Makena

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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. Continue reading

FDA Fights Back In Dispute Over Pricey Drug For Premature Birth

FDA: Power to the pharmacists!

Responding to critics outraged over the exorbitant price of Makena, a new version of a cheaper, older drug to prevent pre-term birth, the FDA issued a statement saying that pharmacists can “compound” the drug themselves, thereby side-stepping the cost controversy surrounding the newly approved medication, marketed by KV Pharmaceuticals, reports NPR’s Health Blog.

Hey, KV Phamaceuticals, that new, $1,500-a-dose drug of yours is about to get some competition!

The Food and Drug Administration said in an unusual statement that it’s quite all right for pharmacists to go ahead and make their own version of the medicine, given by injection to help some women avoid preterm delivery of their babies. Many of them had been doing that for years anyway and charged $20 or less per dose.

But KV, based in St. Louis, pursued formal approval of the medicine, hydroxyprogesterone caproate, to avoid premature deliveries. Starting this month, KV began selling it as Makena at a price of $1,500 a shot. For women who need the drug, given weekly for about 20 weeks, the tab would come to around $30,000, as the Washington Post reported the other day. The price hike led to a backlash from just about everyone except KV shareholders.

Now the FDA has cleared the air about whether pharmacists can make the medicine. The agency’s answer boils down to an emphatic yes.

Makena Backlash: Outrage Over Pricey New Version Of Old Drug To Prevent Premature Birth

The cost of a new drug to prevent pre-term birth jumps by 100-fold

Here’s Our Bodies, Our Blog neatly detailing the outrageous saga of Makena, a pricey new version of an older drug recently approved by the U.S. Food and Drug Administration to prevent pre-term birth.

The cost of Makena, marketed by KV pharmaceuticals and also known as 17-Hydroxyprogesterone, went up 100-fold — from about $300 to $30,000 for a 20-week treatment course — when its status changed from generic to branded drug, according to a recent report in The New England Journal of Medicine. Outraged consumers and interest groups shocked by the new sticker price say the women who most need the medication won’t be able to afford it.

From the blog:

17-Hydroxyprogesterone has been in use for preventing preterm birth for decades, but had not specifically been approved by the FDA – it was usually compounded by pharmacists. It is now the only drug on the market with FDA approval for preventing preterm birth.

Following this new FDA approval for an old intervention, what was once a $10 per dose drug has become a $1,500 per dose drug. This has raised some hackles. Nicholas Fogelson of Academic Ob/Gyn urged readers to “Boycott Makena,” stating that he will try to keeping getting compounded (and cheaper) injections for his patients.

Others have expressed outrage that the March of Dimes, which works in part to reduce premature birth, supported KV Pharmaceutical’s application to the FDA and “has received hundreds of thousands of dollars in donations from KV’s subsidiary Ther-RX, which will market Makena,” according to a Time health blog.

A blogger at The Preemie Primer expresses dismay that the March of Dimes didn’t anticipate such a price hike when they supported the pharmaceutical company’s application.

And The New England Journal of Medicine piece earlier this month makes this sobering point:

Rather than representing a good investment of increasingly scarce health care resources, Makena will force patients, physicians, and those responsible for financing care to make hard choices. K-V Pharmaceutical has announced a copayment-assistance program, but no program providing short-term financial assistance to some patients will mitigate the harm that this new cost will cause to publicly funded programs, including Medicaid, and the women who rely on them. Nor will it mitigate the cost to employers and individuals who purchase insurance coverage and therefore directly bear all increases in health care costs. This tremendous cost increase and the likely decrease in access to an effective medicine are sizable unintended consequences of the FDA approval of 17OHP. They demand reconsideration and corrective action.