As the mother of a child born 3 months premature and a candidate for injections of the synthetic hormone, 17α-Hydroxyprogesterone caproate (17P), during future pregnancies to help prevent preterm labor, I am very upset that 17P gained “orphan drug” status.
All women with a history of spontaneous preterm labor or preterm premature rupture of membranes (pPROM) are candidates for prophylactic 17P injections during pregnancy. In the United States, 70% of preterm births are due to either of these obstetric precursors, and over 500,000 preterm births occur annually. Thus, 17P does not meet the requirements for “orphan drug” status by virtue of the fact that (1) over 200,000 women may benefit from 17P injections each year and (2) the costs of research and development of the drug for the indication can be easily recovered by sales of the drug in the United States. (See 1.usa.gov/e4KmHl )
17P was, in fact, already on the market before it gained “orphan drug” status, and a number of health insurance providers have covered the “off-label” use of 17P to prevent preterm birth since 2003, when an NIH study confirmed its effectiveness. At $10 to $20 per dose, weekly injections of 17P throughout pregnancy cost insurance companies much less than a single day of care for a newborn in the neonatal intensive care unit (NICU).
Now 17P has gained FDA approval for use to prevent preterm delivery, and KV Pharmaceutical has gained exclusive right to sell 17P under the name Makena. A prophylactic treatment that once cost $10 per dose will now cost $1,500 per dose, adding up to $30,000 over the course of an entire pregnancy. As a result, insurance premiums will increase, and some women who may have benefited from 17P will not receive it.
The United States spends over $25 billion annually caring for premature children; this is not an issue to be taken lightly. My son’s 73-day NICU stay, though relatively uneventful, cost over half a million dollars alone.
Please introduce legislation that will revoke 17P’s “orphan drug” status and KV Pharmaceutical’s exclusive right to distribute the drug.