Esketamine Approved Today- Implementation?

Started by Armadillos
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Armadillos

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Saw FDA approved intranasal esketamine today for MDD with med failures. From article I saw will have to be administered in office and patients observed 2 hours later, with no driving allowed that day. Presumably the drug reps are getting ready to load their suitcases as we speak, anyone going to start trying it?

I’m a pretty skeptical of ketamine in general due to the ****ty durability, but on bright side hopefully this will put the anesthesia IV ketamine clinics out of business.
 
Armadillos said:
Saw FDA approved intranasal esketamine today for MDD with med failures. From article I saw will have to be administered in office and patients observed 2 hours later, with no driving allowed that day. Presumably the drug reps are getting ready to load their suitcases as we speak, anyone going to start trying it?

I’m a pretty skeptical of ketamine in general due to the ****ty durability, but on bright side hopefully this will put the anesthesia IV ketamine clinics out of business.
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A couple of people in this neck of the woods have been doing intranasal ketamine take-homes for a couple of years now. Even if this just reins in the cowboys I think it is good.
 
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clausewitz2 said:
A couple of people in this neck of the woods have been doing intranasal ketamine take-homes for a couple of years now. Even if this just reins in the cowboys I think it is good.
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A local NP prescribed nasal ketamine to take every night to one of our very challenging patients with borderline personality disorder. These take home ketamine prescriptions are nonsense.
 
wow, I only ever saw it in severe migraine and thought it was pretty cool....

Edit: I mean that is the only "outside the mainstream" usage I've seen, for chronic pain, specifically migraine. I wasn't referring to more mainstream usage for conscious sedation or induction.
 
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clausewitz2 said:
A couple of people in this neck of the woods have been doing intranasal ketamine take-homes for a couple of years now. Even if this just reins in the cowboys I think it is good.
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I reach for it on rare occasions—better luck with oral and SL with less abuse potential. I think the intranasal is overall a bad idea from an abuse standpoint.

Besides a fact that there is now an fda approved use for a ketamine derivative this doesn’t seem like that big of a deal...you can have a pharmacy compound a similar drug for cheaper already.
 
SourceOfDenial said:
I reach for it on rare occasions—better luck with oral and SL with less abuse potential. I think the intranasal is overall a bad idea from an abuse standpoint.

Besides a fact that there is now an fda approved use for a ketamine derivative this doesn’t seem like that big of a deal...you can have a pharmacy compound a similar drug for cheaper already.
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I mean insurance will have a harder time not covering it and I can imagine our inpatient units possibly using it in a way they could not outside of research protocols before. I suspect our interventional people have already drawn upnplans for modifying their clinic.

I share your concerns about abuse liability of intranasal formulation, but at least on my read the data is pretty clear that oral is ineffective and has very poor bioavailablity (haven't seen numbers higher than 30%). What has your experience with oral been like? You mentioned successes.

And is this in general practice or in your palliative work that you've used it most?
 
Two other psychiatrists in my office part of the same practice do Ketamine.

Bear in mind though now FDA approved it could be several months before this even gets available, the costs are estimated to be very expensive, and there may be some required added training needed to prescribe it.

I think the intranasal is overall a bad idea from an abuse standpoint.
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I very much agree except that perhaps when it finally is available they might add enough restrictions where the nasal spray makes sense. E.g. maybe only 1 weeks worth is given at a time in the nasal spray. There's also talk it might only be allowed via a REMS program kind of like Clozapine is. An article also mentioned it's supposed to be given with an antidepressant, possibly (and I'm speculating here) because the hope is eventually the antidepressant will take over and the Ketamine could be stopped.

Sometime around 2 years ago in I believe the Green Journal (I'm not 100% certain) they published a case where an idiot neurologist was prescribing Ketamine for depression and giving it out via a nasal administration bottle and the whole thing smacked of MD being drug dealer. E.g. he gave out huge amounts of it that could easily be abused, why is he a neurologist, giving it out and no referral to a psychiatrist? The patient kept on getting caught abusing it from other providers, contacted the neurologist and informed him but the idiot kept giving it out instead of doing what was obvious-either stop giving it out or only give it in an office setting.
 
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Based on NYT article it has to be administered at a clinic and patient stays to be observed for 2 hours. Logistics of how that will work out may be interesting.

Seems Relprev proved 3hrs is enough to make most psychiatrists not bother, so maybe two will be more acceptable?

Addendum: granted folks needing Relprevv generally don’t have buckets of cash to pay for more services, so maybe the ketamine folks will be getting massages and facials from the in-clinic spa while they wait....
 
clausewitz2 said:
I wonder though if reliance on TMS will make it end up more like ophtho with earnings falling off a cliff because CMS tweaked reimbursement for a handful of procedures.
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Best way to get a major CMS overhaul/audit is to see a huge uptick in billing for a certain code. I think TMS is a pretty ripe target for automation and significant reduction in reimbursement in the next decade.
 
The cowboys are already feeling the heat, just got a Facebook ad from a local IV ketamine clinic saying developing esketamine for FDA approval is just pharmaceutical corporate greed. Not saying they are wrong, but most these ketamine clinics haven’t been the most ethical themselves.
 
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clausewitz2 said:
I mean insurance will have a harder time not covering it and I can imagine our inpatient units possibly using it in a way they could not outside of research protocols before. I suspect our interventional people have already drawn upnplans for modifying their clinic.

I share your concerns about abuse liability of intranasal formulation, but at least on my read the data is pretty clear that oral is ineffective and has very poor bioavailablity (haven't seen numbers higher than 30%). What has your experience with oral been like? You mentioned successes.

And is this in general practice or in your palliative work that you've used it most?
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Palliative work—if a person is not a great candidate for a stimulant, has little time left, an antidepressant isn’t realistic, then oral ketamine is something I’ll consider. Not common by any means. Data is meager, but I’ve had success. Scott Irwin has done a few small studies. Daily Oral Ketamine for the Treatment of Depression and Anxiety in Patients Receiving Hospice Care: A 28-Day Open-Label Proof-of-Concept Trial

For sublingual the dissociative space brought on can be therapeutic, used in the context of assisted psychotherapy. That’s a whole other beast and framework for use though.
 
calvnandhobbs68 said:
Still don't see many ophthalmologists starving these days though.
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The efficacy of TMS right now is a complete joke. The next step is MRI guided TMS. Targeted non-invasive brain stim will eventually happen, and it'll be comparably effective as say botox or fillers for comparably psychiatric performance enhancing indications (mild depression in the severely narcissistic, mild alcoholism etc.)

I'm frankly shocked by how much people are paying for ineffective garbage like TMS out of pocket. They'd rather sit in a hairdrier than doing something that's actually effective like 6 months of DBT. Why isn't insurance reimbursing enough for that again? Be that as it may, the field is still gonna become derm.
 
dl2dp2 said:
The efficacy of TMS right now is a complete joke. The next step is MRI guided TMS. Targeted non-invasive brain stim will eventually happen, and it'll be comparably effective as say botox or fillers for comparably psychiatric performance enhancing indications (mild depression in the severely narcissistic, mild alcoholism etc.)

I'm frankly shocked by how much people are paying for ineffective garbage like TMS out of pocket. They'd rather sit in a hairdrier than doing something that's actually effective like 6 months of DBT. Why isn't insurance reimbursing enough for that again? Be that as it may, the field is still gonna become derm.
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It's also hard to imagine patients/insurance paying $8000 per dose for several months of twice-weekly ketamine--and that's before whatever the psychiatrist/clinic is charging for the 2 hours of chillaxin time.
 
FlowRate said:
It's also hard to imagine patients/insurance paying $8000 per dose for several months of twice-weekly ketamine--and that's before whatever the psychiatrist/clinic is charging for the 2 hours of chillaxin time.
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Especially considering how cheap ketamine is, and how easy it would be to compound it for nasal use and do essentially the same thing.
 
NickNaylor said:
One of our hospitals was a clinical site for the phase 3 study.

I am skeptical of esketamine's revolutionary magic.
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Compounded nasal ketamine is about 80$ for a send home supply, last time I checked.

I too am skeptical, esketamine to me just seems like a way to get a bite of the market, get an FDA indication, and potentially less adverse effects than ketamine, but that part remains to be seen.
 
One thing that crossed my mind is this FDA approved nasal ketamine is going to be thousands of dollars. Yes insurance could pay for it but often times it can be tedious doing the PA, it might not be approved and even if so the patient might still have to pay a tremendous amount of money.

Two colleagues in my office do it $300 first visit and $150 thereafter. That might just be a heck of a lot easier and cheaper for the patient despite the FDA approved version.
 
nexus73 said:
Olneys lesions.
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My understanding is that olney's aren't really a concern for humans, but especially not at the doses they're using therapeutically. Not that there aren't terrible effects on the brain from long term high dose ketamine abuse (grams a day) because there are. The bladder problems sound pretty nightmarish as well.
 
justabanana said:
My understanding is that olney's aren't really a concern for humans, but especially not at the doses they're using therapeutically. Not that there aren't terrible effects on the brain from long term high dose ketamine abuse (grams a day) because there are. The bladder problems sound pretty nightmarish as well.
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Glad you brought up the bladder problems. Am curious to see what happens with this as well in the coming years as more and more folks use ketamine.
 
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I don't know enough about this guy.

Let me expand. I've done pharmacogenetic testing years ago, low-dosage naltrexone starting about 1.5 years ago, I've considered hyperbaric O2 treatment, never did it, but only cause I didn't have any access to a hyperbaric chamber and insurance wouldn't pay for it. I was at first against L-Methylfolate but the science was too solid, I started giving it out and noticed significant improvements.

But in all the above, that are considered too cutting edge for some doctors, I always based is on 2 main factors. How much does the science back it up and were more conventional treatments tried and failed?

When there's science backing it up, and the conventional have been tried and failed that's when these other treatments have a place, but the clinician has a duty to explain these aren't as conventional and why. When docs offer, say Ketamine, without at least trying a few antidepressants, and want some outrageous amount of money for it (e.g. $1000 first treatment) and the person isn't even a psychiatrist and is giving it out in a manner that can be abused, doesn't exactly prove he's a quack but makes that doc look very suspicious.

Adding to the above-microdosing with LSD and Psilocybin are showing some data that they could be possible and effective treatments in the psychiatric list of FDA approved meds. Like I said above, what rigors did the clinician go through before using the unconventional? If the patient went through several prior treatments that failed or only had marginal success to the point of exhausting options, the doctor is well versed, read the existing data concerning this unconventional treatment, warned the patient of the risks, and gave it out in a manner to prevent abuse then I'd consider maybe that guy was legit.

Here's an example of irresponsibly pushing a treatment. I've actually seen worse but can't find the worse stuff at this moment.
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It's basically making Testosterone out to be a can of Popeye spinach. The worse one I'm taking about had some old guy with testosterone with hot 20 year old girls in bikinis.
 
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I talked to some drug reps today who were pushing the new Ketamine nasal spray. They told me it'd be available in my area literally within a few days.

I addressed some issues with them. It does require a REMS but to bypass this the the manufacturer is trying to have it done in specific locations only where the staff are trained in the REMS requirements. One of those requirements is the person be driven to the facility. They have to wait there for two hours after it's been administered. The person doing the administering will likely be an NP.

The treatment is thousands of dollars.

I talked to two providers in my practice who offer Ketamine, one of which is highly academically respected but he went into private practice cause frankly the money is better but he does maintain excellent practice standards. The bioavailability is much more with Ketamine vs Esketamine. Further the cost of Ketamine is literally a small fraction of Esketamine.

I mentioned it above but even with the FDA approval Esketamine might not be worth it if there's already a Ketamine provider in the area that's providing it in a competent and safe manner.
 
Crayola227 said:
wow, I only ever saw it in severe migraine and thought it was pretty cool....
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I've seen it used in intubations for patients with low blood pressure in the past. Fun fact, ketamine is also a bronchodilator and it is BP neutral.

We are planning on using it for treatment-resistant patients on an outpatient basis, every two weeks or so depending on when they need it. It's a community mental health clinic so it's going to be a very limited panel but I'm pretty excited
 
whopper said:
I talked to some drug reps today who were pushing the new Ketamine nasal spray. They told me it'd be available in my area literally within a few days.

I addressed some issues with them. It does require a REMS but to bypass this the the manufacturer is trying to have it done in specific locations only where the staff are trained in the REMS requirements. One of those requirements is the person be driven to the facility. They have to wait there for two hours after it's been administered. The person doing the administering will likely be an NP.

The treatment is thousands of dollars.

I talked to two providers in my practice who offer Ketamine, one of which is highly academically respected but he went into private practice cause frankly the money is better but he does maintain excellent practice standards. The bioavailability is much more with Ketamine vs Esketamine. Further the cost of Ketamine is literally a small fraction of Esketamine.

I mentioned it above but even with the FDA approval Esketamine might not be worth it if there's already a Ketamine provider in the area that's providing it in a competent and safe manner.
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I was having this discussion on Facebook actually- ketamine is good enough, esketamine only exists to give big drug companies profits.
 
I’m curious what is going to happen to all the folks who feel way better then insurance stops paying after a couple doses and they invariably crash back into depression? Ketamine seems like psych equivalent of dialysis or insulin, but I doubt insurance would see it that way.
 
Mad Jack said:
I've seen it used in intubations for patients with low blood pressure in the past. Fun fact, ketamine is also a bronchodilator and it is BP neutral.

We are planning on using it for treatment-resistant patients on an outpatient basis, every two weeks or so depending on when they need it. It's a community mental health clinic so it's going to be a very limited panel but I'm pretty excited
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oh, yeah I didn't really mention its use in induction or conscious sedation (I've seen little kids get it for a fracture reduction in the ED, for example) because I guess I took it for granted as mainstream and accepted uses for it.

Outside the uses of basically just putting patients totally out in a setting where emergent airway management was on the table, like, on the floors for chronic pain, that is where everyone sort of shat their pants. Where I saw it most outside of induction/conscious sedation, was for migraine. The providers and patients that use it for that and find it effective, seem to be satisfied. I'd be happy to do it but I think if you have no experience and aren't being supervised by someone who does, then it's pretty daunting.

I think in the context of your program, it's a pretty exciting thing to explore and I'm glad you're going to get that training and experience.
 
Mad Jack said:
I've seen it used in intubations for patients with low blood pressure in the past. Fun fact, ketamine is also a bronchodilator and it is BP neutral.

We are planning on using it for treatment-resistant patients on an outpatient basis, every two weeks or so depending on when they need it. It's a community mental health clinic so it's going to be a very limited panel but I'm pretty excited
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Watch out for referrals for every depressed borderline patient, where every med worked for 2 weeks then stopped, and they’ve been on everything already.
 
Mad Jack said:
I was having this discussion on Facebook actually- ketamine is good enough, esketamine only exists to give big drug companies profits.
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you mean to give Janssen Neuroscience big profits

Crayola227 said:
wow, I only ever saw it in severe migraine and thought it was pretty cool....
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ketamine is used primarily as an induction anesthetic in Pediatrics and Veterinary medicine (works excellent in children and animals. they even use it up in norway on raindeer to remove antlers)
 
I used to work at a research place where Ketamine was offered even years ago.

Watch out for referrals for every depressed borderline patient, where every med worked for 2 weeks then stopped, and they’ve been on everything already.
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A problem with the Ketamine treatment is Borderline PD patients also responded well to it, and the lines between depression and Borderline blur as it does with so many other psychiatric disorders. Yeah you could have both.

But here's what was the problem. Apparently the Ketamine also erased the emotional dysphoria that accompanies Borderline. Is that a good thing? Well heck yeah if that person is also trying to work on the Borderline in other ways such as psychotherapy. The reality was that these patients, when the Ketamine wore off, regressed back to their usual screaming, blaming others, etc, and wanted the short term thing, another Ketamine shot, instead of considering the long-term thing as is often the case with Borderline PD patients. It made me wonder if the Ketamine actually turned these people off to DBT cause of the typical black and white thinking with that disorder--> a med works, it works quick, and now it's the only thing they think they should ever do to treat the bad symptoms.

The behaviors with the demands for Ketamine were on the order of drug abuse even though I don't believe they were getting high off the medication, but like I said, such is associated with Borderline such as, "this medication works for me! You better give it!" Accompanied by angry outbursts and even belligerent behavior. Because the research place often times only had rich patients (and mind you-what kind of wealthy family has a borderline kid, often times a dysfunctional one), borderline-o-genic mom and dad then also give some very belligerent demands. "How much cash do you want? Is that what this is about!?!?!" "I'm the CEO of this corporation so you better listen to me!"

It's as if it was an anti-pharm commercial going on in front of my eyes for people who needed psychotherapy instead of meds. Not just one but several from a one-time dosing.

It's to the point where I'd be wary of giving it to anyone with Borderline PD unless that person was also underoing DBT and taking the therapy seriously.
 
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