In a cautious win for off-label prescribing, one of the world's most commonly used drugs for more than 50 years has recently evolved into what can only be described as a phenomenon in the treatment of severe depression and suicidal ideation. Ketamine - a psychoactive analgesic (pain-blocking) sedative - is considered by many in the medical community to be one of the safest and most conventionally used anesthetics for medical surgeries. It is also known for being an illicit party drug. This versatile medicine with a colorful past may hold the potential to help those suffering from treatment-resistant clinical depression in a bold new way.
A recent boom in the proliferation of ketamine infusion clinics opening up all across the country has left many people wondering: what does this mean for behavioral healthcare treatment, and how might this new industry affect the payments industry, addiction treatment, and other related businesses? We'll explore all of that in this blog post.
Ketamine and Depression
Depression is among the leading causes of disability in the United States and is being closely monitored by health authorities amid rising suicides nationwide. According to the Food and Drug Administration, patients with major depressive disorder who, despite trying at least two antidepressant treatments given at adequate doses for an adequate duration, and have not responded to treatment are considered to have treatment-resistant depression. There have been no major pharmaceutical innovations for depression since the launch of Prozac and related antidepressants in the late 1980s, according to CBS News.
Unlike traditional antidepressants that target the brain's serotonin systems (which can take weeks or months to take effect) ketamine instead targets the neurotransmitter glutamate, according to the National Institute of Mental Health (NIMH). Research conducted by NIMH has shown that if a person responds to ketamine, it can rapidly reduce suicidality (life-threatening thoughts and acts) and has been shown to relieve other serious symptoms of depression in as little as two hours. There is also burgeoning support for the use of ketamine to treat conditions such as anxiety, post-traumatic stress disorder (PTSD), and complex regional pain syndromes (CRPS).
How Ketamine Is Administered
There are two main types of ketamine currently being indicated for treatment-resistant depression. The first is racemic (IV) infusions into the bloodstream. When IV ketamine works, patients suffering from treatment-resistant depression usually respond to it within one to three infusions, and have been shown to achieve dramatic and long-lasting relief of their symptoms. The second, esketamine (brand name Spravato), is a fast-acting nasal spray that can only be administered in a doctor's office.
In March of 2019, the FDA-approved Spravato nasal spray, in conjunction with an oral antidepressant, for the treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them. Due to the risk of serious adverse outcomes resulting from sedation and dissociation caused by Spravato administration, and the potential for abuse and misuse of the drug, it is only available through a restricted distribution system. Johnson & Johnson touted esketamine as the first new drug treatment approved for depression in decades.
Ketamine Uses and Effects
It's important to note that ketamine has a recreational past. Its development was born out of the creation of phencyclidine - the drug known as PCP or "angel dust" - in the early 1960s. Colloquially referred to as Special K, it rose to popularity as a dance party drug in the rave scenes of the 1990s. It is known to cause a state of derealization - a feeling that one's surroundings are not real - which include visual hallucinations, increased awareness of sound and color, and euphoria. Taken in large doses, it can have a significant dissociative effect, cause temporary immobilization and out-of-body experiences. Ketamine has addictive properties and can be considered a drug of abuse.
According to the World Health Organization (WHO) ketamine is listed as an essential medicine, meaning that it should be available at all times in adequate amounts for health care needs. Ketamine is considered extremely safe because, unlike other anaesthetic agents, it does not depress breathing or blood pressure. It was added to the WHO Model List of Essential Medicines (and has remained since 1985). It can also be found on the Model List of Essential Medicines for Children, and is the most widely used anaesthetic in veterinary surgery. It does not require reliable electricity supply, oxygen, highly trained staff, or monitoring systems to administer. As a result of these factors, in 2015 the WHO Expert Committee on Drug Dependence recommended for the fourth time that ketamine should not be controlled under the international drug control conventions due to its essential role in surgery in low-resource countries, disasters, and conflict zones.
Potential for Abuse
Proponents for the use of ketamine to treat chronic pain, PTSD, anxiety, and depression reason that when the substance is administered in an appropriate dose by a physician in a clinical setting, the risks of abuse or addiction are significantly reduced. However, there are other providers who are more wary of the phenomenon of ketamine clinics. Some worry that the FDA's stamp of approval for ketamine to treat depression could encourage patients who have no access or resources for ketamine treatment to seek the drug on the street in order to self-medicate. An increase in access to the drug could lead to a new widespread object of addiction.
Dr. Indra Cidambi, Addiction Expert and Medical Director at the Center for Network Therapy, cautioned against the risk of a new addiction epidemic: "Ketamine is an inexpensive street drug and it provides immediate relief from symptoms, incentivizing patients with depression symptoms to gravitate to this alternative. This could cause an explosion in addiction to ketamine, which currently is not very common. Recall that when states belatedly started to implement restrictions on opiate pain pill prescriptions, many patients who were already on opiate prescriptions turned to street heroin for relief from pain or withdrawal symptoms."
Ketamine Costs and Dosing
Seeking legitimate treatment via clinical ketamine infusions isn't cheap. It is estimated that there are at least 150 ketamine clinics (and growing) in the US. In comparing the pricing of several ketamine infusion clinics across the country, the cost per infusion varies widely, as does the price differential with regard to the medical reason a patient is seeking treatment. For depression, the costs can range anywhere from $250 to $700 per infusion, and for pain management, the cost can range anywhere between $450 and $1400 per infusion. Most patients get at least six to eight rounds of treatment, and currently such therapies are generally not covered by insurance.
There is also no standard protocol in place for ketamine treatment. Optimal dosing, duration of treatment, methods to maintain the drug's positive effects, and the kind of aftercare to complement ketamine treatment have not yet been officially established. The potential for bad actors and providers who are not adequately trained in mental health is an industry concern. An American Psychiatric Association task force issued a consensus statement in April 2017 that laid out the medical evidence on ketamine, the kind of training it thought physicians should have, and advice for thoroughly screening patients.
Looking Forward
As with any rapidly expanding industry, there is always a potential for abuse and for substandard care from those looking to turn a quick buck. As ketamine clinics proliferate, payments companies who process transactions for these businesses will want to make sure they are operating in compliance with all applicable state and federal laws.
The medical and regulatory communities will continue to evaluate the risks and benefits associated with this rapidly expanding market. If your business partners with ketamine clinics, it's important to stay up-to-date on the latest advancements and best practices to be aware of proper uses of the drug and protocols for administering it. As ketamine's therapeutic use evolves - to treat not only depression but possibly other mental health and pain conditions - regulations around the drug are likely to change with it. For those who have been suffering with chronic and debilitating depression, access to this new treatment may in fact be a life saver.
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