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Saturday, February 12, 2011

Health care "rationing" and the case of Pradaxa, the new drug to prevent blood clots

Very recently a new drug came out which is significantly better than the drug it seeks to replace. Every year many new drugs are marketed, and most of them offer no improvements over what is already in use, but confuse physicians and patients with false choices, and contribute to increased drug costs. Dabigatran, or Pradaxa (its brand name) is a drug which prevents the blood clots that can cause strokes or other serious mischief, and may eventually replace warfarin (Coumadin) which has been in use for decades. It has several very significant benefits, including the fact that frequent blood test monitoring is not necessary and bleeding risk is reduced.

Some background may be useful.

Warfarin (coumadin) was originally introduced as a rat poison because it reduced the little guys' vitamin K levels and thus prevented the production of a few proteins involved in blood clotting. With no available vitamin K rats would bleed to death from minor injuries. Not long after its release as a poison, it became clear that with judicious use, this anti-blood clotting effect could be useful medicinally in preventing dangerous blood clots in humans, and it was approved as a medication in the 1950s.  It is used for patients with atrial fibrillation, an arrhythmia of the heart that can lead to strokes, and to treat and prevent blood clots in the legs that can lead to pulmonary emboli, blood clots that land in the lungs. Warfarin has over the years prevented many deaths and disabilities, but because it is poisonous at levels not much higher than the levels at which it is useful, it has also lead to death and disability from bleeding incidents.

There are other chemicals which can prevent clotting, but the ones that are safe and effective are not absorbed in the gut and have to be given as a shot or by vein. Aspirin and a number of drugs like it can reduce clotting by affecting the platelets, but their effectiveness is limited in preventing or treating the clotting issues I mentioned.

Just recently, a chemical that had been used in laboratories because of its effect on various enzymes was modified in such a way that it could be absorbed when taken by mouth and was tested in large studies and found to be at least as effective in preventing and treating blood clots as warfarin.  This drug was recently released and is now on the market, called "Pradaxa", by the drug company that developed it, Boeringer-Ingleheim. 

Warfarin is not at all an uncommon drug, and is responsible for many visits to my office, as patients come in to have their "protimes" checked, which needs to be done at minimum monthly, and have their doses adjusted.  The doses often change due to changes in diet or health status or other medications which change how their bodies respond to this drug.  It is also not uncommon to find that a patient has a protime that is too low, thus they are not protected from blood clotting, or too high, such that they are at increased risk of bleeding, or are bleeding. Pradaxa requires no such adjustment and does not have the same drug interactions. A person on Pradaxa is free to go travelling for several months without finding a doctor who will check and monitor their blood tests.  A forgetful person on pradaxa is far less likely to significantly mess up their dosage since that dosage is always the same.

So one might think that I will switch all of my warfarin patients to Pradaxa. Perhaps, eventually, but right now this clearly superior drug is financially out of the reach of all but the most financially gifted of my patients.  Today the pharmacist I called at my favorite local pharmacy told me that a month's supply of warfarin at a standard dose is about 10 bucks, whereas 30 Pradaxa pills costs about $130.  A study recently reported in the Annals of Internal Medicine (http://www.annals.org/content/early/2010/11/01/0003-4819-154-1-201101040-00289.full) calculated that, compared to use of warfarin, use of Pradaxa would save lives, but at a cost of somewhere between $50,000 and $86,000 per year of life saved.  That, frankly, is not such a bad deal, when compared to such accepted services as mammograms and pap smears, but is a difficult step to make for insurers such as Medicare at a time when money is tight.

I have put one of my patients, so far, on Pradaxa, but the cost to him is a hardship. He cannot tolerate warfarin and has a real need for an anticoagulant, so he just has to pay the cost.  Most of my other patients, when I tell them about the cost, have refused to consider changing.  They, mostly, pay their drug costs, and the other costs, including blood test monitoring and hospitalizations for complications of treatment, are paid for by their insurance companies, which are mostly Medicare.  Medicare has not limited the use of Pradaxa, but they only pay for part of it, and in the "donut hole" after Medicare drug benefits are used up, the patient will have to pay full cost.

So how does this relate to rationing? 

The US government, as far as I can tell as an outsider, is so afraid of being perceived to ration health care that, although they have created a "Patient Centered Outcome Research Institute" to help us define what medical interventions are valuable, they have strictly forbidden this organization to use the common metric of "Cost per Quality Adjusted Life Years" to guide their recommendations .  Knowing how much it costs to buy a good year of life is a way that things as diverse as a mammogram and a new drug can be compared to each other.  This metric is certainly not the only measurement of importance, but it is tried and true and has been very useful to me.

My patients who refuse to take Pradaxa because it is just too expensive are engaging in a rationing of health care on a personal level.  They have decided that they have a limited amount of money and that they don't want to spend a large portion of it on a drug.  I respect that. What bothers me is that even though rationing is going on every day in health care, at the level of individuals, corporations, providers and insurers, our government is too squeamish to look at that, and is micromanaging their own Patient Centered Outcome Research Institute and hamstringing its ability to do the job of guiding us in spending our resources wisely.

Because we are unable to make educated decisions about health care spending, we continue to spend too much and our health care budget balloons, having the direct effect that many people have little or no health care while others have gold plated excess.

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