Coverage Policies

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Zulresso (brexanolone) requires prior authorization.

2)    Zulresso is used to treat postpartum depression in patients 15 years and older.

3)    Zulresso is covered under the medical benefit.

Zulresso (brexanolone) is considered medically necessary when members meet the following criteria:

I.             Initial Approval Criteria

a.    Postpartum Depression (must meet all):

                                          i.    Diagnosis of a major depressive episode that began no earlier than the third trimester and no later than the first 12 weeks following delivery, as diagnosed by Structured Clinical Interview for DSM-5;

                                        ii.    Prescribed by or in consultation with psychiatrist;

                                       iii.    Age ≥ 15 years;

                                       iv.    Member meets one of the following:

1.    HAMD score is ≥ 24 (severe depression);

2.    MADRS score is ≥ 34 (severe depression);

3.    PHQ-9 score is ≥ 20 (severe depression);

4.    Failure of a 4-week trial of one of the following oral antidepressants at up to maximally indicated dose but no less than the commonly recognized minimum therapeutic dose, unless clinically significant adverse effects are experienced or all are contraindicated: selective serotonin reuptake inhibitor (SSRI), serotoninnorepinephrine reuptake inhibitor (SNRI), tricyclic antidepressant (TCA), bupropion, mirtazapine

                                        v.    No more than 6 months have passed since member has given birth;

                                       vi.    Dose does not exceed 90 mcg/kg per hour over 60 hours (2.5 days) as follows:

1.    0 to 4 hours: Initiate with a dosage of 30 mcg/kg per hour;

2.    4 to 24 hours: Increase dosage to 60 mcg/kg per hour;

3.    24 to 52 hours: Increase dosage to 90 mcg/kg per hour (alternatively consider a dosage of 60 mcg/kg per hour for those who do not tolerate 90 mcg/kg per hour);

4.    52 to 56 hours: Decrease dosage to 60 mcg/kg per hour;

5.    56 to 60 hours: Decrease dosage to 30 mcg/kg per hour. Approval duration: 30 days (one-time infusion per

6.    pregnancy)

No reauthorization allowed.

Codes Used In This BI:

1)    J2632 – Injection, brexanolone, 1mg

1)    Zulresso Prescribing Information. Cambridge, MA: Sage Therapeutics, Inc.; June 2022. Available at: www.zulresso.com. Accessed February 6, 2023.

2)    Meltzer-Brody S, Colquhoun H, Riesenberg R, et al. Brexanolone injection in post-partum depression: two multicentre, double-blind, randomised, placebo-controlled, phase 3 trials. Lancet. 2018 Sep 22;392(10152):1058-1070.

3)    American Psychiatric Association. Practice guideline for the treatment of patients with major depressive disorder, third edition. November 2010. Available at: http://psychiatryonline.org/guidelines.aspx.

4)    Sharp, Rachel. The Hamilton rating scale for depression. Occupational Medicine. 2015; 65(4):340

5)    Montgomery–Åsberg Depression Rating Scale. Available at: http://www.liquisearch.com/montgomery%E2%80%93%C3%85sberg_depression_rating_sc ale/interpretation. Accessed February 6, 2022.

6)    Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001;16(9):606–613.

7)    Stewart DE, Vigod SN. Postpartum Depression: Pathophysiology, Treatment, and Emerging Therapeutics. Annu Rev Med. 2019;70:183-196.