Provider Perspectives on Prescription Digital Therapeutics for Psychiatric Disorders

AJMC: What unmet needs in psychiatric treatment might prescription digital therapeutics (PDTs) address?

CROWN: Psychiatric care traditionally relies on medication management, psychotherapy, peer support, and community-based services. While effective, these approaches face significant limitations: they are not available 24/7, and access is especially limited in rural areas compared with urban centers. This creates substantial disparities in psychiatric treatment across the US.

PDTs can help address these gaps. They are condition specific, with available programs for major depressive disorder (MDD), schizophrenia (including negative symptoms), generalized anxiety disorder, posttraumatic stress disorder (PTSD), and insomnia, among others. Importantly, PDTs are accessible in real time, when patients are most in need—something traditional care cannot provide.

For example, a patient struggling with negative symptoms of schizophrenia may be motivated to engage in therapy late at night, outside typical clinic hours. While clinicians cannot be available around the clock, PDTs allow patients to access evidence-based support at the moment they are ready to engage.

AJMC: How do PDTs differ from general wellness apps or other digital health tools?

CROWN: Patients often ask about wellness apps they find in app stores—many of which are inexpensive or free. However, clinicians cannot reasonably evaluate the thousands of such tools, and most lack evidence of benefit or safety. In contrast, PDTs are FDA cleared, developed through rigorous clinical trials, and evaluated for efficacy and safety against control or sham applications, much like traditional medications. This distinction is critical. Anyone with technical skills can build and market a wellness app, but without psychiatric or psychological expertise, the potential for harm is real. PDTs, by contrast, are backed by robust scientific data, regulatory oversight, and evidence-based design. For clinicians, this provides confidence that these tools deliver meaningful, measurable benefit (beyond placebo) and can be recommended as part of high-quality psychiatric care.

AJMC: How might PDTs impact access to psychiatric treatment for populations with limited provider availability?

CROWN: Access to psychiatric care remains a major challenge; more than 140 million US adults live in federally designated mental health shortage areas, and more than half of US counties lack a single psychiatric provider. Patients in rural communities may travel hours (sometimes more than 100 miles) for appointments, making ongoing psychotherapy or specialty care unrealistic.

PDTs can help bridge this gap. Most patients, even in rural regions, have access to smartphones and the internet. PDTs enable individuals to engage in evidence-based treatment from home, on their own schedule, without the geographic and logistical barriers of in-person care. For patients with conditions such as schizophrenia, depression, or anxiety, PDTs can support improvements in daily functioning, relationships, and vocational outcomes. For underserved populations, particularly in rural America, PDTs represent a scalable, evidence-based solution to extend psychiatric treatment where provider availability is most limited.

AJMC: Could you discuss the relationship between PDTs, polypharmacy, and treatment adherence?

CROWN: Polypharmacy is a significant concern in psychiatric care, particularly for patients with schizophrenia who already face elevated risks of cardiovascular disease, diabetes, and metabolic syndrome. Adding medications to address residual symptoms—such as flat affect, alogia, or social withdrawal—often yields limited benefit while increasing the likelihood of adverse events and drug interactions.

PDTs provide an evidence-based, FDA-cleared option to augment treatment without adding to medication burden. By addressing symptoms through nonpharmacologic, digital interventions, PDTs can reduce reliance on additional oral or injectable therapies, lower the risk of complications, and improve adherence by aligning treatment with patient needs and preferences.

From both a clinical and economic standpoint, PDTs represent a safer, lower-cost strategy to enhance outcomes before escalating to more complex pharmacologic regimens.

AJMC: How do stakeholders’ evidence thresholds influence the adoption of PDTs?

CROWN: Multiple stakeholders—patients, families, clinicians, and payers—influence adoption of PDTs. Among these, payers often set the highest evidence thresholds, as cost considerations drive coverage decisions. Patients with schizophrenia, for example, frequently live on limited incomes and cannot afford out-of-pocket costs for high-priced treatments. For this population, polypharmacy not only raises safety concerns but also significantly increases costs, with many oral and injectable antipsychotics priced at hundreds to thousands of dollars per month.

PDTs offer a lower-cost, evidence-based alternative with the potential to improve outcomes, reduce disability-related expenses, and mitigate the burden of comorbid conditions. For payers, this translates to meaningful savings in health care utilization, absenteeism, and disability spending. Importantly, PDTs also align with patient preferences: younger populations familiar with smartphones and digital tools are more likely to accept PDTs as part of care. Given their FDA clearance, demonstrated efficacy, and potential to reduce both clinical and economic burden, PDTs meet the threshold of evidence that should warrant broader adoption.

AJMC: Which barriers to PDT adoption do you see most often in the psychiatric space, especially for Medicaid and other public insurance programs?

CROWN: The primary barrier to PDT adoption is payer coverage. Even FDA-cleared, evidence-based PDTs, such as cognitive behavioral therapy (CBT)-based treatments for MDD, are often inaccessible due to prohibitive out-of-pocket costs, which can exceed $200. This is particularly concerning amid rising living expenses and severe provider shortages, where patients may wait months for psychotherapy. PDTs could provide immediate, evidence-based intervention, potentially reducing or delaying the need for traditional therapy while lowering overall health care costs. Lack of coverage, especially by Medicaid and public insurers, effectively withholds FDA-cleared treatments from patients who need them most.

Pharmacists play a critical role in supporting PDT adoption. In addition to dispensing traditional medications, they can provide access codes, assist with app setup, and counsel patients on potential drug-drug interactions or allergy concerns related to any pharmacologic components. While prescribing clinicians remain responsible for safety oversight, pharmacists serve as an essential checkpoint and support resource, helping ensure safe, effective integration of PDTs and reinforcing patient adherence.

AJMC: What kind of policy changes do you think might encourage broader coverage and reimbursement for PDTs?

CROWN: If a treatment has undergone rigorous clinical trials, received internal review board oversight, and achieved FDA clearance, it is evidence based and should be accessible to all patients with the appropriate diagnosis—regardless of whether it is delivered digitally. Current policies that exclude PDTs are outdated and effectively limit access to proven therapies.

Broader coverage would not only improve individual health outcomes but also positively impact families, social functioning, and vocational or educational engagement. By recognizing FDA-cleared digital therapeutics as reimbursable treatments, policy makers and payers could help ensure equitable access to effective psychiatric care while supporting overall societal and economic benefits.

AJMC: What considerations are important to ensure equitable access to PDTs for older adults and lower-income populations?

CROWN: Older adults and lower-income populations face unique barriers to accessing PDTs. Many seniors may feel anxious or unfamiliar with smartphones or tablets, which can limit engagement with digital treatments. Industry partners should collaborate with community resources—such as senior centers, Area Agencies on Aging, or local university programs—that offer technology training for older adults.

Payers can also support equitable access by providing case managers or nurse navigators to guide older patients through setup and use, ensuring that the investment in PDTs translates into meaningful engagement and clinical benefit. By combining community-based education with supportive follow-up, PDTs can become accessible, effective tools for populations who might otherwise face technological or economic barriers.

AJMC: What innovations or changes in the PDT landscape might maximize their impact on psychiatric care?

CROWN: Recent innovations in PDTs are expanding evidence-based treatment options for psychiatric conditions. CT-155, for example, targets negative symptoms of schizophrenia, particularly motivational deficits, addressing a population with few effective therapies. Other PDTs now treat generalized anxiety disorder, PTSD, MDD, and insomnia, offering nonpharmacologic alternatives that avoid controlled substances and associated risks of dependence, diversion, or abuse. CBT-based PDTs, such as those for insomnia, have demonstrated efficacy superior to medications but remain underutilized due to limited access.

Barriers to adoption include restricted payer coverage, which limits clinician awareness and distribution. Without reimbursement, PDTs often lack a field presence to educate providers, leaving many clinicians unaware of therapies like DaylightRx or reSET unless they actively seek information through journals or professional conferences. Even then, coverage limitations can restrict patient access.

While broad adoption may shift financial returns away from early developers who assumed initial risks, these challenges should not deter efforts to expand access. Maximizing the impact of PDTs requires improved distribution, integration into clinical workflows, and partnerships with payers and community organizations to ensure FDA-cleared, evidence-based digital treatments reach patients in need.

AJMC: Looking ahead, what PDT developments might better support psychiatric care?

CROWN: There is potential for PDTs to expand across nearly all areas of psychiatric care. Most patients today have access to smartphones and the internet, enabling real-time, private engagement when they feel ready. Future PDT development could target unmet needs such as cognitive and negative symptoms of schizophrenia, as well as MDD, generalized anxiety disorder, panic disorder, and PTSD—areas where pharmacologic options are often limited or minimally differentiated within their class.

As younger, digitally fluent generations engage with care, PDTs offer an accessible, evidence-based, and lower-risk alternative to conventional treatments. Greater awareness, continued development, and expanded coverage could help ensure that these underutilized tools reach patients and deliver meaningful clinical benefits.