Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Major depressive disorder (MDD)-severe-recurrent
Treatment: Spravato (Esketamine) nasal spray 1 milligram (mg) (Code S0013)
The insurer denied coverage for Spravato (Esketamine) nasal spray 1 mg (Code S0013).
The denial is overturned.

This patient reportedly started Spravato treatment a few months ago as he had presented with a major depressive episode and had depressed mood, fleeting suicidal ideation, hopelessness and helplessness, anhedonia, decreased motivation, concentration problems, sleeping problems, guilt, feeling as if a failure, and low self-esteem. He had diagnoses of major depressive disorder (MDD)-severe-recurrent, attention deficit hyperactivity disorder (ADHD)-combined presentation, and unspecified anxiety disorder. He reportedly had a past suicide attempt. He had multiple past unsuccessful medication trials to treat depression including Zoloft 200 milligrams (mg) for 5 years with limited efficacy, Wellbutrin 450 mg for 5 years with limited efficacy, Cymbalta 90 mg for 6 months with no efficacy, Prozac 80 mg for every year with no efficacy, and also took Lithium for 2 years, Seroquel 400 mg and Lamictal 250 mg with limited efficacy, Ritalin 20 mg for 1 year with no efficacy, and Adderall 20 mg with limited efficacy. He reportedly had an incredible response to Spravato and noted improvement in mood and functioning. He reportedly has a job and loves it, his wife noticed a significant improvement, and he denies major depressive episodes and reports stable mood since taking this. He reportedly was receiving Spravato 28 mg 3 times a day once weekly in a maintenance phase. He also reportedly was taking Wellbutrin SR (sustained release) 200 mg per day and Seroquel 400 mg per day and Lamictal 250 mg per day.
 
The medical records provided did support that this was considered medically necessary treatment for this patient and that he had a significant response, reported no depressive episodes, and had much improved functioning. This patient had severe major depression that was treatment resistant and tried multiple antidepressants at adequate dosages and duration and from different classes as well as multiple augmentation medications with lack of efficacy or only limited efficacy. He reportedly had a diagnosis for MDD-severe-recurrent which is a Food and Drug Administration (FDA) approved diagnosis for treatment with Spravato and was taking 3 psychotropic medications for depression including Wellbutrin SR 200 mg per day and Seroquel 400 mg per day and Lamictal 250 mg per day which met another requirement. He reportedly had a pre depression screen with a depression scale MADRS (Montgomery-Asberg Depression Rating Scale) and had a high score for depression of 44 prior to Spravato use. His score on the PHQ-9 (Patient Health Questionnaire-9) went from 18 to 3 which is significant improvement as well. 

The United States (US) FDA approved Spravato (esketamine) nasal spray, in conjunction with an oral antidepressant, for the treatment of depression in adults who have tried other antidepressant medicines, but have not benefited from them, to treat treatment resistant depression. This patient had a diagnosis of MDD and multiple antidepressant medications and augmentation medications from different classes. 

It was reported that the patient was still in the maintenance phase weekly and getting 18 mg 3 times for a total of 84 mg per day and had treatment with Spravato since starting the medication. 

Based on the above, the insurer's denial must be overturned. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. The medical necessity for Spravato (esketamine) nasal spray 1 mg (Code S0013) is substantiated.