U.S. Sen. Mark R. Warner  today called on Ohio-based K-V Pharmaceutical to voluntarily roll-back its dramatic increase in the price of a drug used to prevent premature labor for women in high-risk pregnancies. The prenatal progesterone treatment, which had been priced between $10 and $20 per weekly injection when compounded and dispensed by pharmacies, now will be sold under the brand name Makena at a cost of $1,500 per week.

Today, Senator Warner sent a letter to the CEO of K-V Pharmaceutical urging the company to reconsider its pricing decision. In addition, Sen. Warner joined Sens. Sherrod Brown (D-OH) and Richard Durbin (D-IL) in a letter last Friday asking the  administrator of the federal Medicaid program to determine the strain this 150-fold price increase will place on federal and state Medicaid budgets.  

In addition to putting the shots out of reach for some women, the higher price will have a ripple effect on insurance companies and already overburdened Medicaid programs.,” Senator Warner said. “And taxpayers are likely to end up helping to pay for the care of newborns who arrive prematurely because their moms didn't get the shots.”

Virginia’s Medicaid program paid for about 600 doses of the cheaper version of this drug last year at a total combined cost to Virginia taxpayers of $14,700.  Under K-V’s pricing for Makena, Virginia’s Medicaid costs for those same 600 doses would increase to $920,000 a year. That’s a 6,000% increase.

Each insurance company must decide whether to cover the drug. But even women whose insurance will pay could face thousands of dollars in out-of-pocket costs to satisfy co-payments and deductibles.

“K-V didn't discover this drug, taxpayers funded the initial clinical work, and K-V doesn't even manufacture it themselves.  They may have the right to set the price, but not at a level so high that it hinders patient access and blows-up state Medicaid budgets,” Senator Warner said.  “I believe K-V Pharmaceutical deserves an opportunity to make back their investment, but not at the expense of pregnant women and taxpayers.”

K-V recently purchased the rights to manufacture Makena and was granted "orphan" status for its version of the drug by the U.S. Food and Drug Administration, which allows a seven-year exclusivity period. The FDA grants orphan status to drugs and biologics which treat or prevent diseases or disorders that affect fewer than 200,000 people in the U.S., and for which a company is not expected to recover its R&D or marketing costs. 

"Women who must deal with the diagnosis of a complicated pregnancy have enough to worry about without the additional anxiety of a huge increase in the price of a once affordable treatment," Senator Warner said. "This price increase will undermine public health and have a huge impact on the taxpayers who fund state Medicaid programs. I am calling on K-V Pharmaceutical to do the right thing here, and voluntarily reconsider and roll-back this astronomical and unjustified price increase."