The firestorm over KV Pharmaceutical Co.'s pregnancy drug Makena is just the tip of the iceberg when it comes to pricing Orphan Drugs.

Until recently, payers have routinely reimbursed these drugs, even those costing hundreds of thousands of dollars, because the limited number of patients would have a small impact on their budgets. But that was beginning to change even before KV thrust Orphan pricing back into the spotlight by introducing Makena hydroxyprogesterone caproate at a price that was 100 times higher than the same drug purchased through compounding pharmacies (see BioCentury, April 4).