Unjustified increase in cost of care resulting from U.S. Food and Drug Administration approval of Makena (17α-hydroxyprogesterone caproate).

U.S. Food and Drug Administration (FDA) approval of 17α-hydroxyprogesterone caproate for the indication of decreasing the risk of preterm delivery in those high-risk patients who previously had spontaneous preterm birth has come at considerable cost to the health care system. Weekly injections provided by compounding pharmacies starting at 16-20 weeks of gestation and continuing until 36 weeks currently cost the health care system $200 to $300 per pregnancy. This cost is significantly less than the costs associated with delivering and caring for preterm children. Makena, by KV Pharmaceutical, the same 17α-hydroxyprogesterone caproate product, is priced at $1,500 per injection, or a projected cost of $30,000 per pregnancy. With approximately 132,000 pregnancies being eligible for treatment annually, this increase in cost of 75-150 times what previously had been paid far exceeds the benefits derived from the FDA-approved Makena when compared with previously available compounded versions of 17α-hydroxyprogesterone caproate. This increased health care cost is not justified at this time. The price barrier to access imposed by KV Pharmaceutical actually could result in an increase in preterm deliveries over current rates. Actions are needed by the FDA, national societies, and the manufacturer to ensure that all high-risk patients continue to get the needed therapy to reduce the number of preterm births.