Su-Freakin-Gammadex!!!

Started by soonerfrog
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soonerfrog

soonerfrog

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So the Rep from Merck popped over the other day (mostly just to say hi and tell us its prob gonna be another 3 mo, Sept maybe) and it got me to thinking...what in the world is up the FDA? Have they finally lost their minds? Did the last round of Cox2i drugs burn their asses so much they've finally lost all reason?!? I'm aware of the political backstory(ies) but I still don get it. I think if you tried to push a drug like Neostigmine through today, they'd laugh you out of the room! "You want us to approve a cholinergic poison people use to kill bugs and and in some cases, people if you're the Vietcong or Al-Qaida....the only difference in yours being the dose and an ionic bond?!?!?!?"
I just don't get it. Neo's side effect profile is atrocious for a reason. Just because we've had it for years doesn't mean there's not a better way and a designer drug meant to work as an inclusion complex seems brilliant! Am I bonkers? Anyone else have a love affair with this drug, or more likely, a deep, seething hatred of our current reversal agents? Thoughts?
 
I think the key to loving it or not will be the price point. If it is as expensive as the rumors I've heard, it will sit on the shelf unused.
 
jwk said:
I think the key to loving it or not will be the price point. If it is as expensive as the rumors I've heard, it will sit on the shelf unused.
Click to expand...

Just until your institution has a root cause analysis for a patient who got in serious trouble for inadequate reversal and failure to recognize and treat appropriately.
 
I've used it during the clinical trials... it's pretty impressive... we would give it 15 mins after the last dose of Rocuronium (I think it was at least 0.6 mg/kg) and within 45 seconds return of 70% muscle function, 90% at 90 seconds... and we used the fancy schmancy monitor....

I think it'll have some purpose.. routine use on everyone? No... but definitely some utility...

I like that the FDA is being cautious.. remember Rapacuronium?

drccw
 
i wouldnt use it for the cost alone. we deliver millions of anesthetics a year in this country without and have probably done close to a billion with only our monitoring, our clinical judgement, and our 'physiologic' reversal agents. i rarely worry about patient safety. it would be nice to have in a pinch when you think someone is weak and you want to be sure they are reversed or for the RSI gone bad (although i still think you wont get saved from that) but i cant see myself using it as more than a novelty drug otherwise. in outpatient settings with quick turnovers etc i could see it taking off, going from totally still to strong that quickly would keep the conveyor belt moving and potentially eliminate some of the annoying s/e of sux.
 
I use this drug reasonably frequently. It is very impressive and works unbelievably fast. Some of the things we have used it for: allergic reactions to non depolarizers, reversing NMB in pt with MG, and obviously it is great if you need to reverse an NMB like roc or vec quickly. If I have a pt that is totally relaxed at the end of a case, it's a lot nicer than giving a huge dose of reversal and hoping for the best while inducing a lot of unwanted side effects.
 
Sonny Crocket said:
I use this drug reasonably frequently. It is very impressive and works unbelievably fast. Some of the things we have used it for: allergic reactions to non depolarizers, reversing NMB in pt with MG, and obviously it is great if you need to reverse an NMB like roc or vec quickly. If I have a pt that is totally relaxed at the end of a case, it's a lot nicer than giving a huge dose of reversal and hoping for the best while inducing a lot of unwanted side effects.
Click to expand...

i understand that things happen (aborted case, etc) but we have ways of preventing patients from being totally relaxed at the end of cases. what is the unit cost and is it worth it over vigilance re: lower dosing of NBM?
 
Sonny Crocket said:
I use this drug reasonably frequently. It is very impressive and works unbelievably fast. Some of the things we have used it for: allergic reactions to non depolarizers, reversing NMB in pt with MG, and obviously it is great if you need to reverse an NMB like roc or vec quickly. If I have a pt that is totally relaxed at the end of a case, it's a lot nicer than giving a huge dose of reversal and hoping for the best while inducing a lot of unwanted side effects.
Click to expand...

I think these are really the only utilities it's going to have - reversal in unexpectedly short cases, short cases where RSI was needed but sux wasn't used for whatever reason, or cases where the patient was overdosed on NMB's during the case. I don't see it replacing neo/glyco for routine reversal of NMB's unless it has a favorable price point.

With experienced practitioners, residual blockade should almost never be an issue. It's a very rare thing for our group to see a patient that is "totally relaxed at the end of the case" because that means someone wasn't really paying attention. Sure, you get the occasional patient at the far end of the bell curve that acts unexpectedly, but most of the time if it happens, it's because someone gave too much too close to the end of the case and got burned. Perhaps the savings in OR/anesthesia time might make it reasonably cost effective, but I'm not sure. Do any of you that are already using it know what the hospital cost and/or patient charge is at your facilities?
 
In Belgium it"s around 70 euros for the small vial of 80mg (i think) but i've never used it. It's been on the market for a couple of years now and i don't have knowledge that it's being usded dwidely. Where i work everyone uses atracurium so it's not around.
 
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Idiopathic said:
i understand that things happen (aborted case, etc) but we have ways of preventing patients from being totally relaxed at the end of cases. what is the unit cost and is it worth it over vigilance re: lower dosing of NBM?
Click to expand...

Bro. My point is that it is a useful drug to have access to. You may be vigilant but are all your new residents and crnas that good? and it is a drug that can save lives.

4mg/kg for reversing a TOF < 25% costs around $275 for a 70kg pt. 16mg/kg is the dose for emergent reversal in case of airway problem. It aint cheap but neither is that novo 7 that your heart surgeon asks you to give for no apparent reason.
 
Sonny Crocket said:
Bro. My point is that it is a useful drug to have access to. You may be vigilant but are all your new residents and crnas that good? and it is a drug that can save lives.

4mg/kg for reversing a TOF < 25% costs around $275 for a 70kg pt. 16mg/kg is the dose for emergent reversal in case of airway problem. It aint cheap but neither is that novo 7 that your heart surgeon asks you to give for no apparent reason.
Click to expand...

Doesn't matter. If it costs big $$$ and it's new, we'll use it here in good ol' Amurrica.
 
fakin' the funk said:
Doesn't matter. If it costs big $$$ and it's new, we'll use it here in good ol' Amurrica.
Click to expand...

Actually this only applies to the big university hospitals where money is not an issue.
This medication is going to have a very hard time convincing the pharmacy committees in smaller hospitals to have it on formulary because of the price.
 
Sonny Crocket said:
Bro. My point is that it is a useful drug to have access to. You may be vigilant but are all your new residents and crnas that good? and it is a drug that can save lives.

4mg/kg for reversing a TOF < 25% costs around $275 for a 70kg pt. 16mg/kg is the dose for emergent reversal in case of airway problem. It aint cheap but neither is that novo 7 that your heart surgeon asks you to give for no apparent reason.
Click to expand...

thats more than the profit margin on most medicare cases. why suck up your profits (and teach your junios to be lazy) when you could just keep the patient less relaxed.

i agree that there are some cases where it would be nice to have, i just cant see myself using it routinely
 
Impromptu said:
OR costs are around $2000/hour. Could be useful and cost beneficial for an emergent RSI globe rupture case that takes just a couple of minutes.
Click to expand...

The operating room BILLS $2000/hr. It doesn't "cost" that. They don't even get that reimbursed. Actual costs are much much lower, but impossible to calculate exactly because they include fixed building costs, electricity, opportunity costs, etc.
 
soonerfrog said:
So the Rep from Merck popped over the other day (mostly just to say hi and tell us its prob gonna be another 3 mo, Sept maybe) and it got me to thinking...what in the world is up the FDA? Have they finally lost their minds? Did the last round of Cox2i drugs burn their asses so much they've finally lost all reason?!? I'm aware of the political backstory(ies) but I still don get it. I think if you tried to push a drug like Neostigmine through today, they'd laugh you out of the room! "You want us to approve a cholinergic poison people use to kill bugs and and in some cases, people if you're the Vietcong or Al-Qaida....the only difference in yours being the dose and an ionic bond?!?!?!?"
I just don't get it. Neo's side effect profile is atrocious for a reason. Just because we've had it for years doesn't mean there's not a better way and a designer drug meant to work as an inclusion complex seems brilliant! Am I bonkers? Anyone else have a love affair with this drug, or more likely, a deep, seething hatred of our current reversal agents? Thoughts?
Click to expand...

Lots of drugs already available today would never be approved. Aspirin and diphenhydramine come to mind immediately.
 
Planktonmd said:
Actually this only applies to the big university hospitals where money is not an issue.
Click to expand...

No it doesn't.

I'm talking broadly about medicine in general.

Tell me that we (physicians and patient "consumers") don't have a boner for things that are new, expensive, and shiny just like everyone else does for every other type of product.

Chemotherapy drugs and dexmedetomidine come to mind.
 
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At a lower pricepoint, this drug could be incredibly useful. Can you imagine offering the surgeon a completely limp patient for abdominal closure and then reversing them to full strength in a matter of 3 minutes. They could get spoiled. There may be a new standard of relaxation for closure....and I say why not? Part of our job is to make things easier for our surgical friends. Everyone benefits in the end. This is progress.
 
Idiopathic said:
those things make people better and practice safer. this drug makes people lazier and practice poorer (my opinion)
Click to expand...

I don't know about that.

If the day comes that Suggamadex turns out to be as safe, and costs the same as neostigmine, would you ever choose the IV insecticide (+ glyco) over the specific reversal agent? I wouldn't.

I might never use neostigmine again ... or cisatracurium either, for that matter. Except maybe for unexpected takeback cases that needed a relaxant, I guess.
 
no we would probably abandon the stigmines entirely. However, at 1000 times the cost, there is no reason to use it when we have a perfectly acceptable system that is based on not overdosing your patient, effectively monitoring said patient, and knowing when and how to effectively antagonize the blockade.

obviously there are exceptions which have been discussed but for 99.5% of the patients we see, I would think the cost significantly outweighs any benefit
 
Idiopathic said:
no we would probably abandon the stigmines entirely. However, at 1000 times the cost, there is no reason to use it when we have a perfectly acceptable system that is based on not overdosing your patient, effectively monitoring said patient, and knowing when and how to effectively antagonize the blockade.

obviously there are exceptions which have been discussed but for 99.5% of the patients we see, I would think the cost significantly outweighs any benefit
Click to expand...

It will be like Zofran before it lost the patent. Back then there were protocols indicating which patients warranted Zofran. Giving it was a rare event. You felt like a wimp for using it. When the patent was lost suddenly it became as common as using a pulse ox.
 
fakin' the funk said:
No it doesn't.

I'm talking broadly about medicine in general.

Tell me that we (physicians and patient "consumers") don't have a boner for things that are new, expensive, and shiny just like everyone else does for every other type of product.

Chemotherapy drugs and dexmedetomidine come to mind.
Click to expand...

In the real world:
We... Physicians do not decide what medication gets approved by the pharmacy committee.
And patients have no say what so ever in what kind of care they get.
 
fakin' the funk said:
No it doesn't.

I'm talking broadly about medicine in general.

Tell me that we (physicians and patient "consumers") don't have a boner for things that are new, expensive, and shiny just like everyone else does for every other type of product.

Chemotherapy drugs and dexmedetomidine come to mind.
Click to expand...

Plank is spot on - things are different in the real world.

BTW - We do 40k+ anesthetics a year and not a single patient has gotten dex.

There's a difference between things like pulse ox and US for blocks (+) and CVL's (+/-) and using sugammadex. We had to decide whether those things were useful compared to previous modes of practice, but cost was not a huge factor. SaO2 was a no brainer - the only other option was "...the blood's gettin' a little dark, son...". US is a no-brainer as well for the types of blocks we're doing but there are still a lot of us old guys that can still pop in an IJ before you get the US machine booted up. And a single US machine can be used for a whole OR suite worth of blocks.

With sugammadex, you're taking a drug that is probably hundreds of times more expensive than what we use now, with very limited benefits. There are still places that use isoflurane instead of desflurane due to cost issues, and they're much closer together in price than sugammadex and glyco/neo. You think those places will make the jump? Nah.
 
Last edited:
jwk said:
Plank is spot on - things are different in the real world.

BTW - We do 40k+ anesthetics a year and not a single patient has gotten dex.

There's a difference between things like pulse ox and US for blocks (+) and CVL's (+/-) and using sugammadex. We had to decide whether those things were useful compared to previous modes of practice, but cost was not a huge factor. SaO2 was a no brainer - the only other option was "...the blood's gettin' a little dark, son...". US is a no-brainer as well for the types of blocks we're doing but there are still a lot of us old guys that can still pop in an IJ before you get the US machine booted up. And a single US machine can be used for a whole OR suite worth of blocks.

With sugammadex, you're taking a drug that is probably hundreds of times more expensive than what we use now, with very limited benefits. There are still places that use isoflurane instead of desflurane due to cost issues, and they're much closer together in price than sugammadex and glyco/neo. You think those places will make the jump? Nah.
Click to expand...


I used to worry a lot more about costs until I saw the sh 1t that goes on in our ICUs daily.
Suggammadex is the business. I'm not saying to use it as a reversal agent in all of your patients. When you need it, it is great.
 
Bump. Any new info or will this be the unicorn drug of our future: everyone knows what it is but no one's ever actually seen it.
 
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