Zurzuvae™
Drug - Zurzuvae™ (zuranolone) [Biogen Inc.]
January 2025
Therapeutic area - Antidepressants, Other
Approval criteria
- Patient is ≥ 18 years of age; AND
- Patient has a diagnosis of postpartum depression (PPD) based on Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria for a major depressive episode (DSM-5); AND
- Baseline PPD severity has been assessed using a standardized, validated depression rating scale (e.g., Hamilton Rating Scale for Depression [HAM-D], Patient Health Questionnaire-9 [PHQ-9], Montgomery-Åsberg Depression Rating Scale [MADRS]); AND
- Patient is not currently pregnant and is using effective contraception; AND
- Patient has ceased lactating or has agreed to refrain from providing breast milk to the infant prior to receiving the first dose until 7 days after the last dose; AND
- Prescriber attests that the patient has been counseled:
- To refrain from engaging in potentially hazardous activities requiring mental alertness, including driving, for ≥ 12 hours after each zuranolone dose; AND
- To take the medication with 400 to 1,000 calories of food containing 25% to 50% fat; AND
- If patient is taking another oral antidepressant medication, the dose has been stable for ≥ 30 days; AND
- Prescriber attests to assessing concomitant medications for potential drug interactions and adjusting zuranolone dosage according to labeling (e.g., CNS depressants, CYP3A4 inhibitors, CYP3A4 inducers); AND
- Baseline renal and hepatic function have been assessed and dosing is appropriate according to labeling; AND
- Patient has an estimated glomerular filtration rate (eGFR) ≥ 15 mL/min/1.73 m2 and does not require dialysis; AND
- Prescriber attests that the clinic has established protocol for follow-up care including patient safety monitoring, reporting and dosage adjustments.
Renewal criteria
Zuranolone treatment has not been evaluated for more than 1 course of treatment per pregnancy. Safety and efficacy of retreatment for a postpartum depression (PPD) episode have not been established.
Quantity limits
- One time fill of 28 capsules/14 days
- Capsules of lower strengths needed for subsequent dose adjustments are provided by the manufacturer and will not be covered.
- Maximum dose = 50 mg (2 capsules) once daily
Questions?
Provider Call Center (844) 575-7887