (e.g., amphetamine-dextroamphetamine)
OR
• Patient is not a candidate

Brand Intuniv, Brand Onyda XR, Qelbree, Brand Strattera

*Intent is to accept immediate release and/or extended release generic preparation of the listed prerequisites when available

Non Formulary

Length of Approval: 12 Month(s)

• Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
AND
• One of the following:
• Submission of medical records (e.g., chart notes) or paid claims confirming trial and failure of a minimum 30 day supply, contraindication, or intolerance to BOTH of the following:* [A-B, D]
• a generic methylphenidate class stimulant (e.g., methylphenidate)
• a generic amphetamine class stimulant (e.g., amphetamine-dextroamphetamine)
OR
• Submission of medical records (e.g., chart notes) confirming patient is not a candidate
AND
• Submission of medical records (e.g., chart notes) or paid claims confirming trial and failure of a minimum 30 day supply, contraindication, or intolerance to ALL of the following: [C]
• generic atomoxetine
• generic guanfacine ER
• generic clonidine ER

P & T Revisions

2024-10-31, 2024-10-19, 2024-10-18, 2024-04-02, 2023-09-13, 2022-05-29, 2022-01-24, 2021-11-22, 2021-06-01

References

1. Qelbree Prescribing Information. Supernus Pharmaceuticals, Inc. Rockville, MD. April 2022.
2. Intuniv Prescribing Information.Takeda Pharmaceuticals America, Inc. Lexington, MA. Jan 2021.
3. Kapvay Prescribing Information.Concordia Pharmaceuticals. Dublin, Ireland. August 2021.
4. Strattera Prescribing Information. Eli Lilly and Company. Indianapolis, IN. Jan 2022
5. Rodden, J. Non-Stimulant ADHD Medication Overview. Available at https://www.additudemag.com/non-stimulant-adhd-medication/. Accessed January 24, 2022.
6. Qelbree Clinical Consult June 2021
7. Cortese, S. Evidence-based prescribing of medications for ADHD: where are we in 2023? Available at : https://www.tandfonline.com/doi/full/10.1080/14656566.2023.2169604. Accessed March 18, 2024.
8. Mechler, K., Banaschewski, T., Hohmann, S., et al. Evidence-based pharmacological treatment options for ADHD in children and adolescents. Available at: https://www.sciencedirect.com/science/article/pii/S016372582100142X. Accessed March 18, 2024.
9. Biederman J., DiSalvo, M., Green, A., et al. How Frequent Is Switching From an Initial Stimulant Family to the Alternative One in the Clinical Setting?: A Pilot Study of 49 Consecutively Referred Medication-Naive Adults With Attention-Deficit/Hyperactivity Disorder. Available at: https://pubmed.ncbi.nlm.nih.gov/33657069/#:~:text=Findings%2Fresults%3A%20Sixty%2Dseven,treatment%20because%20of%20poor%20tolerability. Accessed March 18, 2024.
10. Wolraich, M., Hagan, J., Allan, C., et al. Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents. Available at: https://publications.aap.org/pediatrics/article/144/4/e20192528/81590/Clinical-Practice-Guideline-for-the-Diagnosis?autologincheck=redirected. Accessed March 18, 2024.
11. Onyda XR Prescribing Information. Tris Pharma, Inc. Monmouth Junction, NJ. May 2024.

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End Notes

1. Stimulants are usually given as 1st-line treatment for ADHD, but a subcategory of patients cannot (e.g., difficulty swallowing) or will not take stimulants (e.g., abuse potential). ,In general, all nonstimulants are considered to be slower-acting than stimulants, due to their mechanism of action. The availability of viloxazine ER as a sprinkle capsule that can be opened is an advantage, but it is not needed for most patients. [6]
2. Following poor response to two stimulants (methylphenidate and amphetamines), some clinicians would quickly move to second- or third-line approved compounds. . Indeed, it should be highlighted that the majority of patients with ADHD respond to one or both classes of psychostimulants, when used properly A review [Citation26] of RCTs found that around 40% of children treated with immediate-release stimulants responded equally well to amphetamine or methylphenidate, nearly 38% responded better to amphetamines, around 15% had a better response to methylphenidate, and around 15% did not respond to either medication. A more recent review showed that around 90% of the individuals with ADHD respond to either or both class of stimulants. [7]
3. It is important to note that the treatment effects are not usually observed until several weeks after initiation of treatment with atomoxetine (6–12 weeks), clonidine and guanfacine (2–4 weeks) [8]
4. Findings/results: Sixty-seven percent of ADHD patients were initially prescribed a methylphenidate product, and 33%, an amphetamine product. Forty-one percent of ADHD patients needed to switch from their initially prescribed stimulant family within 90 days of initiating treatment because of poor tolerability [9]

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Revision History

• 2024-10-31: update guideline
• 2024-10-19: update guideline
• 2024-10-18: Apply ST for Onyda XR
• 2024-04-02: Update guideline
• 2023-09-13: update guideline
• 2022-05-29: Update guideline
• 2022-01-24: 2022 UM Update Product List
• 2021-11-22: Update guideline
• 2021-06-01: New Guideline

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