Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Depression
Treatment: Spravato
The health plan has denied the requested treatment as not medically necessary.
The health plan's determination is overturned.

The case involves an adult female diagnosed with recurrent and severe major depressive disorder and a history of treatment refractory depression. She has had treatment failure with multiple medication trials. The patient is diagnosed with psychiatric co-morbidities, including unspecified anxiety disorder and insomnia. There was no substance use disorder in this case or acute general medical conditions that were a focus of treatment.

The patient has a documented history of treatment failure with multiple antidepressants which were ineffective due to a lack of efficacy or tolerability problems (adverse effects). They have included two selective serotonin reuptake inhibitors (SSRIs), including Prozac, Zoloft, as well as Wellbutrin prescribed alone and in combination. The patient is currently prescribed Cymbalta augmented with Abilify. The patient is receiving regular treatment with supportive psychotherapy. Her Montgomery-Asberg Depression Rating Scale (MADRS) scale score was 32; this is in the severe range of depression. She had a reduction in her MADRS score to 24 after starting treatment with Spravato with seven sessions from at a clinically appropriate dosage of 84 milligrams (mg) (three 28 mg kits) following the initial dose of 56 mg in the first induction session.

The clinician recommended that the patient continue treatment with Spravato (intranasal esketamine) in the context of the usual protocol with twice weekly dosing for four weeks (induction phase), then continuation treatment of once weekly dosing for four weeks as clinically appropriate and subsequent esketamine maintenance therapy in combination with the currently prescribed psychotropic regimen to include the Cymbalta and Abilify. The use of Spravato is to address treatment refractory/resistant depression and to achieve and maintain mood stability in a patient with disabling depression and history of treatment refractory depression. Dosing of Spravato is individualized at the approved dose of 84 mg per session (three 28 mg kits).

At issue is the medical necessity of Spravato nasal spray solution with continued treatment per protocol for treatment resistant major depressive disorder.

The health plan's determination regarding the proposed health service or treatment is overturned, in whole.

The requested health service/treatment of Spravato is medically necessary for this patient.

In this case scenario, medical necessity is met for Spravato-esketamine intranasally. Requesting 84 mg or three kits intranasally twice weekly as clinically appropriate. The services requested in this case are in keeping with prevailing standards of medical practice for the conditions under treatment in this case with evidence-based treatments; the requested services being provided in this case are clinically appropriate and are backed by credible scientific evidence known to benefit patients with the conditions diagnosed in this case. The requested health service of Spravato with requested dosing strategy is clinically appropriate and considered medically necessary as an adjunct and augmentation treatment strategy for the patient's antidepressant regimen in order to achieve and sustain a remission of symptoms related to severe major depressive disorder in the context of suicidal risk. The requested Spravato is proposed in the best interest of the patient and reflects sound medical judgment with respect to the recommendation for the requested treatment and services. This answer is consistent with the scientific literature and societal guidelines, referenced below.