Digital Therapeutics is a subset of digital health. It focuses on the use of high-quality software to prevent, treat, and manage medical disorders. Many of the technologies being developed in this field are also applicable to children. This article discusses the current state of digital therapeutics and how investments in these technologies can benefit children.
Investments in digital therapeutics
Unlike conventional therapy, digital therapeutics can help patients and physicians manage a variety of chronic conditions. These treatments often involve software programs that are customized for the individual patient and often work in conjunction with other therapies. These products are designed with the latest advances in technology and incorporate best practices in usability, clinical validation, and data security. They are also tested by regulatory bodies to ensure patient safety.
The digital therapeutics market is growing at a rapid pace. There are two models of work for these companies: business-to-business (B2B) and business-to-consumer (B2C). B2B companies sell to healthcare facilities and B2C companies sell directly to consumers. Both models are expected to surpass $5 billion in value by 2027.
Although digital therapeutics do not replace traditional treatments, they can greatly improve patient outcomes. In addition to boosting patient engagement and reducing the number of missed appointments, digital therapy can provide tailored dosages and educate patients about side effects. Incorporating these technologies into existing treatment plans can help pharmaceutical companies take advantage of the growth potential in digital therapeutics.
The growing burden of chronic diseases is putting an increased emphasis on the use of digital therapeutics in health care. In the USA alone, six out of 10 adults have two or more chronic conditions. The cost of managing such diseases is estimated to rise by 19.9% of the country’s GDP. Digital therapeutics offer an increasingly cost-effective solution to this rising burden.
The global digital therapeutics market is in its early stages, but it is rapidly gaining momentum. The total investment in digital therapeutics is expected to reach USD 8 billion by 2027.
Digital therapeutics are segmented by type: business-to-business (B2B) and business-to-consumer (B2C) segments. The B2B segment is estimated to account for the highest share of the global digital therapeutics market. This segment is predicted to grow at a CAGR of 24.3% over the forecast period.
FDA approval
Digital therapeutics are a growing trend in health care. While they are not FDA-approved, they can be used by physicians to help patients manage a variety of conditions. Although they are relatively inexpensive, these interventions raise questions regarding safety and accessibility. Moreover, they may not be covered by insurance. Nonetheless, a few developers are working to get their products approved by the FDA. One of these products, EndeavorRx, is a game-based therapy. It was approved by the FDA in June of 2020.
Digital therapeutics have been gaining momentum in Germany, which does not have a single payer health system. The country’s public health insurance providers cover about 73 million people. With this new law, physicians can prescribe digital therapeutics for public-insured patients and receive reimbursement the same as for traditional treatments. This has catapulted Germany into the forefront of digital therapeutics regulation.
The first FDA-approved prescription digital therapeutic was approved five years ago. Since then, nearly a dozen more have been cleared. These software-based medical devices are prescribed by a physician and are intended to treat, manage, or prevent a specific medical disorder. The cleared PDTs cover a range of clinical indications, including substance use disorders, attention deficit hyperactivity disorder, and insomnia. But they do not yet have a Medicare benefit category or physician fee schedule.
A digital therapeutic is a software-based treatment combining apps and monitoring devices to target a specific clinical outcome. One example is Daylight, which is FDA-approved for the treatment of chronic insomnia in adults. In a clinical trial, 71 percent of patients with chronic insomnia improved their condition. The Massachusetts Medicaid program approved two PDTs for addiction treatment. And the same company has several more in the pipeline. So, what does the future hold for digital therapeutics?
Major pharma companies have established in-house digital health teams, and many are partnering with digital health manufacturers to develop digital therapeutics for patients. In addition to being an alternative therapeutic intervention, digital therapeutics can help patients manage chronic or acute pain. They may also improve the health of populations that have poor health.
Iteration after approval
Digital therapeutics are still in the early stages of development, with a regulatory framework that is unclear in many jurisdictions. They are based on cutting-edge technology and use the logic of continuous innovation, and may not fit within the framework of medical device regulation. As a result, there may be risks to patients from improperly regulated digital therapeutics. This article discusses the need for a regulatory framework for these products and the role of self-regulation by developers.
The digital therapeutics industry values the legitimacy of regulatory approval, and is actively working towards a revised review process. But digital therapeutics products need to demonstrate real-world proof of their performance and their economic benefit in order to obtain reimbursement. For example, 2Morrow Health‘s behavioral therapy app delivers Acceptance and Commitment Therapy, a mindfulness training program that can help people deal with stress. In the coming months, the company expects to receive more Health Economics and Outcomes Research data. That data may be meaningful for some payors, but it does not guarantee coverage.
Regulatory agencies are increasingly interested in addressing these issues, and the FDA has shown its willingness to consider new proposals for digital health regulation. The FDA’s Digital Health Software Precertification Program, which approves software-based medical devices, is one example of forward-thinking policy. The agency has also been proactive in tackling the inefficiency of premarket approval processes for digital therapeutics.
In short, digital therapeutics have the potential to change the healthcare system. The use of new technologies will enable innovators to leverage the best ideas from every discipline to create new products. In turn, this innovation will benefit payers and providers. However, the regulatory environment will need to provide incentives to enable this innovation.
Adverse effects on children
Digital therapeutics have recently received significant attention from patients, providers, regulators, advocates, and investors. This technology can be effective in managing neurodevelopmental disorders, provide highly personalized care, and improve access to treatment. Additionally, digital therapies can be implemented in the comfort of the home and on a regular basis. This can minimize the stigma that traditionally comes with these treatments.
One way to address this challenge is to develop digital therapeutics that empower physicians and reach more children at critical times. By incorporating new information and using predictive analytics, digital therapeutics can help physicians identify the correct conditions and prescribe appropriate treatment. This approach will improve accuracy, personalization, and efficiency.
In addition to the benefits of digital therapeutics, they can also have negative effects. The use of these technologies may have harmful effects on children. For example, many children are exposed to content that may not be appropriate for them. However, it’s important to note that these technologies are not inherently harmful to children, and should not be viewed as a double-edged sword.
The use of digital therapeutics has expanded dramatically across the healthcare industry. Not only are they being used to treat children, but they are also used to treat chronic conditions. For instance, digital therapies are available for chronic conditions such as anxiety, depression, and ADD. However, there is a need to assess whether digital therapies can help address these problems.
