by Leslie Small
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.
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.
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