The public outcry over KV Pharmaceuticals' pricing on its new Makena drug is giving the company pause. KV said in an SEC filing that consumer and physician complaints may interfere with its ability to persuade government and private payers to accept the $1,500-per-injection cost
KV recently won FDA approval for the drug, designed to prevent premature births. It's a commercial version of an unapproved remedy that had been sold for years for $10 to $20 per shot, given weekly during pregnancy. The sudden bump in price has everyone from individual patients to physician groups to congressional reps to the March of Dimes up in arms, calling the price "extremely expensive" and even "outlandish."
The company is now acknowledging the complaints may be a problem. The company said in an SEC filing that its success is "largely dependent" on negotiations with payers, including health insurers, pharmacy benefits managers and Medicaid--as well as on its ability to handle the pressure from media and politicians, the St. Louis Post-Dispatch reports.
In a statement on its website, KV said, "We appreciate the concerns expressed by multiple audiences, and are committed to working collaboratively with all interested parties to make this vital medication even more available and affordable to women across the country." The company announced a patient assistance program to help women afford the drug, but doctors called those discounts inadequate.
- read the Post-Dispatch piece
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