Spravato Treatment For TRD – Cost, Process & More
Treatment-resistant depression (TRD), also called refractory depression, occurs when depression treatments help slightly or not at all. Even when a conventional treatment like an antidepressant alleviates depression a bit, it may not feel like adequate relief from suffering. So this still falls under the category of TRD — which is why Spravato treatment may be an option.
Standard depression treatments don’t work for a significant number of people with depression. The prevalence of medication-treated major depressive disorder (MDD) in the U.S. is around 8.9 million adults. About 2.8 million (30.9 percent) of those have TRD.
A European study, meanwhile, has found that 50.7 percent of depressed patients were considered treatment-resistant after two consecutive courses of treatment with antidepressants.
However, since a diagnosis of TRD requires trying at least two antidepressants at an adequate dosage for a certain amount of time, TRD does not mean someone cannot respond to any treatment. There are many alternatives to antidepressant medications, including not just different forms of psychotherapy but also different kinds of drugs.
One drug that can be highly effective in alleviating TRD is ketamine, which is now an FDA-approved treatment in the form of esketamine (Spravato). This post will detail what this form of treatment involves, how much it costs, its effectiveness, how it works, and the potential risks.
Contents of this article
What Is Spravato Treatment?
Spravato is the brand name of the esketamine nasal spray made by the pharmaceutical company Janssen, a subsidiary of Johnson & Johnson. Esketamine or S-ketamine is one of three types of ketamine.
The other types are R-ketamine (or arketamine) and R,S-ketamine, which is an equal 50/50 mixture of both R and S types. Medical professionals use R,S-ketamine as an anesthetic, and most recreational ketamine use involves this form as well (as a crystalline powder).
Esketamine is more potent than arketamine. It induces stronger dissociative effects. This means taking esketamine is more likely to lead to effects like feeling detached from your body, surroundings, and sense of self. Esketamine’s affinity for the glutamate NMDA receptor is four times higher than that of arketamine. Ketamine’s binding to this receptor is responsible for the drug’s unique effects.
Spravato treatment refers specifically to Janssen’s formulation of esketamine, delivered as a nasal spray. On March 5, 2019, The FDA approved Spravato as a treatment for TRD – in other words, for people who have tried antidepressant medications but who have not benefited from them.
However, the FDA’s approval requires that Spravato treatment be given in combination with an oral antidepressant.
On August 3, 2020, the FDA also approved Spravato for the treatment of MDD with acute suicidal behavior ideation or behavior.
How Much Does Spravato Treatment Cost?
Spravato treatment has a price tag of $590-885 per dose, which adds up when taking regular doses. The recommended frequency of dosing with Spravato is twice per week for four weeks. So the full cost of treatment can amount to $4,720-7,080.
Nonetheless, you should know that Spravato treatment is almost always covered by insurance, including Medicare, as it’s FDA-approved. To be eligible for insurance coverage for esketamine, you need to have tried at least two other antidepressants without benefit.
In contrast, ketamine infusions aren’t covered by insurance because they’re experimental and not FDA-approved.
What Is The Spravato Treatment Process Like?
In order to get a prescription from your doctor for Spravato treatment, you need to show that it’s a medical necessity. To reiterate, you need to have tried at least two antidepressants at the right dosage and for an adequate amount of time, without responding to treatment, to be considered a good candidate for Spravato treatment.
Due to restrictions, you can only take Spravato in the presence of a healthcare provider in a medical setting. You cannot get a prescription for esketamine, take it home with you, and then administer it on your own.
This is due to the risk of adverse outcomes resulting from sedation and dissociation caused by the ketamine, as well as the potential for abuse and misuse of the drug. Ketamine certainly has the potential to be addictive. Spravato treatment is, therefore, only available through a restricted distribution system.
Because of the risk of sedation and dissociation, a healthcare provider will monitor you for at least two hours after you receive your Spravato dose. You and the prescriber are required to sign a Patient Enrollment Form that states you understand the need to make arrangements to safely leave the healthcare setting to get home.
You also shouldn’t drive or use heavy machinery for the rest of the day on which you receive the drug. In addition, Spravato treatment is dispensed with a patient Medication Guide that outlines the drug’s uses and risks.
You will self-administer the Spravato nasal spray under the supervision of a doctor. The doctor doesn’t administer it for you.
However, the healthcare provider will instruct you on how to operate the nasal spray device. During and after each use of the Spravato nasal spray, your healthcare provider will check up on you and determine when you are ready to leave.
Spravato Treatment’s Effectiveness
The FDA recommended approval of Spravato after reviewing four clinical trials looking at the use of the ketamine nasal spray for TRD. These were three short-term trials and one long-term trial. In the short-term trials, patients were randomized to receive Spravato or a placebo nasal spray.
Given the serious nature of TRD and the need for patients to receive some form of treatment, all patients in these studies started a new oral antidepressant at the time of randomization. Patients also continued to use the new antidepressant throughout the trials. Researchers judged the efficacy of the treatment based on a scale used to assess the severity of depressive symptoms.
One of the short-term trials showed statistically significant antidepressant effects compared to the placebo. Moreover, some effect was seen within only two days. The two other short-term trials did not meet the pre-specified statistical tests for demonstrating effectiveness.
In the longer-term trial, patients in stable remission or with stable response who continued treatment with Spravato plus an oral antidepressant experienced a statistically longer time to relapse compared to patients using the placebo nasal spray plus an oral antidepressant.
Up to 33 percent of people with depression don’t respond to multiple kinds of conventional antidepressants. Yet esketamine can reduce depression symptoms in a majority of these people.
The only other approved drug therapy for TRD is a combination of olanzapine (an antipsychotic drug) and fluoxetine (a conventional antidepressant). However, this treatment can have significant long-term effects, including substantial weight gain, metabolic changes, diabetes, and high blood pressure.
Conventional antidepressants may actually increase suicidal thoughts at the beginning of treatment, particularly in children and young adults. This is a recognized risk. Other than lithium — a drug most common for treating bipolar disorder — esketamine is the only drug that decreases suicidal thoughts. This is according to Adam Kaplin, a psychiatrist with Johns Hopkins Medicine.
How Does Esketamine Treat TRD?
Spravato treatment appears to help people with TRD for a number of reasons.
Esketamine’s antidepressant function works through a different mechanism than other drugs. Conventional antidepressants increase levels of naturally occurring chemicals such as serotonin, norepinephrine, and dopamine. Esketamine, in contrast, increases levels of glutamate, the most abundant chemical messenger in the brain. The result is a greater impact on more brain cells at one time.
Research suggests that untreated depression causes long-term brain damage and is a risk factor for dementia. Studies show that people with depression have up to 20 percent shrinkage of the hippocampus. This is a region of the brain that’s critical for both memory and learning. But esketamine may be able to counteract these harmful effects of depression.
Animal studies indicate that connections between brain cells diminish under chronic stress, but esketamine can reverse these stress-related changes.
Says Kaplin: “Esketamine is different than any other antidepressant in that it not only prevents the neurotoxic effects of depression on the brain, but it also seems to have a growth-promoting effect.”
The Side Effects Of Spravato Treatment
Like all treatments, Spravato carries some potential side effects. The most common side effects experienced by patients treated with Spravato in the clinical trials are the following:
- Decreased feeling or sensitivity (hypoesthesia)
- Increased blood pressure
- Feeling drunk
Harm Reduction Tips For Spravato Treatment
Patients with TRD who also have unstable or poorly controlled hypertension or pre-existing aneurysmal vascular disorders may be at increased risk for adverse cardiovascular or cerebrovascular effects.
Spravato may impair attention, judgement, thinking, reaction speed, and motor skills. This is why you should not drive or operate machinery until the next day after a restful sleep.
In addition, Spravato may cause fetal harm, making the treatment unsuitable for women who are pregnant. Women who are breastfeeding should not use Spravato, as the manufacturer states that esketamine would be present in breast milk. This, in effect, may cause harm to the baby. Although, due to a lack of data, the nature of the risk is unclear).
While Spravato treatment for TRD is a promising option for people who have not responded well to antidepressants, there is no guarantee that the treatment will work.
Fortunately, there are other treatments that may help people with TRD. These include psilocybin-assisted therapy, which involves a longer and more classic psychedelic experience, as well as TMS therapy, which alleviates TRD through brain stimulation.