Patients with major depression who haven’t responded to other treatments will soon have a new option: esketamine, a rapid-acting therapy derived from the long-used anaesthetic ketamine. But, Stat News reports, the drug’s approval sparked a string of new questions, from how much patients will have to shell out for the drug to how clinicians will be able to accommodate patients who need to be monitored for two hours after every dose.
“This is an extraordinarily exciting time,” said Dr Robert Meisner, a psychiatrist and the medical director of the Ketamine Service at McLean Hospital in Belmont, Massachusetts. “That said, it’s important to proceed with enthusiastic caution.”
The report looks at five key questions as the drug, which will be sold under the brand name Spravato, heads to the market.
The cost of the treatment will depend on the dose used per session and how many sessions a person will need, according to Janssen Pharmaceuticals, the Johnson & Johnson subsidiary that developed the nasal spray. The wholesale acquisition cost, or list price, will be between $590 and $885 per treatment session. That means the wholesale acquisition cost for the first month of treatment – which includes two sessions a week – will range from $4,720 to $6,785.
Patients who respond well to the treatment during that first month will then move over to maintenance therapy, which means they’ll receive a dose every week or every other week – at a cost of anywhere between $2,360 to $2,540 a month. There’s still a need for more data on how long patients might need to stay in that maintenance phase.
Janssen is quoted in the report as saying that those prices are “generally comparable” to other specialty mental health drugs, like long-acting injectables that are used to treat schizophrenia. But those totals aren’t the amount a patient will pay out of pocket. They don’t include insurance coverage, discounts, or rebates that might be paid to the government and private insurers. And they also don’t account for the cost of seeing a provider to receive Spravato or the two hours of observation needed after each treatment.
The report says every provider who wants to offer esketamine has to be certified by Janssen – and every patient who is prescribed the treatment has to be registered in the company’s distribution program. Health care centres that want to provider Spravato will have to have the prescriber on site while the drug is administered and while patients are being monitored. They’ll also have to submit a patient monitoring form for every patient after every dose. Pharmacies, too, will be have to be certified in order to dispense the drug.
Those steps are all part of a robust system to make sure esketamine isn’t misused or diverted.
“Janssen is working quickly to educate and certify centres that wish to administer Spravato, which may include clinics, community mental health centres, hospitals, or integrated health systems, to appropriately monitor the administration of Spravato and address patient needs,” Kristina Chang, a spokesperson for Janssen is quoted in the report as saying.
“Certain safeguards absolutely need to be in place,” said Meisner. He added that the requirements from the US Food and Drug Administration (FDA) and Janssen appear to be “exceptionally good.”
Patients will have to visit their provider for every dose of Spravato, which is delivered in a single-use nasal spray. Patients will have to stick around for at least two hours after every treatment while a provider monitors them for sedation, blood pressure changes, and out-of-body experiences known as dissociation.
According to the report, that presents several big hurdles for both patients and providers. Many health care facilities aren’t set up to have patients wait in the office for several hours under observation. A health care facility also might not have enough staff
to properly monitor them.
“It’s going to be an expensive treatment in terms of what’s required for health care providers,” said Dr Gerard Sanacora, a psychiatrist and the director of the Yale Depression Research Programme. Sanacora has been involved in the esketamine trials and has consulted for Janssen.
The report says how hard it will be for a facility to get set up for Spravato depends on the infrastructure they have in place. At McLean’s neurotherapy unit, which already provides IV ketamine and electroconvulsive therapy, “all the basic elements” are already in place, Meisner said.
Being able to receive Spravato also won’t be an easy process for patients. For the first month, they’ll have to commit to at least two hours – likely during work hours – twice a week to go in for a dose. And since patients will be told not to drive until the day after each treatment, many also might have to coordinate transportation after every single appointment.
Actify’s centres are among the dozens of free-standing clinics that have opened across the US in recent years to provide ketamine to patients who are desperate for an effective treatment for depression. (Ketamine is a combination of two enantiomers, or mirror image molecules. Esketamine is what’s known as the s-enantiomer, or a component of ketamine.)
The report says typically, ketamine clinics – run by anaesthesiologists, psychiatrists, and other health care providers – have offered ketamine off label through an intravenous infusion. Some of those clinics might be particularly well-prepared to start providing Spravato, given that they are accustomed to having patients remain in the office for monitoring during and after an infusion. Levine said Actify plans to apply for esketamine certification and will continue to provide IV ketamine.
“Nasal esketamine and IV ketamine are going to happily co-exist,” he said.
And while the waiting period might be inconvenient for patients receiving Spravato, Levine also sees it as a “boon for more comprehensive treatment.” He said in the report that the company plans to create a patient lounge for peer support and set up stations where patients can do digital psychotherapy during the monitoring period.
In the weeks leading up to the FDA’s decision, the report says the psychiatry field has been buzzing with excitement about the potential new option. But it’s not clear yet how widely the drug will be used. Some in the psychiatry field still aren’t convinced there’s enough evidence to support the use of Spravato yet. And even for providers who do want to provide Spravato, the lack of space or staff to properly administer and monitor patients after each dose might make it too difficult for some to do so.
But some are eager to start providing Spravato to patients in need of a new option. “I think this is a tremendous advance for a lot of people, as long as it’s done responsibly,” Sanacora said in the report.Stat News report