Vabysmo

[hello lady!]

For those of us who have been spoiled and been using pre-filled Eylea syringes, what syringe are you using for Vabysmo? Are you using a silicone free one? Those options seem to be limited.

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[MstaKing10]

doesn't it come with syringe, filter and needle?

 

[hello lady!]

doesn't it come with syringe, filter and needle?

Just a filter. It's BYO syringe and 30G needle

 

[MstaKing10]

I suppose we are likely to use a standard 1ml tuberculin syringe from BD. We haven't used much vabysmo due to reimbursement issues. Have you experienced any issues? Do they have a J code yet? I'm interested in using but I think we still haven't gotten paid for one of the earlier injections so we are a bit hesitant to do more.

 

[Slide]

I suppose we are likely to use a standard 1ml tuberculin syringe from BD. We haven't used much vabysmo due to reimbursement issues. Have you experienced any issues? Do they have a J code yet? I'm interested in using but I think we still haven't gotten paid for one of the earlier injections so we are a bit hesitant to do more.

J code should be coming Oct 1st, from what the Genentech rep told me last weekend. We’ll see.

 

[MstaKing10]

Ok thx. I feel like genetech is in a bit of a pickle. Launched susvimo and vabysmo concurrently sort of competing with itself, major reimbursement issues for both, regeneron will soon have high dose Eylea, and on top of that biosimilars are on the near horizon

 

[Slide]

Ok thx. I feel like genetech is in a bit of a pickle. Launched susvimo and vabysmo concurrently sort of competing with itself, major reimbursement issues for both, regeneron will soon have high dose Eylea, and on top of that biosimilars are on the near horizon

I agree, Susvimo is Genentech's last attempt to squeeze out whatever they can out of Lucentis, but financially it reimburses poorly for both the surgery and the refill. More worrisome, I'm hearing reports of endophthalmitis from surgeons who were initially pretty high on it during clinical trials. PDS is great as a concept but I don't think it'll catch on due to the risks - there's a reason why glaucoma surgeons have been trying to move away from trabs and tubes. They should really be pushing Vabysmo hard.

For the biosimilars, it'll come down to cost, but the Lucentis biosimilar currently isn't that much of a cost reduction.

 

[4424]

Financially Susvimo does not reimburse poorly for either the surgeon or the surgery center. 67027 reimburses quite well considering the implant takes about 20-25 min to do. The refill is an intravitreal injection and is reimbursed at 67028 appropriately. The black box warning on it likely makes it less of an appeal but it will have its place.

 

[RetinaDude]

I agree, Susvimo is Genentech's last attempt to squeeze out whatever they can out of Lucentis, but financially it reimburses poorly for both the surgery and the refill. More worrisome, I'm hearing reports of endophthalmitis from surgeons who were initially pretty high on it during clinical trials. PDS is great as a concept but I don't think it'll catch on due to the risks - there's a reason why glaucoma surgeons have been trying to move away from trabs and tubes. They should really be pushing Vabysmo hard.

For the biosimilars, it'll come down to cost, but the Lucentis biosimilar currently isn't that much of a cost reduction.

I’ve tried to sign a few pts up for the PDS because I figured there’d be strong interest in only needing a refill every six months. Most pts are excited until I tell them about the reported 4% endo rate with the PDS.

 

[Dusn]

The septum in the PDS also apparently has a high rate of dislodging in actual real world use.

I avoid most drugs and devices the first year they come out. The adverse event rates detected and reported by company funded trials don’t always seem to reflect what’s seen after the trial.

 

[Slide]

The septum in the PDS also apparently has a high rate of dislodging in actual real world use.

I avoid most drugs and devices the first year they come out. The adverse event rates detected and reported by company funded trials don’t always seem to reflect what’s seen after the trial.

Just heard from one of my colleagues that due to the septum dislodgement rate being much higher than expected from clinical trials, it will likely undergo voluntary recall. Oops.

Yeah I don't see Susvimo really working out long term, especially if Vabysmo really gets us to Q4 month extension or more. Maybe if Genentech filled the reservoir with Vabysmo and was able to show no treatment for a year...

 

[MstaKing10]

Just heard from one of my colleagues that due to the septum dislodgement rate being much higher than expected from clinical trials, it will likely undergo voluntary recall. Oops.

Yeah I don't see Susvimo really working out long term, especially if Vabysmo really gets us to Q4 month extension or more. Maybe if Genentech filled the reservoir with Vabysmo and was able to show no treatment for a year...

Heard about this. This is a major problem. Device needs to be redesigned sounds like. I was told this is an issue with re-filing, and more likely a problem after multiple refills. At any rate, great proof of concept, but not ready for prime time is my take. Now that Vabysmo has permanent J code, will likely start moving more non-responders that direction.

 

[MstaKing10]

The septum in the PDS also apparently has a high rate of dislodging in actual real world use.

I avoid most drugs and devices the first year they come out. The adverse event rates detected and reported by company funded trials don’t always seem to reflect what’s seen after the trial.

clear throat...Beovu...cough...cough

 

[Dusn]

clear throat...Beovu...cough...cough

Beovu is the most blatant example. But we can keep going

Remember jetrea?

Now tepezza (drug for thyroid eye disease) is apparently causing a lot more hearing loss than previously reported.

As expected, I’m hearing about more cases of RD after Vuity use from colleagues, when somehow the trials had nearly no AEs

And on a different topic, I find it interesting that regeneron suddenly realizes that simply increasing the concentration of eylea will substantially decrease the frequency of needing eylea. They didn’t know this before? coincidentally they only realize this when they have competition that can compete with eyleas duration.

Sorry. Feeling a bit curmudgeonly today.

 

[MstaKing10]

You are 100% on point. they used higher dose (4mg) in their phase 2 and it showed no benefit over 2mg a decade ago. They want you to forget that and say 8mg is something new and miraculous. Also the higher dose may have more systemic side effects, but these studies are always underpowered to demonstrate that but there have been signals regarding systemic risks associated with Eylea. I would not inject bilateral high dose Eylea (since studies don't we won't know of any increased systemic risk but I suspect there is with bilateral injections) and definitely not in diabetics.

Who's tried a biosmilar? They are approved now. Can't wait to see what kind of issues are uncovered with those.

 

[TheLesPaul]

The issue with tepezza is that TED is a rare disease so the n in the treatment arms was only 40 pts for each of the phase 2, 3 studies. Very hard to adequately power a study for side effects that are also rare. i think 10-20% is realistic (bit higher than the papers) but not all of it is reversible and it is just poorly understood. i wouldn't have suggested to delay the approval to suss it out, however, as the drug is doing a lot of good and there are no alternatives