FDA announces approval of Esketamine (Spravato) for depression

Esketamine (Spravato) For Depression

On March 5th, 2019, the FDA approved Spravato (esketamine) nasal spray for the treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them (treatment-resistant depression). This is a major milestone in the treatment of depression and Johnson and Johnson (the manufacturer of Spravato) has been putting resources and effort into getting this breakthrough medication approved since 2013. As the most experienced provider of ketamine treatments for depression and other psychiatric illnesses*, with the FDA approval announcement Kadima has experienced a surge of inquiries about esketamine. Below we answer some of the most common questions posed. 

*Dr. Feifel established the world’s first ketamine treatment program for psychiatric disorders in 2008

“David Feifel established the first program using the anesthetic drug ketamine to treat patients with depression” – PRNewswire

Can I get esketamine now?

No. It will be months before Spravato is physically available to patients. FDA approval only means the manufacturer can now proceed to manufacture the drug in a scaled-up fashion. Keep checking back to our website for updates on Spravato’s availability.

Will esketamine be covered by Insurance since it is FDA approved?

FDA approval and insurance coverage are distinct processes. Each insurance company will now have to decide whether to add esketamine to their covered drug formulary. We expect it will become covered by most insurance companies, but it will likely have restricted coverage. Because Spravato will be significantly more expensive than other FDA approved antidepressants, insurance companies are very likely to restrict their coverage of it to certain situations. They will likely require a “prior authorization” (PA) be obtained from the prescribing physician for Spravato and will only approve the PA for patients who have tried a certain number of traditional antidepressants first.

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The bottom line is that Esketamine (Spravato) is not available yet and it is not known when it will be covered by any given insurance company and under what circumstances it will be covered.

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When it does become available will any physician be able to prescribe esketamine for me?

It is likely that insurance companies will only authorize prescriptions of Spravato written by psychiatrists in order to limit the prescription of this expensive drug. Furthermore, only psychiatrists who have the appropriate space, qualified staff and resources to store Spravato securely (as it is a controlled substance) and to monitor patients in a private space for 2 hours after taking the nasal spray will be certified to prescribe Spravato.

Will I be able to take esketamine at home?

Spravato will be provided by pharmacies to the offices of psychiatrists who have prescribed it and not given to patients directly. The FDA approval stipulates that Spravato must be self-administered under the supervision of a licensed health care provider (e.g. nurse or physician) and the patient must be monitored for side effects by a licensed provider for at least 2 hours after the drug is administered. The spray cannot be taken home by patients. Furthermore, the FDA approval stipulates that patients cannot drive until the day following their Spravato treatments.

How is esketamine treatment different than ketamine treatment currently given at Kadima?

There are several important differences between Spravato treatment and the ketamine treatments currently provided by Kadima and many other ketamine providers.

The main difference is that much less drug gets in the brain with intranasal Spravato treatment than with the typical intramuscular ketamine treatments given at Kadima. To get into the brain ketamine and esketamine must first enter the bloodstream. When given intravenously (IV) or intramuscularly (IM), as we do at Kadima, about 95% of the total dose gets into the bloodstream, whereas only 25-50% of the total dose given intranasally gets into the bloodstream. This percentage of dose that gets into the bloodstream is called “bioavailability”.  

Virtually all the patients treated with IM ketamine at Kadima experience a transient therapeutic dissociative / “psychedelic” experience lasting between 40 and 90 minutes. Most of them believe that this experience contributes to the therapeutic (i.e. symptom reducing) effects that frequently occur the days and weeks after the ketamine treatment.  At the approved doses of Spravato most patients do not experience a dissociative/psychedelic effect.

Furthermore, the doses of Spravato are fixed in a single use intranasal device to administer one of the two doses approved by the FDA. This will restrict a physician’s ability to provide a customized dose to the patient who may need higher doses to get the optimal antidepressant effect. Dose is completely customizable with ketamine administered IV or IM and at Kadima we find the optimal dose of ketamine (that balances effectiveness and side effects) for each patient individually.

Despite this, Spravato is the only FDA approved ketamine-based treatment for depression and a breakthrough for the millions of patients suffering from treatment-resistant depression.

For more information about Spravato and the treatments offered at Kadima contact us at: (858) 412-4130 or info@kadimanp.com