Is Esketamine (Spravato) medically necessary for a patient with Major Depressive Disorder, Recurrent Severe without Psychotic Features?

Medical Necessity Assessment for Esketamine (Spravato)

Esketamine is medically necessary for this patient IF AND ONLY IF the patient has failed at least 2 adequate antidepressant trials at appropriate doses and durations, AND there is documented objective improvement using standardized depression rating scales (PHQ-9, MADRS, or HAM-D) from baseline to current visit. 1, 2

Critical Documentation Requirements

Before approving continuation, the following must be explicitly confirmed:

• Treatment-Resistant Depression (TRD) criteria: The patient must have failed at least 2 adequate antidepressant trials with documented adequate dose and duration for each failed trial 1, 2
• Objective therapeutic benefit: There must be documented improvement in standardized depression rating scales (PHQ-9, MADRS, or HAM-D) comparing baseline scores to current visit scores 1
• Not as initial treatment: Esketamine is explicitly NOT recommended as initial treatment and is reserved exclusively for patients who have failed previous therapies 2, 3

Analysis of This Patient's Case

The patient's medication history includes Vilazodone, Trazodone, and Lamictal XR, which suggests prior treatment attempts. However:

• Documentation gap: The medical necessity determination requires explicit confirmation that each failed trial was at adequate dose and duration 1
• Missing baseline data: There is no mention of standardized depression rating scale scores (PHQ-9, MADRS, HAM-D) at baseline or current visit to demonstrate objective therapeutic benefit 1
• Diagnosis consideration: The patient has F33.2 (recurrent severe MDD without psychotic features), which is appropriate for esketamine, though the evidence base is strongest for TRD specifically 2, 4

Dosing Regimen Assessment

The prescribed regimen appears non-standard:

• FDA-approved dosing: Esketamine is typically dosed twice weekly during the induction phase (weeks 1-4), then weekly or every-other-week for maintenance 2
• Prescribed regimen concerns: The dosing of "4 sprays twice weekly for week 1, then 6 sprays twice weekly for weeks 2-4, then 3 sprays once weekly" requires verification against FDA-approved dosing parameters 2

Evidence Supporting Use When Criteria Are Met

• Rapid symptom improvement: Meta-analyses demonstrate that esketamine as augmentation to ongoing oral antidepressants improves depressive symptoms and remission rates in TRD patients at up to 28 days 1, 2
• Sustained benefit: Esketamine shows significant improvement within 24 hours, with effects documented through day 25 in clinical trials 5
• VA/DoD endorsement: The 2022 VA/DoD guidelines represent a major shift, now suggesting ketamine or esketamine as treatment options for patients who have failed at least 2 adequate antidepressant trials 1, 2

Critical Safety Monitoring Requirements

• Blood pressure monitoring: Required due to hypertension risk during and after administration 2
• Dissociative symptoms: Common adverse effect requiring monitoring during treatment sessions 2, 5
• Abuse potential: Ongoing surveillance needed for potential misuse and substance use disorder development 2
• Long-term safety unknown: The most significant limitation is absence of long-term safety and efficacy data for esketamine in MDD 2

Common Pitfalls to Avoid

• Inadequate documentation: Failing to explicitly document adequate dose and duration of prior failed antidepressant trials is the most common reason for denial 1
• Missing objective measures: Not using validated depression scales (PHQ-9, MADRS, HAM-D) to demonstrate therapeutic benefit 1
• Premature use: Prescribing esketamine before exhausting at least 2 adequate antidepressant trials 2, 3
• Lack of concurrent antidepressant: Esketamine should be used as augmentation to ongoing oral antidepressant therapy, not as monotherapy 1, 5

Final Determination Algorithm

APPROVE if:

• Documented failure of ≥2 adequate antidepressant trials (adequate dose + duration) AND
• Baseline depression severity documented with validated scale AND
• Objective improvement demonstrated on follow-up validated scales AND
• Patient is on concurrent oral antidepressant therapy

DENY or REQUEST ADDITIONAL INFORMATION if:

• Inadequate documentation of prior treatment failures OR
• No baseline or follow-up depression rating scale scores OR
• Used as monotherapy without concurrent antidepressant OR
• Used as initial treatment before adequate trials of standard antidepressants