Pharmacy Prior Authorization Criteria

ADHD

Indications for Prior Authorization

Adderall XR (amphetamine-dextroamphetamine mixed salts extended-release)

• For diagnosis of Attention Deficit Hyperactivity Disorder (ADHD)
  Indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older.

Concerta (methylphenidate extended-release)

• For diagnosis of Attention Deficit Hyperactivity Disorder (ADHD)
  Indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65.

Cotempla XR-ODT (methylphenidate extended-release)

• For diagnosis of Attention Deficit Hyperactivity Disorder (ADHD)
  Indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age.

Daytrana (methylphenidate transdermal system)

• For diagnosis of Attention Deficit Hyperactivity Disorder (ADHD)
  Indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age.

Desoxyn (methamphetamine)

• For diagnosis of Attention Deficit Hyperactivity Disorder (ADHD)
  Indicated for the treatment of attention deficit disorder with hyperactivity as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children over 6 years of age with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity.

ProCentra (dextroamphetamine oral solution)

• For diagnosis of Attention Deficit Hyperactivity Disorder (ADHD)
  Indicated for the treatment of attention deficit disorder with hyperactivity as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity.

• For diagnosis of Narcolepsy
  Indicated for the treatment of narcolepsy.

Focalin (dexmethylphenidate)

• For diagnosis of Attention Deficit Hyperactivity Disorder (ADHD)
  Indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD)

Focalin XR (dexmethylphenidate extended-release)

• For diagnosis of Attention Deficit Hyperactivity Disorder (ADHD)
  Indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged 6 years and older.

Methylin (methylphenidate oral solution)

• For diagnosis of Attention Deficit Hyperactivity Disorder (ADHD)
  Indicated for Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years of age and older.

• For diagnosis of Narcolepsy
  Indicated for the treatment of narcolepsy.

Ritalin (methylphenidate)

• For diagnosis of Attention Deficit Hyperactivity Disorder (ADHD)
  Indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in pediatric patients 6 years and older and adults.

• For diagnosis of Narcolepsy
  Indicated for the treatment of narcolepsy.

Ritalin LA (methylphenidate extended-release)

• For diagnosis of Attention Deficit Hyperactivity Disorder (ADHD)
  Indicated for the treatment of attention deficit hyperactivity disorder (ADHD), in pediatric patients 6 to 12 years of age.

Quillivant XR (methylphenidate extended-release oral suspension)

• For diagnosis of Attention Deficit Hyperactivity Disorder (ADHD)
  Indicated for the treatment of attention deficit hyperactivity disorder (ADHD).

Aptensio XR (methylphenidate HCl extended-release)

• For diagnosis of Attention Deficit Hyperactivity Disorder (ADHD)
  Indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older. Limitations of Use: Pediatric patients younger than 6 years of age experienced higher plasma exposure than patients 6 years and older at the same dose and high rates of adverse reactions, most notably weight loss.

Zenzedi (dextroamphetamine)

• For diagnosis of Attention Deficit Hyperactivity Disorder (ADHD)
  Indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity.

• For diagnosis of Narcolepsy
  Indicated for the treatment of narcolepsy.

Dyanavel XR (amphetamine extended-release)

• For diagnosis of Attention Deficit Hyperactivity Disorder (ADHD)
  Indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older

Quillichew ER (methylphenidate extended-release, chewable)

• For diagnosis of Attention Deficit Hyperactivity Disorder (ADHD)
  Indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD)

Adzenys XR-ODT (amphetamine extended-release, orally disintegrating tablet)

• For diagnosis of Attention Deficit Hyperactivity Disorder (ADHD)
  Indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older.

Mydayis (mixed amphetamine salts)

• For diagnosis of Attention Deficit Hyperactivity Disorder (ADHD)
  Indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 13 years and older. Limitation of use: Pediatric patients 12 years and younger experienced higher plasma exposure than patients 13 years and older at the same dose, and experienced higher rates of adverse reactions, mainly insomnia and decreased appetite.

Jornay PM (methylphenidate extended-release capsule)

• For diagnosis of Attention Deficit Hyperactivity Disorder (ADHD)
  Indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older.

CNS Stimulants

• For diagnosis of Augmentation of Depression [21-23]
  Have been used in the treatment of depression as part of an augmentation strategy in patients who are refractory to standard antidepressant therapy.

Azstarys (serdexmethylphenidate and dexmethylphenidate)

• For diagnosis of Attention Deficit Hyperactivity Disorder (ADHD)
  AZSTARYS is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older.

Dexedrine (dextroamphetamine sulfate)

• For diagnosis of Narcolepsy
  Indicated for the treatment of narcolepsy.

• For diagnosis of Attention Deficit Hyperactivity Disorder (ADHD)
  Indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years to 16 years.

Relexxi, Brand Methylphenidate ER

• For diagnosis of Attention Deficit Hyperactivity Disorder (ADHD)
  Indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults (up to the age of 65 years) and pediatric patients 6 years of age and older.

Xelstrym (dextroamphetamine) transdermal system

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

  Limitations of Use: Pediatric patients with ADHD younger than 6 years of age experienced more long-term weight loss than patients 6 years and older.

Evekeo ODT (amphetamine sulfate) orally disintegrating tablets

• For diagnosis of Attention Deficit Hyperactivity Disorder (ADHD)
  Indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age.

Evekeo (amphetamine sulfate)

• For diagnosis of Attention Deficit Hyperactivity Disorder (ADHD)
  Indicated for the treatment of attention deficit disorder with hyperactivity as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability , and impulsivity.

• For diagnosis of Narcolepsy
  Indicated for the treatment of narcolepsy.

• For diagnosis of Exogenous Obesity
  Indicated as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction for patients refractory to alternative therapy, e.g., repeated diets, group programs, and other drugs.

Vyvanse (lisdexamfetamine dimesylate) capsules, Vyvanse (lisdexamfetamine dimesylate) chewable tablets

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

  Limitation of Use: Vyvanse is not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of Vyvanse for the treatment of obesity have not been established.

• For diagnosis of Binge Eating Disorder (BED)
  Indicated for the treatment of moderate to severe binge eating disorder (BED) in adults.

  Limitation of Use: Vyvanse is not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of Vyvanse for the treatment of obesity have not been established.

Metadate CD (methylphenidate hydrochloride)

• For diagnosis of Attention Deficit Hyperactivity Disorder (ADHD)
  Indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 15 years of age.

Adderall (amphetamine-dextroamphetamine mixed salts)

• For diagnosis of Attention Deficit Hyperactivity Disorder (ADHD)
  Indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

• For diagnosis of Narcolepsy
  Indicated for the treatment of Narcolepsy.

Criteria

Azstarys, Jornay PM

*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 one of the following [8-14]:*
• amphetamine-dextroamphetamine
• dexmethylphenidate
• dextroamphetamine
• methylphenidate
• lisdexamfetamine

Adzenys XR-ODT, Aptensio XR, Brand Adderall, Brand Metadate CD, Brand Methylphenidate XR, Brand Methylphenidate ER, Cotempla XR-ODT, Daytrana, Evekeo, Evekeo ODT, Brand Desoxyn, Brand Dexedrine, Dyanavel XR, Brand Focalin, Brand Focalin XR, Brand Methylin oral solution, Brand Mydayis, Brand ProCentra, Quillichew ER, Quillivant XR, Brand Relexxii, Brand Ritalin, Brand Ritalin LA, Brand Zenzedi, Xelstrym

*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 three of the following [8-14]:*
• amphetamine-dextroamphetamine
• dexmethylphenidate
• dextroamphetamine
• methylphenidate
• lisdexamfetamine

Brand Concerta, Brand Adderall XR, Brand Vyvanse

*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)

• Both of the following:
• 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 three of the following [8-14]:*
• amphetamine-dextroamphetamine
• dexmethylphenidate
• dextroamphetamine
• methylphenidate
• lisdexamfetamine
OR
• For continuation of prior therapy if a minimum 30-day supply was used within the past 120 days

P & T Revisions

2024-09-22, 2024-04-19, 2024-03-15, 2023-12-21, 2023-11-29, 2023-11-25, 2023-11-06, 2023-05-26, 2023-03-02, 2022-12-19, 2022-10-31, 2022-08-01, 2022-03-04, 2021-11-17, 2021-10-18, 2021-08-05, 2020-11-12, 2020-05-11, 2020-04-23, 2020-01-24, 2019-10-29, 2019-07-31, 2019-07-02

References

1. Adderall XR Prescribing Information. Shire US Inc. Lexington, MA. October 2023.
2. Concerta Prescribing Information. Janssen Pharmaceuticals, Inc. Titusville, NJ. July 2021.
3. Desoxyn Prescribing Information. Recordati Rare Diseases, Inc. Lebanon, NJ. April 2019.
4. Focalin XR Prescribing Information. Novartis Pharmaceuticals Corporation. East Hanover, NJ. June 2021.
5. Ritalin LA Prescribing Information. Novartis Pharmaceuticals Corporation. East Hanover, NJ. June 2021.
6. U.S. Food and Drug Administration. Safety Information about Medications for ADHD. Available at: http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm283449.htm. Accessed July 24, 2014.
7. American Academy of Pediatrics. ADHD: Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents. Pediatrics. 2011 Nov;128(5):1007-22.
8. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 5th Ed. Arlington, VA: American Psychiatric Publishing. 2013.
9. American Psychiatric Association. Fact Sheet: Attention Deficit/Hyperactivity Disorder changes in Diagnostic and Statistical Manual of Mental Disorders, 5th Ed. Arlington, VA: American Psychiatric Publishing. 2013. Available at: http://www.dsm5.org/Documents/ADHD%20Fact%20Sheet.pdf. Accessed July 24, 2014.
10. American Academy of Child and Adolescent Psychiatry. Practice parameter for the assessment and treatment of children and adolescents with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2007 Jul;46(7):894-921. .
11. The Medical Letter. Treatment Guidelines: Drugs for ADHD. Med Lett Drugs Ther.2015 Mar 16;57(1464):37-40.
12. Morgenthaler TI, Kapur VK, Brown TM, et al. Practice parameters for the treatment of narcolepsy and other hypersomnias of central origin: An American Academy of Sleep Medicine report. Sleep. 2007 Dec;30(12):1705-11.
13. Daytrana Prescribing Information. Noven Pharmaceuticals, Inc. Miami, FL. October 2023.
14. ProCentra Prescribing Information. Independence Pharmaceuticals, LLC. Newport, KY. February 2017.
15. Methylin Oral Solution Prescribing Information. Shionogi, Inc. Florham Park, NJ. July 2021.
16. Methylin Chewable Tablet Prescribing Information. Shionogi, Inc. Florham Park, NJ. January 2017.
17. Quillivant XR Prescribing Information. NextWave Pharmaceuticals, Inc. New York, NY. October 2017.
18. Zenzedi Prescribing Information. Arbor Pharmaceuticals, LLC. Atlanta, GA. March 2021.
19. American Psychiatric Association. Clinical Practice Guideline: Treatment of Patients with Major Depressive Disorder. 3rd ed. Arlington, VA: American Psychiatric Association; 2010. Available at: http://psychiatryonline.org/guidelines.aspx. Accessed July 24, 2014.
20. McIntyre RS, Lee Y, Zhou AJ, et al. The efficacy of psychostimulants in major depressive episodes: A systematic review and meta-analysis. J Clin Psychopharmacol. 2017 Aug;37(4):412-418.
21. Trivedi MH, Cutler AJ, Richards C, et al. A randomized controlled trial of the efficacy and safety of lisdexamfetamine dimesylate as augmentation therapy in adults with residual symptoms of major depressive disorder after treatment with escitalopram. J Clin Psychiatry. 2013 Aug;74(8):802-9.
22. Aptensio XR Prescribing Information. Rhodes Pharmaceuticals, L.P. Coventry, RI. June 2021.
23. Quillichew ER Prescribing Information. NextWave Pharmaceuticals, Inc. New York, NY. March 2018.
24. Dyanavel XR Prescribing Information. Tris Pharma, Inc. Monmouth Junction, NJ. June 2022.
25. Adzenys XR-ODT Prescribing Information. Neos Therapeutics, Inc. Grand Prairie, TX. June 2021.
26. Mydayis Prescribing Information. Shire US, Inc. Lexington, MA. January 2021.
27. Cotempla XR-ODT Prescribing Information. Neos Therapeutics Brands, LLC. Grand Prairie, TX. July 2021.
28. Adzenys ER Prescribing Information. Neos Therapeutics, Inc. Grand Prairie, TX. June 2021.
29. Jornay PM Prescribing Information. Ironshore Pharmaceuticals, Inc. Cherry Hill, NJ. June 2021.
30. Ritalin Prescribing Information. Novartis Pharmaceuticals Corp. East Hanover, NJ. June 2021.
31. Focalin Prescribing Information. Novartis Pharmaceuticals Corporation. East Hanover, NJ. June 2021.
32. Azstarys (serdexmethylphenidate and dexmethylphenidate) prescribing information. Grand Rapids, MI. Corium Inc. August 2021.
33. American Academy of Pediatrics. Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents. Oct 2019. Accessed Oct 13, 2021 at https://pediatrics.aappublications.org/content/144/4/e20192528.
34. Silver, L. ADHD Medications for Adults and Children: ADD Stimulants, Nonstimulants & More. Additude. 2021 Aug. Accessed Oct 13, 2021 at https://www.additudemag.com/adhd-medication-for-adults-and-children/
35. Dexedrine Prescribing Information. Catalent Pharma Solutions. Winchester, KY. June 2019.
36. Relexxi Prescribing Information. Vertical Pharmaceuticals, LLC. Alpharetta, GA. June 2022.
37. Xelstrym Prescribing Information. Noven Pharmaceuticals, Inc. Miami, FL. March 2022.
38. Evekeo Prescribing Information. Arbor Pharmaceuticals, LLC. Atlanta, GA. August 2019.
39. Evekeo ODT Prescribing Information. Arbor Pharmaceuticals, LLC. Atlanta, GA. April 2021.
40. Vyvanse Prescribing Information. Takeda Pharmaceuticals America, Inc. Lexington, MA. January 2022.
41. Adderall Prescribing Information. Teva Pharmaceuticals, Parsippany, NJ. October 2023.

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End Notes

1. Per OptumRx consultant, although there is limited evidence for Adderall, all stimulants are options for augmentation of antidepressant therapy.
2. According to the American Psychiatric Association (APA) Clinical Practice Guidelines for Treatment of Patients with Major Depressive Disorder, there are a number of strategies available when a change in the treatment plan seems necessary. Particularly for those who have shown minimal improvement or experienced significant medication side effects, other options include augmenting the antidepressant with a depression-focused psychotherapy [I] or with other agents [II] or changing to another non-MAOI antidepressant [I]. One option is to add an adjunctive, nonantidepressant medication—such as lithium [II], thyroid hormone [II], an anticonvulsant [III], a psychostimulant [III], or a second-generation (atypical) antipsychotic [II]. Many clinicians find that augmentation of antidepressants with low doses of stimulants such as methylphenidate or dextroamphetamine may help ameliorate otherwise suboptimally responsive depression, although not all clinical trials have shown benefits from this strategy. [23]

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Revision History

• 2024-09-22: 2024 Annual Review
• 2024-04-19: update guideline
• 2024-03-15: update guideline
• 2023-12-21: Updated criteria for Concerta, Adderall XR, and Vyvanse.
• 2023-11-29: Added new Relexxi strengths to guideline.
• 2023-11-25: update guideline
• 2023-11-06: 2023 Annual Review
• 2023-05-26: Updated brand Concerta criteria due to shortage of generic Concerta.
• 2023-03-02: Removed Brand Adderall IR as target from ST program.
• 2022-12-19: Added ABA for Relexxi (methylphenidate ER) and Xelstrym.
• 2022-10-31: 2022 Annual Review
• 2022-08-01: Update Guideline
• 2022-03-04: 2022 Update Product List
• 2021-11-17: 2021 Annual Review
• 2021-10-18: 2021 Annual Review
• 2021-08-05: UM Criteria Update to include Azstarys eff 9.1.2021
• 2020-11-12: 2020 Annual Review: no changes
• 2020-05-11: Added ABA for Aptensio XR (methylphenidate ER [XR])
• 2020-04-23: Updated Quillivant XR GPI
• 2020-01-24: Updated guideline to include Brand Amphetamine ER.
• 2019-10-29: Annual review
• 2019-07-31: Added Adhansia XR to guideline
• 2019-07-02: new product Jornay PM added to guideline

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