Three Arkansans with cystic fibrosis, including a 14-year-old girl, are challenging a state Medicaid policy that they say is blocking their access to an expensive drug needed to treat the deadly disease.
Chloe Jones, 14, of Walnut Ridge; Elizabeth West, 21, of St. Charles; and Catherine Kiger, 21, of Lavaca say in the lawsuit filed last month that their doctors have determined they need the drug Kalydeco, but the Medicaid program has denied their requests for it.
The plaintiffs' attorney, James Passamano of Houston, said the drug, manufactured by Boston-based Vertex Pharmaceuticals Inc., is considered the standard treatment for patients over the age of 6 with a genetic mutation, known as G551D, that each of the plaintiffs has and is the only available treatment that addresses the cause of the disease.
But his clients have been told they must first use other methods for a year before Medicaid will cover the drug, he said.
The U.S. Food and Drug Administration approved Kalydeco for patients with the G551D mutation in January 2012.
By denying coverage for the drug, the state program is violating its obligations under federal Medicaid law, Passamano said.
Passamano said his clients qualify for the traditional fee-for-service Medicaid program, rather than the expanded program approved by the Legislature last year, because of their ages or disabilities caused by the disease.
"Our goal in this lawsuit is simply to get the girls the medically necessary treatment that their doctors have prescribed," Passamano said. "They've waited long enough. They are suffering without it. They will die prematurely without it, and we want to help them."
William Golden, the Medicaid program's medical director, said the state's policy requires patients to use other treatment methods -- a saltwater mist known as hypertonic saline and the drug Pulmozyme, which thins the mucus in the lungs -- for a year before they can be approved for Kalydeco.
But a patient could be approved for Kalydeco earlier if "the patient was adherent and not doing well" with the older methods, he said.
"Our approach has been -- if you have a mild disease or you're doing well on the old therapy, you'd stay on that until you need a different agent," Golden said.
The cost of the drug -- about $350,000 per year per patient -- was a factor in developing the criteria, he said.
"We have an interesting responsibility in the Medicaid program to look after the interests of patients, but also to be accountable to the taxpayers of the state," he said.
Golden added that one of the plaintiffs in the lawsuit was approved for Kalydeco last month, before the lawsuit was filed. The most recent request for the drug by either of the other two plaintiffs was in June 2013, he said.
Passamano said neither his clients nor their doctors have been notified of any of the plaintiffs being approved for Kalydeco.
His clients hadn't made a more recent request for the drug because their earlier requests were denied, he said, and they haven't yet met the criteria for trying other treatments for a year.
Golden said only one other Medicaid recipient has requested coverage of Kalydeco. The state approved that request shortly after the FDA authorized Kalydeco, he said, but the person left the Medicaid program after one prescription was filled.
He said Medicaid officials will likely consider shortening the amount of time patients are required to use other treatment methods to six months.
Passamano said he doesn't know of any other insurers with similar requirements for approval for Kalydeco.
Approving the drug wouldn't have a big effect on the Arkansas Medicaid program, he said.
The lawsuit, assigned to Judge Timothy Brooks, was filed in U.S. District Court in Fayetteville on June 23 and was transferred to the Fort Smith division July 3.
It asks that Medicaid officials be ordered to cover Kalydeco when a doctor certifies it to be medically necessary and for a declaration that the denials violated federal law. The suit also asks for attorneys fees and court costs.
During the fiscal year that ended June 30, 2013, the Medicaid program covered an average of about 680,000 people including children, elderly and disabled people with low incomes. Spending totaled about $4.7 billion, including $351.1 million for prescription drugs.
Last year, the Legislature approved expanding eligibility for the program to adults with incomes of up to 138 percent of the poverty level: $16,105 for an individual, for instance, or $32,913 for a family of four.
Under the state's so-called private option, most newly eligible adults receive coverage through private insurance plans on the state's exchange, with Medicaid paying the premium.
Two of the three insurers that offer plans on the insurance exchange do not require prior authorization for Kalydeco coverage, according to a spokesman for one and the drug formulary for another.
The federal government pays about 70 percent of the cost of medical expenses for patients covered by the traditional Medicaid program and is expected to pay the full cost of coverage for private option enrollees and other newly eligible adults until 2017, when Arkansas will begin paying a portion of the cost.
The state-administered health plans for school and state employees require prior authorization similar to the one used by Medicaid, except the trial period for older methods is six months instead of a year, said Dwight Davis, director of the University of Arkansas for Medical Sciences College of Pharmacy's Evidence Based Prescription Drug Program.
Only one person has requested the drug, and that request was approved, he said.
Metro on 07/18/2014