THE HEART OF THE MATTER
a special program of the National Emergency Medicine Association (NEMA) 

Week: 569.6 Guest: Dr. Susan Fagan, Pharmacology, Henry Ford Health System, Wayne State Univ., Detroit, MI Topic: The cost effectiveness of TPA for stroke patients Producer/Host: Steve Girard

NEMA: Half a million of us will suffer strokes this year, and 150 thousand will die from them. Stroke costs the nation 30 billion dollars a year. A while back, a study conducted by the National Institute of Neurological Disorders and Stroke, or NINDS, found that the clot dissolving drug called t-PA could increase full recovery months, 9 months and 12 months. And so we had some new data that hadn't been published yet....from those data, we were able to model the cost of using TPA, compared to not using TPA. And so, some of the things we had to model were things like the cost of having a hemorrhage, the cost of being monitored in an ICU for 24 hours, which normally stroke patients wouldn't do unless they received a thrombolytic. Also we put in estimates of how much it costs to be in a nursing home per year...and how long an average patient would stay in a nursing home. We didn't have the primary data from the trial. Also how much it costs for rehab, and then outpatient rehab services if you went home. We modeled it out for 30 years, including an estimate for mortality after one year, and an estimate of recurrent stroke. And we also did an analysis at one year, because the data we had was to one year....we wanted to see what the cost would be at one year, since we didn't have to extrapolate with the model at that point. So, we did it because as soon as these results were announced...the press was asking the investigators, "Is it worth it"?...because of the drug being 2 thousand dollars a dose! So we had planned on doing this all along, because the public is interested in it.

NEMA: That's exactly right, because from our aspect, we notice that administering TPA, unlike a lot of new developments or technological advances of many sorts that you see in hospitals, is projected to reduce overall costs for that patient, rather than increase the costs....as when the patient needs to have a new machine of some sort, or to take drugs indefinitely that will cost a lot of money. The savings are estimated at more than a million dollars for every 1 thousand patients treated...

FAGAN: It does appear that you need to spend a little up front to get a little bit down the line, though. The costs of the therapy are all incurred in the initial hospitalization...so the hospital may end up, it may cost the hospital more to take care of those patients. But it's quickly made up, because so many more patients treated with TPA go home...versus nursing home or rehab institute, which are very expensive forms of post-stroke care. And they often persist for years after the patient is discharged from the hospital. So, we found that after one year, most of the costs incurred were made up - when you treat the patients with TPA. But it's important that the public understands that more money needs to be given to hospitals in order to save more money down the road.

NEMA: One question that I have...and we've been following TPA since it came out several years ago...and people ask, "TPA has been out for years, so why is it still 2 thousand dollars a dose"? Don't treatment costs usually go down after a time? Why is the cost so high?

FAGAN: That's a question that only the manufacturer can really answer, but I will tell you that, actually, most drugs go up over time, and they have never increased the price of the drug, since it was marketed. The only thing that drives down the cost of drugs is when there are generic drug equivalents...and there still isn't for TPA...so, until there's a generic form, until the patent runs out, the drug won't decrease in price. We're just hoping it won't increase. They'll never increase the price of the drug...they say....it's been 2 thousand dollars since it was introduced in the early 80's.

NEMA: As an aside...that has a real connection to TPA down the line...have you had any vision of the importance of citicoline in the cost effectiveness of stroke treatment?

FAGAN: Well, the thing that excites me is the fact that we may be able to use a drug like citicoline, which may be safer than TPA, earlier on in the course of the stroke to actually widen the time whereby TPA might be safe and effective. So I think combination therapy is the next thing that we're going to have to look at...and which can actually increase the eligibility of patients, hopefully, for the thrombolytic...that's what I'm hoping.

NEMA: Since hospitals are reimbursed for the procedures performed for patients...stroke patients in this instance...they must be very interested in your study on cost effectiveness...maybe the first ones peeking over your shoulders as the data came in....

FAGAN: Initially, it was journalists. I think hospitals are very interested in this. The good thing about it is the length of stay decreased, which is something hospitals are looking at. In our analysis, the length of stay in the hospital was shorter for the people treated with TPA, versus treatment with a placebo. The total cost was higher, because we had to allow for more intensive monitoring, etc... But they were excited about the decreased length of stay. I think it hasn't become an issue yet because there are other things that are being barriers for people implementing the therapy...you know...as far as having a team ready, all those kinds of things. I don't think the cost alone has been much of a barrier thus far.

NEMA: So facilities are really just catching up...as far as trying to provide the service, or the treatment....

FAGAN : Yes, I think that's where it stands right now. And also, because the public hasn't been educated. There are actually very few people who are coming in on time to get the therapy, so the total impact on the drug budget hasn't been felt. Our hope is to get more and more patients coming in earlier. Right now, if you only treat one a month in a very busy stroke center...that really doesn't....it's not a lot in the drug budget, you know?

NEMA: We at NEMA have been trying to make people understand the import of knowing the signs of stroke, and taking action in getting to a hospital...so that these wonderful methods of treatment can be used...and the patient has a much better chance of retaining their faculties, their lives, after a stroke....

FAGAN: There's a lot of different organizations that are trying to improve and increase the number of patients that come in early. And if that does happen....if we're successful, then cost may become an issue, but I don't think it's a big cost now. But I think this analysis sort of gives more ammunition to the people that are saying, "Come in!", you know? Not only, I think the drug can be justified based on the health benefits alone, definitely....this just adds more fuel to the fire, gets more people, hopefully convinced that we need to do it.

NEMA: Is there something else in the cost area you'll be working on now...or will you move on to other things?

FAGAN: We're not doing any more with the cost effectiveness of TPA, but I'm still looking at outcomes of stroke, and I'm very interested in this area. I think it's going to become more important as we get more therapies.

NEMA: Stroke is the country's fourth biggest killer...behind only trauma, heart disease, and cancer. Know the signs of stroke: temporary vision dimming or blurring, numbness or deadness in an arm or leg, a blinding headache, trouble speaking or understanding speech, or a tingly feeling around the mouth. The promise of treatments like TPA or, down the road...citicoline, to reduce the damage stroke can cause...can only come to fruition if we know the signs, and get to a hospital quickly. In fact, Dr. Thomas Brott of the University of Cincinnati Medical Center urges us to realize stroke is every bit as dangerous as heart attack, and both physicians and citizens should know that. As for the high cost of TPA, at more than 2 thousand dollars a dose, rounding out to near six thousand dollars for a patient's treatment...that cost is made up in the first year...as hospital stays are shortened, and stays in nursing homes and rehab centers are shortened or avoided all together. It's a win - win situation for the long term.

SPOT: 15 years in the prevention of heart disease, stroke and trauma - The National Emergency Medicine Association. This show is just part of what NEMA does. We send out millions of pieces of prevention information to people around the country, give grants to organizations in research, public information and emergency services, and have been instrumental in the creation and expansion of the Chest Pain Emergency Room movement. To play a role, call 800-332-6362.

NEMA: Thanks for joining us for today's program. If you have any comments or suggestions, contact this station. Or visit our home page at: www.NEMAhealth.org ...for a look at transcripts of this or past programs, or to find out more about the National Emergency Medicine Association. I'm Steve Girard at The Heart of the Matter.