Pregnancy Woes: Why Did The Price Of My Progesterone Skyrocket?

(Photo: Rekha Murthy)

(Photo: Rekha Murthy)

By Rekha Murthy
Guest Contributor

Update: KV Pharmaceutical changed its name to Lumara Health, two days after this post was published.

I’m 34 weeks pregnant and working hard to keep this baby inside me for as long as possible. As with my last pregnancy, there’s a real risk that the baby could come too early. But we’re both holding on so far, thanks to a combination of luck, modified bed rest and medical science.

The science is my biggest concern right now. I will spare you much of it because, man or woman, you will instinctively cringe and close your legs. However, one critical medical intervention that has been proven to work for countless women and babies is again under threat, and I must speak up.

Every week, my husband injects me with 250 mg (1 ml) of 17 alpha-hydroxyprogesterone caproate (“progesterone” for short). Leaving aside what this does to an otherwise tender and loving marriage, these injections have been found to significantly lower the risk of preterm birth.

Two weeks ago, my insurance co-pay for progesterone went from $5.50 per dose to $70 per dose. Just like that. For those without insurance (or with a deductible), the medication went from $32.50 per dose, according to my local compounding pharmacy, to…wait for it…$833 per dose, according to the new pharmacy my insurer is now requiring me to use.

$833. Per. Dose.

Pricing varies somewhat across pharmacies and insurers, but not enough to make this price change any less breathtaking. In fact, the drug’s list price is $690 per dose.

The 12-fold leap in my co-pay sent an epic shock through my (natural and synthetic) hormone-laden system. I immediately called both pharmacies, my insurer, and my doctor, and started digging around online. I soon learned that the price increase came from a new requirement to buy expensive brand-name progesterone, instead of the affordable compounded version I had been getting. A disturbing picture came into focus.

In 2011, a company called KV Pharmaceutical received FDA approval for its own brand-name version of progesterone, Makena. The approval came with seven years of market exclusivity. Monopoly in hand, KV set a price of $1,500 per dose for Makena, compared to $10-$20 for compounded versions. The public noticed, and got mad. The company responded by cutting Makena’s price in half, but it still got a well-deserved public scolding. Patients, medical organizations and members of Congress issued statements of protest, some of which were covered by this very blog at the time. The March of Dimes, which had championed FDA approval of Makena, broke off its close relationship with KV and its subsidiary, Ther-Rx, when the price was made public. For more, here’s an overview of the saga.

Two senators called for a federal antitrust investigation. Senator Sherrod Brown (D-OH) did not mince words:

“Price-gouging is never acceptable, particularly not when it undermines public health and fleeces taxpayers.”

Sen. Brown was not alone in pointing out that KV Pharmaceutical gained FDA approval for Makena thanks in part to millions of dollars of help from taxpayer-funded National Institutes of Health studies.

Amid the controversy, the FDA decided to allow compounding pharmacies to continue dispensing their own versions as well, preserving progesterone access for all in need. KV Pharmaceutical did not appreciate this: It sued the FDA to compel it to shut down the compounders. The suit didn’t save them from bankruptcy, and a month after their filing the suit was dismissed anyway. Suffice it to say that 2012 was not a great year for KV.

But things have since turned around for the company. By early 2014, KV had emerged from bankruptcy, and attitudes and laws regarding compounders had changed (in no small part due to this tragic outbreak). This past January, a U.S. Court of Appeals in Washington, D.C., reversed the dismissal. In other words, KV is again actively suing the FDA to shut down compounders and secure its monopoly on progesterone.

But a decision has not yet been made, so why did my price skyrocket? It took quite a few inquiries to find out, and the answer was not what I expected, nor does it feel complete.

My inability to acquire compounded progesterone doesn’t seem to be due to the lawsuit, but rather to the Drug Quality and Security Act, signed into law last November. The International Academy of Compounding Pharmacists (IACP) told me they and their members have interpreted the new law to mean that the FDA prohibits compounders from legally preparing progesterone injections unless the dosing or method of delivery prescribed by a physician are different from Makena.

So, unless I can convince my doctor that I have a medical need for, let’s say, mint-scented progesterone delivered in half-doses by purple needles, I have to go with Makena. Nothing wrong with that…except for the price.

Now’s probably a good time to remind you that I’m on bed rest, with an abundance of time on my hands. I asked the FDA what they thought of the IACP’s interpretation, and here’s what I got:

The agency cannot speculate on why a compounder would have discontinued compounding hydroxyprogesterone caproate.

Hmmm, FDA, I’m no expert, but maybe it was those “guidance documents” for compounders you released just days after the new law went into effect? But why did my compounder take months to act? Did lawmakers and the FDA realize the DQSA would give KV what it is suing for? I don’t know. But I’m keen to find out if someone has a clear answer. Anyway, moving on…

With just two weeks’ worth of compounded progesterone left, I called Makena Care Connection, set up by KV to help a subset of women afford their pricey meds. They promptly sent me a free vial of five doses. Thanks, guys, that finishes off my treatment. But what about everyone else? That’s not a rhetorical question: My CommonHealth editor, Rachel Zimmerman, asked KV directly. To hear them tell it, $690 a dose is just a formality. Here’s part of the statement they sent over:

The price to insurers varies depending on the level of rebates the company pays to them, which results in a price considerably less than the list price of $690 per dose. State Medicaid programs, as an example, receive a deeply discounted price through a combination of statutory rebates and additional rebates offered by the company…

Our company has a financial assistance program in place for Makena with no upper income limits to qualify for assistance. This financial assistance applies to copays and deductibles. We also provide the drug at no cost to uninsured women.

Well, $70 a dose is certainly “considerably less” than $690. But it’s also considerably more than $5.50, and I doubt my compounding pharmacy cared about me enough to price it at a loss. Plus, $70 is just my co-pay; my insurer is likely paying much more. I know little about the economics of pharmaceuticals and insurers, but I think it’s fair to assume that added cost will make its way into my premium at some point. (The numbers junkies among you will appreciate this New England Journal of Medicine article from 2011.)

As for the “financial assistance program,” it seems to work great for women like me who are fortunate enough to have learned about it, navigated the paperwork and the phone calls with the help of a competent and responsive medical office, and met the somewhat opaque eligibility criteria. Let’s not assume all women get to have a high-risk pregnancy in such favorable conditions.

Don’t get me wrong: I understand the upsides of brand-name progesterone. A good manufacturer can bring uniformity and improved safety to a drug that was being prepared by hundreds of different compounding pharmacies. I’ll try to set aside the fact that the FDA shut down KV five years ago for “making, marketing and distributing adulterated and unapproved drugs.” I’ll also try to set aside research by the FDA and others, and statements by major medical groups indicating the compounders were doing fine (with one exception: the pharmacy where my insurer now requires me to fill my prescription).

Here’s how it looks to me and many others: KV has taken an affordable, effective drug that was in use for decades, a drug they did not invent, and is exploiting it shamelessly. To me, it doesn’t really matter who’s to blame for removing affordable alternatives, when all we’re left with is an effective drug at an insane price. My doctor’s office told me that they are scrambling to help women deal with this. Women who can’t afford Makena are faced with finding alternatives, shortening their course of treatment, or going entirely without. I can tell you firsthand that changing a treatment mid-course when your baby’s well-being is on the line is terrifying.

If KV is indeed bringing value, they deserve fair compensation. But raising prices astronomically when hundreds of thousands of women, babies and their families depend on it? No. Preterm births have huge emotional, physical and financial costs. What KV is doing with Makena reaches beyond issues of legality into morality.

I am well aware that unfair pricing happens throughout the U.S. health care system. burdening patients, providers, private and public insurers and taxpayers. But this one landed in my corner, and I’m speaking out. Don’t mess with a woman on bed rest. Time is on my side… until the progesterone runs out.

Rekha Murthy lives in Arlington with her husband and 2-year-old daughter. She is getting more pregnant by the day.

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  • Lawrence

    Bravo, for such an intensive investigation. Something all of us should be doing when it comes to our healthcare.

    My hope is that you will continue to ask the tough questions, keep fighting and yes, have a healthy, beautiful baby.

    The only problem I see, is that after the baby is born, you will not have the time to do this fantastic journalism!

  • Akachi Anadu

    Hi Rekha, like you I was prescribed weekly progesterone shots for 16 weeks. This was from December 2013 through April 2014. My co-pay never changed from $50 for 5 doses. This may be because my doctor ordered it from a local compounding pharmacy. I’m surprised that you are being compelled to pay more.

    • http://www.rmurthy.com/ Rekha Murthy

      I was fine through April 2014 as well. My compounder called me in early May to tell me they would no longer dispense the injections, and my insurer told me at that same time that I must buy Makena from another pharmacy.

  • Nurse Bevy

    And I hope you keep getting more and more pregnant until both you and Baby are completely ready to tackle this world. I’m a nurse and every day my mind grows more and more boggled by what a mess we’ve made of health and healthcare in this country. May you have a big, fat, pink, lusty, and healthy baby.

    • http://www.rmurthy.com/ Rekha Murthy

      Thank you!

  • http://www.whitneyforPA160.com whitneyhoffman

    Hi Rekha! The problem is that compounders have also ended up having all sorts of problems- they were implicated in the drugs that spread meningitis (http://en.wikipedia.org/wiki/New_England_Compounding_Center_meningitis_outbreak) and recently, even compounding pharmacies have made mistakes in drug combos they have put together for lethal injections for prisoners. They tend not to have the same high standards that many of the drug manufacturing companies do, and that’s a serious concern. That said, the Makena issue is outrageous and extreme, and brings the issue of industry mark up and pricing in sharp relief. the drug is priced so high in part because of the money it saves by keeping babies out of the NICU, and that way, insurers will pay more; but that never takes the consumer into account, and that when co-pays go up, the patient bears the cost, making the “money saved” argument less direct, since the patient isn’t getting the direct bottom line choice “Hey, a $70 co pay, or $300K in NICU costs plus time and complicated outcomes for your child”

    When drug companies price something based on “value proposition” versus cost of manufacturer, risk, insurance, etc. We all end up getting the short end of the stick in terms of astronomical pharmaceutical costs. That’s what’s really going on here.

    • http://www.rmurthy.com/ Rekha Murthy

      Thanks for this. It’s hard for KV to argue it’s saving the system money when they’ve priced a course of treatment at $30K — 75 times higher than it had been. (Incidentally, a frequently cited study put the cost of a preemie birth at $50K, which is the number KV itself used to justify Makena’s price. http://www.iom.edu/~/media/Files/Report%20Files/2006/Preterm-Birth-Causes-Consequences-and-Prevention/Preterm%20Birth%202006%20Report%20Brief.pdf)

      I would welcome greater FDA oversight and greater product uniformity, but not if it taxes our healthcare system and puts the drug out of reach for so many people who need it. Obviously, it doesn’t matter if I’m the only one who thinks so, but hopefully my article shows I’m in good company.

      Of course, I first reacted as a typical consumer to the rise in my own copay. But this article is motivated by a less myopic view: Not everyone’s copay buffers them from exorbitant pricing, and the costs ultimately make their way back to all of us.

      • http://www.whitneyforPA160.com whitneyhoffman

        My husband is an OB and the state coordinator fir the progesterone project, so I got to see the outrage when this happened first hand from providers, especially fir clinic patients versus the privately insured. I still think there needs to be substantial oversight here, because the price of avoided consequences versus actual cost and risk is so great in this case, it becomes ethically suspect. I hope the rest of your pregnancy is textbook perfect and wish you and your family the very best