Arkansas Medicaid patients suing over Kalydeco denial

Three cystic fibrosis patients filed suit in the U.S. District Court for the Western District of Arkansas alleging the state's Medicaid program denied coverage of Kalydeco ivacaftor from Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) because of the drug's cost. The plaintiffs said Arkansas Medicaid violated the Social Security Act in part by "establishing limitations on providing Kalydeco that are not consistent with the standards of care in the medical community." William Golden, medical director of Arkansas Medicaid, said the program decided to cover Kalydeco as a second-line agent, noting "its potential, but limited clinical impact" in clinical trials.

All three patients in the Arkansas suit have the G551D mutation, one of nine CF transmembrane conductance regulator ( CFTR) mutations for which the product is approved in the U.S. Golden said one of the three patients was approved for Kalydeco prior to filing the suit, while the other two have not requested Kalydeco since June 2013. ...