Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Attention deficit hyperactivity disorder (ADHD)
Treatment: Guanfacine extended release (ER) 1 milligram (MG) tablet, 1 tablet twice daily
The insurer denied: Guanfacine extended release (ER) 1 milligram (MG) tablet, 1 tablet twice daily
The denial is upheld

The patient is a school-aged male who was reported to have been diagnosed with attention deficit hyperactivity disorder. The patient's provider is requesting the use of guanfacine extended release (ER) 1 milligram (MG) tablet, 1 tablet twice daily, for treatment of the patient's symptoms related to attention deficit hyperactivity disorder. The requested medication was noted to have been previously denied as the dosing frequency of twice daily was noted to be inconsistent with the Food and Drug Administration (FDA) labeling and the requested dosing frequency exceeded the maximum recommended dose and frequency of once daily for treatment of attention deficit hyperactivity disorder.
The patient's provider is appealing the previous denial indicating that the request for guanfacine extended release (ER) 1MG tablet, #60 for 30 days is medically necessary. An appeal request form provided by the treating provider indicated that the patient has been taking guanfacine extended release 1MG twice daily with good benefit. The provider indicates that the patient's morning dose manages the symptoms during the school day and the second dose in the evening assists the patient in calming and sleeping through the night. A pharmacy paid claims report indicates that the patient was treated with psychotropic medications including dexmethylphenidate extended release, sertraline, amphetamine/dextroamphetamine, amphetamine/dextroamphetamine extended release and guanfacine extended release. Most recent paid claim for guanfacine extended release was for #30 for 30 days. There were no previous paid claims noted for guanfacine extended release at a dosing frequency of twice daily or at a quantity of #60 for 30 days.

The proposed treatment (guanfacine extended release 1MG tablet, 1 tablet twice daily, #60 for 30 days) is not medically necessary.

The patient is a school-aged male who was reported to have been diagnosed with attention deficit hyperactivity disorder. The patient's provider is requesting the use of guanfacine extended release 1MG tablet, 1 tablet twice daily, for treatment of the patient's symptoms related to attention deficit hyperactivity disorder. The requested medication was noted to have been previously denied as the dosing frequency of twice daily was noted to be inconsistent with the Food and Drug Administration (FDA) labeling and the requested dosing frequency exceeded the maximum recommended dose and frequency of once daily for treatment of attention deficit hyperactivity disorder. Clinical information provided indicates that the patient was most recently treated with guanfacine extended release 1MG tablet, 1 tablet daily and amphetamine/dextroamphetamine extended release 15MG capsule, 1 capsule daily for treatment of attention deficit hyperactivity disorder. Guanfacine extended release is an extended-release formulation of the alpha-adrenergic agonist, 
guanfacine, that is indicated for treatment of attention deficit hyperactivity disorder in children above the age of six years. The extended-release formulation of guanfacine is indicated for once daily administration at the same time of the day based on the pharmacokinetic profile of the formulation. There is no evidence in current peer reviewed, evidence-based medical literature to indicate the safety of efficacy of twice daily dosing of extended-release formulation of guanfacine. There is a potential for adverse effects including significant hypotension with greater than recommended dosing frequency of vasoactive adrenergic medications. Therefore, the proposed treatment (guanfacine extended release 1MG tablet, 1 tablet twice daily, #60 for 30 
days) is not medically necessary.