FDA Approves New Indication for Spravato (Esketamine) Nasal Spray

FDA, Medicare Set-Aside Blog on October 9, 2020
Posted by Leah King, PharmD, JD, Independent Pharmacy Consultant

Last month, the FDA approved a new indication for Spravato (esketamine) nasal spray. Spravato, in combination with an oral antidepressant, is now approved to treat adults with major depressive disorder (MDD) who are experiencing suicidal thoughts or ideation.

In granting approval for the new indication, the FDA relied on the results of two phase III clinical trials involving 456 patients, in which esketamine demonstrated a rapid reduction in depressive symptoms as measured by the Montgomery-Asberg Depression Rating Scale.[1] Improvements in depressive symptoms were observed within 24 hours of initiating therapy, with some patients reporting improvement in as little as 4 hours. The improvement in depressive symptoms persisted for anywhere between 4 hours and 25 days.[2] Due to how quickly symptom improvement was observed in clinical trials, Spravato will likely be used to control acute episodes of MDD where patients experience suicidal thoughts or ideation. Once the acute depressive episode is controlled, the treating provider can shift his or her focus to implementing a more effective treatment regimen for long-term symptom control.

This is the second approved indication for Spravato nasal spray. Spravato was initially approved by the FDA in March 2019 for treatment-resistant depression. Spravato’s approval in 2019 was noteworthy because it represented the first new mechanism of action for the treatment of depression since Prozac was approved in the late 1980s. If you missed our blog on the approval of Spravato, you can read it here. While early data shows that Spravato has the potential to be a life-saving treatment for patients with MDD experiencing acute suicidal thoughts or ideation, treatment costs are expected to be high. In patients with treatment resistant depression, the first month of treatment can range from $4,720 to $6,785 in cost, while maintenance treatment can cost $2,360 to $3,540 per month. These costs translate into an annual price tag of between $33,000 and $49,200[3]. These figures include the cost of the medication itself, in addition to the cost of administration in a certified doctor’s office or clinic.

From a chemical standpoint, esketamine is the mirror image of an older drug called ketamine. Ketamine has long been used as a surgical anesthetic, but in recent years it has gained momentum for use in depression and various types of chronic pain. A few months ago, we blogged about the effectiveness of ketamine infusion for the treatment of pain. If you missed that blog, you can read it here. It should be noted that unlike ketamine infusion, Spravato nasal spray is not recognized for use in patients with a diagnosis of chronic pain. 

Unfortunately, depression is prevalent in the injured worker population. Medications for the treatment of depression are common within WCMSAs and can present a challenge for insurers. With a growing list of FDA approved indications, Spravato has a unique place in the treatment of depression. We’ll continue to monitor for changes with Spravato and post updates on our blog. Don’t forget that MEDVAL is uniquely qualified to assist in the assessment of a prescription drug regimen for depression and many other conditions. Please contact us with questions about your claimant’s drug therapy.

[1] https://clinicaltrials.gov/ct2/show/NCT03039192; https://clinicaltrials.gov/ct2/show/NCT03097133

[2] Ibid.

[3] https://www.statnews.com/pharmalot/2019/03/22/antidepressants-cost-effective-johnson-and-johnson