The case of Makena: Speaking out against unfair drug pricing

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 $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. 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.

Hmm, 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.

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.

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

Rekha Murthy can be reached at her self-titled site, Rekha Murthy. This article originally appeared in WBUR’s CommonHealth.

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  • DeceasedMD1

    Great post. This is exactly what is wrong: price gouging and the ACA certainly did not address these very core issues. The law is on the side of pharm lobbyists. The profits have to be enormous. And what a great ploy to change their name!! LOL! If you have time on your hands write to your Congressman. (I know what good will it do?)

    • May Wright

      Crony capitalism at work again.

      “When buying and selling are controlled by legislation, the first things to be bought and sold are legislators.” –P. J. O’Rourke

  • PoliticallyIncorrectMD

    Greedy bastards !

  • John C. Key MD

    Dramatic story but not out of the ordinary, unfortunately. Just a small star the the larger constellation of pricing abuse engaged in every day by hospitals, Big Pharma, insurance companies and governmental programs. No heroes in that group.

  • Ava Marie Wensko George

    Amazing and astounding. Good research. America and Americans cannot continue to pay for the drug research and development for the world….Now with that said, this is not the typical case. This company took a drug that they did not invent, package it, market it, have their cronies support it, and stomped out the compounded version, which I believe is a criminal offense, especially if they cornered the market. Keep up the publicity and pressure on Lumara Health, nee KV.

  • Eric W Thompson

    The simple solution is to reverse the law on compounding. Done.

  • Dave Given

    Have your doctor write for a strength that is slightly different than Makena, say 255 mg. Probably not enough to make a difference clinically, but could be compounded because strength isn’t commercially available. You know manufacturers change formulations on things all the time to try and maintain market share. I remember when there was a product with 595 mg of guaifenesin (instead of 600 mg which was in generic version of Humibid LA).

    • Rekha Murthy

      Creative idea, and easier to achieve than “mint-scented progesterone delivered in half-doses by purple needles.”

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