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)    Spravato (esketamine) requires prior authorization.

2)    Spravato is used to treat treatment-resistant depression.

3)    Spravato is covered under the medical benefit.

Initial Approval Criteria

I.             Treatment Resistant Depression (must meet all):

a.    Diagnosis of TRD;

b.    Prescribed by or in consultation with a psychiatrist;

c.    Age > 18 and < 65 years;

d.    Member has a documented baseline Patient Health Questionnaire (PHQ-9) score > 15, indicating moderately severe major depression, within the previous 4 weeks;

e.    Members meets both of the following (i and ii):

                                  i.    Failure of TWO antidepressants from at least two different classes at up to maximally indicated doses but no less than the commonly recognized minimum therapeutic doses, each used for > 4 weeks, unless clinically significant adverse effects are experienced or all are contraindicated (e.g. SSRI, SNRI, TCA, bupropion, mirtazapine)’

                                ii.    Failure of TWO of the following antidepressant augmentation therapies, each used for > 4 weeks, unless clinically significant adverse effects are experienced or all are contraindicated: second-generation antipsychotic, lithium, thyroid hormone, buspirone;

f.     Currently stabilized on an oral antidepressant for at least two weeks (must not be one of the aforementioned agents previously failed and Spravato will be used in combination with oral antidepressant;

g.    Member meets one of the following (i or ii):

                                  i.    No prior history of treatment with Spravato;

                                ii.    Documentation of a prior positive response to Spravato as documented by a history of > 50% reduction in PHQ-9 score;

h.    Dose does not exceed 168mg per week during four-week induction phase.

Approval Duration: 3 months (up to 23 nasal spray devices)

II.            Major Depressive Disorder with Suicidal Ideation or Behavior (must meet all):

a.    Diagnosis of MDD;

b.    Prescribed by or in consultation with a psychiatrist;

c.    Age > 18 years;

d.    Spravato is prescribed in combination with initiation or optimization of oral antidepressant therapy;

e.    Members recently (within last 5 days) discharged from or currently in an acute or subacute inpatient care for suicidality;

f.     Member meets one of the following:

                                  i.    No prior history of treatment with Spravato;

                                ii.    Documentation of a prior positive response to Spravato

g.    Member meets one of the following:

                                  i.    Montgomery-Asbert Depression Rating Scale (MADRS) score is > 20 (moderate depression);

                                ii.    Hamilton Rating Scale for Depressoin (HAMD) score is > 17 (moderate depression);

                               iii.    PHQ-9 score is > 15 (moderately severe depression);

h.    Dose does not exceed 84mg (3 nasal spray devices) twice weekly.

Approval Duration: 4 weeks (up to 23 nasal spray devices)

Continued Therapy Criteria

Treatment Resistant Depression

A.   Member is responding positively to therapy as evidenced by at least a 50% reduction in PHQ-9 score compared to baseline;

B.   Spravato is being used in combination with an oral antidepressant;

C.   If request is for a dose increase, new dose does not exceed 84mg (3 nasal spray devices) per week.

Continued Therapy Approval Duration: 6 months

Reauthorization is not permitted for MDD with Suicidal Ideation or Behavior.

Codes Used In This BI:

1)    S0013 – esketamine, nasal spray, 1mg

1. Spravato Prescribing Information. Titusville, NJ: Janssen Pharmaceuticals; July 2020. Available at: http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/SPRAVATO-pi.pdf. Accessed February 7, 2023.

2. 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.

3. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc. Updated periodically. Accessed February 7, 2023.

4. 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.

5. Montgomery–Åsberg Depression Rating Scale. Available at: http://www.liquisearch.com/montgomery%E2%80%93%C3%85sberg_depression_rating_scale/interpretation. Accessed February 9, 2022.

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

7. Ochs-Ross R, Daly EJ, Zhang Y et al. Efficacy and safety of esketamine nasal spray plus an oral antidepressant in elderly patients with treatment-resistant depression TRANSFORM-3. Am J Geriatr Psychiatry. 2020 Feb;28(2):121-141.