The NEW cost of P17 to prevent premature labor

 Recently, KV Pharmaceutical of suburban St.Louis won government approval to exclusively sell the drug, known as Makena (Mah-KEE’-Nah). The March of Dimes and many obstetricians supported that because it means quality will be more consistent and it will be easier to get.

That being said, the cost will change from $10-20 per shot to $1,500 per shot, costing approximately $30,000 to prevent premature labor.  Oh but don’t you worry, since they’ve made this nearly impossible for the average person to afford, they have developed a Patient Assistant Program to ensure that NOBODY goes untreated.  Nobody that is, that falls within the guidelines of their program, which is copied directly from their website below.

The patient assistance program for Makena covers both uninsured and insured patients, and is based on income eligibility requirements. The program has been designed with the following guidelines in place:

  • Insured patients with annual household incomes of up to $100,000 who apply for and are eligible for copay assistance will have a copay of $20 or less per injection for Makena.
  • Uninsured patients with annual household incomes of up to $60,000 who apply for and are eligible for patient assistance will receive Makena at no cost. Uninsured patients with annual household incomes between $60,000 and $100,000 will be able to acquire Makena at a cost that is comparable to the average copay assigned by commercial insurance plans.

If you haven’t worked this out, if you’re lucky enough to make over $100K a year, then $30K out of pocket isn’t a big deal for you and your family.  I mean come on, it’s only $30K…don’t you keep that under your mattress or in a cookie jar for rainy days?  And so what if your mortgage takes up a big chunk of that, you can move to afford saving your child’s life…right?  Seriously KV Pharmaceuticals?  I think while you weren’t developing the actual drug P17, you were smoking another one.

Yes, that’s right, KV Pharmaceuticals didn’t actually come up with the drug, many other companies worked that out, and were only charging $10-20 per shot.  But since the CEO of KV was trying to not let his company go bankrupt, this was a great “Go directly pass jail, collect $200 million” landing spot on their game of Screw the Preemies monopoly. 

What struck me the hardest was that the March of Dimes actually lobbied for KV to get the sole rights to produce this drug.  They have publicly stated that they didn’t think they would push the price up so much.  I have been a huge advocate for the March of Dimes, have a team ready for the March for Babies and was about to do some serious fundraising when all of this came out.  At first their stance was basically…well we didn’t tell them how to price it.  But since then, a letter was released from the March of Dimes which renewed some hope (you can read this letter at

So I will continue to raise funds, but still not thrilled about it all.  I think the another HUGE hit for me when this came out was that my son was an IVF baby, and if I desire more children, will also have to be an IVF baby.  We have one frozen egg left and I truly want to use this egg, but that will require me to take 2 progesterone shots a day after the egg is inserted.  This means I wouldn’t be able to afford my last egg and Spencer would be an only child.  THEN, I actually stopped by my fertility clinic and discovered that the P4 shot is what we take after IVF, not the P17.  But since I did have a preemie, whose to say I won’t need the P17 shot next time?

So there is my opinion on the matter, KV Pharmaceuticals should be stripped of having the “Sole Survivor” title for P17 unless they make it affordable by changing the pricing back to the same as it stands currently.  March of Dimes, as large of an organization as you are, did you really not discuss pricing with KV when supporting them?   I’m shocked, but am hoping you’re busting your butts to ensure this pricing is changed or I’m sure you will lose some major support.

If you’d like your voice to be heard, you can always send a letter to your Senator regarding this issue.  Someone thoughtfully sent me the letter below so I will share with you.  Just copy, paste and send…make a difference, help another preemie family save their children and prevent KV Pharmaceuticals from smoking their P17 all the way to the bank.  (Soap box is now available for the next person to stand on…)

I am writing you today to ask you to call for the P17 drug to be exempt from FDA Orphan status. KV Pharmaceuticals recently won Orphan status rights for this drug and will market it under the name Makena.

As you know Orphan drug status is a form of a grant given by the FDA to support the development of drugs for rare diseases affecting less than 200,000 people. This drug was already invented before KV Pharmaceuticals won rights to produce it. This drug came on the market more than 50 years ago for other purposes. A 2003 study brought new
light to the drug when it was shown beneficial in preventing pre-term labor in those who had already had a previous case of pre-term labor.

The study showed a reduction in pre-term births from 55 percent to 36 percent. Currently the US averages 500,000 premature births per year.

By granting Orphan status to the drug, KV Pharmaceuticals has raised the price per dose from $10 to $1,500. This means that for a pregnancy, the price to take this drug would go from $200 to $30,000.  As preterm labor affects 500,000 births a year, the increase in cost will undoubtedly mean less access to the drug, causing a higher preterm birth rate, straining the public health system and causing countless unnecessary suffering to our citizens.

Thank you for your time. I urge you and other members of Congress to call for the P17 drug to be exempt from FDA Orphan status.

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About the Author: Julie of IAPT Howard

9 Comments + Add Comment

  • Yes the pharmacy assistance is great until your husband gets a promotion that bumps him over the eligibility limit by 2 dollars per year.

  • I am still disgusted by this and if we choose to have another baby I am sure this shot will be recommended for me. But, to be honest, according to my OB I have a 30% odds of having another preemie and this drug gives you a 36% chance (I believe) of delivering full term. Hmmm, I think I might want to take my chances. Not to mention we wouldn’t be able to afford 30k. Jeez Louise!

  • This just makes me feel sick and very hopeless! As if I ever get pregnant again, i will have to take p17 injections, so that we can prevent another preemie!

  • @Andrea – For women with a history of preterm delivery due to spontaneous preterm labor or pPROM, 17P reduces your chance of preterm delivery in your next pregnancy by a third – down from 55% (placebo) to 36% (with 17P).

    I posted my letter to my legislators on my blog:

  • Keep the letters and the postings going. KV is beginning to realize that this action will put them out of business when the additional premature births and stillbirths are shown to be from their price gouging. If they care at all about their companies future, they will adjust down Makena to reasonable levels

  • I cannot believe the money grubby insanity of this! I had daily progesterone shots (I don’t know if it was P17) until I was at week 12. So that would be 588 shots at $1500 per shot? Insane.

    Granted, I have twins and if I wanted another child, my partner would have to be the one who carried them because I SUCKED as a pregnant woman. But still. Insane.

  • Good infonto know about!

  • If someone makes $100,000/yr, shouldn’t they have access to an insurance plan that covers this sort of thing? We make quite a bit less, and still can afford premium insurance that will cover it as part of pre-natal costs.

    Not that it should have to. Dumb FDA, boooo. Last I heard they weren’t going to reverse their decision, but they’ve stated that they’d unofficially exempt this drug from the rules that state compounding pharmas can’t make a named drug blend.

  • I got the Makenna shot which is the name brand for the 17P. My insurance covered the cost for this so I only had to pay $45 per vile which is still pretty expensive, but hey it worked. I carried my daughter to 37 weeks. I was even dialted to a 3 and progressed a CM every week. Pretty sure if I didn’t get the shot I would of had another preemie.

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