State health officials have settled a federal lawsuit that demanded Arkansas' Medicaid program provide a high-priced drug to cystic fibrosis patients afflicted with a rare form of the deadly disease.
When the suit was filed in June, no Medicaid patients in Arkansas received the drug Kalydeco, said James Passamano, one of the Houston lawyers who represented the Arkansas residents.
Now five people take the drug that costs about $311,000 annually per patient.
Among them is 14-year-old Chloe Jones of Walnut Ridge, Passamano said, who was one of the plaintiffs in the lawsuit.
Since she started the drug in August, "Chloe's health has been the best it has ever been. She has not needed to be hospitalized, and she has not missed any school," her father, Billy Jones, said in an email released by the Texas attorneys. "For the first time in her life, Chloe can finally enjoy good health."
Jones; Elizabeth West, 21, of St. Charles; and Catherine Kiger, 21, of Lavaca sued officials with the Arkansas Department of Heath Services and its Medicaid division.
The dispute was settled Thursday without any financial award to the cystic fibrosis patients, according to documents filed in U.S. District Court in Fayetteville.
When the drug first gained approval from the U.S. Food and Drug Administration in January 2012, "there weren't a lot of studies that showed [it] helped long-term outcomes," said Kate Luck, state health services spokesman. "Because this was a pricey drug, we had to be good stewards with public money while balancing patient care."
About the time the lawsuit was filed last summer, more studies were released showing Kalydeco's effectiveness, Luck said.
State Medicaid officials began approving the drug for the lawsuit plaintiffs and others under the old rules.
This fall, they decided to stop requiring Medicaid patients with the disease to undertake 12 months of standard therapy before trying Kalydeco, Luck said.
The new policy, which removed many of the restrictions outlined in the lawsuit, went into effect in January.
The settlement requires Arkansas' Medicaid program to keep its new provisions in place for at least two years.
Kalydeco treats cystic fibrosis patients with the G551D genetic mutation. They represent about 6 percent of people diagnosed with the illness.
Manufactured by Vertex Pharmaceuticals Inc., Kalydeco carries the generic name Ivacaftor. Experts say it's the first drug to treat genetic defects that cause the disease.
Work is underway on a related drug that may be used in combination with Ivacaftor to treat larger numbers of cystic fibrosis patients, experts said.
Cystic fibrosis is a genetic illness that generates thick, sticky mucus in the body and interferes with breathing and digestion, according to the national Cystic Fibrosis Foundation.
Passamano said Friday that Arkansas was the only state where Medicaid officials set up rules that made it almost impossible for cystic fibrosis sufferers to qualify for the drug.
"The problem in Arkansas [was] there was a standard that you could not get the drug, even when the circumstances demonstrated medical necessity," Passamano said. "That's not a lawful standard."
The state "now has a policy that complies with federal law and provides a reasonable access to the drug when it's medically necessary," he said.
Passamano and a law partner, Beth Sufian, decided to represent the Arkansas patients for free. Sufian also suffers from cystic fibrosis, Passamano said.
Metro on 02/07/2015