Perhaps the first breakthrough drug in the treatment of depression since Prozac, the FDA has recently approved esketamine nasal spray, marketed by Johnson & Johnson under the trade name of Spravato. Spravato is approved for use in conjunction with an oral antidepressant for treatment-resistant depression. It is indicated for those patients who have failed to achieve relief of depression symptoms from at least two other depression therapies. Depression is the leading cause of disability worldwide, affecting about 300 million people globally. Approximately 50% of patients with depression are taking anti-depressant drugs. About one-third of those patients report that the medications they are taking are ineffective in alleviating their symptoms of depression.

Esketamine acts on a different group of receptors than traditional antidepressants such as fluoxetine (Prozac) and venlafaxine (Effexor), which block serotonin and norepinephrine receptors. Esketamine, on the other hand, has affinity for N-methyl-D-aspartate (NMDA)/glutamate receptors and gamma-amino-butyric acid (GABA) receptors. Its fast-acting mechanism proves extremely valuable in those patients who experience episodes of major depression with suicidal tendencies. Clinical trials have shown that esketamine demonstrates a 60-70% response rate in study populations with treatment-resistant depression. In large part due to the dissociative effect it produces and therefore it’s potential for abuse, esketamine will be available through a limited distribution network of pharmacies under a Risk Evaluation and Mitigation Strategy (REMS) program.

As with any medication drug, there are possible side effects to be mindful of. Patients utilizing Spravato are at risk for sedation, difficulty with attention, judgment and thinking (dissociation), misuse and suicidal thoughts or behaviors. Patients with unstable or poorly controlled hypertension or certain types of pre-existing vascular disorders may be at higher risk of adverse cardiovascular side effects. Considering these risks, Spravato must be administered in a certified medical office where the healthcare provider can monitor the patient for at least two hours after administering each dose. The recommended dosing is once or twice per week. Under guidance from a healthcare provider, a patient can self-administer Spravato but will not be permitted to take the nasal spray home. It is the discretion of the healthcare professional to determine when a patient is ready to leave the medical office. Patients should make transportation arrangements to get home, as they will be advised not to drive or operate heavy machinery for the rest of the day.

Because depression is highly common among injured workers, the FDA’s approval of esketamine will likely have a significant impact for workers’ compensation carriers and Medicare Set-Aside allocation amounts. According to Johnson & Johnson, each treatment will range from $590 to $885 in cost, depending on the dose. Based on those costs, one can expect twice-weekly treatment to cost anywhere between $4,720 and $6,785 per month. Other costs to consider include those associated with the instruction and monitoring rendered by the healthcare professional.