DECEMBER 20219Evidence­ The practice of evidence-based medicine is guided by a body of peer-reviewed research and clinical evidence linking modality of treatment to outcomes. The primary mechanism of action of traditional therapeutics is often linked to a biological pathway. However, digital medicines must rely on an expanded range of real-world evidence and digital biomarkers as regulatory agencies and national health systems scramble to keep pace with the flood of digital products and expansion of indications. In Europe, leading markets, such as Germany, the United Kingdom, and France are taking steps to develop standards and risk-based tiers for digital technologies, as well as national coverage decisions. Products that utilize cognitive behavioral therapy and remote monitoring for high-risk conditions, such as depression and gestational diabetes, land in the highest tier of the UK NHS guidelines. The link between digital medicines and how the treatment compares to the current standard of care is essential for physicians to be able to evaluate the hierarchy of traditional and digital drug delivery options. Metrics, whether quantitative or qualitative, should also be in place to evaluate effectiveness at the preclinical and post-market stage. Firms such as Evidation Health are leading the way in the current landscape to collect key evidence and help both digital and traditional manufacturers measure, analyze, and communicate clear value propositions for patients, physicians, and payers.Access ­ Cost is one the biggest obstacles to access to prescription medicines in the U.S., with the national annual prescription drug expenditure reaching $345 billion in 2019. The introduction of mobile technology has lowered barriers to entry and cost in other markets, such as finance, retail, real estate, and many more. The debate overpricing and coverage for digital medicines has yet to be decided ­should they be priced like a traditional new drug, or do they fall into a category of OTC drugs or companion diagnostics that come with a typically much-reduced list price? To date, the absence of coverage for digital therapeutics under Medicare Part B signals CMS has not yet landed on clarity of guidance on how to establish coverage. Digital manufacturers' approach to pricing is slowly revealing itself with the number of FDA approvals increasing each year and an influx of apps coupling tech-enabled services or devices, like Livongo, Welldoc, Omada, and Glooko. The distribution of complex medicines, such as specialty pharmaceuticals, are subject to rigorous controls on packaging, storage, and administration. While medicine packaged in a phone or coupled to an existing device or drug may not have the same restrictions, the introduction of cybersecurity concerns, protection of patient information, and data storage and delivery arise as beacons for digital manufacturers to install data safeguards. As providers look to prescribe digital solutions, cost and coverage are central to matching the right therapy to the patient. Outcomes­ Outcomes, no matter how great, are largely dependent on adherence, which has long evaded drug manufacturers and physicians alike in the desire to deliver continuous therapy to patients. A major cause of non-adherence is human psychology as it relates to the motivational tradeoffs between short-term rewards and long-term gains, particularly in the case of asymptomatic or chronic conditions that progressively worsen over time. Digital engagement may increase adherence through several modalities, including cognitive behavioral therapy, gamification, orpredictive analytics. One of the biggest questions facing the entry of digital drug delivery solutions in medicine is the assumption that more data will equate to better understanding of individual patient populations, better engagement through agile interfaces, and ultimately, better adherence to treatment regimens and outcomes. For example, Akili Interactive's EndeavorRX, an ADHD digital medicine platform prescribed by a doctor and delivered via video game, generates over 900,000 user data points in just the first 72 hours of prescribed use. Providers and manufacturers can play a role in facilitating these hypotheses by closely evaluating back-end analytics and two-way communication between patients and physicians as digital biomarkers and digital medicines unfold in tandem. Like traditional counterparts, patient education will remain central in the adoption of digital medicine. Even so, the ability for digital platforms to demonstrate lasting change and significant outcomes through improved adherence may not catapult them to the reimbursement level of traditional therapeutics. The success of digital medicine adoption is dependent on the ability of stakeholders to triage the balance between evidence, access, and outcomes to provide physicians and patients with a toolkit of therapies for better care. Healthcare has much to herald in the response to the COVID-19 pandemic and the swift removal of the previous barriers to telehealth and digital care. Patients with the most to benefit from digital medicines, adjunct or otherwise, should be able to seek reimbursement coverage for the emerging class of digital products. In a post-pandemic world, will the virtual bubble burst, or will the new normal in a world dominated by telemedicine pave the way for digital medicines to enter the main arena in healthcare? While the U.S. Food and Drug Administration has established guidance on digital technology, coverage for the Medicare population is still a jigsaw puzzle of codes for remote monitoring and durable medical equipment and associated supplies
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