Vyvanse (lisdexamfetamine) (PG098) Form

Attention-deficit/hyperactivity disorder (ADHD)

ADHD is a chronic condition that includes a combination of persistent problems, such as difficulty sustaining attention, hyperactivity and impulsive behavior. Children with ADHD may also struggle with low self-esteem, troubled relationships and poor performance in school. Symptoms sometimes lessen with age. However, some people never completely outgrow their ADHD symptoms. ADHD often affects people with other overlapping psychological disorders. Treatment typically involves medications and behavioral interventions.

Vyvanse (lisdexamfetamine)

Vyvanse (lisdexamfetamine) is a centrally acting stimulant that is FDA approved for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients as well as binge-eating disorder (BED) in adults. Vyvanse (lisdexamfetamine) is considered first-line therapy in the treatment of ADHD and is utilized as part of a comprehensive approach including psychological, educational, and/or social interventions. Vyvanse (lisdexamfetamine) is available as oral tablets or capsules.

Definitions

• ADHD is a chronic psychological condition characterized by inattention, hyperactivity and impulsivity. While the exact cause of ADHD is not clear, possible factors that may be involved are genetics, the environment or problems with the central nervous system at key moments in development.
• Binge Eating Disorder (BED) is a severe, treatable eating disorder characterized by recurrent episodes of eating large quantities of food (often very quickly and to the point of discomfort); a feeling of a loss of control during the binge; experiencing shame, distress or guilt afterwards; and often using unhealthy compensatory measures like purging to counter the binge eating. It is the most common eating disorder in the United States.

Medical Necessity Criteria for Initial Authorization

The Plan considers Vyvanse (lisdexamfetamine) medically necessary when ALL of the following criteria are met for the applicable indication below:

For the treatment of moderate to severe Binge Eating Disorder (BED):

1. The requested medication is being prescribed by or in consultation with a psychiatrist;
2. The member is at least 18 years of age;
3. The member has a diagnosis of binge-eating disorder;
4. The member has a documented prior, concurrent or planned course of therapy or counseling [such as interpersonal psychotherapy, cognitive-behavioral therapy, dialectical behavior therapy];
5. Chart documentation must be provided for review to substantiate the above listed requirements.

For the treatment of Attention Deficit Hyperactivity Disorder (ADHD):

1. The member is at least 6 years of age;
2. The member has a documented diagnosis of attention-deficit/hyperactivity disorder (ADHD) ;
3. The member is unable to use, or has adequately tried and failed (at maximum tolerated dose for a minimum of 30 days) an extended-release amphetamine product;
4. The member is unable to use, or has adequately tried and failed (at maximum tolerated dose for a minimum of 30 days) an extended-release methylphenidate product;
5. Chart documentation must be provided for review to substantiate the above listed requirements.

If the above prior authorization criteria are met for the applicable indication, Vyvanse (lisdexamfetamine) will be approved for 6 months.

Medical Necessity Criteria for Reauthorization

Reauthorization for 12 months will be granted if the member has chart documentation demonstrating a clinical improvement in symptoms since starting the requested medication.

Experimental or Investigational / Not Medically Necessary

Vyvanse (lisdexamfetamine) for any other indication is considered not medically necessary by the Plan, as it is deemed to be experimental, investigational, or unproven.

References

1. Aigner M, Treasure J, Kaye W, Kasper S. World Federation of Societies of Biological Psychiatry (WFSBP) guidelines for the pharmacological treatment of eating disorders. World J Biol Psychiatry 2011;12:400-43.
2. American Academy of Child and Adolescent Psychiatry. Practice parameter for the assessment and treatment of children and adolescents with AttentionDeficit/Hyperactivity Disorder. J Am Acad Child Adolesc Psychiatry. 2007;46(7):894-921.
3. American Academy of Pediatrics subcommittee on attention-deficit/hyperactivity disorder, steering committee on quality improvement and management. ADHD: clinical practice guideline for the diagnosis, evaluation, and treatment of attention deficit/hyperactivity disorder in children and adolescents. Pediatrics 2011;128(5):1007-1022.
4. Amianto F, Ottone L, Daga A et al. Binge-eating disorder diagnosis and treatment: a recap in front of DSM-5. BMC Psychiatry. 2015 Apr 3;15:70. doi: 10.1186/s12888-015-0445-6.
5. MayoClinic.org - ADHD. Posted June 2019. Updated Jan 2021. Available at: https://www.mayoclinic.org/diseases-conditions/adhd/symptoms-causes/syc-20350889.
6. National Eating Disorder Association - BED. Updated Jan 2021. Available at: https://www.nationaleatingdisorders.org/learn/by-eating-disorder/bed
7. Reas DL, Gril CM. Pharmacological treatment of binge eating disorder: update review and synthesis. Expert Opin Pharmacother. 2015;16(10):1463-78. doi:10.1517/14656566.2015.1053465.
8. Vyvanse (lisdexamfetamine) [prescribing information]. Lexington, MA: Takeda Pharmaceuticals America Inc; January 2022.
9. Vyvanse Drug Monograph. Clinical Pharmacology. Accessed Sept 2021. Available at: http://www.clinicalpharmacology-ip.com.
10. Wolraich ML, Hagan JF Jr, Allan C, et al. Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents [published correction appears in Pediatrics. 2020 Mar;145(3):]. Pediatrics. 2019;144(4):e20192528. doi:10.1542/peds.2019-2528
11. Yager J, Devlin MJ, Halmi KA et al. Treatment of patients with eating disorders, 3rd edition. American Psychiatric Association. Am J Psychiatry. 2006 Jul;163(7 Suppl):4-54.

Clinical Guideline Revision / History Information

Original Date: 10/14/2021 Reviewed/Revised: 12/01/2021, 06/23/2022, 06/29/2023