October 6, 2015—For the second time in less than a month, a generic-drug manufacturer under congressional investigation for price increases has announced that it owes 340B covered entities refunds due to overcharges. [ms-protect-content id=”2799″]
Zydus Pharmaceuticals, the U.S. division of Indian drugmaker Cadila Healthcare, posted the announcement yesterday on the Health Resources and Services Administration’s Office of Pharmacy Affairs website. The company listed 278 product lines for which it has recalculated its 340B ceiling prices from the first quarter of 2012 through the fourth quarter of 2014, based on an associated recalculation of its Medicaid average manufacturer prices and best prices for corresponding calendar quarters. Based on its spring 2015 catalog, Zydus currently has 295 product lines.
Zydus said in its public letter that will give 340B covered entities refunds via Apexus, the 340B prime vendor, if its records show that an entity “has overpaid by $10 or more in the aggregate for the impacted products.” If a provider believes it has overpaid by $10 or less in the aggregate and wants a refund, the letter says it should contact Zydus directly at (609) 730-1900 or via email at 340BRefund@zydususa.com.
Zydus said if a provider has not been contacted by Apexus by Nov. 30, it should assume it “is not above the $10 impact level” and needs to ask Zydus directly for a refund on or before Dec. 31.
Zydus is one of the 14 makers of generic drugs under investigation by Sen. Bernie Sanders (I-Vt.) and Rep. Elijah Cummings (D-Md.) for “enormous price increases.” In an Oct. 2, 2014 letter, the lawmakers asked Zydus to provide them with documents and information about its pricing on two drugs, divalproex (the generic of the anticonvulsant Depakote) and pravastatin (the generic of the statin Prachol) “for the time period covering January 1, 2012 to the present.” That timespan generally corresponds with the same timespan for 340B refunds set out in the company’s public letter.
Citing data from the Healthcare Supply Chain Association, Sen. Sanders and Rep. Cummings said that from October 2013 to April 2014, the average price charged for a formulation of divalproex rose by as much as 736 percent and for pravastatin by as much as 573 percent.
In mid-September, Heritage Pharmaceuticals, another company under investigation by Sen. Sanders and Rep. Cummings, posted a letter on the OPA website stating that it “recently determined that 340B pricing to participating 340B covered entities was not extended on purchases of its products made between April 18, 2008 and December 31, 2014.” [/ms-protect-content]