QUVIVIQ (daridorexant)

QUVIVIQ (daridorexant)

Self-Administration – oral

Diagnosis considered for coverage:

• Indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.

Coverage Criteria:

For diagnosis of insomnia:

• Dose does not exceed FDA label maximum dose of 50 mg per day; AND
• Diagnosis of insomnia; AND
• Potential factors contributing to sleep disturbances have been addressed (e.g., education on sleep hygiene and sleep environment issues, medications, physical or psychiatric disorder); AND
• One of the following:
  • For patients < 65 years old:
    • •  
    • Has tried and failed at least two preferred medications (e.g., eszopiclone, zaleplon, zolpidem/zolpidem ER, triazolam, temazepam, generic ramelteon) as confirmed by medical record documentation and/or prescription claims history; AND
    • Has tried and failed Dayvigo as confirmed by medical record documentation and/or prescription claims history
  •  
  • For patients > 65 years old: 
    • •  
    • Has tried and failed at least one preferred medication (e.g., generic ramelteon) as confirmed by medical record documentation and/or prescription claims history; AND
    • Has tried and failed Dayvigo as confirmed by medical record documentation and/or prescription claims history

Reauthorization Criteria:

For diagnosis of insomnia

• Dose does not exceed FDA label maximum dose of 50 mg per day; AND
• Documentation of positive clinical response to therapy (e.g., improvement in sleep onset from baseline, sleep maintenance from baseline, total sleep time from baseline)

Coverage Duration:

• Initial: 1 year
• Reauthorization: 1 year

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:

• Dosing:
  • The recommended dosage is 25 mg to 50 mg once per night, taken orally within 30 minutes before going to bed, with at least 7 hours remaining prior to planned awakening
  • Hepatic impairment:
    • Moderate hepatic impairment: maximum recommended dosage is 25 mg no more than once per night
    • Severe hepatic impairment: not recommended
• Contraindication:
  • Quviviq is contraindicated in patients with narcolepsy
• Drug interactions:
  • Strong CYP3A4 inhibitors: avoid concomitant use
  • Moderate or strong CYP3A4 inducers: avoid concomitant use

Policy Updates:

• 08/16/2022 – New policy approved by P&T.

References:

• Quviviq Prescribing Information. Idorsia Pharmaceuticals US Inc. Radnor, PA. April 2022.
• Sateia MJ, Buysse DJ, Krystal AD, Neubauer DN, Heald JL. Clinical practice guideline for the pharmacologic treatment of chronic insomnia in adults: An American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. 2017;13(2):307-349. Available at https://jcsm.aasm.org/doi/10.5664/jcsm.6470. Accessed May 9, 2022.
• UpToDate. Overview of the Treatment of Insomnia in Adults. Available at https://www.uptodate.com/contents/overview-of-the-treatment-of-insomnia-in-adults?search=insomnia&source=search_result&selectedTitle=1~150&usage_type=default&display_rank=1. Accessed May 9, 2022.
• The 2019 American Geriatrics Society Beers Criteria Update Expert Panel. American Geriatrics Society 2019 Updated AGS Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. J Am Geriatr Soc 00:1-21, 2019. Available at https://www.uclahealth.org/geriatrics/workfiles/education/clinical-skills/handouts/Education-Updated-Beers-List-2019.pdf. Accessed May 9, 2022.