Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: PTSD; Depression
Issue under review: Ketamine

Determination:
The health plan should not cover the Ketamine.

The patient is an adult male with posttraumatic stress disorder (PTSD), obsessive-compulsive traits, generalized anxiety disorder, and treatment refractory depression. The patient underwent interventional treatment with ketamine infusion at a frequency of two infusions per week for three weeks with dramatic improvement of symptoms and improved functioning. 

The clinician is recommending that the patient continue ketamine infusions with a protocol of weekly infusions for one year with booster infusions as clinically needed thereafter.

The use of ketamine is being provided in order to address treatment refractory depression and to achieve and maintain mood stability in a patient with disabling depression and co-morbid conditions, as noted.

There is no report of current or past history of alcohol or illicit drug or prescription medication abuse, or complications with general medical illness. 

Antidepressant medications alone or in combination with or without augmentation and combined with psychotherapy are the standard treatments known to be effective in producing a sustained response or remission in patients with treatment refractory depression. These clinically appropriate approaches have not clearly been exhausted in this case with at least four or more therapeutic trials provided with clinically appropriate doses of medications and duration of treatment together with combination therapy or augmentation therapy in order to establish that the patient is treatment-refractory. Additionally, there is no submitted information that the patient has tried or failed to respond to other standard interventional treatments with electroconvulsive therapy (ECT), repetitive transcranial magnetic therapy (rTMS) or intranasal esketamine (Spravato), all of which are FDA-approved or standard treatments for treatment refractory depression or depression associated with suicidal risk. Thus, standard therapeutic options have not clearly failed to produce a sustained clinical response or remission.

In this case, the use of ketamine is considered experimental and investigational. Moreover, antidepressant medications alone or in combination with or without augmentation and combined with psychotherapy are the standard treatments known to be effective in producing a sustained response or remission in patients with treatment refractory depression. The submitted information does not provide information to suggest that standard and available treatments have proven to be ineffective or intolerable. Thus, clinically appropriate approaches have not clearly been exhausted in this case with at least four or more therapeutic trials of antidepressant medication provided with clinically appropriate doses of medications and duration of treatment together with combination therapy or augmentation therapy in order to establish that the patient is treatment refractory. Additionally, there is no submitted information that the patient has tried or failed to respond to other standard and interventional treatments for depressive disorder with either electroconvulsive therapy (ECT), repetitive transcranial magnetic therapy (rTMS) or intranasal esketamine (Spravato), all of which are FDA-approved or standard treatments for treatment refractory depression or depression associated with suicidal risk. Thus, standard therapeutic options have not clearly failed to produce a sustained clinical response or remission, and the requested treatment is not likely to be more beneficial that any of the standard treatments available to this patient.

This answer is consistent with the guidelines and scientific literature, referenced below and with NY State instruction for this review with regard to the use of treatments or procedures or services considered experimental or investigational or unproven.