In recent months, some innovative treatments have emerged for attention deficit hyperactivity disorder (ADHD), which affects millions of children and is one of the most common neurodevelopmental disorders in childhood. But because those therapies are so new — and in one case, very unconventional — payers appear reticent to change their coverage tactics to accommodate them, AIS Health reported.
On April 2, the FDA approved Supernus Pharmaceuticals, Inc.’s Qelbree (viloxazine extended-release capsules) for treating ADHD in patients ages 6 to 17 — a therapy that “represents the first novel non-stimulant treatment for ADHD in a decade,” according to the manufacturer.
“Qelbree may bring competition to the non-stimulant ADHD market if it continues to show promising data of earlier onset of action compared to Strattera,” says Mesfin Tegenu, R.Ph., CEO of RxParadigm. Both Qelbree and Eli Lilly and Co.’s Strattera (atomoxetine), which are non-stimulants, have the advantage of avoiding the abuse and addiction risks posed by other ADHD therapies like Ritalin (methylphenidate) and Adderall (amphetamine/dextroamphetamine).
“Based on current Phase III studies, Qelbree began to show improvement after the first week of therapy through the end of the study at week 7, while Strattera requires 4 to 8 weeks to begin working,” Tegenu points out. Ultimately, he adds, “more information will be needed before we see a shift in payers’ attitude towards Qelbree.”
Qelbree is not the only new ADHD treatment to make headlines in the last year. In June 2020, the FDA approved the “first game-based digital therapeutic device to improve attention function in children with ADHD.” The EndeavorRx device, manufactured by the Canadian company Ehave, Inc., is available only by prescription and is designed for patients between 8 and 12 years old who are primarily inattentive or combined-type ADHD with a demonstrated attention issue. The device currently is not covered by health insurance, according to the EndeavorRx website, although the manufacturer said it is trying to change that.
Even with these new treatments coming to market, Tegenu points out that behavioral therapy is generally recommended as the first-line treatment for preschool-age children who have been diagnosed with ADHD. That may be “followed by the addition of methylphenidate based on tolerability profile, if warranted,” he says.
Similar to their younger counterparts, children and adolescents who are in elementary school and older “may receive behavioral therapy and stimulant medication to help achieve target goals and improve symptoms,” Tegenu adds.
by Leslie Small