Diagnosis: Autism spectrum disorder (ASD)
Treatment: Clonidine HCl (hydrochloride) ER (extended release) 0.1MG (milligram) OR TB (oral tablet) 12
The insurer denied coverage for Clonidine HCl ER 0.1MG OR TB 12.
The denial is overturned.

This is a child with a diagnosis of autism spectrum disorder (ASD). His main issues are: "sleep and aggression". There is a family history of autism and absence seizures. His mother describes periods of staring in space and not responding to his name being called. He had good response to short acting clonidine "for sleep" but was too sedated with Guanfacine/Tenex. He had a short trial with aripiprazole (Abilify) but developed urinary retention and constipation.

Alpha-2-adrenergic agonists (guanfacine, clonidine) also are used to manage symptoms of inattention, hyperactivity, and impulsivity in children with ASD. Two small crossover trials using clonidine suggest decreased irritability, stereotypy, hyperactivity, inappropriate speech, and oppositional behavior. Side effects included hypotension and sedation.

The atypical antipsychotic agents, risperidone and aripiprazole, are the only medications approved by the US Food and Drug Administration (FDA) to treat irritability and self-injurious and aggressive behaviors in children with ASD. Agents that are used off-label include other atypical antipsychotics (olanzapine, clozapine, quetiapine, ziprasidone), haloperidol (a typical antipsychotic), antiseizure medications, alpha-2 agonists, mood stabilizers, SSRI (Selective serotonin reuptake inhibitors), and beta-blockers.

Clonidine (an alpha-2-adrenergic receptor agonist) has sedative effects. In an observational study, clonidine was effective in reducing sleep latency and nighttime awakening in children with ASD. Due to its sedating effect, it has become one of the most widely used medications for insomnia by both pediatric and mental health practitioners, particularly in children with sleep-onset delay and ADHD (attention deficit hyperactivity disorder). Clonidine, however, is known to be more sedating than Guanfacine/Tenex. Which, according to the mother's report, was too sedating for the patient.

According to Lippincott Advisor (indications and doses):
Clonidine Extended release (ER) (Kapvay) is used for attention deficit hyperactivity disorder (ADHD) as monotherapy or as adjunctive therapy to stimulant medications. For children, initially, give 0.1 milligrams (mg) extended-release tablet (Kapvay) orally (PO) at bedtime. Adjust by 0.1 mg/day at weekly intervals to desired response. With first dosage increase, give tablets twice each day (b.i.d)., with equal or higher dose given at bedtime. Maximum dose is 0.4 mg/day. Guanfacine ER / Intuniv have similar indications.

Clonidine ER has indication to be used as monotherapy or as adjunctive therapy in treatment of ADHD. Clonidine short acting, due to its sedating effect, is used widely off-label in addressing symptoms of irritability and sleep disturbance in patients with ASD. Extended release (ER/XR) form provides smoother coverage compared to short acting form. However, considering Guanfacine/Tenex ER was given at the dose of 1 mg and was already making this patient too sedated, Clonidine ER 0.1 mg would probably have even more sedating effect. It would be beneficial for him to have a trial of Clonidine ER for a short time to see the response, which would be evident very quickly.

Based on the above, the insurer's denial must be overturned. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient.

The medical necessity for Clonidine HCl ER 0.1MG OR TB 12 is substantiated.