Women who are high-risk may have one more thing to worry about.
Until recently, one successful treatment for women who were likely to deliver prematurely was to give weekly progesterone injections to help maintain the pregnancy. These injections were prepared by special compounding pharmacies by the individual dose, because there was no standard, FDA-approved version of the treatment. These injections normally cost $10 – $19 each, depending on which pharmacy compounded them.
Unfortunately, that’s about to change.
The FDA just approved a branded progesterone injection called Makena. The benefit is that this product is standardized so that each dose contains the same amount of progesterone (not true with versions from compounding pharmacies, which can vary from pharmacist to pharmacist). It’s been studied and shown to reduce premature births by up to one-third in high-risk women.
The problem? Its price tag. It will cost $1500 per dose.
Some women who are at risk of premature delivery need to take up to 20 shots per pregnancy. At a cost of $1500 per dose, this makes the cost of the new drug prohibitively high. Doctors are also concerned because many of the patients who are high risk are also low-income, and Medicaid cannot pay for this new drug. Many women who need it may not be able to afford it. Since premature babies can be permanently disabled, and currently cost $26 billion a year in medical costs, this is a huge problem.
Although the compounding pharmacies’ versions are not standardized, they do have advantages. First, these versions have been used for around 50 years, so they have a long track record for safety and efficacy. Second, dosages can be adjusted individually based on a particular woman’s needs (shots have to be prescribed specifically by a doctor). Third, these shots cost only $10 – $19 per dose, making them very affordable for most women — even women who may need the full 20 shots per pregnancy.
At this point, although the company behind Makena is threatening compounding pharmacies who continue to sell their versions (undercutting the profits on Makena), compounding pharmacists may have found a loophole: if they use different oils in their preparations than Makena does, they may not be breaking the patent. Many compounding pharmacists intend to do just that, in order to make this very important medication available to their customers.
What do you think about this news? Have you ever had a premature baby or needed progesterone injections to prevent premature birth?
Top image by Cesar Rincon