Dr. Randy Craven: Thank you all for being here. Today one of the things that I’ve seen change over the last months, and really the last few years, has been the evolution of generics and how much that’s had an impact on the practice of ophthalmology and glaucoma care

You know, if you take a look at kind of the information we have out there as far as what the risks are to patients with elevated intraocular pressure, what we know is if somebody has ocular hypertension, and we’re good about lowering the pressure, we make a difference. You know, we drop the likelihood of them developing nerve damage or field loss by a significant amount. And certainly as we get more aggressive, and we drop the pressure further, as you see in the Collaborative Initial Glaucoma Treatment Study and in the AGIS Study, when we’re more significant about dropping the pressure it seems to make a difference for our patients. So, we know that pressure really matters for glaucoma

And recently the group in New York, and what they call the New York Glaucoma Progression Study, they’ve released more information that gives us tidbits about how important keeping intraocular pressure under control really is. And basically what they looked at is they went through a group patients that they compared all their visual fields and found a subset of patients that had progressive field change. And then, they said, “Let’s try to sort out why do these people have progressive visual field changes.” So, what they found is that if people had higher pressure and per millimeter of mercury it made a significant difference in what happened to their likelihood of progression. And then, they also found that if people had peaks or spikes in their IOP that that seemed to make a difference in the likelihood of them progressing

So, what this story tells us is that for glaucoma patients we know we need to keep the pressure on a lower mean and try to avoid fluctuation, which I have more information on that. But, one of the other things they found in this study, which I found interesting, certainly if you have exfoliation syndrome those people are very responsive to laser treatment. That seems to be a significant risk factor, but those are patients frequently I’ve seen have pressures that bounce around more and they have higher pressures, but then also how much damage that they have, you know, coming in as far as on their optic nerve and disc hemorrhages and beta parapapillary atrophy seem to be significant risk factors

So, you know, if you see somebody that has significant nerve damage that that’s somebody that we want to pay more attention to trying to keep the pressure lower. And, you know, now as we see more and more people coming along that need glaucoma treatment, we know we need to work harder in trying to keep the pressure down. And we’ve seen that our issues with trying to find the right way to keep patients onboard with medications is a challenge, because you talk to patients and you spend time with them, and we know that from demographics that have looked at basically, what’s the refill rate, how often do patients really do what we ask them to do and to stick with their medications or adhere to long-term usage, we see that there’s problems. You know, they don’t refill the medications. They don’t stick with medicines like we’d like to. And, you know, their ability to stick with it is just not as good as we want

You know, this is a study that Dave Friedman and Nordstrom were on where they took a look basically of kind of the behaviors that patients had as they talked to them about, you know, what do you do to make sure that you’re staying on medications. And what the bottom line really boils down to is that if you ask a patient, you know, “Are you compliant,” and they say, “No,” they’re not, and if they say, “Yes,” they usually are. So, the patients usually will tell you, you know, truthful if they’re not. So, this helps you, because if, you know, a patient tells you, “I really don’t want to be on my medications,” or “I’m not doing well with it,” that’s a time to start looking at other options. And, you know, there’s medication reasons that people don’t like them, because they don’t like the side effects or the cost of the medications, which I’ll get into in a little bit more in a minute, and then there’s some, you know, just kind of personal barriers, that some people don’t like them. They can’t get in to get their medications. They’re--they have a tremor. Whatever the other things are that make it hard for them to use it

So, I think that SLT, especially because of the positive things that we’ve seen through numerous studies looking at the effects of SLT long-term on the trabecular meshwork, and what it does acutely to the trabecular meshwork, we see that it’s able to in a more gentle way control pressure for the long-term for people from what we’d seen certainly with ALT. So, SLT I think is a good option to think about

So, I wanted to hit on where I’m certainly moving more towards and that’s offering SLT as a primary option for my patients because of the issues with compliance and the cost of medicines and how all that ties together. And this was a study that was done several years ago, but basically they were trying to look to see if you have somebody that comes in and they have the option of generic latanoprost or an SLT, you know, how are we going to compare? And it showed basically that they’re very similar. You know, so if you’re going to look at just the pressure control component of it, we’re going to end up with about the same results over a period of at least a year and probably, you know, three to five years of the same control between SLT versus latanoprost

And this is another study that Jay Katz did with Bill Steinmann, their statistician friend from New Orleans. And, basically, what they did is they tried to take a look to say, “What’s our efficacy of dropping the pressure?” And they found that really for the SLT therapy it was extremely close in this population to medical therapy as far as in the drop of IOP and there was much less concern about what was going to happen with the patient between visits, because we know that the pressure is down is what happened with the laser

And then, this was another one that Chuck Malamed [sp] had, which took a look at the mean IOP reduction over 18 months. And you ended up in the range of between 15 to 17 for the IOP sustained out. So, we know that SLT as primary therapy seems to be a very good option

And the other thing I think that--you know, that all doctors consider is when you have somebody whose pressure’s in the 20s, how low a pressure are you going to get? Are you going to be able to reach the target goal that you want to have with the SLT? And in my own hands, I’ve found that I usually end up with a pressure, if it’s somebody who comes in presenting in the low 20s, frequently in the mid to low teens. So, I’ll get somewhere between 13 to 17, depending upon the starting pressure for the patients. And this study really bears out to show a very similar thing. And this was the mean IOP reduction with SLT as primary therapy for 60 patients that was sustained out for five years with a pressure of around 13 to 14, which I think’s excellent

And the other thing that’s been brought out by Asrani and co-workers when he was working with Jake Wilensky is they were taking a look to see what happens with the pressure throughout the day. When patients go home are their pressures the same as we see when we measure them in the office? And what they found is there’s a lot of bouncing around. The pressure at home when patients were checking their pressures frequently higher later in the day. So, we know that our control that we get that we measure in the office isn’t really realistic from what’s happening outside of the office hours. So, that’s where we start to take consideration about what happens throughout other times of day

This was a study that was done by Dr. Weinreb’s lab and his fellow at the time, which was Sameh Mosaed, as well as Lee, took a look at the effects of the SLT on a 24 hour period of time, which was done in the sleep lab at the Hamilton Eye Research Institute there. And what they found is that the pressure control was better for the people who had had SLT

So, the message is kind of evolving here. Is that we have concerns about, you know, patients being able to use medications. Their pressures may be bouncing around at different times of the day. Maybe, we don’t get the control throughout 24 hours that we’d like to have with mediations. So, perhaps SLT makes a little more sense for these patients in trying to get the pressures down. And if you start taking a look at the--you know, the cost that goes into glaucoma healthcare, we see that clearly the earlier stage of disease we don’t need to do as much, but once people start progressing along, we need more medications, surgery, more testing, and it adds up to where it’s thousands of dollars per year to take care of these people. You know, the average cost for a routine glaucoma patient just coming in the doctor’s office is somewhere between two and three hundred dollars as far as Medicare costs per year. Then you add medications on top of that or surgeries, treatments, you know, and then you have to kind of look at the big picture

And this was a study that came from Steve Vold was the primary drive behind this, but what they did is they went back through and they looked at the pharmacy costs for different medications and how much it cost over a year. And what they found is that, you know, people who are on brand name prostaglandins, or brand name alpha agonists, or fixed combination products, what it actually cost for them to be on it, and, you know, per year it’s a substantial amount of money that we spend

This study here was just recently published. And I reviewed it in a journal club not too long ago. And I really find it interesting, but what it was it was a population based study trying to take a look at a model of what it actually costs us to take care of somebody with glaucoma. And they said, “Okay, let’s just say that somebody does get generic latanoprost or they get a brand name prostaglandin.” So, here you have--this was brand name Xalatan. Then you have generic latanoprost down here. And then, they took a look at the actual wholesale cost of the medication. So, it’s the true cost of medicines according to the wholesale catalog. And then, they said, “If that’s the cost of that, how would that compare to the actual cost of what it would cost a Medicare beneficiary to get bilateral SLT, maybe have a bottle of predacitate [sp] used and maybe timolol for a short period of time to control the pressure?

So, what they were saying is, you know, you just assume that there might be a little bit of pressure issues for a short while after the SLT, maybe some inflammation, and you take that total cost package, okay, and look at that and then compare that, what’s the cost going to be comparing that with brand name medications or with generics, and how long does it take you to cross the threshold for equal costs doing bilateral STL compared to using medications? What’s interesting is it only takes you half a year with brand name products to be at a cost saving benefit. You know, for our patients with generic drugs it’s longer. We see that it’s at, you know, a year to longer than a year to cross that threshold, but nonetheless what we’re facing right now with our healthcare crisis is analysis of what we do as providers

You know, so what we’re going to have is big brother, whoever that is, insurance companies, you know, Medicare, looking at us, and then saying, “Okay. Well, your behaviors are such that it cost this much per year for you to take care of this glaucoma patient. You know what; we see down the street somebody else is doing it at a lower cost. We want to question, you know, why is this?

So, I think this plays right into our role about decision for primary therapy. And, you know, I think that the primary procedure intervention for glaucoma we’re getting much more comfortable with that as an option, because we have better diagnostic capabilities. We feel more comfortable about our diagnosis. We have better ability to follow for progression, and we feel better about that. So, I think the comfort of moving towards SLT as primary therapy is here. And I--you know, I’ve certainly talked to my patients much more about it over the last few years than ever. And even with generic latanoprost, you know, there’s--that’s a lower cost but there’s issues with it because there’s differences in the formulations, patients who come in, who have been pretty well controlled, sometimes they’ll show back up and their pressures will be higher. And so, there’s all these variables, and they’re just kind of getting stirred up and up to the forefront for us to look at, but I think what the bottom line is, is that we know that primary SLT therapy, as short as six months, and as long as a few years crosses the threshold of where it’s more cost benefit with similar pressure controls we saw within those studies to using medication. So, I think SLT as primary therapy makes some sense. It’s at least a reasonable option to discuss with patients and to consider. And, you know, that its mechanism of action doesn’t seem to have any side effects with the body. It’s very selective. It doesn’t seem to damage the meshwork, and we know that it--you know, it just really makes sense. It’s smart and it makes sense as far as what it does to our patients and to help them stay under better control

Thank you