Monday, January 08, 2007

The Business of Diabetes: The real story behind why Americans are being denied generic insulin


Generic insulin. To some, the mere words imply slightly less-than-perfect -- something that a hysterical fishwife or a tobacco auctioneer might buy, but no one else.

But a majority of Americans view generics favorably, so much so that it is estimated that more than half of all prescriptions dispensed in the U.S. are generics. In fact, Express Scripts Inc., the No. 3 U.S. pharmacy benefit manager, estimated that the savings from generics in 2006 alone to total nearly $24.7 billion. The impact on healthcare costs is well-known. According to figures released by the U.S. Food and Drug Administration (FDA), once a second generic version of a drug hits the market, the cost of a drug usually sells for about half the original's price and multiple copies often cost 80% less.

Although the patents for Eli Lilly and Company's Humulin insulin products expired in 2001, and Novo Nordisk's Novolin insulin products expired in 2002, today, more than five years later, Americans are still being denied access to generic insulin formulations.

In this special issue of The Business of Diabetes, I concluded that I could not do adequate justice to this topic in a typical blog posting, so instead, I have prepared a document that you can (and should) download and read here. Be forwarned: it IS a few pages in length, but chances are, you will walk away more informed of this topic than you were before you read it! By the way, I created this graphic myself using a public domain image of an insulin vial from the NIH/NIDDK and a bit of Photoshop Elements, although nothing too extensive (I only started using this software within the last few months). I welcome any comments you care to add, so please drop by once you've read the entire article and let me know what you think!

***** EDITOR'S NOTE: Apparently, I was not alone in my interest in this subject, as Diabetes Self Management published an article on this subject in its December 2006 issue (although my article is much more comprehensive), but I've included links below! *****

9 comments:

Scott K. Johnson said...

Great write up Scott. Amazing some of the things that happen that the general public are pretty much unaware of.

BetterCell said...

But while biologic medicines are more difficult to copy than chemically
engineered drugs because they require highly precise conditions in order to grow, it doesn’t mean that highly
similar versions cannot be manufactured".
The problem w/this statement Scott, is that highly similar versions of "brand name" insulin manufacturers are just that, similar but not the same. Let me explain, while patients will save more $$ on a generic version of a drug, it does not necessarily mean that they are getting the same bio-availability and bio-equivalency of the medication that the original Pharmaceutical/Bio-Tech company has manufactured. The FDA sets different standards and requirements for Generic versions of drugs to be allowed to get on the Market compared to "Brand Name Pharmaceuticals. There is more leeway and flexibility that is given to Generic Drugs than to Brand Name. While the bio-availability and action of a Brand Name has to be 100% to pass FDA protocols, the same does not hold true for generic versions where the acceptable levels are lower.
This reminds me of affirmative action regarding education admissions and the bias that results.
I cannot choose for others, but if $$ is not a "problem", I would ALWAYS buy "Brand Name" medications, rather than generic because the quality control and standards are much better.

Scott said...

I appreciate the comment, but by "highly similar" this also applies to the differences between rapid-acting analogs (Humalog, Novolog, Apidra), or for that matter, analogs vs. regular human insulin. You are right in that given a choice, most people would probably buy a brand name medication, but this is kind of splitting hairs for people who cannot afford any meds. There is no easy solution, but my argument is that denying generics is hardly a solution, either.

BetterCell said...

Then it stands to reason, that ALL companies involved in Generics have to have higher/safer and better control issues regarding their drugs than now exists w/o the FDA giving them, "a nod and a wink".

Lili said...

Thanks for posting this.

Drea said...

Is there a patent on the genetic insulin? seems strange there is no generic version available. When I am without insurance, I am always asking for the generic version of whatever drug I am prescribed....this is an intereting topic....

Scott said...

Not on rDNA human insulin, the patents expired for for Eli Lilly & Company's Humulin insulin products expired in 2001, and Novo Nordisk's Novolin insulin products expired in 2002. Both the Humalog and Novolog rapid-acting insulin analogs enjoy patent protection until 2014.

Steve said...

Scott-Thanks for your efforts on this. I have been following the Biocon human insulin story for some time. Imagine a human insulin equivalent to Novo/Lilly human r that is a generic and in use. Yet it can not be sold here. Soon it will be available in Europe but not here. It would offer a tremendous cost benefit to user of these products. Biocon may even get some to switch back from the more expensive and patent protected analogs.

And switching does happen. I switched from Lipitor to Simvastatin when it became available as a generic. And my Simvastatin costs $15 for a 90 supply at K-mart. This is actually cheaper than my co-pay on insurance.

The other thing that really burns me about the FDA is infusion sets. Why are infusion sets a prescription item and needles are not? And why are they so expensive compared to needles? There seems to be little competition on these as well and the cost and regulation reflect it.

Armand said...

In the case of perscriptions I think they need to de-regulate the need for a perscription for supplies and for insulin(s). Here in Canada our health plans have realized how much money they save by avoiding the sometimes up to $14.00 dispensing fees that are applied to perscriptions for items like infusion sets and insulin that can be bought over the counter. I order my supplies directly from medtronic and just print and sumbit my invoice the next day from thier website. Same with Insulin, Needles.. etc buy them from a pharmacy and submit the reciept for re-insbursment. Much simpler.