It's been another month of great events at HealthXL, with topics ranging from ‘DTx Reimbursement: Navigating Medicare & Medicaid Coverage’ to ‘Quantifying the Benefits of Digital Biomarkers in Pharma’. 

To make sure you don't miss the top insights from our communities, here are my top five takeaways from HealthXL meetings that took place in August:

‍1. Pharma should compete on assets, not on digital endpoints!

Digital measures, digital biomarkers, digital endpoints, eCOAs...

Digital measurements, digital endpoints, eCOAs - the rise of connected sensor technologies and wearable devices has opened a treasure trove of opportunities for healthcare stakeholders to innovate health measurement methods. Digital biomarkers, in particular, have emerged as potential game-changers within drug development. However, the journey to their full-scale implementation is challenging, and the pharmaceutical industry has only cautiously adopted digital biomarkers in R&D.

While the potential of these measurements is beginning to show in the digital health space, there is still a level of ambiguity surrounding their proper use. Regulators have well-accepted definitions of endpoints and biomarkers, but consensus on the proper and relevant application of digital measures is still being ironed out.

During our recent roundtable discussion, 'Quantifying the Benefits of Digital Biomarkers in Pharma,' there was unanimous agreement that the pharmaceutical industry must collaborate to validate, streamline, and harmonise digital biomarkers rather than compete against one another.

Missed the session? Don't worry; you can read more about how pharma can leverage digital measures here. 

2. The DTx Market Needs to Mature Before Generic DTx Becomes a Reality

The ubiquity of generic drugs naturally raises the question: Could there be generic versions of digital therapeutics (DTx)? What would this mean for the DTx and healthcare industries? 

We wanted to answer just this! In our recent roundtable discussion on ‘Are Open Source DTx Solutions the Path to Scalability?’, we brought heads together to assess its potential reality in the not-too-distant future. Unfortunately, the consensus was that, although this could pave the way for an innovative approach to healthcare provision in the future, the DTx market still has a long way to go before this becomes a reality.

While the market may not be ready for this shift, there was a consensus that generic DTx could be a significant part of healthcare's future landscape. Interested in finding out more about this area?  Read the key discussion points here!‍

3. A Structured Evaluation Blueprint for Effective Digital Health Solutions

The surge in digital health solutions has left stakeholders with the daunting task of differentiating the ones that are genuinely transformative from ones that are not. So, how can you ensure true impact and safety with your solutions, such that they are deemed effective by various stakeholders?

In our recent masterclass on ‘Showcasing Impact & Effectiveness for Digital Health Solutions’, Dr. Simon Matthews guided us through a structured six-step approach to effectively evaluate digital health solutions and ensure they demonstrate true value. The approach includes:

• Clinical Claims and Regulatory Support: Determine whether a solution makes clinical claims and if there is regulatory backing for these claims.
• Gold Standard Alignment: Ensure solutions align with established gold standards for managing specific conditions and adhere to these standards.
• Quality of Evidence: Examine the quality of evidence supporting a solution's proposed approach.
• Technology Application Evaluation: Assess the strength of evidence supporting a technology's specific application.
• Regulatory Filings Examination: Scrutinise regulatory filings to confirm the existence of clinical claims.
• Clinical Team Assessment: Ensure the presence of a clinical team equipped with the expertise to manage pertinent medical issues.

A mix of rigorous evidence and open-mindedness to innovation will be necessary to pave the way for truly transformative healthcare solutions. Dive deeper into this topic here.‍

‍4. The Evolution to Hybrid Care and D2C Solutions in Digital Mental Health

The mental health domain presents unique challenges and opportunities for sustainable direct-to-consumer (D2C) business models. Despite the crowded digital mental health landscape and the hurdles faced by vendors in obtaining reimbursement and integrating into health systems, D2C emerges as a promising approach. Companies like Akili have indicated a transition from prescription digital therapeutics (PDT) to over-the-counter (OTC) products, showcasing the potential for differentiation and economic efficiency.

Nonetheless, transitioning to a D2C approach is intricate, necessitating meticulous planning of go-to-market strategy. Companies must ensure that their solutions are not only affordable but also effectively cater to the specific needs of their target audience. During a recent session on 'Mental Health: Getting your D2C Solution to be the Consumer's Top Pick,' experts agreed that starting with D2C is beneficial for gathering user feedback and data, which are crucial for securing payer reimbursement. However, the feasibility of pivoting to and maintaining a D2C approach exclusively warrants careful evaluation.

Dive deeper into this topic by reading the key takeaways here.‍

5. Medicaid Offers Greater Reimbursement Flexibility for DTx than Medicare

Securing reimbursement for digital therapeutics (DTx) in the United States requires a strategic approach due to the fragmented nature of reimbursement across states. Understanding the differences between Medicare and Medicaid and the implications of each for DTx companies is crucial in shaping a go-to-market strategy. Many questions arise such as whether to target state or private coverage, medicare or medicaid, one or multiple states. To help us understand and improve our strategies, Mike Pace took us through some of the nuances of CMS coverage and how to approach them. 

Firstly, it's essential to understand the nuanced differences between Centers for Medicare & Medicaid Services (CMS) coverage. Medicaid, with its greater flexibility compared to Medicare, often offers a more feasible route for the adoption of innovative technology at the state level. For instance, Medicaid allows opting out of specific services, a crucial aspect for the implementation of innovative technologies. Moreover, the absence of designated codes in Medicare presents a significant barrier for most digital solutions, emphasising the need for DTx providers to adopt a nuanced approach targeting both Medicare and Medicaid while considering the nuances across different states.

Secondly, DTx companies must leverage both commercial and state players as the adoption of DTx not only increases the workload for clinicians and administrators but also necessitates reimbursement for the time spent on the technology.

Discover other key takeaways and strategies to effectively navigate the CMS landscape here. 

Join the HXL community, where members can rewatch our webinars, read the takeaways from virtual and in-person events, and more. 

These are just a few top takeaways from some of our discussions this month. Apply to attend an upcoming HealthXL Community event and get all the insights first hand. 

See you in a HealthXL meeting soon!