Cobenfy
Started by Attending1985
I tried to order it from patient's pharmacy. They required PA. I filled out the PA. It was declined immediately. Said patient needed to have failed either Vraylar or Caplyta, and we have to provide them copies of a recent EKG, LFTs and CBC. We appealed and again described how patient has tried and failed: Zyprexa, Vraylar, Latuda, Risperdal, Clozapine, Caplyta and is currently on ECT #10 (bilateral) with mild to moderate response, depending on who you ask. All of this info was in the first PA we submitted.
We got a response that they will take the next 30 days to review the appeal....so we called today for an expedited appeal and the person told us to re-fax the appeal with the words "Please expedite" on the cover sheet.
I know insurance companies are a necessary evil, but this process is a joke.
We got a response that they will take the next 30 days to review the appeal....so we called today for an expedited appeal and the person told us to re-fax the appeal with the words "Please expedite" on the cover sheet.
I know insurance companies are a necessary evil, but this process is a joke.
I looked at the efficacy a while back and if i recall, efficacy did not seem overly impressive? But it can be used as an add on which is nice. Seems like GI side effects may be an issue.
nice not to have to worry about movement symptoms though, and at least have something fairly different
nice not to have to worry about movement symptoms though, and at least have something fairly different
Recent case: I used in a run of the mill psychosis case. It didn't produce side effects, but in the end the patient found olanzapine to be more effective.
I have one patient on it who really should be on Clozapine but blood draws are just not an option (even looked into the Athelas device and that was a no-go). So far...results have not been impressive but to be fair, this is a pretty tough patient.
It was super easy to get covered though, after a PA. Has Medicare.
It was super easy to get covered though, after a PA. Has Medicare.
Tried it once. The insurance covered the starter pack and intermediate dose, but not the high dose. The patient did not notice much of anything, positive or negative, from the trial.
How often are you seeing this? Because if that's the case that would be massive, as those are the symptoms that are typically residual and cause long-term dysfunction. Would be one of the biggest breakthroughs in psych in a long time...
Worth examining in depth:
More Xanomeline Data On Cognitive Outcomes
A new analysis that suggests some benefits in cognitively impaired schizophrenics at baseline
polypharmacy.substack.com
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After reading this completely agree. Also makes me even more curious about it's use as an adjunctive medication for our more classic antipsychotics (anit-dopaminergic agents). I think I'm most impressed by a PGY-3 with a blog post that breaks that study down so nicely!Worth examining in depth:
More Xanomeline Data On Cognitive Outcomes
A new analysis that suggests some benefits in cognitively impaired schizophrenics at baseline
Idk how I feel about adding Cobenfy to Haldol. What would be your plan if they had an acute dystonic reaction / needed agitation medications? Obviously, could just go with a benzo or something, but adding a central pro-cholinergic to Haldol...just seems off to me for some reason. I recognize that this might not be relevant / based on data.
Doesn't have to be haldol, could specifically go for an indication to add to SGAs or partial agonists. I'd be more curious about combining with something like olanzapine or Abilify, but I think your concern is certainly valid.
Update: My PA appeal was denied. Stated reason was because we didn't submit labs (we did) and that patient didn't fail Caplyta (which they did). Despite these things clearly written and highlighted on the documents submitted, this was their excuse for denying the Cobenfy.
The audacity. At the bottom at the appeal it says that this appeal was reviewed by a "board certified physician trained in psychiatry." Hope that person loses their license..
They probably got a raise
Why did you have to submit labs?
Nils was a resident of mine and is fantastic as is his Substack - which I’ve had the pleasure of reviewing a few posts.
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I do kind of wish there were a way to add the central pro-cholinergic effects without increasing peripheral anticholinergic burden when adding to clozapine or Zyprexa or other anticholinergic meds. Obviously all hypothetical. Maybe there will be different combo pills in the next twenty years.
Great question. It was part of their requirements. We submitted the labs. They said we didn't.
I'm both annoyed by this requirement and impressed. Requiring baseline labs as part of prior authorization for a medication that recommends it is not nearly as upsetting a requirement as step therapy or failure of 5+ alternatives.
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My understanding is a liver panel and checking heart rate before starting it. Why ekg and cbc?
Hey, that's me! I'm actually a PGY-4 now, so I'm not quite as impressive as you think, but I'm glad you enjoyed my work.
Thanks also @clausewitz2 for thinking highly enough of that post to share it in the first place.
@Taddy Mason - are you the former owner of a Jeff Goldblum picture, perhaps?
This is very much at odds with what the data from the RCTs say. It seems to be as good as the average antidopaminergic with treating positive symptoms, better than the average antidopaminergic at treating negative symptoms (but not that much better), and probably treats cognitive symptoms in a subset of schizophrenics who are impaired at baseline.
I walk through the data on positive and negative symptoms here:
A New Therapeutic For Schizophrenia
It's Not Just A New LAI This Time, I Promise
polypharmacy.substack.com
Ha - guilty.
I have a patient with well controlled schizophrenia who has been on clozapine and a stimulant to counter the sedation for a number of years and has heard of this drug and has some interest in it. Wondering if any of you all have more thoughts or experiences with it since last posts.
Awesome, love your Substack! I'm anonymous here but I've commented on some of your posts on Substack with my real name.
Now I'm wondering if Awais Aftab, Scott Alexander, and some of the other psychiatrists I follow on Substack are also here under aliases... maybe Hannah Spier as well
Nope, but if they're well controlled on their current regimen and it was difficult to get them to that put, I wouldn't screw around with their meds because they relate to "Bryan's Story".
Side note, is anyone else confused how Cobenfy ads are getting away with saying "Cobenfy is not an antipsychotic"?!? This seems like a pretty egregious violation as everyone I know and have seen calls it an antipsychotic. The FDA packet insert even has links in it to a page for more information on atypical antipsychotics in pregnant women? My SO was in advertising for 10+ years and was insistent that this would very illegal and that it must not be an antipsychotic if they're saying it's not. Anyone have any idea how they're justifying this to not get massive fines or penalties?
I’m guessing that’s just their way of differentiating it from DA antagonists. Idk that “antipsychotics” are a recognized “formal” drug class legally (I believe it’s just by chemical structure/class) and it’s kind of misleading as they aren’t just used for psychosis and some have different MOAs (clozapine for example, I suspect some or most of it’s efficacy is related to M4 agonism, pimavanserin, etc). I personally don’t like the term “antipsychotic” and tend to refer to them as dopamine antagonists even with patients and have found that some patients are more receptive to taking them when I explain this as they find it less “labeling” or pejorative. Overall, I like Ghaemi’s way of classifying/labeling psychotropic drugs by their MOAs rather than the primary disorders they’re used to treat (e.g., monamine agonist v. antidepressant, 2nd messenger modifiers v. “mood stabilizer,” etc.)
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I get that, but traditionally speaking “antipsychotics” in lay terms are used to treat psychotic symptoms and advertising laws are extremely strict about what can and can’t be said to the point of ridiculousness at times. For example, products can’t even use words like “approved by (any kind of healthcare worker)” in their ads as it violates FDA regulations. My wife used to write ads for a major dog food company and the things they can’t say are astounding.
So I’m just baffled how they can say it’s approved for schizophrenia and is effective for positive and negative symptoms while claiming it’s not an antipsychotic.
Over rated
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What have been your experiences with it?
Over rated. Not that clinically effective in severe psychosis and aggression
Any new perspectives on cobenfy? I am in a position where I interface with drug reps often and the cobenfy reps rave about how well it helps with negative symptoms and cognition in psychotic patients. Of course I take what they say with a grain of salt, to put it mildly. Has anyone seen this is in practice or have colleagues who can corroborate this?
EMERGENT-4 trial was just published in AJP, worth reviewing, it was the first of the year long follow up trials but with the same population (spoiler: the same population apparently did not like being followed for a year... so most left). I found the results underwhelming compared to what was said about it before it was published - shocker. No additional experience yet though.
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Think you meant EMERGENT-5? (4 was published in 2024).
Lot of dropouts like you said:
"Fourth, the trial discontinuation rate of 51.1 % should be considered when interpreting results."
Whatever this is (I got the journal wrong and edited my post)
Have yet to see a patient failing trials of the classic go-to options do better with this. I have watched stable patients deteriorate, however.
N of maybe 10 SPMI inpatient setting.
Interesting. What were the reasons for switching over to Cobenfy? Why would they be inpatient if they were stable?
Are you seeing this with switching to Cobenfy or using it as augmentation?
I'm assuming it's either a forensics or long-term unit if they're "stable" SPMI patients.
Only new notable data is that it looks like it is probably not a very good adjunct to the SGAs:
Cobenfy Might Not Be A Good Adjunct
Some disappointing preliminary data from BMS
polypharmacy.substack.com
I've found that the BID dosing and food timing really matters and can really trip up patients on already complex regimens. It otherwise seems well tolerated in the few inpatients I've had on it.
Otherwise, I don't really think that anyone's anecdotal experience with it here should matter too much when it comes to how we understand efficacy. That's what the RCTs are for.
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Try saying that on the “Psychiatry Network” Facebook page…it’s really disheartening.
Either that or the "they were stable but they were switched to Cobenfy to address cognitive concerns and now they decompensated and are in the hospital."
This.
Large RCT's should guide our decision making. But a clinician's anecdotal experiences also end up playing a role. There is so much more nuance and noise in real cases. I know my patient's histories almost never look as neat and tidy as the perfectly tee'd up study participants who researches feel are an ideal fit for a particular clinical trial population.
I’m referring to people blatantly rejecting or going against the findings of established RCTs and other forms of higher quality objective data (e.g., well established pharmacokinetics and dynamics) over their subjective, anecdotal n of <10 or whatever.
My patients with PTSD who have benefited significantly from a certain medication (not stating which one-not a benzo) being added to their regimen do not care about the RCTs that show it is not an efficacious treatment for this illness.
I hope providers will continue to share their experiences with Cobenfy so that we all may benefit.
