Why Don't Insurance Companies Cover Ketamine Treatments?
To simplify the question, we will limit the discussion to ketamine COVERAGE FOR depression.
The short answers are: 1) Unawareness of ketamine as a treatment 2) Ketamine is not FDA approved for mood disorders 3) Ketamine is considered an experimental or investigational drug
But to leave it at this doesn’t fully explain it. To explore more, let’s do a deeper dive into each of these answers.
The Background: Ketamine & Treating Depression
Ketamine, a derivative of phencyclidine, was first used in humans in 1964 experimentally as a potential anesthetic medication. It was ultimately approved by the FDA in 1970 for these indications:
Indicated as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation.
Indicated for the induction of anesthesia prior to the administration of other general anesthetic agents, and to supplement low-potency agents, such as nitrous oxide.
Accordingly, ketamine was used in operating rooms and emergency departments, and covered by health insurance companies. Then in February 2000, the first randomized, placebo-controlled double-blinded study was published in Biological Psychiatry.
In this study, Dr. Berman & colleagues reported the significant antidepressant effects of ketamine in a small group of patients suffering from depression. More studies continued and in 2012 researchers called ketamine, “the biggest breakthrough in depression research in a half century.” These studies along with others would show that ketamine infusions can alleviate depression symptoms within hours to days and be effective in 60-80% of patients (depending on the study).
Learn more about ketamine’s history here and explore further ketamine studies here where we give a quick synopsis for your reading pleasure!
So If Ketamine Can Help In Depression, Why Isn’t It Covered?
Unawareness of Ketamine a Potential Treatment Option for Depression
Many people have never heard of ketamine, and if they have, it’s typically associated as a veterinary medication or a recreational drug. If you were to call your insurance company and ask about coverage, the insurance agent would likely be unaware that ketamine is being used to treat depression in outpatient clinics.
Surprisingly, this is true amongst not only the general population, but even amongst doctors and nurses. By reading this post, you are in a small percentage of people who are aware of ketamine as a therapeutic agent for depression.
Why? Simply, the lack of education. You’re not going to see any commercials on television because ketamine has been around for over 50 years and is now a generic medication. Nor are there pharmaceutical reps going to doctors’ offices giving doughnuts and brochures about the latest ketamine studies. Since it’s generic, there isn’t a large motivation to market this medication to prescribers, insurance companies, and patients.
Read more about how to talk with your doctor about ketamine here.
Ketamine Is Not FDA Approved for Mood Disorders
Ketamine is approved by the FDA for use as an anesthetic and analgesic in the setting of operating rooms and emergency departments. Outpatient ketamine treatment for depression, along with PTSD, anxiety, OCD, postpartum depression, and bipolar disorder are not approved by the FDA. When it is used in this way, it is considered an “off-label” use of the medicine.
To get FDA approval for a drug or for them to approve a drug for a new indication, it requires researchers to perform large randomized, blinded, and controlled trials with long term follow up to prove that it is safe and effective. For some medicines, the FDA approval process can cost billions of dollars.
Just to submit an application to begin the FDA approval process, the fee in 2020 was $2,942,965! The primary way to get that funding is from a drug company who wants to own the rights to a breakthrough drug that can be protected by a long-term patent. As you can imagine if they are going to provide that upfront money, they have a vested interest in making a significant return once the drug becomes FDA approved.
But, ketamine is generic. This means that there is no longer a patent protection on it and no single pharmaceutical company has exclusive rights to manufacture this medication. Therefore, there is little incentive for them to pour money into clinical research into a generic medication.
On a side note, there are incentives to take a generic medication (or soon to be generic) and slightly modifying it or isolating a portion of it to create a new patent. One example of this is the medication citalopram (a selective serotonin reuptake inhibitor). When it’s patent was set to expire in 2002, the drug company isolated a portion of it - escitalopram (aka Lexapro) to create a new patent. This concept is known as “evergreening,” so a drug company can increase the profit margin for its shareholders. This was controversial because studies showed that escitalopram may have only been slightly better than citalopram but multiple times more expensive.
This similar concept is seen with ketamine and esketamine. Read more about it here.
Ketamine Is Considered Experimental & Investivational
Studies on the efficacy of ketamine for the treatment of depression AND other mood disorder are still ongoing. This is a relatively “new” treatment and often these studies are small scale with a limited number of subjects. Although a meta-analysis and systematic review of ketamine show its effectiveness in depression, it’s still not enough evidence in the eyes of the insurance companies, thus making them reluctant to cover it.
Insurance companies argue that IV ketamine for depression has not been vetted through middle and long term studies (typically done during the FDA approval process). This is challenging because of the lack of funds available to follow up with patients for a long period of time. The last thing an insurance company wants to do is cover something that may be potentially hazardous and doesn’t have the long-term evidence backing it up.
Insurance companies also look to guidelines and recommendations by a consensus of physicians. Although it's on the radar of some doctors, ketamine is not well known nor recommended by a large group of mental health providers, who are more familiar with oral medications, T.M.S, and/or electroconvulsive therapy. Like it or not, doctors can be quite slow to adopt to new practices.
Read more about ketamine & it’s slow acceptance by the medical community here.
Conclusion
Ketamine for depression is not covered by the vast majority of insurance companies for several reasons. The majority are simply unaware of ketamine’s benefits or are more familiar with ketamine’s as a recreational drug or veterinary medication. Insurance companies argue that ketamine for depression is experimental and investigational, and not FDA approved for this purpose. Unfortunately, the FDA approval process is costly and there is little incentive for any pharmaceutical company to fund the research needed since ketamine is an old, generic medication.