SPRAVATO® Approval and Cost Comparison

The FDA has given approval to Janssen Pharmaceuticals' new ketamine-containing medication for treatment-resistant depression, SPRAVATO® – also known as esketamine. Molecularly, the generic ketamine and Janssen Pharmaceuticals' patented SPRAVATO® are very similar; unfortunately, that's where the similarities end. SPRAVATO® is much more expensive, with an out-of-pocket expense close to $1,000 per dose, while an equivalent dose of generic ketamine is under $15. With such a dramatic price difference, SPRAVATO® must be vastly more efficacious than generic ketamine, right? Not so fast.

"Ketamine will almost always be the better choice when compared to SPRAVATO®..."

Treatment Method

SPRAVATO® is an antidepressant nasal spray that works together with an oral antidepressant. This is the new recommended treatment method for patients suffering from depression who have tried multiple antidepressants without success. Researchers found that those who took SPRAVATO® with their oral antidepressant experienced a greater reduction of depression symptoms at four weeks compared to those who received a placebo plus an oral antidepressant.

Why Choose Ketamine?

My aim as a practitioner is to provide the very best clinical advice I can to my patients. It is my opinion that ketamine will almost always be the better choice when compared to SPRAVATO®—here is why:

Ketamine and a Proven Track Record

The use of ketamine has a much longer and more proven history, and there is much more research to back it up. Ketamine is not FDA-approved to treat depression, but it can be used "off-label," meaning used for a purpose other than what it was originally developed or approved for. Up to a third of all psychiatric medications in the US are used "off-label," so this fact shouldn't alarm anyone. As research continues to mount, it is increasingly evident that ketamine benefits patients with depression, PTSD, anxiety, and chronic pain.

Patients, as well as physicians, are asking: "Why isn't ketamine, esketamine's more popular and cheaper cousin, being developed as quickly or in the same way?" Ketamine’s patent expired in 2002, leading to the abandonment of further studies because Big Pharma recognized they would not see significant financial returns on the drug. However, Janssen, a subsidiary of Johnson & Johnson, isolated one of the components of regular ketamine, esketamine, patented that, and then submitted this "new" version into clinical trials for FDA approval.

Many experts believe that SPRAVATO® could be useful in emergency situations, such as when being admitted to the hospital with suicidal thoughts. Currently, a licensed provider must order your SPRAVATO® nasal spray on your behalf and pick it up on the day of treatment. Patients may submit claims through their insurance. At their appointment, the patient sprays each nostril (with the provider present) and must then be monitored for two hours at the clinic. For four weeks, the drug is administered two times a week, followed by one time a week for another four weeks, and then every other week or weekly, depending on the patient's response.

What Research Exists?

A meta-analysis compares multiple studies and their results. Although there hasn't been a study directly comparing Spravato taken intranasally with ketamine taken intravenously, many studies have investigated each individually, allowing us to draw conclusions by comparing their results. Recently, a meta-analysis comparing intranasal esketamine with IV generic ketamine has been published.

In one meta-analysis of 24 separate studies, researchers evaluated the effectiveness of each administration method. They concluded that intravenous racemic ketamine was significantly more effective than intranasal esketamine, with a greater effect in reducing depression symptoms and a reduction in dropouts due to adverse events.

Dosage Differences

SPRAVATO® comes in two strengths, 56mg and 84mg; that's it. Most patients start with the 56mg dose and then "graduate" to the 84mg. The issue arises when considering that a 21-year-old, 120-pound college student will feel the effects of 84mg of esketamine much more than a 240-pound middle-aged father of three, who will not experience nearly the same treatment. There is no adjustment for weight—it's pre-measured, and the directions are clear.

On the other hand, ketamine is dosed based on weight, so that a 120-pound college student, at a moderate dose level, would receive 45mg infused over 45 minutes, while the 240-pound father would receive 90mg. They would both have very similar experiences. Ketamine infusions allow for customization of the dose, whereas with SPRAVATO®, it's just two sizes, forced to fit all.

Considerations for SPRAVATO®

Here are some considerations when choosing between SPRAVATO® and ketamine:

• SPRAVATO® may be right for you if your insurance covers the cost of the drug as well as your clinic monitoring time, though this scenario has never been widely observed in real-life settings.
• The cost of IV ketamine treatments, while not inexpensive, may be worth it to avoid the debilitating effects of depression; many providers offer package deals where you buy a block of treatments at a substantial discount.
• Research has shown IV ketamine to be more effective than esketamine delivered nasally.
• Dosages can be personalized to ensure you are always receiving the optimal amount of medication to achieve the best results.
• IV ketamine treatments typically take less time than nasal ketamine (90 minutes versus over 2 hours).

Having been a provider of both SPRAVATO® and now ketamine, I want my patients to have a choice and access to the most accurate information available to help them choose the best treatment for them.