Esketamine - A step in the right direction

On march 5th, the FDA voted to approve Johnson & Johnson’s patented eskatamine nasal spray Spravato for treatment of depression, the first new FDA approved medication for depression in 30 years. Esketamine is a filtered version of the generic medication ketamine. Ketamine is currently administered off-label, intravenously, to address mood spectrum disorders such as depression and anxiety, and is also used on-label as an anesthetic in emergency departments and hospitals around the world.

We see the FDA approval of esketamine as good news on many levels.

For one, it is addressing a major unmet need. In the United States, 18M adults suffer from major depressive disorder. Only half of these people seek help and fewer than 3M people successfully manage their depression. This gap is due to the expensive and often uncovered costs of mental health care, poor existing treatment options, and cultural stigma. The more we talk about depression and present solutions, the more people will seek and realize relief.
Second, the FDA approval represents an advance in our understanding of the brain, depression, and how we manage mental health. Whereas Selective Serotonin Reuptake Inhibitors (SSRIs) such as Prozac are based on the chemical imbalance theory of depression, ketamine has contributed to the neural circuit theory of depression. This model is based on restoring and realigning thought pathways and increasing neural plasticity to break negative ruminations and self talk. Whereas SSRIs are effective in fewer than 30% of patients, ketamine has proven to be effective for eliminating depressive symptoms in over 75% of patients.
Finally, this news is deepening the widespread understanding and awareness of the powerful potential and versatility of ketamine and its derivatives. Over the past twenty years, over 200 clinical trials have explored ketamine’s positive impact on depression, PTSD, bipolar disorder, anxiety, and pain. In addition, ketamine has a 50 year safety profile as a routine anesthetic used in hospitals worldwide. The World Health Organization includes ketamine on the Model List of Essential Medicines, which outlines the most efficacious, safe, and cost-effective medications for priority conditions worldwide.
For these reasons, we at Ember Health are supportive of esketamine. As a clinic set up to provide a safe, monitored environment for people with depression seeking effective treatment, we expect to provide it in our own facility when it becomes available.
That said, we also believe our patients and partner providers deserve a comparison between esketamine and the intravenous treatments of generic ketamine we already provide. Research in fact shows that intravenous ketamine is more effective at addressing depression, more affordable, and already available to patients in need. Consider:

Administration:

Based on the FDA approval, esketamine can only be administered in licenced facilities to patients who have already failed two oral antidepressant agents in the past five years. It cannot be taken at home. The FDA recommends two weekly doses for the first month with unclear guidelines around further care. Qualifying patients who seek treatment must be monitored by a physician for at least two hours after receiving each esketamine dose, and are required to start a new, oral anti-depressant.
Ketamine delivered intravenously must also be administered by a licensed physician. Treatment only takes one hour per session, and generally eliminates depressive symptoms on average between two to ten weeks, requiring booster sessions only as often. Further, there is no evidence that suggests need for an accompanying oral medication.

Effectiveness:

There have been five studies to date examining esketamine and its effects on depression in a nasal spray format. None of these was a traditional randomized placebo controlled clinical trial. Only 3 of the 5 showed any benefit for depression, and none of these have looked at the effects of esketamine taken continuously over years.
Alternatively, over a dozen randomized placebo controlled trials studying intravenous ketamine have shown the relief of depressive symptoms in over 75% of patients treated. Positive effects have been demonstrated to last for several years of continuous treatment.

Price:

Johnson & Johnson said the wholesale cost of each Spravato treatment will range from $590 to $885, based on the dosage (NPR). That means that the twice-weekly treatments required by the FDA will cost between $4,720 and $6,785 for the medicine alone in the first month of treatment. This does not account for the 10+ hours of physician monitoring, which in itself will run several thousand dollars. It is unclear how much, if any, of this cost will be covered by insurance.
The price of the generic version of ketamine is between $10 and $50 for the first month of treatment. Most clinics offering intravenous ketamine charge between $500 – $700 per infusion, which includes the cost of physician time and services, equipment and medicine used, and the monitoring facilities. In our clinic, the first month of treatment typically costs $2,000 total.

Availability:

The FDA approval of esketamine is only the first step in ensuring access to the treatment for patients in need. Guidelines did not make clear who should administer it, what training they will require, and how those healthcare professionals will charge for their time and services. It will likely take months to years before treatment is widely available to patients.
Ketamine is available to treat depression today. Many clinics that provide intravenous therapy have invested in understanding how to tailor the patient experience and contribute to a patient’s more comprehensive care plan to deliver the best results possible.
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At Ember Health, we are dedicated to helping people combat their depression. We therefore see the FDA approval of esketamine as a step in the right direction, as we support any increase in access options for people in need. We hope this marks the first step of many for FDA approval and insurance coverage of a wider spectrum of treatment options that will provide the best results at the best value for people battling depression.