Dec 21, 2022

Health Tech World By Jake de Medeiros, Director of Commercialization Strategy at Limbix Published Jake de Medeiros is Director of Commercialization Strategy at Limbix , the company behind SparkRX , the first digital treatment for adolescent depression currently being offered under the FDA’s Enforcement Policy. Since the FDA’s clearance of the first prescription digital therapeutic (PDT) in 2017, limited market access has been a major headwind for the category. Payers have largely deemed digital therapeutics as investigational, not to be covered or reimbursed. As a result, these evidence-based digital therapies proven to treat, manage, or prevent diseases or disorders have seen minimal real-world patient use despite their significant clinical potential. However, a recent announcement from Pittsburgh, PA based Highmark BCBS may offer the boost digital therapeutics need. In August 2022, Highmark, which covers 6 million lives across multiple states, released a Commercial Medical Policy that deemed select digital therapeutics approved by the FDA as medically necessary and reimbursable. While Highmark is not the first to cover PDTs, it is the first large commercial payer that plans to pay for them. Highmark is blazing the trail by showing a willingness to work with PDTs who have already met FDA ’s standard for clearance. Typical plans have shown trepidation and lack of acceptance toward PDTs, citing the lack of existing real-world data and cost reduction outcomes. Highmark’s policy will, ideally, cause a domino effect of plans to reconsider their PDT policy. Their decision adds legitimacy to the category and places pressure on plans whose members desire novel ways to address their medical needs. While PDTs are being developed for a broad range of indications, they show significant promise for mental health . Jake de Medeiros Disorders such as depression, anxiety, ADHD, and substance abuse are at  all-time highs in the US. However, there are simply not enough medical professionals equipped to manage these complex and often comorbid disorders. 2021 alone saw an exodus of 330,000 healthcare providers, many of which were frontline providers for mental health conditions, like paediatricians and family medicine doctors. These access issues are further compounded in areas like paediatric mental health, where child specialists are few and far between. Paediatric patients commonly experience 6-month waitlists for mental health specialists, leading to worried caregivers in need of treatment options for their children. That is why digital therapeutic companies like Limbix are developing digital treatments    specifically aimed at addressing paediatric mental health disorders. Limbix, for example, is developing SparkRx, a digital therapeutic designed to provide an evidence-based adjunct treatment intervention for adolescents aged 13-22 with symptoms of depression. SparkRx is a five-week program that delivers the core components of CBT through a self-guided mobile app. While SparkRx has been used by hundreds of patients and providers for free under the FDA Enforcement Policy for Digital Devices during COVID-19 , payer coverage will be paramount for ongoing patient access to solutions like SparkRx. Highmark’s policy decision is a pivotal stepping stone for increasing access to digital treatments across disorders and disease states. Their process and decisions will continue to serve as a framework for how digital therapeutics are evaluated and covered by other US health plans in the future. While it still may take a few more years for digital therapeutics to gain broad coverage and adoption, early access wins allow PDT manufacturers to develop a rich, real-world evidence base for clinical outcomes and engagement. This data will further solidify the rationale for covering PDTs from outcomes and cost perspectives. Manufacturers can use this information as evidence for why broad access to PDTs is vital for the well-being of health plan members. As the category gains ground in market access, PDT companies are in the process of building their pipeline and evidence base for the next generation of therapies. Early signs of good faith from leaders in healthcare, such as Highmark, further solidify the promise this industry has to offer for patients and providers in need of accessible healthcare. 60