Appeal type: Medical necessity
Decision: Upheld

Diagnosis:  Depression.
Treatment:  Spravato 84mg (milligram) DOS SOL.

The insurer denied the Spravato 84mg (milligram) DOS SOL.  The denial is upheld. 

The patient is a adult male.  He has recurrent and severe major depressive disorder in the context of a history of treatment refractory depression, due to failure with multiple medication trials.  The current medication regimen includes a combination of Wellbutrin SR (sustained release) 100 mg (milligrams) three times per day, along with supplemental treatment with Deplin.  The patient is not diagnosed with a co-morbid psychiatric disorder or co-occurring substance use disorder or significant general medical problems.

The patient has a documented history of treatment failure with multiple SSRIs (selective serotonin reuptake inhibitors) and Trintellix and Wellbutrin XL (extended release), as well as augmentation with Deplin.  He has not been treated with evidence-based augmentation treatment with atypical antipsychotic medications or lithium or thyroid supplementation.

The patient started treatment receiving Spravato (intranasal esketamine) at a dose of 56 mg (milligrams) as an initial dose and subsequent dosing at 84 mg (milligrams) per protocol in combination with the prescribed psychotropic regimen or Wellbutrin SR and Deplin (L-methlyl-folate) supplementation.  During the course of treatment with Spravato combined with the psychotropic medications, the patient's MADRS (Montgomery-Asberg Depression Rating Scale) score decreased from 34 to 12, indicating a robust response during treatment.

The treatment with Spravato was stopped due to the COVID-19 (Coronavirus disease 2019) Pandemic and/or due to a job change with a change of health plans.  The new health plan in effect has denied coverage of Spravato, indicating that treatment with at least two antidepressants with disparate mechanism of action and at least two augmentation trials are required under the plan in order for approval of treatment with Spravato. 

The continued use of esketamine nasal spray (Spravato) is being requested by the treating physician and patient in order to address persistent symptoms of major depression and treatment refractory depression and to better achieve and maintain mood stability in this case.  Symptoms have included depressed mood with anhedonia, anergia, hopelessness, low energy, and lack of motivation/volition.

Again, the health plan has denied authorization for coverage of Spravato on the basis that the requested treatment is not eligible for coverage as prior authorization requirements have not been met in this case in order to allow a coverage exception.  Specifically, the health plan indicates that the requested benefit of Spravato is not a covered benefit because the patient could be managed with augmentation of the current regimen with quetiapine, olanzapine, aripiprazole, risperidone or lithium or thyroid supplementation (liothyronine) which are standard augmentation strategies for patients with refractory depression or with less than a full response to antidepressant medications.

No, the proposed treatment with Spravato is not medically necessary in this case scenario.

The coverage of Spravato (84 MG [milligrams] Dose) solution (Esketamine Nasal Spray) for a patient who meets criteria for treatment refractory depression is not reasonable in this case scenario.  The patient's treatment of major depressive disorder can be effectively managed and treated with combination therapy or augmentation therapy in keeping with prevailing standards of medical practice for the conditions under treatment in this case, and the alternative treatments offered by the health plan are clinically appropriate and backed by credible scientific evidence known to benefit patients with the condition diagnosed in this case, severe depressive disorder associated with treatment refractory depression, as noted in the clinical summary and submitted information.

This answer is consistent with the scientific literature, referenced below. 

The alternative treatments offered by the health plan are clinically appropriate, and backed by credible scientific evidence known to benefit patients with the condition diagnosed in this case-severe depressive disorder associated with treatment refractory depression, as noted in the clinical summary and submitted information.  The health plan's guidelines for the use of Spravato are reasonable and provided with sound medical judgment in keeping with prevailing standards of medical practice. 

This answer is consistent with the scientific literature, referenced below, as well as NY State instruction for medical necessity reviews.