Objections Build to Price Hike for Makena, Drug to Prevent Preterm Birth

March 28, 2011

Earlier this year, the FDA approved Makena (a progesterone injection from KV Pharmaceuticals, generically known as 17-Hydroxyprogesterone or 17OHP) for use to reduce the risk of preterm delivery in pregnant women with singleton pregnancies and a history of at least one spontaneous preterm birth.

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 also notes that Rep. Henry Waxman and colleagues have sent a letter to the drug company with a list of pointed questions about the pricing. Objections also include the steep costs to Medicaid programs and the lack of affordability for low-income women. The Preemie Primer has several additional posts on this issue for further reading.

Time also indicates that KV Pharmaceuticals “has warned compounding pharmacies that they face FDA action if they continue to sell nonbranded versions of the drug.” This aspect of the controversy is still being disputed, as the drug company does not hold a patent on Makena and so it is questionable as to whether they can prevent compounding.

The New England Journal of Medicine included a perspective piece on the issue, which concluded:

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.

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