The New Cost of Preventing Prematurity: Will KV Back Off the High Price of Makena?

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KV Pharmaceutical’s Makena, a new brand of an old drug to prevent premature birth, went on sale last week at an exponentially increased price — going from about $10-$20 per dose to $1,500, and inviting widespread criticism and scrutiny.

The price hike resulted from the FDA’s Feb. 4 approval of the branded version of the medication; now, pharmacies that have long made the less costly version of the hormone specially for doctors can no longer do so without risking FDA action. On March 16, an article in the New England Journal of Medicine (NEJM) tallied up the overall costs of the new drug to the health-care system. (More on TIME.com: Can Patients Get Around the Exorbitant Price of a Pregnancy Drug?)

The NEJM article estimated that the synthetic hormone (17 alpha-hydroxyprogesterone caproate, or 17OHP) could prevent about 10,000 premature births each year, resulting in savings of $519 million in medical costs. The prevention of 10,000 premature births using the old, non-branded drug would cost about $41.7 million (that’s for weekly injections of the drug, at $15 per injection for 20 weeks, for the 139,000 women who are candidates for the treatment).

Using the newly approved Makena, however, the drug costs reach $4 BILLION.

Writes Dr. Joanne Armstrong in the NEJM:

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.

Senators Sherrod Brown (D-Ohio) and Amy Klobuchar (D-Minnesota) sent a letter to the Federal Trade Commission last week calling for an investigation and price reduction.

As I noted previously, at the same time as the drug’s price was making headlines, KV’s former CEO was being sentenced to prison and fines for his company’s mislabeling of oversized morphine tablets — an ironic turn, considering that the main advantage of branded drugs over compounded products is consistent dosing and labeling. (More on TIME.com: KV Backlash: Senator Condemns Price Hike As Former CEO Sentenced to Prison)

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