KV Cuts Makena Price 54%, Increases Medicaid Rebates, But Is It Enough?
Bowing to public pressure and following an unusual intervention by FDA, KV Pharmaceuticals announced April 1 it has cut the list price of its new preterm birth prevention drug Makena (hydroxyprogesterone caproate) by 54% – from $1,500 to $690 per injection – effective immediately.
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The controversies have shown that, while it may be easy to scapegoat outliers, it is remarkably hard to lower a drug price by political fiat. It took a while, but now Makena, Daraprim and Acthar are all facing very different days of reckoning.
The agency says its decisions not to take enforcement action against pharmacies compounding hydroxyprogesterone are discretionary and that KV has not shown that payers are likely to change their reimbursement policies if the court follows its request.
KV seeks a court order requiring FDA to desist from permitting importation of unapproved API for compounded hydroxyprogesterone and to state its intent to take enforcement action against compounders.