About a year ago I wrote a post called “The real seroquel bill.” It was a reaction to the reports of Tennessee being part of a settlement reached for the off label use of antipsychotics. That post is reprinted below. The link below is to a current article about research to the costs of off label use of antipsychotics to medicaid budgets. It is well worth reading. Many of the points I make out earlier are borne out in this research. It is a real issue that has not gotten near as much serious consideration as it deserves.
A recent newspaper story linked to in an earlier post on this blog stated that Tennessee was to get $1.5 million as their part of a settlement of over $68 million from AstraZeneca for the illicit marketing of Seroquel for uses it had never been approved for. Much has been made about the risks of seroquel and the other atypical anitpsychotics to cause rapid weight gain, diabetes, and heart problems among others. The risk for conditions that Seroquel supposedly has some effectiveness in is great enough. Prescribing a dangerous medication for a condition that is has no proven positive effect is more than questionable. It is wrong. Wrong. Very wrong.
One psychiatrist I know tells me he no longer prescribes atypical antipsychotics on a long term basis. It is not that he thinks they are ineffective. He believes prolonged use is dangerous. He uses them for stabiilization or for crisis. He says he sees no justification for their use past 8 weeks. He is insistent there are safer alternatives.
I recently talked to a close family friend. She is 23 years old. She has no family history for diabetes. She has no family history for any risk factors. She was told about a week ago she is diabetic. Her only risk factor is the atypical antipsychotic she has been taking for a couple of years.
I really wonder if we even realize the real seroquel bill? Have we even begun to count the cost to us? Obviously there has been considerable off label use in Tennessee. Otherwise there would have been no settlement. Aside from the human misery of someone cured of something by being given a bigger problem I really wonder about the ultimate financial ticket.
TennCare (Tennessee’s medicaid) is had a several hundred million dollar shortfall that, it seems, be solved by the hospital association agreeing to a tax on their income. Without it thousands of Tennesseans would face cuts in crucial benefits, for some life saving benefits. Many providers would have faced cuts in reimbursement rates that would have ultimately threatened their ability to continue to provide any services. It would have been a human disaster of the first proportion. But I cant help but wonder how or if this crisis has been stoked by the off brand use of drugs like seroquel. I read where its sales have been in the billions of dollars worldwide and that as much as 50% of those sales are for off brand use. What has that meant for Tennessee?
I dont know. I dont know for sure if anyone does. But I would like to.
The following is a quote from medicaid regulations:
“Non preferred products will only be approved for their FDA approved indications and age limits and only if the client has failed on three preferred products in the last 5 years. (Failure is defined as lack of efficacy, allergy, intolerable side effects or significant drug-drug interactions.)”
If indeed this regulation is true it should prove very hard to get any kind of off brand use approved. This passes into an area where I am by no means an expert. The words seem real clear to me though. Yet of the people I know very few have reported to me they had to jump these hoops to get off brand use approved by TennCare. I understnd there is some kind of provision where the commissioner of health can order insurance companies to pay for off brand use, but even that requires an active decision. And if he is doing that with drugs so potentially dangerous why is he doing that? Is he even aware of the risks?
I cant help but to go back to an idea expressed in an earlier post: “If we did better we wouldnt have to face doing less.” I have absolutely no quarrel with any drug being used in a way it has proven results. I know many people whose life without an atypical antipsychotic would be much worse than it is. But even most of them know the risks they are taking. I have every quarrel with drugs being used in a way they have no proven benefit, that have great risks, and that may be helping to destroy our financial capacity to meet other needs. These are hard times and we dont need to make them any harder. Too many people are in need and too many people are looking at having no way to meet their needs to turn a blind eye.
I plan to continue to look at this issue and will post more on it in the coming days. In the short run, I plan to write my state legislators and ask them to find out what is going on.
How much is TennCare paying for the off brand use of drugs like Seroquel?
When a drug is used off brand is the last choice and not the first one made? Have other options been tried?
What, if any, are the medical complications that have been caused by this usage? What are we paying for we wouldnt have to if there were saner prescribing practices? How many people have been hurt that perhaps did not need to be?
If the Commissioner of Health has indeed okayed this practice why? And can that decision be reviewed and changed?
Maybe you have your own questions. If you live in Tennessee I urge you to write your legislator also. In fact, whatever state you live in I urge you to also ask for an answer. You deserve to know.
But all this really only tells part of the real seroquel bill. The rest I saw in the face of my young friend who was wondering what hell she had been sentenced to.