Wednesday, March 16, 2011

Makena & Ther-Rx: Where Saving Babies Meets Price Gouging

I am now over 23 weeks pregnant. In a couple of weeks and a couple of days, I will be the most pregnant I have ever been before. No freak water breaks, excellent prenatal monitoring, and a special drug called 17-alpha Hydroxyprogesterone Caproate, or 17P, have made heroic contributions. I want to talk about 17P.

The drug is meant to help prevent preterm labor. There are a handful of drugs that can stop preterm labor, called tocolytics, but these drugs can only reliably put off labor for a couple of days. A couple of days is long enough for a dose of life-saving corticosteroids to prepare a preemie's lungs for birth, but not long enough to save a baby for a woman who goes into labor before 23 or 24 weeks, or to give a baby a better chance at life by being born later.

Besides reducing risk factors, progesterone therapy with 17P is the only preventive measure against preterm labor for women with a history of preterm births. For someone like me, who has had preterm labor and delivery, and is currently carrying a single fetus, this drug is the only thing that might keep preterm labor from even happening. If I were to suddenly discontinue my weekly injections of 17P, minus the support of the drug my body might begin preterm labor again. And because of Ther-Rx and their new patent on Makena, that's exactly the possibility I'm facing in three weeks when my 17P prescription needs to be refilled.

Yesterday my pharmacy notified me that they would no longer be able to compound 17P for me, and my doctor's office confirmed that the same drug would now cost around $1,200 per weekly dose. When I bought my first ten doses of the drug at 16 weeks pregnant, without submitting the cost to insurance, I paid $7 per weekly dose.

A couple of weeks ago everyone was singing the praises of FDA approval for Makena, which is exactly the same chemical compound as 17P, which has been around for years, originally under another brand name, and then available generically. The only difference with Makena is that Ther-Rx will have it mass produced, while 17P has, in the past, been compounded by specialty pharmacies. Mine was compounded in the same town as my OB's office. With smaller batches made local to patients, 17P inevitably has variances in quality and efficacy. The claim with mass production is that everyone will get the same drug. Of course, we all know that mass production is no guarantee of quality, since we've all heard of drug contamination or efficacy issues with other mass produced drugs. Of course, if there's a problem in mass production, these companies are much more likely than local compounders to have deep pockets for a lawsuit, and they will have already distributed the product to women far and wide.

Anyway, I'm just not sure if there are real benefits to mass production, except that mass production should make the drug cheaper and more available. And yet, with the cost of Makena, the opposite is true. At $1,200 per dose (or more), only those with generous insurance or plenty of cash on hand will be able to afford Makena for the 20 weekly doses required to maintain a pregnancy to term.

Of course, if Makena is so expensive, can't people still get the $7 per dose generic? Somehow, no! Usually, drug companies are required to change the chemical composition of their drug in some way to re-patent it and make a new, more expensive competition for generics of their old drug. It's such minor changes that have turned birth control pill Yasmin into Yaz and then Beyaz (now with folate!), each with a new patent so the company has some time to exclusively produce the unique drug and recoup the costs of researching, developing, testing, and gaining FDA approval for the new chemical compound. Creating a new drug for public use is an expensive and long process.

But Makena, even though it is the same chemical compound as the 17P that has been around for years, received a patent that legally prevents the generic compounding of any other 17P. All women prescribed the only drug available to prevent preterm labor are now fully dependent on Ther-Rx for Makena, now the only form of the drug. I can't imagine how this deal was done, but I don't understand how a company can gain a patent on a generic already in use. Even if it were a new drug with a new patent, the generics should still be allowed, just like generic Yasmin and Yaz are available in spite of the recently patented Beyaz. In other words, this sudden monopoly reeks.

So though I have two or three doses of 17P left in my prescription vial, once those are gone I have no choice for the second half of my course of 17P but to buy Makena from Ther-Rx at more than 171 times the price, an astronomical increase from $7 to $1,200 per week, or at least $12,000 to maintain my pregnancy to term. Discontinuing 17P puts me back at heightened risk for preterm labor, and considering my complex history, that might be fine, or it might mean I go into labor shortly after my last dose wears off. Both my peace of mind and the safety of my baby are being held hostage at a steep price for any woman, let alone one with a young family and a bread-winner only two years out of college.

I am lucky to have excellent insurance. It comes at a high premium, but the coverage is generally great. Still, I'm waiting for the results of a benefits investigation that will decide whether my insurance will pay for Makena's ridiculous price. If it doesn't, we simply can't afford the price, and we won't qualify for low-income programs that have been proposed to make the drug more available. Even the half of the prescription course that's left costs more than 20% of our annual gross income.

But if my insurance does cover it, and I will have to take it because the safety of the baby I'm carrying is more important than even my own morals, I will have severe objections to my insurance company or anyone else paying such an exorbitant price. Ther-Rx's work was already done with the research and development of the drug when 17P was invented years ago—so the high price is for what, the new cheaper manufacturing practices? Someone's pockets are being thickly lined with the dollars of pregnant women at risk for preterm labor, who are often young, poor, sickly, or otherwise at a disadvantage. Preterm labor is an affliction of the lower classes—not exclusively, but largely.

We don't have much recourse when a patent has already been approved, but what can we do against a company so corrupt as to price gouge poor pregnant women by holding the safety of their babies at ransom? First, we can write to Ther-Rx (as March of Dimes did, though I'd use stronger language) at this address:

Greg Divis, President
Ther-Rx Corporation
One Corporate Woods
Bridgeton, Missouri 63044

But since I doubt this guy will listen to letters from people who actually care about the health and safety of babies, I say we make a giant PR problem for them. ABC, NPR, and other networks have covered the story (KV and Ther-Rx are just corporation/branding differences, same people), but if we can get this problem on TV and on every news site and public health forum, we might make enough of a dent in their image to make it worth Ther-Rx's while to lower to price to a reasonable level. Let's do it.


Jenny said...

What? That is outrageous! I'm not familiar with the drug (although I'll keep it in mind as I also had preterm labour) but the whole situation sounds ludicrous! I do hope your insurance covers a hefty portion of it even if it does seem so wrong to support that company. The health of your little one is the most important thing. Also glad that you're already at 23 weeks and you've got another two or three weeks covered.

anna said...

ignoring the whole picture here and just thinking about YOUR current and urgent situation, i suggest this: talk to you dr and have them write a new prescription for you NOW to FILL [@ $7 each] NOW, before your local pharmacy is unable to make the drug. That would mean you would be covered for 12-13 more weeks without this price "increase". good luck!

Amy said...

@Anna: great suggestion, but I actually found out about the problem by calling for a refill. They already can't make it! I had no idea it would happen like this.

Anonymous said...

Hi Amy -
Thanks for your post! I'm in the same boat...I'm 25 wks pregnant and have one vial of 17P left. My previous son was born at 28 wks. My insurance will make me pay for 20% of shots, which is over $1,700 for a 30-day supply!

For lots more links, and information, feel free to join the FB Page called "Shame on you, KV Pharmaceutical and CEO Greg Divis"

Anonymous said...

Find a "compouding pharmacy" in your area that will still mix 17P and make sure your MD makes arrangements to get the drug there. It is as safe and effective as the branded drug.

Christi said...

We are in the same position, but I got my refills the day before the Cease and Desist letter went into effect.

You can still order online from Canadian Pharmacies at reasonable prices. It is only here in the USA that Makena is solely granted approval.

My compounding pharmacy said they were also looking into changing the compound slightly and still offering it.

My insurance doesn't cover the brand name for this compound - only generic, which is no longer legally allowed to be compounded in the USA.

There are options while this mess gets sorted out.

Good luck to you (and me and other Mamas out there in this situation).

Anonymous said...

btw, the comment that KV is not spending anything to develop the drug is untrue. FDA required KV to do additional study and overall the company already spent $250m on clinical studies and the cost to purchase the patent. It's true that the price is high, but this is a sterile injectable, which carried a risk of contamination. We all know that compounding pharmacy is unregulated, hence you can't be sure that the batch that you are using are not contaminated by bacteria. With KV, the manufacturing is regulated by the FDA, it has to go stringent reviews to be able to produce the drug, especially a sterile injectable. I think what people are missing here is KV is on the brink of bankruptcy after spending millions of dollars on the drug (admittedly, there were also other problems from previous management). The bottom line is, the company followed FDA guidelines in getting the drug to market, now suddenly, after spending the money, the congress decided that they can't and shouldn't make any profit to recoup their investment.