This month KV Pharmaceuticals gained FDA approval for their drug Makena, or 17 Hydroxyprogesterone Caproate, for use in prevention of preterm birth. This drug has been shown in randomized studies to moderately decrease the rate of preterm birth in women with previous preterm deliveries.
While this is the first FDA approved product for this indication, this very compound has been available on the market for many years, generated by compounding pharmacies nationwide for as little as $9 a dose. One major supplier, Wedgewood Pharmaceuticals, provides the product in vials every bit as professional looking as anything you would get from a major Pharma manufacturer.
The big problem, as most already know, is that KV Pharmaceuticals has decided to price their drug at approximately $1500 a week. Furthermore, they are extending legal power to prevent compounding pharmacies from creating any more of the drug.
This is outrageous. This is a well studied drug, already having gained acceptance in the community based on the landmark 17-OHP trial published in 2003. Millions of doses have been given nationwide without adverse effect. The fact that it has become FDA approved has done nothing for women or infants. The only effect has been that KV now has legal protection to price the drug at 200 times the previous price and block out competitors who previously had been providing the same drug at a tiny fraction of the cost.
An article was recently written in the New England Journal decrying this usurious pricing scheme. In their analysis, they write “For every dollar spent for compounded 17OHP, $8 to $12 in health care costs related to pematurity are saved.. by contrast, Makena will require $8 to $12 in drug spending for every dollar in such prematurity costs avoided.” Further editorials have been published in both print and digital media, such as this, this, and this. My friend @drjengunter weighs in here
KV has responded to the criticism, pointing out that they have a patient assistance program. To be fair, they are willing to give the drug for free to uninsured women making less than 60,000 a year, and at a small copay for women making less than 100,000. But to be fair to women and the world, this isn’t nearly enough. No matter what individuals are paying for the drug, the medical system will be paying billions of dollars for something that used to cost a few million a year.
Positive spin on Makena has promoted it as the first drug to decrease the rate of preterm delivery. This is an agregious mistruth. The drug has been on the market for over 50 years, and has been used for the indication for almost a decade in the United States.
At the core, KV Pharmacueticals is a leech on the blood of our society. They are providing nothing of value, but through our bureacratic process have been guaranteed that they can extract billions of dollars a year from our healthcare system – all to get a benefit we already had. They didn’t even have to do the research; it was done for them and published in 2003 (with compounded drug.) The idea that their particular FDA approved product is somehow better or safer than the compounded product is completely theoretical, cannot be justified by any data. Furthermore, the underlying efficacy of the drug KV claims has immeasurable benefit is worthy of some skepticim despite the 2003 trial, as since it went into widespread use the preterm birth rate has risen from 12.3% to 12.7%.
So what are we to do about this. I am doing this.
I will not write a single dose of Makena, and I call for you to do the same.
If I can, I will continue to use compounded 17-OHP. If I can’t, I will recommend daily vaginal prometrium, which very likely will have the same effect as 17-OHP. Its off label, but so was 17-OHP before KV got ahold of it. If a patient asks, I will politely explain that I refuse to give in to KV Pharmaceuticals and their piracy. The cost of healthcare is destroying this country, and this is an area in which we cannot afford to give in. Patients need to understand that these are the kinds of decisions that drive the cost of healthcare, and that we are all responsible for protecting our country’s healthcare future.
I encourage everyone over which I have any influence to refuse to write Makena for any reason, and to pass this message on to anyone who will listen.