Wednesday, November 5, 2008

The Diabetes Conspiracy (Part I)

Avandia continues to get bashed by the press, though I have tried hard to defend it. Today's firing of 1800 GSK employees may have something to do with the declining sales of this product.

The latest bashing has to due with cost, and comes from a study in the Archives of Internal Medicine that revealed spending on diabetes medication has increased by 87% (almost double) in the past six years, from $6.7 Billion in 2001 to $12.5 Billion in 2007.

This was not only picked up by the mainstream media (MSNBC) but the medical blogsphere as well. Dr. Kevin Pho of Kevin MD noted that:

"these drugs (Avandia and Januvia) are markedly more expensive than the recommended first-line generic medication metformin.It's no wonder than spending on diabetes drugs has doubled to $12.5 billion over the past 6 years. Unless there's a medical contrindication, doctors shouldn't be reaching for these brand name medications first."

Kevin's comment seems to make sense. On his blog he also linked to Pizaazz' post Diabetes Drug Costs on the Rise which stated:

"The study investigators noted that the newer drugs Januvia, Avandia and the wildly popular Actos were prescribed in 28% of all doctor visits by the end of the study period." Pizaazz included this quote from Dr. David Nathan, who is Chief of the Diabetes Unit at Massachusetts General Hospital:

“We need to pay attention to this...if you can achieve the same glucose control at lower cost and lower side effects, that’s what you want to do.”

Sounds like expensive drugs such as Januvia and the thiazolidinediones (TZD's) like Actos and Avandia are just expensive pills made by the evil drug companies, which are doing nothing more than doubling the cost of medicines for diabetes. But hold on....

Before we (once again) malign branded prescription pills for diabetes, lets look beyond the sound bites and see what the data is really telling us about the changes in diabetes and diabetes care.

First, the number of patients with diabetes in the United States has increased. The study quotes 14 million diabetics in 2000 which increased to 19 million in 2007. This is due to the fact that as a nation we are becoming more and more overweight and obese, and thus more likely to get diabetes. Thus, an 87% increase in spending can be partially accounted for by the 36% increase in incidence of diabetes. If we are going to start throwing around blame, then we need to include McDonalds, Starbucks, Microsoft, etc.

Second, we need to look at the overall trends in diabetes. Metformin has replaced sulfonylurea as the most commonly prescribed pill for diabetes, likely due to better results with fewer side effects. The TZD's are a new class of medications that have slowly risen since their introduction, but are still prescribed less the the other two medications. Another less mentioned trend is the use of insulin, which started to decline a few years ago, but it has recently made a resurgence. More importantly the older (cheaper, generic) insulins have been almost entirely replaced by the newer, more expensive insulins. Finally, two new drugs (Byetta and Januvia) have been more recently introduced to market and are starting to gain acceptance.

Let's looks at the trends and costs of ALL of these products over the last 6 years, based on the data from the study.

Lispro (a very short acting insulin) increased from 2% of visits in 2001 and $0.4 Billion, to 7% and $1.4 Billion in 2007 (more than triple the use and cost)

Lantus (a very long acting insulin) increased from 2% and $0.1 Billion in 2001 to 12% and $2 billion in 2007 (six times the use and 10 times the cost)

The TZDs (Avandia and Actos) did peak in 2005 at 34%, but their use in 2007 is now the same as it was back in 2001 and prescribed at 28% of visits. The money spent doubled from about $1.9 billion in 2001 to $4.2 billion in 2007.

Per the study's estimates TZD's, Lispro and Lantus all cost $160, $156 and $123 respectively, which is not that much different. Thus, of the extra $5.8 billion dollars we are paying more for diabetes, $2.3 billion is coming from the TZD's, and $1.9 billion is coming from the newer insulins.

Januvia and Byetta, new types of drugs which I am calling (and thus hopefully coining the term) glucose regulators were new or non-existent in 2001 and they are now prescribed at 10% and 3% visits respectively for a combined additional $1.5 billion. Though Januvia is prescribed three times more often than Byetta, Byetta ($205) costs about 30% more than Januvia ($160-about the same price as new insulins and TZD's). Of note, Byetta is currently a twice daily injection, but will soon be available as a once weekly injection which may increase demand for this product incredibly.

Thus, though spending on diabetes medications has nearly doubled in the last six years (in part due to increased number of Americans with diabetes), the newer and more expensive insulins have contributed about as much to this as the TZD's like Avandia. However, unlike the TZD's of which overall prescribing hasn't changed, the newer insulins are being used 3 to 6 times more and that trend is likely to continue to rise. Furthermore, the introduction of Januvia and Byetta combined is still less of a factor than the newer insulins.

Where's all the negative press about insulin? Why does Avandia always get the bad rap? Why are the experts (like Dr. Nathan) not also calling for an immediate reduction in these newer insulins since they are equal contributors to the rising cost of diabetes, are rapidly increasing in their number of prescriptions where Actos and Avandia are stable, and they are no more effective (though they do have fewer side effects) then the older, generic insulins? Is Dr. Nathan "paying attention?"

More to come........


brettruben said...

In diabetic patients because of deficiency of insulin hyperglycemia occurs which cannot stimulate the satiety center.

Mr. MedSaver said...
This comment has been removed by the author.
Mr. MedSaver said...

To a large extent, I agree with what you're saying. Insulin is just as much to blame for these rising costs. A few more points I've noticed about insulin therapy:

1. Virtually everyone who uses insulin now, uses the newer, more expensive forms. I understand prescribers' wishes to go away from the more complicated dosing regimens that go along with NPH. However, I really fail to see a true advantage of Humalog or Novolog compared to regular insulin (Humulin R or Novolin R) when cost is taken into consideration.

2. Insulin's short four week shelf life (except for Levemir) leads to considerable wastage when it comes to patients on lower doses.

3. Congress is supposedly working on a system to provide for the approval of generic biologic drugs, but as of right now nothing like this exists. As such, no generic insulin exists at all--only less expensive ($30-$50/vial) and more expensive ($90-$100/vial) forms. Because insulins are only available as brand name products, they (at least the newer forms) will only continue to increase in price (like other brand name drugs). In fact, this reliance on biologic drugs makes tallying the total drug costs for diabetes very different from other types of diseases.