WHA

ADHD Stimulants, Extended-Release (ER) Agents

(Adderall XR® capsule, Adzenys XR-ODT™ tablet, Aptensio XR™ capsule, Azstarys™ capsule, Concerta® tablet, Cotempla XR-ODT™ tablet, Daytrana® patch, Dexedrine Spansules® capsule, Dyanavel XR® suspension, Focalin XR® capsule, Journay® capsule, Mydayis™ capsule, QuilliChew ER™ chew tablet, Quillivant XR® suspension, Ritalin LA® capsule, Vyvanse® capsules and chew tabs, Xelstrym™ patch, Relexxii® tablet and its ABA products)

Self-Administration - oral or transdermal 

 

Indications for Prior Authorization:

 

  • Attention Deficit Hyperactivity Disorder (ADHD): Treatment of 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.
  • Attention Deficit Hyperactivity Disorder (ADHD) (Mydais only): Treatment of ADHD in patients 13 years and older.
    • Limitations 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.
  • Binge Eating Disorder (BED) (Vyvanse only): Treatment of moderate to severe BED in adults.
    • Limitations of Use: Vyvanse is not indicated 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.

 

Coverage Criteria:

 

For diagnosis of attention deficit hyperactivity disorder (ADHD):

 

  • The prescribed dose and age of the patient are consistent with the FDA-approved indication:
    • For Mydayis: patient is 13 years of age or older
    • For all other non-preferred ADHD: patient is 6 years of age or older; AND
  • Patient has tried one of the following generic extended-release (ER) agents:
    • amphetamine-dextroamphetamine ER capsule (Adderall XR)
    • dextroamphetamine ER capsule (Dexedrine Spansule)
    • lisdexamfetamine dimesylate oral capsule (Vyvanse)
    • lisdexamfetamine dimesylate oral tablet chewable (Vyvanse)
    • methylphenidate HCl ER (CD) capsule (Metadate CD)
    • methylphenidate HCl ER (LA) capsule (Ritalin LA)
    • methylphenidate HCl ER (OSM) tablet (generic)
    • methylphenidate HCl ER (XR) capsule (Aptensio XR)
    • methylphenidate HCl ER tablet (Metadate ER)
    • methylphenidate HCl ER tablet (Concerta)
    • dexmethylphenidate HCl ER capsule (Focalin XR)
    • methylphenidate transdermal patch (Daytrana)

 

For diagnosis of binge eating disorder (BED):

 

  • Request is for Vyvanse up to 70 mg once daily; AND
  • Patient is 18 years of age or older; AND
  • Patient has failed generic lisdexamfetamine, AND
  • Documented diagnosis of moderate to severe BED.

 

Reauthorization Criteria:
 

For diagnosis of ADHD or BED:

  • Dose prescribed dose and age of the patient are consistent with the FDA-approved indication; AND
  • Documentation of a positive clinical response to therapy.

 

Coverage Duration: 
  • 1 year

 

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:
  • Step therapy through a WHA preferred extended-release (ER) stimulant to treat ADHD include the following agents:
    • amphetamine-dextroamphetamine er oral capsule extended release 24 hour 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 5 mg (generics to Adderall XR)
    • dextroamphetamine sulfate er oral capsule extended release 24 hour 10 mg, 15 mg, 5 mg (generics to Dexedrine Spansule)
    • lisdexamfetamine dimesylate oral capsule 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 70 mg (generics to Vyvanse)
    • lisdexamfetamine dimesylate oral tablet, chewable 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg (generics to Vyvanse)
    • methylphenidate hcl er (cd) oral capsule extended release 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg (generics to biphasic 30-70 Metadate CD)
    • methylphenidate hcl er (la) oral capsule extended release 24 hour 10 mg, 20 mg, 30 mg, 40 mg, 60 mg (generics to biphasic 50-50 Ritalin LA)
    • methylphenidate hcl er (osm) oral tablet extended release (TB24) 18 mg, 27 mg, 36 mg, 54 mg, 72 mg
    • methylphenidate hcl er (xr) oral capsule extended release 24 hour 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg (generics to biphasic 40-60 Aptensio XR)
    • methylphenidate hcl er oral tablet extended release 10 mg, 20 mg (generics to Metadate ER)
    • methylphenidate hcl er oral tablet extended release 24 hour (TBCR) 18 mg, 27 mg, 36 mg, 54 mg (generics to Concerta)
    • dexmethylphenidate hcl er oral capsule extended release 24 hour 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, 40 mg, 5 mg (generics to Focalin XR)
    • methylphenidate transdermal patch 10 mg/9hr, 15 mg/9hr, 20 mg/9hr, 30 mg/9hr (generics to Daytrana)

 

Policy Updates:
  • 06/01/2023 – Add Xelstrym patch and Relexxii ER tablet to non-preferred ADHD ER policy (P&T 05/16/2023).
  • 11/16/2021 – Azstarys, Jornay PM, Evekeo added to policy
  • 06/01/2021 – New policy approved by P&T.
  • 02/20/2024 – Add generic lisdexamfetamine to policy

 

References:
  1. American Academy of Pediatrics. ADHD: Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents. Pediatrics. 2019 October;144(4):e20192528.
  2. 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.
  3. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 5th Ed. Arlington, VA: American Psychiatric Publishing. 2013.
  4. Cutler AJ, Suzuki K, Starling B, et al. Efficacy and safety of dextroamphetamine transdermal system for the treatment of attention-deficit/hyperactivity disorder in children and adolescents: Results from a pivotal phase 2 study. J Child Adolesc Psychopharmacol. 2022b;32(2):89-97.
  5. U.S. Food and Drug Administration. Safety Information about Medications for ADHD. Accessed March 01, 2023. Available at: http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm283449.htm.
  6. Azstarys Prescribing Information. Corium, Inc. Menlo Park, CA. August 2021.
  7. Adderall Prescribing Information. Teva Pharmaceuticals. Horsham, PA. January 2017.
  8. Adderall XR Prescribing Information. Shire US Inc. Lexington, MA. July 2019.
  9. Concerta Prescribing Information. Janssen Pharmaceuticals. Titusville, NJ. January 2017.
  10. Dexedrine Spansules Prescribing Information. Amedra Pharmaceuticals. Horsham, PA. December 2018.
  11. Desoxyn Prescribing Information. Recordati Rare Diseases, Inc. Lebanon, NJ. April 2019.
  12. Focalin XR Prescribing Information. Novartis Pharmaceuticals Corp. East Hanover, NJ. January 2019.
  13. Metadate CD Prescribing Information. UCB, Inc. Smyrna, GA. October 2016.
  14. Ritalin LA Prescribing Information. Novartis Pharmaceuticals Corp., East Hanover, NJ. January 2019.
  15. Ritalin/ Ritalin SR Prescribing Information. Novartis Pharmaceuticals Corp. East Hanover, NJ. January 2019.
  16. Vyvanse Prescribing Information. Takeda Pharmaceuticals America, Inc. Lexington, MA. January 2022. 
  17. American Academy of Pediatrics. ADHD: Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents. Pediatrics. 2011Nov;128(5):1007-22.
  18. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 5th Ed. Arlington, VA: American Psychiatric Publishing. 2013.
  19. 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.
  20. Daytrana Prescribing Information. Noven Therapeutics. Miami, FL. January 2017.
  21. Sateia MJ. International classification of sleep disorders - third edition: highlights and modifications. CHEST. 2014 Nov;146(5):1387-1394.
  22. Morgenthaler TI, Kapur VK, Brown TM, Swick TJ, Alessi C, Aurora N, et al. Practice parameters for the treatment of narcolepsy and other hypersomnias of central origin: An American Academy of Sleep Medicine report. Sleep. 2007;30(12):1705-1711.
  23. ProCentra Prescribing Information. FSC Laboratories. Charlotte, NC. June 2010.
  24. Focalin Prescribing Information. Novartis Pharmaceuticals, Inc. East Hanover, NJ. January 2019.
  25. Methylin Oral Solution Prescribing Information. Shionogi, Inc. Florham Park, NJ. January 2017.
  26. Methylin Chewable Tablet Prescribing Information. Shionogi, Inc. Florham Park, NJ. January 2017.
  27. Quillivant XR Prescribing Information.NextWave Pharmaceuticals, Inc. New York, NY. January 2017.
  28. Metadate ER Prescribing Information. KVK-Tech, Inc. Newtown, PA. July 2015.
  29. Zenzedi Prescribing Information. Arbor Pharmaceuticals, LLC. Atlanta, GA. August 2019.
  30. 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.
  31. 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.
  32. 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;74(8):802-9.
  33. Evekeo Prescribing Information. Arbor Pharmaceuticals, LLC. Atlanta, GA. August 2019.
  34. Aptensio XR Prescribing Information.Rhodes Pharmaceuticals, L.P. Coventry, RI. January 2017.
  35. Quillichew ER Prescribing Information. NextWave Pharmaceuticals, Inc. New York, NY. March 2017.
  36. Dyanavel XR Prescribing Information. Tris Pharma, Inc. Monmouth Junction, NJ. May 2017.
  37. Adzenys XR-ODT Prescribing Information. Neos Therapeutics, Inc. Grand Prairie, TX. September 2017.
  38. Mydayis Prescribing Information. Shire US Inc. Lexington, MA. June 2017.
  39. Cotempla XR-ODT Prescribing Information. Neos Therapeutics, LP. Grand Prairie, TX. June 2017.
  40. Adzenys ER Prescribing Information. Neos Therapeutics, Inc. Grand Prairie, TX. September 2017.
  41. Tsai AG, Wadden TA. In the clinic: obesity. Ann Intern Med. 2013 Sep 3;159(5):ITC3-1-ITC3-15. doi: 10.7326/0003-4819-159-5-201309030-01003.
  42. Jornay PM Prescribing Information. Ironshore Pharmaceuticals, Inc. Cherry Hill, NJ. April 2019.
  43. Adhansia XR Prescribing Information. Purdue Pharmaceuticals, L.P. Wilson, NC. July 2019.
  44. Strattera Prescribing Information. Lilly USA, LLC. Indianapolis, IN. May 2017.
  45. Azstarys (serdexmethylphenidate and dexmethylphenidate) prescribing information. Corium Inc. Grand Rapids, MI. June 2021.
  46. Daytrana Prescribing Information. Noven Therapeutics. Miami, FL. November 2022.
  47. Xelstrym Prescribing Information. Noven Pharmaceuticals, Inc. Miami, FL. August 2022.

Last review date: March 1, 2024