Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Insomnia
Treatment: Quviviq (daridorexant)
The insurer denied Quviviq (daridorexant).
The denial is upheld.

The patient is an adult male who was reported to have been diagnosed with insomnia. The patient's provider is requesting the use of Quviviq (daridorexant) 25 mg (milligrams) tablet, 1 tablet by mouth daily at bedtime, 30 tablets for 30 days for treatment of symptoms related to insomnia. The requested medication (Quviviq) was noted to have been previously denied coverage by the health plan, as there was no indication that the patient had tried and failed an adequate trial of preferred alternative medications available for treatment of insomnia. 

The requested Quviviq is not medically necessary.

The health plan's preferred alternatives indicated include estazolam, eszopiclone, flurazepam, temazepam, triazolam, zaleplon, zolpidem, extended-release zolpidem, ramelteon and doxepin. Clinical documentation and paid claims report provided indicates that the patient was previously treated with quetiapine, mirtazapine and ramelteon. There was no indication that the patient was treated with any other medications for insomnia. The patient was reported to have a history of substance abuse in the past including alcohol and benzodiazepines. It is notable that the assertions made in the appeal letter provided by the treating provider are erroneous. Temazepam is not similar to Ambien (zolpidem) and doxepin is not the same as quetiapine. Temazepam is a benzodiazepine while zolpidem is a non-benzodiazepine GABA (Gamma-Aminobutyric acid) agonist. Doxepin is an antidepressant medication while quetiapine is an atypical antipsychotic. Each of these medications have different mechanisms of action. There is no evidence in current peer-reviewed, evidence based medical literature to indicate that the requested drug (Quviviq) would be more effective than other covered preferred alternative medications for treatment of symptoms related to insomnia. Quviviq (daridorexant) is a medication approved for insomnia that works by blocking the binding of wake-promoting neuropeptides orexin A and orexin B to receptors OX1R (orexin receptor type 1) and OX2R (orexin receptor type 2), which is thought to suppress the central drive for wakefulness. This is similar to suvorexant and lemborexant and a unique mechanism of action, unlike other medications used to treat insomnia (7-9). However, there are several medications that may be utilized for treatment of symptoms related to insomnia, including melatonin, ramelteon, zolpidem, zaleplon and eszopiclone which would be expected to be equally effective as the requested medication (Quviviq) in this patient (1-6). In addition, there are several other medications including antidepressants, tricyclic antidepressants, antihistamines and anxiolytics may also be used off label for treatment of symptoms related to insomnia. There is no evidence in current peer-reviewed evidence-based medical literature to indicate that the requested drug (Quviviq) would have less adverse effects and all other preferred alternative drugs available for treatment of insomnia. Common adverse effects of Quviviq include drowsiness, dizziness, abnormal dreams, and mood symptoms, which are similar to other medications for insomnia (7-9). The requested drug, Quviviq, would not be expected to have less adverse effects than all other preferred alternative drugs. There is no evidence in current peer-reviewed evidence-based medical literature to indicate that use of non-benzodiazepine GABA agonist sedative hypnotics are contraindicated in patients with a history of substance abuse. Therefore, based on current peer-reviewed, evidence based medical literature, the requested medication was not found to be exclusively medically necessary for treatment of the patient's symptoms related to insomnia.