Last week NPR ran a story about why insulin is so expensive. It wasn’t a perfect story about diabetes—so few are—but it was better than most in the non-diabetes press. The crux of the feature is this: Despite being a life-preserving drug taken by millions of people, there are no generic versions of the high-priced insulin analogues most people with type-1 diabetes take, and the drugs are becoming more expensive. That is undeniably true. The most common insulin analogues—fast-acting Humalog/NovoLog/Apidra and “peak-less” Lantus/Levemir—do not have inexpensive generics.
Like a fool, I skimmed the page’s comments. Once you get past the mostly superfluous confirmation bias comments (“More evidence that corporations are evil!” “More evidence that fat, lazy Americans want to take a drug instead of making lifestyle changes!” etc. . . . sigh) there was a class of interesting comments. “But there are less expensive versions of insulin out there! Regular insulin is $25/vial at Wal-Mart!” From there the comment devolved to the usual “discussion” of whether Wal-Mart is evil, whether Big Pharma has doctors in their pockets not to prescribe these low-cost alternatives, etc.
It’s true: Not having generic versions doesn’t mean there aren’t inexpensive alternatives. “Regular” human insulin is widely available as a fast-acting insulin, and (trigger warning!) NPH is relatively inexpensive when compared to Lantus. But these are alternatives in the way that a taxi is an alternative to a bus. They’ll both pick you up and drive you in the direction of your destination. You’ll wait for each, but you’ll probably wait longer for the bus. The bus also requires you to go to it and adhere to its schedule and probably doesn’t drop you off exactly at your house, hotel, or workplace. Taxis are more expensive but you get flexibility for that cost. They’re similar but not the same.
Regular insulin and Humalog/NovoLog/Apidra have similar insulin actions, but the former takes longer to start acting and has a longer duration of action. They are different enough that Regular is not recommended for use in contemporary insulin pumps. The action of Lantus/Levemir and NPH are extremely different. NPH has a huge peak in its action, making it a terrible “basal” insulin for multiple daily injections (MDI) therapy. Trust me. I’ve been there. It was awful.
I can hear the follow-up question. “So these insulin analogues are fundamentally different from their low-cost counterparts, but why aren’t there generic versions of them? Many of them have been around long enough.” That’s because insulin analogues are really complicated. They’re grown in huge fermenters by E. coli whose DNA have been modified to produce an insulin-like substance. In fact, none of the insulin varietals on the market are really human insulin at all. They’ve all been changed in some fundamental way to make them behave more like insulin (fast-acting) or less (slow-acting, peak-less).
Unlike most generic pharmaceuticals, there’s no “simple” compound for insulin you can mass-produce if you know the chemical formula. Producing insulin requires knowing how to modify the genetic material of the bacteria in the fermenters. It requires knowing the process for separating the insulin analogue from the E. coli. It requires knowing how to stabilize the end result. The insulin people with diabetes take isn’t a compound so much as a process.
Processes can be reverse-engineered, of course, but it’s a lot more difficult than reverse engineering a compound. The FDA has just recently approved rules for “biosimilars,” which are generic versions of products (like insulin) which are too complicated to reverse engineer to an exact chemical copy. Essentially if it looks more-or-less like an insulin analogue and acts almost exactly like an insulin analogue, then it’s a biosimilar insulin analogue and can go on the market without being treated as a completely new drug requiring all of the layers of new drug approvals which take time and cost money. (This is, after all, why generic drugs are less expensive to bring to market.)
Personally, I’m really excited about the idea of biosimilar insulin analogues, which were mentioned in the NPR piece, by the way. Downward pressure on prices is a good thing. It helps more people get access to insulin at a more-or-less reasonable price. And it also encourages drug manufacturers who currently have a corner on the high-cost insulin analogue market to come up with even better insulin analogues for us in order to maintain their market share. (Some people are using the term “smart insulin” for the next generation of products.) Because—until we get a cure—we need a lot of treatment options, and better insulin is part of the mix.
p.s. — A commenter did make a good point
(if it’s true) that the same bottle of insulin costs much more than it did a few years ago even though the cost to produce it should be about the same and the R&D investment has long been paid. That is an entirely different issue to be sure.