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Why a much-hyped treatment for depression faces an uncertain future

Earlier this year, the FDA approved Spravato, a move that gave the controversial practice of using ketamine to treat depression an air of professional legitimacy. But insurance companies have been slow to sanction the treatment.

Spravato
Janssen Pharmaceutica
Nearly two months into a new medical treatment for her long bout of depression, Katie is feeling better. Typical daily undertakings like cooking meals are no longer the challenge they once were. “I’m a lot more patient and calm,” said Katie, 35, who lives in Minneapolis and has suffered from severe depression since she was 14. “I don’t get upset quickly.” 

Katie — who asked to go by a pseudonym due to the stigma of dealing with severe depression and treating it with drugs — gives much of the credit for the improvement to Spravato, the brand name for a medicine derived from the dissociative drug ketamine. Unlike previous treatments, such as SSRI antidepressants, Spravato doesn’t make her feel like a dull version of herself, Katie said. “If anything, it enhances the senses.” 

For years, select doctors and clinics across the nation have been using ketamine as a treatment for depression “off-label.” That is: without approval from the U.S. Food and Drug Administration. But earlier this year, the FDA approved Spravato, a move that gave the controversial practice of using ketamine to treat depression an air of professional legitimacy it long lacked. 

But insurance companies have been slow to adopt the treatment. Before beginning Spravato in late August, Katie said she spent at least 24 hours on the phone with HealthPartners, her insurance provider, to get the company to cover her treatment. 

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Stories like that have left a lot of potential patients in Minnesota and elsewhere frustrated, says Gregory Simelgor, an anesthesiologist who runs the Minnesota Ketamine Clinic, where Katie takes Spravato. The vast majority of people who come to Simelgor seeking the treatment never get as far as Katie, he said — a problem for those without deep pockets. Each Spravato dose, which comes in a nasal spray, costs between $700 and $900, and the FDA and Janssen Pharmaceutica, the subsidiary of Johnson & Johnson that manufactures the drug, recommends a treatment of 12 doses over two months. For those counting, that’s a price tag of at least $9,000.

Making things even more complicated: After each nasal spray, federal law requires a medical staffer monitor the Spravato patient for two hours, and it isn’t clear how much money insurance companies will reimburse them for these sessions, or if they will at all, said Semelgor. 

All of which points to an uncertain future for the otherwise widely hyped drug — and for those who hold out hope that it could be an effective treatment for their depression. “It’s frustrating for the patients, knowing that there is a drug out there that might potentially help them and they can’t get it,” Simelgor said. 

FDA breakthrough

Until recently, doctors used ketamine solely for anesthesia. The drug was discovered and synthesized in the 1960s and came to prominence during the following decade through use on wounded soldiers in the Vietnam War. 

Along the way, ketamine also developed a recreational reputation, first in New Age circles and then in the club scene. That’s because ketamine causes hallucinations. If ingested in high quantities, the drug sends users into an impaired reality that some call the “k-hole.”

But by the early 2000s, researchers began discovering medical breakthroughs in the drug’s potential to treat severe depression. Particularly, they discovered how low infusions of ketamine can work as a less intrusive alternative to electroconvulsive therapy.

Medical professionals like Simelgor saw enough potential in this practice to start offering ketamine treatment to patients off label. Simelgor can do this legally as an anesthesiologist because he is trained to administer ketamine during medical procedures like surgery.

Today, more than 200 clinics across the country offer off-label ketamine infusion to treat depression, according to the American Society of Ketamine Physicians, and there are least three stand-alone ketamine treatment clinics operating in the Twin Cities. Ketamine treatment is also available at several hospitals and clinics throughout the metro, including at the University of Minnesota. 

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But the practice remains controversial to some within the psychiatric community. Medical studies that point to ketamine as an effective treatment for depression are so far preliminary and small-scale. Still, the skepticism wasn’t enough to stop Janssen from patenting esketamine — one of the two mirror-image molecules that chemically make up ketamine — into Spravato in 2018. 

Then, in March, came a breakthrough: The FDA approved Spravato, giving ketamine treatment for depression the federal government’s seal of approval.

Because health insurance companies will often not cover off-label drug treatments, the FDA’s approval was a big deal. Though ketamine treatment for depression has been widely available for the past few years, it’s been accessible primarily to patients who can afford to pay for the expensive infusions out of pocket. 

Questions over required monitoring

The FDA approval of Spravato changes this, at least theoretically. Yet psychiatrists still must prescribe Spravato to patients before they can go to clinics like Simelgor’s for treatment, and many are reluctant to do so. 

Alik Widge, a psychiatrist at the University of Minnesota, said he often recommends other treatments to patients who come to him seeking Spravato.  “Somewhere between 50 and 75% of the people who come into the door and already know they want Spravato treatment, I have to tell them, ‘Yeah, I don’t think that’s the best answer for you,’” he said. 

Patients with histories of schizophrenia or drug abuse, for example, are recommended to stay away from the treatment. And Widge said he sees numerous patients who want Spravato but have not yet tried more evidence-based treatments, like cognitive behavioral therapy or a full dose of antidepressant medication.

Dr. Gregory Simelgor
MinnPost photo by Mike Dvorak
Medical professionals like Dr. Gregory Simelgor saw enough potential in this practice to start offering ketamine treatment to patients off label, or without approval from federal authorities.
For those who do need Spravato, however, Widge said he sees a bigger roadblock for treatment than insurance companies’ reluctance to cover the drug. Per FDA requirements, all clinics that offer Spravato treatment must make medical personnel available to monitor the patient for two hours after each dose. That’s because ketamine can cause side effects like high blood pressure and arrhythmia in some people. 

“Ketamine can make people hallucinate, it can make them anxious, they can go unconscious,” Widge said. “These are things that actually require someone who knows what they’re doing.”

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But the required monitoring also ties up skilled medical staff from completing other tasks, Widge said. And so far insurance companies have reimbursed the university clinic where Widge works at a rate that “just barely breaks even” with the cost of placing medical staff on two-hour monitoring, he said. 

“It should work, though it won’t be profitable,” Widge said. “Which is fine for us — we’re an academic group. Our job is to help patients and do research. I imagine a private clinic might have different economics.”

In other words, if the reimbursement rate ends up being too low to justify the time medical staff could otherwise spend on other tasks, it may prevent health clinics from offering Spravato on a large scale. Spokespeople from UCare and UnitedHealthCare both said that their companies have insurance plans that cover Spravato treatment, including the two-hour monitoring. But they did not provide specifics on what the reimbursement rate for monitoring looks like. 

Simelgor and Katie are both waiting to see what her insurance coverage does with her monitoring sessions. Katie said she billed HealthPartners for both her Spravato doses and two-hour monitoring sessions. 

“Whether they’re going to reimburse us, that’s a big unknown,” Simelgor said. 

Simelgor’s goal is to be added to insurance provider networks for Spravato, much the same way insurance companies and doctors handle more established prescription drugs. He said he began calling a number of insurance companies in April to register for Spravato and never heard back. 

“Maybe they’re willing and we’re just not able to get through,” Simelgor mused. 

He added: “It’s a waiting game at this point.”