March of Dimes response to Makena pricing reveals they are woefully out of touch

Preemie message boards are all fired up by KV Pharmaceutical’s pricing of 17 Alpha-hydroxy progesterone caproate (17P, a hormone than can help prevent premature delivery for some women who have previously delivered prematurely). Once KV was awarded the patent, the price metastasized from $10 to $1500 a shot. More expensive per ounce than gold.

The March of Dimes supported KV Pharmaceutical’s application to the FDA, apparently over concern about product consistency in compounding pharmacies. However, I can’t find one article in PubMed to support this claim. I suspect some compounding pharmacies make inferior products, just like some doctors give bad advice, and some non-profits make bad choices.

The FDA has long had an issue with compounding pharmacies, so I wonder who actually got this whole process underway. Personally, I think a lot of compounding (such as tailoring “bioidentical hormones,” is nothing but snake oil, but that doesn’t mean the drugs are not mixed up correctly, just that the superiority of such preparations compared to standard commercial preparations has never been tested. I’m all about the evidenced based medicine).

Once the backlash began, the March of Dimes quickly released the following statement:

The FDA’s decision to approve Makena will help ensure that a consistent drug will be more widely available to prevent premature births. We played no role in the pricing of products. We have discussed the price with manufacturer Ther-Rx and have received their assurance that no medically eligible women will be denied the drug due to inability to pay. Financial assistance is available through Makena Cares Connection.

I have no doubt that the March of Dimes had no role in the price point, but the result can only mean one of two things:

The March of Dimes were incredibly stupid/naive thinking KV Pharmaceuticals (who barely escaped bankruptcy last year) would have a reasonable price point. I was interviewed by Matthew Herper, a reporter from Forbes magazine yesterday and he was not shocked at all by the price of $1500 per shot. In fact, he felt that price was pretty easy to predict based on how Big Pharma prices drugs. But he actually studies the business of health care. I dunno, maybe the March of Dimes could have thought of the implications before supporting the application. Maybe they could have, you know, asked around, done some research.

The other option is that The March of Dimes thinks it is justifiable to charge $30,000 per treatment, which would mean they all flunked grade 5 math. A premature baby costs $50,000 to get home from the hospital (this is average, some kids like mine are $250,000 babies and others cost $20,000). You need to treat at least 5 pregnant women with 17P to prevent one premature delivery, so it will cost $150,000 (5 X $30,000) to prevent one premature delivery. At this price point, 17P becomes cost ineffective.

Of course 17P should be used regardless of price, but the reality is the price will make it harder for some women to get the treatment and the added price tag to 50,000 or so pregnancies a year will have a ripple effect that we will undoubtedly all feel in higher premiums.

If the March of Dimes wants to win back my support or the support of the majority of preemie moms (check out all the nasty comments on the March of Dimes Facebook page), they’re gonna have to do better than their tepid statement. Perhaps they should start by proving, you know, with scientific evidence, that this whole process was even needed in the first place.

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19 Responses to March of Dimes response to Makena pricing reveals they are woefully out of touch

  1. Cassie Brown says:

    As the mom of a preemie, although not due to premature labor or ever needing this particular drug, what MOD, FDA and KV Pharmaceuticals has done is a huge slap in the face to preemie babies and parents. You have stated my feelings on the subject perfectly.

  2. Would you consider writing at template letter for petition? You are a fantastic writer, an experienced mother of a preemie, and a doctor. The trifecta! I would love to assit in any way I can if you are interested.

  3. Jennifer Gunter says:

    I guess I could. I think the best place to start is the FDA…

  4. Jim says:

    If the March of Dimes had been this “helpful” when the organization began the polio
    vaccine would be $$$$$ per dose and lots of leg braces would be sold every year! Common sense is not that comon.

  5. krista says:

    I am most confused by the quote that it takes only $50,000 to get a preemie home. My daughter’s hospital bill alone was over $400,000 and her twin brother’s hospital bill was over $850,000 (almost 6 years ago so I am sure it is more now). This whole article is biased and I question any of the information in it. I would like to understand the entire situation better but I do not believe this article is the best place for that!

  6. Jennifer Gunter says:

    The average cost per preemie is $50,000. Some babies are in for 6 days and cost $2000, and others are in for 200 days and cost $400,000. There are many more babies born at 35 or 36 weeks so the majority of preemies have “smaller” NICU bills. 500,000 babies are preemies, but only 50,000 are micropreemies with the biggest bills.

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  8. Andrew says:

    Just saw a ABC news clip on line discussing premature births…good base info. I guess my questions are:
    - if this drug has been around for so long for so cheap, how come not more pregnant women have been treated over the past decade? In the new clip, U.S. was ranked 30th in enfant mortality rates (mostly attributed to premature births).

    - How much money is KV pharma spending on universal access (supporting those who can’t afford this drug)?

    - How do we, as a society, measure efficacy of the enfant healthcare system going forward?

  9. Laura says:

    Andrew,
    There are several reasons why the USA has a higher infant/maternal mortality rate. One reason is that we count any baby born alive as a live birth and thus, if the baby passes away after s/he is born, an infant death. In some countries, a baby is not counted as a live birth unless it is x grams or a certain gestational age. Thus a 22 weeker in the US who is born alive but is unable to be saved because he is too preterm is a “live birth” and an “infant death.” The same 22 weeker in another country might be listed as a miscarriage, still birth or not at all. The WHO, who askes for am recordes these things, does not have international standards or definations for a “live birth.” It is up to each country to determine “live birth” and submit the information accordingly.
    In the US, it is more acceptable to carry a baby who has, or might have, a fatal birth defect. In some countries, it would be unthinkable to cont the pregnancy. Again, if the baby is born alive at term and then passes, most places would consider that an infant death. If the parents chose to induce labor pre-viability, or even at viability, and allow a child with a fatal birth defect to pass, is that a live birth/infant death, miscarriage or still birth? If the baby is delivered dead, is it a miscarriage or still birth? Again, it depends on how the country would list it.
    Someone can clarify this, but I think women in the US have greater access to IVF and other fertility treatments. Women who have undergone fertility treatments have a greater likelyhood of having a preemie. Thus, if you have more women who got pg with IF treatments, then you will have a greater likelyhood of babies being born early.
    Finally, not all babies are born early due to pre-term labor. Progestrone treats women with a history of pre-term labor. I am unsure if it is given to mothers who are pg for the first time and having early contractions. Normally, I believe, it is given to those who delivered early with another pregnancy or had PTL, again, with a previous pg. However, if there is something wrong with the baby that necessitaties a pre-term (IUGR for example), placenta previa, pre-e, HELLP, an infection and so on- no, progestrone won’t help with those.
    What can we as a nation do? Now, these are just my opinions but I believe embracing the midwifery model of care would help. Increased focus on prenatal health, care and even before conception care of women. International standards of what defines a live birth, infant death, still birth and miscarriage would be nice.
    Oh and supposidly KV says that no woman will be turned away because they cannot afford their drug. Color me cynical, but since they jacked up the price of the drug… I don’t believe it. And if they do, they won’t make it easy. My fourth child was carried to term with the aid of progestrone and I am horrified that another child might not have the same chance as my baby simply because of the greed of this company.

  10. Pingback: How I would have handled the “compounding issue” with 17 hydroxyprogesterone | The Preemie Primer Guide from Dr. Jen Gunter

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  12. Jan,

    I greatly appreciate the work you do to educate the public about Makena and KV Pharmaceutical (KVP). In Oklahoma, several outraged physicians banded together and started a campaign to boycott Makena. We spoke to KV’s marketing director for Makena, ACOG’s executive director(Hale), and March of Dimes’ (MOD) medical director (Alan Fleischman) to get everybody’s point of view before acting. ACOG is now very active with the Society of Maternal Fetal Medicine and the American Academy of Pediatrics to initiate congressional investigation of KVP. We Oklahomans felt that the letter they sent to KVP was anemic but they assured us that much more is happening behind the scenes. I pointed out to MOD that their response to KVP was also weak. They are fully aware that many see their involvement with Makena as collusion, even though they had nothing to do with this egregious pricing policy. I certainly hope that MOD will save face with their donors by being a bit more assertive in their opposition to the Makena pricing. Starting tomorrow, March 21, all OB/GYNs in Oklahoma will be asked to refuse seeing the Makena rep in their offices, They will be made aware that compounded (and legal) 17OHPC is available at pharmacies throughout the state for low price. I hope other states follow suit.

  13. Pingback: Makena hits the market and it’s a show down at the OK corral | The Preemie Primer Guide from Dr. Jen Gunter

  14. Mitchell Dombrowski says:

    hello
    I have been increasing public pressure for a rational cost of Makena. I made a Youtube video about this and this made front page of 3-21-11 Detroit Free Press. Please forward if you wish, I think only public outrage will make KV Pharmaceuticals lower their outrageous price.

    Makena article in The Detroit Free Press, please see:
    http://www.freep.com/article/20110321/NEWS06/103210344
    or google “freep makena pregnancy”

    The youtube video can be seen if you google “prematurity death Makena”

    thanks
    Mitchell Dombrowski MD
    Chairman St John Department of ObGyn
    Professor, Wayne State University School of Medicine

  15. Pingback: The longer the March of Dimes takes to act on Makena, the worse it gets | The Preemie Primer Guide from Dr. Jen Gunter

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