LITTLE ROCK, Ark. (Legal Newsline) - Arkansas Medicaid officials overstepped their authority when they refused to authorize prescriptions for a Food and Drug Administration-approved drug for treating a rare childhood disease, an appeals court ruled.
Sarepta Therapeutics sued the Arkansas Dept. of Health and Human Services in state court in 2018, seeking a declaratory judgment that its drug Exondys was covered under the state Medicaid program. The FDA approved Exondys in 2016 under a fast-track process for treating Duchenne muscular dystrophy, a fatal heart condition in children.
Arkansas fought Sarepta, arguing its experts determined Exondys was “unproven,” “experimental” and not “medically necessary.” The trial court rejected the state’s claims, citing federal Social Security law requiring state Medicaid programs to cover all FDA-approved drugs prescribed for their intended purpose.
It appealed and fared no better at the Arkansas Court of Appeals. In a Sept. 15 decision, the appeals court said federal law trumps any claims by state officials about the efficacy of a drug.
On appeal, Arkansas relied upon another case, Naturalis Health, that rejected a challenge to how the state administered rules governing marijuana cultivation licenses. The state argued that precedent held the lower court should have denied jurisdiction to challenge a rule.
The appeals court disagreed, finding Sarepta’s case was challenging a decision by state officials, not how they applied a rule.
“It is the FDA’s job, not that of the Arkansas Medicaid agency, to evaluate the clinical data to determine whether a drug meets efficacy and safety standards,” the court ruled. “DHS impermissibly substituted its judgment about the efficacy of the drug for that of FDA and the patient’s prescribing physician.”