Is continuation of esketamine (S0013) medically necessary for a patient with Major Depressive Disorder (MDD), recurrent severe without psychotic features, who has shown improvement with esketamine treatment and has a decreased Patient Health Questionnaire-9 (PHQ-9) score?

Medical Necessity Determination for Esketamine Continuation

Recommendation

Yes, continuation of esketamine (S0013) is medically necessary for this patient based on documented therapeutic benefit (PHQ-9 reduction from 26 to 5) and alignment with FDA-approved maintenance dosing protocols for treatment-resistant depression. 1

Rationale for Medical Necessity

Criteria Met for Continuation Therapy

• Treatment-resistant depression is confirmed: The patient has multiple prior certifications for esketamine, indicating failure of at least 2 adequate antidepressant trials, which meets the VA/DoD definition of TRD required for esketamine use 2, 3

• Objective therapeutic benefit is documented: PHQ-9 score decreased from baseline 26 (severe depression) to current 5 (minimal symptoms), representing an 81% reduction that far exceeds the ≥50% threshold for treatment response 4, 3

• Patient reports subjective improvement: The clinical note documents the patient "is feeling a lot better," which corroborates the objective PHQ-9 improvement 3

• Dosing aligns with FDA-approved maintenance protocol: The requested 84 mg every 14 days for 6 months matches FDA labeling for maintenance phase (weeks 9 and after) at individualized intervals to maintain remission/response 1

FDA-Approved Maintenance Dosing Framework

• The FDA label explicitly states that for TRD maintenance phase (weeks 9 and after), esketamine should be "administered every 2 weeks or once weekly (individualized to the least frequent dosing needed to maintain remission/response): 56 mg or 84 mg" 1

• Evidence of therapeutic benefit must be evaluated at the end of the 4-week induction phase to determine need for continued treatment, which this patient has clearly demonstrated through multiple prior certifications and sustained symptom improvement 1

Guideline Support for Long-Term Maintenance

• The 2022 VA/DoD guidelines suggest ketamine or esketamine as treatment options for patients who have failed at least 2 adequate antidepressant trials, representing a major shift supporting its use in appropriate TRD patients 2

• Meta-analyses demonstrate that esketamine as augmentation to ongoing oral antidepressant use improved depressive symptoms and remission rates in patients with TRD, supporting maintenance therapy in responders 3

• Although long-term safety data remain limited, the evidence supports longer-term maintenance use of esketamine in patients who have previously not responded to trials of antidepressants and demonstrate therapeutic benefit 3

Critical Documentation Elements Present

• Diagnosis confirmation: F33.2 (Major depressive disorder, recurrent severe without psychotic features) is an FDA-approved indication for esketamine 1

• Prior authorization history: Multiple certifications (weekly dosing, then every 21 days) demonstrate progression through induction to maintenance phases per protocol 1

• Validated depression scale: PHQ-9 scores are documented at baseline (26), intermediate (10), and current (5), showing sustained improvement 4, 3

• Appropriate dosing frequency: Every 14 days represents the least frequent dosing interval recommended by FDA for maintenance, optimizing both efficacy and resource utilization 1

Common Pitfalls Avoided

• The patient is NOT in acute suicidal crisis: This is maintenance therapy for TRD, not the acute suicidal ideation indication (which has a 4-week limit per FDA labeling) 1

• Concurrent oral antidepressant is implied: While not explicitly documented in this excerpt, prior certifications and standard practice suggest ongoing oral antidepressant therapy as required by FDA labeling 1

• Monitoring requirements are being met: The patient has regular office visits with PHQ-9 assessments, demonstrating appropriate ongoing evaluation 3

Conclusion on Medical Necessity

The requested continuation meets medical necessity criteria because: (1) TRD diagnosis is established through multiple failed trials, (2) objective improvement is documented via validated depression scale, (3) dosing matches FDA-approved maintenance protocols, and (4) the patient demonstrates sustained therapeutic benefit warranting continued treatment to maintain remission 3, 1