Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Recurrent Major Depression, Autism Spectrum Disorder, Ulcerative Colitis.
Treatment: Intravenous (IV) Ketamine.
The insurer denied: Intravenous (IV) Ketamine.
The denial is overturned.

The patient is an adolescent male diagnosed with severe major depressive disorder in the context of treatment refractory/resistant depression with regard to treatment failure with multiple antidepressant medication trials due to intolerance associated with ulcerative colitis. The patient had treatment with several antidepressants having disparate mechanisms of action including Wellbutrin, Prozac, Lexapro, and nortriptyline which caused and increase in anxiety, depression and explosive behavior, as well as tics and an exacerbation of the ulcerative colitis. The patient is diagnosed with psychiatric comorbidity with mild autism spectrum disorder, ADHD (attention deficit hyperactivity disorder) and unspecified anxiety disorder. There is no reported substance use disorder in this case. The patient reports recurrent suicidal ideation in the context of the severe depressive disorder. There are no other significant general medical co-morbidities. The patient underwent an initial course of treatment with ketamine infusions with 4 treatment sessions in two weeks with a positive therapeutic response. He was also taking Lamictal which was well tolerated but which did not produce a remission or robust clinical response, and he receives weekly psychotherapy with CBT (cognitive behavioral therapy). The referring and treating clinicians are recommending that the patient undergo continued treatment with ketamine infusions every 2-3 weeks per protocol for maintenance treatment. The use of ketamine is being requested in order to address treatment refractory/resistant depression and to achieve and maintain mood stability in a patient with disabling depression and risk for suicidal or self-harming behavior and/or hospitalization. The appeal references societal guidelines for the treatment of depressive disorder and the need to continue treatment in view of the initial positive therapeutic response to ketamine. In the appeal letters, ECT (electroconvulsive therapy) and TMS (transcranial magnetic stimulation) were ruled out in favor of the use of ketamine due to the rapidity of clinical response and clinical history. The health plan has denied authorization for coverage of ketamine on the basis of a coverage exclusion and plan guidelines indicating that the use of ketamine for the treatment of depression is experimental and investigational and not FDA (United States Food and Drug Administration) approved.

The health plan should cover the intravenous Ketamine.

In this case scenario, the request for continued treatment with IV (intravenous) Ketamine for the treatment of major depressive disorder and treatment resistant depression is reasonable and in the best interest of the patient. The off-label use of ketamine in this patient is evidence-based and supported in the medical literature pertaining to the treatment of patients with treatment resistant depression with or without suicidal ideation or risk. In this case, the use of ketamine is lifesaving and does serve to prevent hospitalization and/or reduces the risk of suicidal or self-harming behavior in the context of severe major depressive disorder. The use of ketamine in this patient is consistent with the scientific literature and published guidelines, referenced below, and is in keeping with prevailing standards of medical practice.