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.
Children with ADHD, who comprise the bulk of people diagnosed with the condition, may be overly active, have trouble paying attention and have difficulty controlling impulsive behaviors. Roughly 6 million children in the U.S. have been diagnosed with ADHD, according to the Centers for Disease Control and Prevention.
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.
“Based on the efficacy demonstrated in the clinical program, we believe Qelbree offers a unique new alternative for the treatment of ADHD,” Supernus President and CEO Jack A. Khattar said in a statement. “Qelbree provides prescribing physicians and patients living with ADHD a therapy that is not a controlled substance with proven efficacy and a tolerable safety profile.”
The approval of Qelbree comes after a development phase that involved four Phase III clinical trials, studying more than 1,000 patients ages 6 to 17. The company also revealed “positive results” from a Phase III trial conducted in adult ADHD patients, and it plans to submit a New Drug Application for Qelbree in adults in the second half of this year.
According to Mesfin Tegenu, R.Ph., CEO of RxParadigm, “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.” 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.”
Game-Based Device Enters Market
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 Boston-based Akili Interactive, 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 treatment uses “sensory stimuli and simultaneous motor challenges designed to target areas of the brain that play a key role in attention function,” according to the device’s official website.
“The EndeavorRx device offers a non-drug option for improving symptoms associated with ADHD in children and is an important example of the growing field of digital therapy and digital therapeutics,” Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, said in a press release unveiling the agency’s approval decision.
However, families who are interested in this option will have to pay out of pocket for it, as EndeavorRx notes on its website that the device is “not covered by health insurance, but we’re actively working to improve health insurance coverage.” To help offset the cost, the site encourages the parents of prospective patients to “take advantage of lower 3-month prescription pricing (regularly $450) through our pharmacy partner,” Phil pharmacy.
Behavioral Therapy Is Often Tried First
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 tells AIS Health. Methylphenidate — which can go by the brand names Concerta, Ritalin, Daytrana, Aptensio XR, Metadate CD, Methylin, Quillivant XR, Jornay PM, Adhansia XR and Cotempla — is a stimulant also used to treat narcolepsy.
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 says. Aside from methylphenidate, other most common stimulant used to treat ADHD is amphetamine/dextroamphetamine. According to Tegenu, the ADHD treatment market is “highly generic with options for both stimulant and non-stimulant drugs with various formulations available.” Which therapy clinicians and patients choose “is primarily dependent on preferences for duration of action, short versus long acting, and whether the child or adolescent can swallow a pill or not,” he adds.
Branded non-stimulant options include Strattera (atomoxetine), a selective norepinephrine reuptake inhibitor, and Intuniv (guanfacine), manufactured by Takeda subsidiary Shire LLC. Back in 2017, PBMs viewed the impending entrance of four atomoxetine generics as a promising sign, as Strattera was one of the priciest medications in the ADHD class.
However, Tegenu points out that the average wholesale acquisition cost for atomoxetine is currently between $100 to $120 per 30-day supply, and it is still about 25% to 50% more expensive than other generic stimulant and non-stimulant ADHD medications.
Qelbree manufacturer Supernus won’t disclose the price of its newly approved ADHD medication, but Jefferies analysts in an April 4 note to investors estimated that the drug could bring in approximately $54 million in its first full year on the market, 2022, and account for roughly $383 million in sales by 2026.
Supernus is planning to launch Qelbree in the second quarter of 2021, which would put it on the market just in time for the back-to-school season this fall, “when upwards of 40% of annual Rx switches occur” in the ADHD class, the analysts noted.
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