ZURZUVAE (zuranolone)

ZURZUVAE (zuranolone)

Self-Administration – oral

Diagnosis considered for coverage:

• PPD: indicated for the treatment of postpartum depression (PPD) in adults

Coverage Criteria:

For diagnosis of PPD:

• One of the following:
  • Diagnosis of severe postpartum depression (PPD), OR
  • Both of the following:
    • Diagnosis of moderate postpartum depression (PPD)
    • Trial and failure (4 week trial at therapeutic doses), contraindication or intolerance to at least one oral SSRI or SNRI (e.g., escitalopram, duloxetine); AND
• Patient is 18 years of age or older; AND
• Onset of symptoms in the third trimester or within 4 weeks of delivery; AND
• Prescriber attests that the patient has been counseled and has agreed to adhere to the following: Will follow instructions to not drive or operate machinery until at least 12 hours after taking each dose of Zurzuvae for the duration of the 14-day treatment course and that patients are informed that they may not be able to assess their own driving competence or the degree of driving impairment caused by Zurzuvae

Dosing:

PPD:

• 50 mg taken orally once daily in the evening for 14 days
• If patients experience CNS depressant effects within the 14-day period, consider reducing the dosage to 40 mg once daily in the evening within the 14-day period
• Reduce the Zurzuvae dosage to 30 mg orally once daily in the evening for 14 days when used concomitantly with a strong CYP3A4 inhibitor 
• Recommended dosage of Zurzuvae in patients with severe hepatic impairment (Child-Pugh C) is 30 mg orally once daily in the evening for 14 days 
• Recommended dosage of Zurzuvae in patients with moderate or severe renal impairment (eGFR <60 mL/min/1.73 m ) is 30 mg orally once daily in the evening for 14 days

Coverage Duration: 

• 14 days

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: 

• Zurzuvae can be used alone or as an adjunct to oral antidepressant therapy
• The safety and effectiveness of Zurzuvae use beyond 14 days in a single treatment course have not been established
• Avoid concomitant use of Zurzuvae with CYP3A4 inducers

Policy Updates:

• Effective 6/01/2024 – New policy approved by WHA P&T Committee. (P&T, 05/21/2024)

References:

• Zurzuvae Prescribing Information. Biogen MA Inc. November 2023.