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New insomnia treatment Quviviq™ now on the market
The U.S. Food and Drug Administration (FDA) approved Quviviq (daridorexant) 25 mg and 50 mg tablets on January 10, 2022. Manufactured by Idorsia Pharmaceuticals US Inc., this sedative/hypnotic is indicated for the treatment of adults with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.
Quviviq is the third, dual orexin receptor antagonist (DORA) to come to market, following Belsomra® (suvorexant) in 2014 and Dayvigo® (lemborexant) in 2019. Like Belsomra and Dayvigo, Quviviq is designated as a federally-controlled substance (schedule IV) due to the potential for abuse or dependence. DORAs alter the effects of orexins, which are neurotransmitters that regulate the sleep-wake cycle and ultimately suppress the signaling for wakefulness.
Place in therapy
Treatment guidelines generally recommend that insomnia be managed based on the potential causes (e.g., pain, depression, anxiety, medications, and comorbid conditions). If medications are prescribed, short-term use is often recommended. Additionally, treatment should focus on reducing time-to-sleep onset, as well as improving sleep maintenance, sleep quality and next-day functioning.
Among DORAs, ODG currently discusses only Belsomra, stating it is not recommended as first-line therapy for insomnia due to adverse effects. Other medications used to treat insomnia include non-benzodiazepine sedative/hypnotics (e.g., zolpidem, zaleplon, eszopiclone), sedating antidepressants (e.g., amitriptyline, trazodone, mirtazapine), melatonin receptor agonists (e.g., ramelteon), and sedating antihistamines (e.g., diphenhydramine).
Although a specific duration of therapy recommendation is not available for Quviviq, the manufacturer’s labeling states that patients whose insomnia persists after seven to ten days of treatment should be re-evaluated.
Impact on workers’ compensation and auto no-fault industry
Upon review by our Pharmacy and Therapeutics (P&T) Committee, Quviviq is non-formulary on our standard formularies, meaning it is either excluded or requires prior authorization. Other classes of medications may be more cost-effective in the treatment of insomnia. It is our recommendation to review claims in which Quviviq has been prescribed to determine if a more cost-effective alternative is clinically appropriate.
Impact on Optum Settlement Solutions
Quviviq is currently available for allocation in Workers’ Compensation Medicare Set-Asides (WCMSAs); both strengths of Quviviq are priced at $18.28 per tablet. The Optum Settlement Solutions clinical team can assist with evaluation of claims and identification of clinically-appropriate, more cost-effective therapy.
If you have any questions, please contact your account manager, clinical liaison or our Clinical Services team at 1-877-275-7674 ext. 8612.
- Idorsia receives US FDA approval of QUVIVIQ (daridorexant) 25 and 50 mg for the treatment of adults with insomnia [media release]. Radnor, PA: Idorsia Pharmaceuticals US; January 10, 2022. Available online at: https://ml-eu.globenewswire.com/Resource/Download/ef08b284-272c-4300-8d0f-34c90294ce1f.
- QUVIVIQ™ (daridorexant) [package insert]. Radnor, PA: Idorsia Pharmaceuticals US Inc.; January 2022.
- ODG by MCG Treatment Guidelines [database online]. An MCG Health Company. Accessed June 22, 2022.
- RED BOOK™ - https://www.ibm.com/products/micromedex-red-book (Subscription required). Accessed July 5, 2022.
- WCMSA Portal - https://www.cob.cms.hhs.gov/WCMSA/login.