Cobenfy

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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.
 
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
 
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.
 
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.
 
It seems effective for negative and cognitive symptoms, has no metabolic issues I've seen, but does not impact positive symptoms (a decent add-on).
 
milesed said:
It seems effective for negative and cognitive symptoms, has no metabolic issues I've seen, but does not impact positive symptoms (a decent add-on).
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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...
 
Stagg737 said:
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...
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Worth examining in depth:

polypharmacy.substack.com

More Xanomeline Data On Cognitive Outcomes

A new analysis that suggests some benefits in cognitively impaired schizophrenics at baseline
polypharmacy.substack.com polypharmacy.substack.com
 
clausewitz2 said:
Worth examining in depth:

polypharmacy.substack.com

More Xanomeline Data On Cognitive Outcomes

A new analysis that suggests some benefits in cognitively impaired schizophrenics at baseline
polypharmacy.substack.com polypharmacy.substack.com
Click to expand...
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!
 
Stagg737 said:
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!
Click to expand...
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.
 
ObsequiousAplomb said:
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.
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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.
 
psych_0 said:
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.
Click to expand...

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..
 
psych_0 said:
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..
Click to expand...
Why did you have to submit labs?
 
Stagg737 said:
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!
Click to expand...
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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Stagg737 said:
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.
Click to expand...
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.
 
psych_0 said:
Great question. It was part of their requirements. We submitted the labs. They said we didn't.
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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.
 
psych_0 said:
Great question. It was part of their requirements. We submitted the labs. They said we didn't.
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My understanding is a liver panel and checking heart rate before starting it. Why ekg and cbc?
 
Stagg737 said:
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!
Click to expand...

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?
 
milesed said:
It seems effective for negative and cognitive symptoms, has no metabolic issues I've seen, but does not impact positive symptoms (a decent add-on).
Click to expand...

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:

polypharmacy.substack.com

A New Therapeutic For Schizophrenia

It's Not Just A New LAI This Time, I Promise
polypharmacy.substack.com polypharmacy.substack.com
 
ClosetCentrist said:
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?
Click to expand...
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.
 
ClosetCentrist said:
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?
Click to expand...
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 :thinking:
 
smalltownpsych said:
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.
Click to expand...
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?
 
Stagg737 said:
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?
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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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Taddy Mason said:
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.
 
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