Dr. Scott Kollins: Tackling the Challenges of ADHD Care Management Inertia

Earlier this month, I had the privilege of joining Akili as Chief Medical Officer. This career move was a welcome and logical step for me as I have become increasingly discontent over the current status of our ADHD care management. Innovation in the treatment and diagnosis of ADHD has stagnated for years, and patients and families deserve better. 

I’ve spent the large majority of my 25-year professional career working with individuals and their families that have been affected by ADHD. Through the specialty clinic I led at Duke University, we provided clinical care for thousands of families. As a clinical researcher, I personally spent most of my time studying the causes and consequences of ADHD, and designing and executing clinical studies to evaluate new treatments. I have served as a principal investigator for dozens of clinical trials conducted to assess nearly all of the currently marketed pharmaceutical products. 

I have been on the front lines of new product development since the introduction of the first long-acting stimulant medication products in the early 2000s. There has been some innovation since that time – for example, there is now a range of different formulations and delivery mechanisms for methylphenidate and amphetamine-based products; and there are more non-stimulant options. But in spite of this progress, our front line treatments are largely identical to the compounds we began using decades ago. Moreover, there have not been improvements in the degree to which patients with ADHD remain adherent to their medication regimens, and many studies report that the majority of patients discontinue medication within a year of initiation due to lack of efficacy or safety concerns. And perhaps most disquieting is the fact that, despite the introduction of dozens of different pharmacological treatments for ADHD, long-term studies on effectiveness are equivocal and the longer-term outcomes for patients with ADHD across domains of functioning are no better than they were when the first longitudinal studies were published in the mid-80s.

It’s well known among providers and clinical researchers that pharmacological treatment is not the only approach for managing ADHD, and behavior therapy has been shown to be effective not only for reducing symptoms, but to improve functional outcomes. Results tend to be better when behavior therapy is combined with medication - so called multimodal treatment. But estimates from the CDC suggest that fewer than half of children and adolescents with ADHD receive behavior therapy either alone or in combination with medication. Access to appropriately trained providers to deliver behavior therapy is limited, due to both overwhelming demand, geographic constraints and affordability.

This leaves the current status quo for ADHD care management to the use of medications that have not changed in decades and behavioral therapy which is difficult to access or afford for many patients. Compounding these realities of traditional treatment options are additional barriers to optimal care. Widely publicized shortages of medication for ADHD upon which hundreds of thousands, if not millions of patients rely for managing symptoms, combined with inconsistent and seemingly arbitrary insurance coverage of a range of evidence-based treatments move decisions about care delivery out of the hands of patients and their trusted health care providers (HCPs), and into the hands of supply chain logisticians and insurance actuaries.

But there’s good news – the status quo can be challenged and we have the tools to challenge it today. This is what drove me to join Akili. My new role enables me to work closely with my fellow Akilians to drive innovation in treatment development and facilitate the dissemination and adoption of EndeavorRxⓇ, a safe, effective, and FDA-authorized treatment of attentional difficulties in 8-12 year old kids with primarily inattentive or combined-type ADHD, as part of a comprehensive treatment plan. You can access indications and safety information for EndeavorRx here.

EndeavorRx represents a first-in-class digital intervention to improve attentional functioning in children with ADHD. It has been favorably evaluated in five clinical studies involving more than 600 children with ADHD and shown conclusively and consistently to improve attention and accompanying impairment, and to do so with a nearly benign safety profile. The body of evidence supporting the safety and efficacy of EndeavorRx led to its authorization as a medical device by the US Food & Drug Administration in 2020. And the digital nature of this intervention means it can be accessed by any patient, anywhere, provided they have a compatible iOS or Android device.

So what can be done to ensure that as many patients as possible can benefit from this easily accessible and well-validated intervention and others like it?

First, we need to raise awareness via education about the unmet needs faced by the millions of patients diagnosed with ADHD. Patients, their caregivers, and healthcare providers need information to advocate for themselves and their patients about the critical gaps with traditional approaches to ADHD care management. A better understanding of how attention dysfunction can impact day-to-day functioning, and how interventions like EndeavorRx can improve these challenges will allow these stakeholders to make more informed decisions to optimize care. As part of education and awareness-building, it will be critical to be balanced and evidence-based. For example, our clinical studies show that not every patient responds to EndeavorRx, but the same is true for traditional treatment options. Having a better understanding of what options are available, what the relative risks and benefits of those options are, and how they can be combined to mount a comprehensive and holistic approach to treatment will increase the likelihood that more children get better care.

Second, we must continue to innovate through research and development. It is critical to better understand how EndeavorRx and other treatment options work for different patient groups who present clinically in different ways. Pivotal clinical trials that helped support the FDA clearance for any treatment are really just the start of optimizing how a new treatment modality can be used to improve care. Real-world studies that engage patients and their health care providers are one approach for collecting additional critical data to guide better treatment decisions. We must also constantly improve the way that EndeavorRx and other similar digital interventions fit into the day-to-day lives of patients and their caregivers, recognizing that there are so many novel ways that a digitally-delivered treatment can promote better care management. We are working on these today.

Finally, we must work collectively across stakeholder groups to ensure that the patients who can benefit from EndeavorRx can access the treatment in an affordable manner. This means patients and HCPs must be educated and aware of the options, and that health plans, payor groups, legislators and others who set policy around reimbursement for medical treatments recognize the value and benefit of an intervention that uniquely targets one of the most impairing features of ADHD - attentional dysfunction. This means EndeavorRx and similar digital/non-drug treatments not only get prescribed, but can be covered by insurance plans to ensure that patients can actually afford to get access to these safe and effective care options. The FDA has vetted EndeavorRx for its safety and efficacy. Providers across every state of the country are prescribing EndeavorRx to their patients. It’s now time for insurers to take action to ensure all families that can benefit from EndeavorRx can afford it so that we can make much-needed new options available to families.

We are on the cusp of transformational change in how we care for ADHD and other disorders that are marked by cognitive dysfunction. We have developed the tools to address historically unmet challenges in safe and effective ways. If we can work together to dismantle existing barriers, we will have the opportunity to advance ADHD care management in ways we have not observed for a very long time. And most importantly, such advances will change the trajectories for millions of people.