The high cost of Makena, a drug used to help stave premature births, at $1,500 a dose, has given rise to the approved use of cheaper, $20-40 per-dose compounded versions. In the face of an ongoing and deadly fungal meningitis outbreak, the compounded version faces scrutiny.
Because of the price disparity, federal officials agreed to allow pharmacies to compound the unapproved versions, said Kaiser Health News. Compounded drugs typically see significantly less oversight.
Vials of a compounded version of the injectable pregnancy drug were among the many products recalled by the now-closed New England Compounding Center (NECC). The NECC is widely believed to be the culprit in the deadly fungal meningitis outbreak linked to contaminated, compounded steroids. Experts say the pregnancy drug would likely not cause fungal meningitis because it is administered into muscle, not the spine; however, a contaminated dose “could cause a local infection,” U.S. Centers for Disease Control and Prevention (CDC) spokesman Curtis Allen, told Kaiser Health News. Also, potency issues could render the drug less effective in preventing early births.
The U.S. Food & Drug Administration (FDA) investigated complaints sparked by KV Pharmaceutical, a brand name drug maker, earlier this year, concerning the quality of some compounded products, said Kaiser Health News. A small sampling revealed that a few failed potency tests; the FDA said that, “approved drug products, such as Makena, provide a greater assurance of safety and effectiveness than do compounded products.”
Yet, about six state Medicaid programs and some large private insurers continue to pay for the less expensive compounds over the very expensive Makena brand, noted Kaiser Health News. Makena recently provided some deeper discounts, but some states’ programs continue to restrict access to Makena, which is still prohibitively expensive to some programs and patients.
In the U.S. alone, some 150,000 women are at risk of suffering a repeat pre-term delivery and may be prescribed the Makena brand or a pharmacy-made compounded version of the progesterone drug, said Kaiser Health News. Although the drug does not prevent premature births in all who take it, it does provide an overall improvement.
KV did not develop the drug, but purchased legal rights to it from another firm for about $200 million and secured market exclusivity for seven years, believing state Medicaid programs and private insurers would cover the FDA-approved brand version, enabling it to make up its investment, explained Kaiser Health News. Instead, a March of Dimes official described the drug’s costs as “outlandish,” which prompted calls by doctors’ groups and Congress for an investigation.
This March, the federal Centers for Medicare and Medicaid Services advised state Medicaid programs that states could continue covering the compounded versions, which have been available for about nine years. On the same day, said Kaiser Health News, the FDA issued what many considered to be an odd statement saying that, “to support access to this important drug, at this time and under this unique situation,” it would not take enforcement action against those compounding pharmacies that properly and safely created compounded versions of the brand drug. In the past, the agency has issued warning letters and pursued legal action against compounding pharmacies that manufacture mass-produced versions of FDA-approved medications, Kaiser Health News explained.
KV has filed lawsuits against a number of states who refuse to cover the brand version, has pointed to what it said is the FDA’s failure to enforce KV’s market exclusivity for Makena, and alleges that Medicaid patients are exposed to “unapproved compounded versions” of drugs “of uncertain quality,” wrote Kaiser Health News. Although it won one injunction, KV filed for Chapter 11 bankruptcy protection this summer.
Makena contains the same active ingredient, hydroxyprogesterone caproate, as the pharmacy-made compounded drugs. In a perfect world, both the brand and compounded version would be equally effective; however, compounded drug potency and sterility have come under serious question in light of the NECC debacle that is being blamed for over 350 illnesses and 28 deaths, nationwide. Massachusetts Democratic Representative Edward Markey said the unsanitary conditions at NECC are “just the tip of an industry iceberg that has long needed reform and federal oversight,” according to Kaiser Health News.
NECC has been blamed for producing and releasing tainted vials of injectable steroid methylprednisolone. Most of the fungal meningitis cases being seen have been linked to Exserohilum, a fungus seen in grass and rotting wood; Exserohilum is known to be very aggressive in how it attacks spine and brain stem tissue. Meanwhile, Ameridose LLC, sister company to the NECC, is recalling its products after the FDA discovered some issues with its testing procedures, the Boston Globe wrote. Dr. Janet Woodcock, FDA director of its Center for Drug Evaluation and Research, said that during Ameridose’s production facility inspections, investigators did not find “an adequate assurance of sterility in the manufacturing of their sterile products.’’