Diagnosis: Mental health/Attention deficit hyperactivity disorder (ADHD) Treatment: Pharmacy prescription drugs. The insurer denied Vyvanse 40 mg 2 tablets (60 tablets a month). The denial is overturned in whole. This case involves a patient diagnosed with attention deficit hyperactivity disorder (ADHD) with a co-morbid diagnosis of bulimia (binge eating). The patient has demonstrated a response to Vyvanse 80 milligrams (mg) daily with noted benefit from this medication. Yes, the requested health service/treatment of Vyvanse 40 mg (lisdexamfetamine) with quantities of 60 pills at 40 mg is medically necessary for this patient. The requested benefit of Vyvanse at a daily dose of 80 mg with two 40 mg caps per day is medically necessary for this patient and clinically appropriate with regard to the indications for use. Vyvanse is being prescribed by a mental health practitioner. Additionally, psychological testing affirmed the diagnosis of ADHD. The Vyvanse is prescribed for a patient who benefits with regard to improved symptoms and functioning, and who has been effectively treated at the current dose of 80 mg daily for over 4 years. The dose of medication is individualized and was titrated as clinically appropriate. Treatment with a lower dose would be detrimental to the patient with a reasonable degree of medical certainty. The requested Vyvanse is backed by scientific evidence that means the results of controlled clinical trials or other studies are published in peer-reviewed, medical literature; the requested medication for the diagnosis of attention deficit hyperactivity disorder is generally recognized by the relevant medical specialty community; and is consistent with prevailing medical standards and clinical guidelines including national consensus statements, nationally recognized clinical guidelines, and national specialty society guidelines, as referenced below. Vyvanse at a daily dosage of 80 mg daily for the treatment of attention deficit hyperactivity disorder (ADHD) is reasonable, in the patient's best interest, and consistent with prevailing standards of medical practice, as well as the Food and Drug Administration (FDA) indicated use for the treatment of ADHD at a dose that has been prescribed for over 4 years with coverage from other health plans. Specifically, in this case, the patient has demonstrated a clinical response to the requested treatment with Vyvanse 80 mg daily (two 40 mg pills); thus, it is in the patient's best interest to remain on this medication that provides clear therapeutic benefit, especially with respect to daily functioning. The requested benefit with Vyvanse 80 mg daily is provided for the purpose of treating ADHD, as clinically appropriate and indicated; and is entirely consistent with nationally recognized scientific evidence as available, and prevailing medical standards and clinical guidelines, referenced below.
1) Frampton JE. Lisdexamfetamine: A Review of ADHD in Adults. CNS Drugs. 2016 Apr;30(4):343-54. 2) Zimovetz EA, Joseph A, Ayyagari R, Mauskopf JA. A cost-effectiveness analysis of lisdexamfetamine dimesylate in the treatment of adults with attention-deficit/hyperactivity disorder in the UK. Eur J Health Econ. 2018 Jan;19(1):21-35. 3) Burcu M, Zito JM, Metcalfe L, Underwood H, Safer DJ. Trends in Stimulant Medication Use in Commercially Insured Youths and Adults, 2010-2014. JAMA Psychiatry. 2016 Sep 1;73(9):992-3. 4) Stark JG, Engelking D, McMahen R, Sikes C. A randomized crossover study to assess the pharmacokinetics of a novel amphetamine extended release orally disintegrating tablet in healthy adults. Postgrad Med. 2016 Sep;128(7):648-55. 5) Walker DJ, Mason O, Clemow DB, Day KA. Atomoxetine treatment in adults with attention-deficit/hyperactivity disorder. Postgrad Med. 2015;127(7):686-701. 6) Kocher J, Adams P. Immediate-release methylphenidate for the treatment of ADHD in adults. Am Fam Physician. 2015 Apr 1;91(7):445-6. 7) Ermer JC, Pennick M, Frick G. Lisdexamfetamine Dimesylate: Prodrug Delivery, Amphetamine Exposure and Duration of Efficacy. Clin Drug Investig. 2016 May;36(5):341-56. 8) Newcorn JH, Nagy P, Childress AC, Frick G, Yan B, Pliszka S. Randomized, Double-Blind, Placebo-Controlled Acute Comparator Trials of Lisdexamfetamine and Extended-Release Methylphenidate in Adolescents with Attention-Deficit/Hyperactivity Disorder. CNS Drugs. 2017 Nov;31(11):999-1014. 9) Cortese S, Adamo N, Mohr-Jensen C, Hayes AJ, Bhatti S, Carucci S, Del Giovane C, Atkinson LZ, Banaschewski T, Simonoff E, Zuddas A, Barbui C, Purgato M, Steinhausen HC, Shokraneh F, Xia J, Cipriani A, Coghill D; European ADHD Guidelines Group (EAGG). Comparative efficacy and tolerability of pharmacological interventions for attention-deficit/hyperactivity disorder in children, adolescents, and adults: protocol for a systematic review and network meta-analysis. BMJ Open. 2017 Jan 10;7(1): e013967. 10) De Crescenzo F, Cortese S, Adamo N, Janiri L. Pharmacological and non-pharmacological treatment of adults with ADHD: a meta-review. Evid Based Ment Health. 2017 Feb;20(1):4-11. 11) Hansen MV, Darling L, Holst H. Safety and Tolerability of Lisdexamfetamine: A Retrospective Cohort Study. CNS Drugs. 2015 May;29(5):415-23. 12) Adler LA, Lynch LR, Shaw DM, Wallace SP, O'Donnell KE, Ciranni MA, Briggie AM, Faraone SV. Effectiveness and Duration of Effect of Open-Label Lisdexamfetamine Dimesylate in Adults With ADHD. J Atten Disord. 2017 Jan;21(2):149-157. doi: 10.1177/1087054713485421. Epub 2016 Jul 28. PubMed PMID: 23657761. 13) Rostain A, Jensen PS, Connor DF, Miesle LM, Faraone SV. Toward quality care in ADHD: defining the goals of treatment. J Atten Disord. 2015 Feb;19(2):99-117.