Spravato (esketamine nasal spray) — Medical Mutual

Initial criteria

• Patient age ≥ 18 years; AND
• Patient has a baseline assessment using any validated depression rating scale (e.g., MADRS, HAM-D, PHQ-9, BDI, QIDS); AND
• Patient has a diagnosis of major depressive disorder (MDD) according to DSM-5-TR; AND
• Patient must not have aneurysmal vascular disease, arteriovenous malformation, history of intracerebral hemorrhage, or known hypersensitivity to ketamine; AND
• Patient is not receiving concomitant ketamine therapy
• For Treatment-resistant depression (TRD): Used as monotherapy or in conjunction with an oral antidepressant; AND
• Patient has tried psychotherapy alone or in combination with an oral antidepressant, if psychotherapy resources are available; AND
• Patient is NOT receiving concomitant electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), vagus nerve stimulation (VNS), or deep brain stimulation (DBS); AND
• Patient has failed a trial of ≥ 2 antidepressants of different classes for ≥ 6 weeks each with adequate adherence at generally accepted doses in the current depressive episode, unless contraindicated or clinically significant adverse effects are experienced (‘Failed trial’ defined as ≤ 25% reduction in symptom severity using any validated depression rating scale)
• For Depressive symptoms in MDD with acute suicidal ideation/behavior: Must be used in conjunction with an oral antidepressant; AND
• Patient is experiencing acute suicidal ideation or behavior; OR
• Patient has recently been discharged from a hospital in which treatment with esketamine has been initiated

Reauthorization criteria

• Patient continues to meet the universal and indication specific criteria; AND
• Absence of unacceptable toxicity from the drug (examples include sedation, dissociation, respiratory depression, signs of abuse/dependence, severe cognitive impairment, ulcerative/interstitial cystitis, suicidal thoughts/behavior, severe hypertension, etc.); AND
• Patient has demonstrated disease improvement and/or stabilization as evidenced by a reduction in symptom severity, compared to baseline, using any validated depression rating scale

Approval duration

initial 6 months, renewal 12 months