Sunday, January 17, 2010

Comparative Effectiveness: Stroke May Be First

It is very likely that health care reform will pass in the very near future. If you are one of about 30 million who will now get some form of coverage, one of the many patients with pre-existing conditions that fear a job change due to loss of health care, or a senior citizen that struggles with medicine during the "donut hole" period; this bill will have an important impact on your life. However, for most Americans, passage of a health care reform will have no short term effect. In fact, this will essentially be a major first step in hopefully a long series of moves that will positively impact our entire health care system.

One part of the proposed legislation that may have an important impact in the short term for Americans not the aforementioned categories will be comparative effectiveness. I have blogged about comparative effectiveness in the past. Essentially, there is money in the proposed legislation that will have the government do studies comparing two agents or devices to see if the newer medication/device/procedure is worth paying for over the current standard of care. This is extremely important, since most studies regarding treatment are funded by the drug and device companies. Not that these studies don't have merit, but many important studies such as comparing two existing treatments are never done because a negative study is generally not worth the financial risk for the company. See what happened to Merck's stock when the ENHANCE study failed to show that Vytorin was any better that generic simvastatin.

However, there are potential issues to comparative effectiveness as well. Many future decisions on what the government will pay for will be based on this research, and what the government feels is worthwhile may be different than patients with a given disease or condition. The US Preventative Health Task Force is the government agency that recently stated that some mammograms are not worthwhile. There were many women upset about this. The first area that you might see, assuming an agency is set up soon, is with stroke.

Patients at risk for stroke generally take a blood thinner called warfarin. Warfarin is essentially rat poison (not kidding here) that thins the blood, prevents it from clotting, and because of this prevents stroke. It has been proven to save lives. The problem with warfarin is that is has what's called a narrow therapeutic window. This means the dose has to be just right. If the dose is too little, the blood is not thin enough and a stroke could follow. If the dose is too high, a patient could bleed to death. In order to get the dose just right, patients have their blood checked on a regular basis, usually once or twice a month. This is quite inconvenient, but potentially life saving.

A new drug, that will likely soon be approved by the FDA (already approved elsewhere) is called dabigatran. Dabigatran works is a different way so that the blood does not have to be monitored. The is an excellent source of the latest information in cardiology (need to sign up for free to get the articles). They do a great job of discussing the outcomes of the Re-LY study, which compares dabigatran to warfarin. This was a large study with over 18,000 patients at risk for stroke. The study showed that at the higher dose, dabigatran was better (prevented more strokes) than warfarin, and there was no more bleeding events compared to warfarin, i.e. it was just as safe. In fact, the worse complication feared is hemorraghic stroke (bleeding into the brain) and this was better with the new drug. Thus, the new drug is just as safe or possibly safer, and works better, and patients don't have to go to their physician's office twice a month to get their blood checked for the rest of their lives. Thus, it should be a slam dunk that dabigatran is used over warfarin, right? Here's the problem: warfarin is cheap as dirt, pennies a day; dabigatran will likely be quite expensive, potentially dollars a day. Will the government, based on this kind of comparative effectiveness research, be willing to pay for the better drug? Probably not, since so many patients are currently on warfarin. It will probably come out with something along the lines of that it will pay for it, but only for patients who have problems with warfarin.

In an effort to control health care costs, these are the kind of conversations that you should expect to hear in the not to distant future.

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