Senator, doctors put pressure on company to lower drug cost

By William K. Alcorn


Pregnant mothers and their premature babies ultimately will pay the health price because they may not be able to afford the medicine that prevents premature births, a U.S. senator and local health officials say.

The progesterone-based medicine (hormone) that used to cost $10 to $20 an injection now costs $1,500.

The usual prescription is one dose per week for 20 weeks, said Dr. Oscar Khawli, who treats high-risk pregnancies at St. Elizabeth Health Center.

Cerebral palsy and other birth defects such as learning disabilities are an increased danger in premature births, Dr. Khawli said.

A medicine that previously cost between $200 and $400 per pregnancy is now about $30,000, said U.S. Sen. Sherrod Brown, D-Ohio, who is attempting to force KV Pharmaceuticals, which has FDA approval to exclusively market the medicine named Makena, to lower the price.

KV Pharmaceutical, based in St. Louis, has issued a cease-and-desist order to pharmacist compounders who used to make the $10 doses, meaning the medicine no longer is available except through KV.

What everybody thought was a good thing — FDA approval for exclusivity because it would provide better quality control and a plentiful supply of the medicine — has turned into a nightmare, Brown said Friday during a press conference at St. Elizabeth’s.

Brown said he does not blame FDA for the outcome. He said, however, it may be necessary for Congress to review the laws that enable drug companies to get exclusivity.

Brown’s campaign ranges from trying to shame KV into lowering its price of Makena to calling for a Federal Trade Commission anti-trust investigation of the company.

He said it is not known if even private insurance will pay for the medicine given its new price.

What Brown said he is sure about is that if the price stays and it is not covered by Medicaid or private insurance, many women will not be able to afford the progesterone treatments leading to more premature births.

Joining Brown and Dr. Khawli at the press conference was Dr. Nick Kreatsoulas, Humility of Mary Health Partners’ chief medical officer, who said 50 percent of HMHP’s deliveries, about 2,500 in 2010 at St. Elizabeth’s and St. Joseph Health Care Center in Warren, are paid for by Medicaid or self-pay.

He said 10 percent to 12 percent of those deliveries are premature, which he said is among the highest rates in Ohio.

Dr. Khawli said progesterone has been shown to prevent premature births, and he fears it will be impossible for most of his patients to get the medicine because they won’t be able to afford it.

It appears KV Pharmaceutical may be listening to the outcry, however.

In a response to a letter from Democratic leaders posted on its website, Ther-Rx Corp., one of KV’s wholly owned subsidiaries authorized to distribute Makena, said it “takes very seriously the concerns raised about the list price of Makena by members of Congress and other stakeholders.”

Ther-Rx said the company has established a Patient Assistance Program with the goal of ensuring that every woman who is prescribed Makena will be able to access and afford it.

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