Appeal type: Medical necessity
Decision: Overturned

Diagnosis:  Major depressive disorder
Issue under review:  Spravato

Determination:  The treatment with Spravato is medically necessary.

The patient is an adult female diagnosed with major depressive disorder (MDD) and a history of treatment refractory depression with regard to treatment failure with multiple medication trials.  The patient is diagnosed with psychiatric co-morbidity with anorexia nervosa, restricting type.

The patient has a documented history of treatment failure with multiple SSRIs (selective serotonin reuptake inhibitors) (Luvox and fluoxetine) , SNRI (serotonin-norepinephrine reuptake inhibitor) (venlafaxine), bupropion and trazodone, as well as augmentation with mood stabilizers/atypical antipsychotic medications (risperidone, aripiprazole, quetiapine and lurasidone), all of which were ineffective due to lack of efficacy or were associated with tolerability problems (adverse effects).

The clinician recommended that the patient undergo a trial of Spravato (intranasal esketamine) with the usual protocol with twice weekly dosing for four weeks, then once weekly dosing for four weeks in combination with the currently prescribed psychotropic regimen of bupropion XL, fluoxetine, ziprasidone, trazodone and clonazepam, all at clinically appropriate dosages. The use of Spravato (intranasal esketamine) is to address treatment refractory depression and to achieve and maintain mood stability in a patient with disabling depression and past history of treatment failure.

The patient's mental status examination reveals a groomed and cooperative female with clear speech and linear thought processing and thought that includes depressive ruminations with hopelessness, helplessness and perseverations.  She has low mood and energy and interest with sleep disturbance and anxiety.  She has had paranoia, but no delusions.  There is no evidence for mood cycling, psychosis, cognitive impairment or perceptual disturbance.  PHQ-Q (patient health questionnaire) has been variable and scored up to 22 reflecting a severe depression. 

There is no report of current or past history of alcohol or illicit drug or prescription medication abuse, or complications with general medical illness.  The eating disorder has required ongoing treatment including a brief hospitalization. 

Per the health plan documents and submitted information, Spravato (Esketamine Nasal Spray) is clinically appropriate and considered medically necessary as an adjunct and augmentation of the patient's antidepressant regimen in order to achieve a remission of symptoms related to severe major depressive disorder in the context of treatment refractory depression and failed trials with at least four or more antidepressants with disparate mechanisms of action and with several appropriate augmentation strategies.  Moreover, the coverage of Spravato (Esketamine Nasal Spray) for a patient, who meets criteria for treatment refractory depression and who is a reasonable candidate for the requested benefit of Spravato, should be approved in this case scenario; the requested Spravato (Esketamine Nasal Spray) is proposed in the best interest of the patient and reflects sound medical judgment with respect to the use of the requested treatment. Indeed, Spravato (Esketamine Nasal Spray) for the treatment of major depressive disorder is a newly-established treatment that is proposed for this patient in keeping with prevailing standards of medical practice for the condition under treatment in this case.