Makena Sets New Precedents

Internists should become aware of the event surrounding the FDA approval of Makena, a commercial preparation of 17-hydroxyprogesterone, an injectable agent to reduce premature delivery in at-risk mothers to be.

Previously, the drug was prepared by local pharmacies, which compounded the preparation for providers, who supervised weekly injections from ~18-36 weeks gestation to mothers with a history of previous premature delivery. The compounded product cost around $50 per dose and the effectiveness of the intervention resulted in great fanfare at the announcement of the FDA approval of a product for larger scale production and distribution.

Unfortunately, Makena's maker then announced a price for the drug of $1,500 per dose, or $30,000 per at-risk pregnancy. An uproar has ensued, especially since Medicaid funds nearly 50%-60% of all pregnancies in the U.S. The potential cost escalation for already strapped state budgets was clear.

Professional societies and Congressional leaders weighed in with protests. The FDA then announced, with CMS endorsement, that it would continue to allow local compounding of the drug if accompanied by a valid prescription. The company has subsequently reduced its price to ~$600 a dose, but is still in a public relations quagmire.

This set of events represents a dramatic statement by the federal government that there are alternatives to high health care pricing. The announcement by the FDA of acceptable local compounding for 17-hydroxyprogesterone has taken many by surprise, especially the manufacturer of Makena. It sends a signal that there really is a price point in health care that results in concerted action to tame the beast of cost escalation.