Over the past month, our HealthXL community members met to discuss topics ranging from evidence gathering for Digital Therapeutics (DTx), to reimbursement in the US, Software as a Medical Device (SaMD) regulation in the EU among others.
We have curated some of the key takeaways from these sessions to showcase the top 5 expert insights from these meetings.
#1 On getting reimbursed in the US
When approaching payers to negotiate an access agreement, clinical data and cost-effectiveness are really important, especially the latter. But even when you have the evidence, becoming a trusted advisor for payers in the US is a huge challenge. The 4 key pillars of account management excellence when working with payers for DTx reimbursement are:
1) Customer interest
2) Seek mutual value creation
3) Bring an integrated team approach
4) Ongoing account management
Although there is still a long way to go to have clear and easy paths to reimbursement in the US, we are seeing new initiatives that point in the right direction. Recently, there has been a new PDT legislation introduced in the Congress, which has already moved to the finance committee and it is very clear on how it codifies PDT coverage in both Medicare and Medicaid, as well as proposed pricing and payment models.
#2 On the challenges and best practices for evidence generation for DTx
Aligning your evidence generation strategy with your commercialization strategy from the early stages is critical to avoid spending more money and time. Knowing who you want to sell to upfront is key to building an efficient and relevant evidence strategy. An approach that some DTx companies take initially is building a less regulated product and collecting real-world evidence. Once they have generated the evidence, they change towards the Software as a Medical Device (SaMD) model, hence a more regulated approach.
#3 On the regulation of Software as a Medical Device (SaMD) in Europe
Given the complexity of the new Medical Device Regulation (EU-MDR) for SaMD in terms of time to market, it can be easier for life sciences companies to start building solutions that are not classified as medical devices and then build a roadmap towards class I, and then class II, or having only some parts of the solution that are SaMD.
Artificial intelligence (AI) is still hard to fit in well with medical regulations. There are some changes expected to happen in Europe in the next few years. COCIR recently published a comprehensive paper, “AI in Medical Device Legislation", that focuses on AI-based devices in the scope of the EU MDR. The European Commission also published its proposal for the Artificial Intelligence Regulation (the Draft AI Regulation), which sets out plans for a comprehensive regulatory framework that covers AI systems in general.
#4 On the implementation and adoption of digital health in Oncology
The combination of a relatively small oncology patient population overall combined with a wide diversity of disease and treatment types results in high levels of customization for small numbers of users or individual drugs. Combining this with distinct geographic differences in treatment paradigms has resulted in a perceived lack of scalability for digital therapeutics in oncology.
Solutions surfaced in this context were devising ways to efficiently adapt a core solution to different disease types - demonstrating this would be valuable to both pharma partners and investors. Another idea was to take a disease agnostic approach and go directly to patients to get them engaged. Then, in turn, having these people push the tools onto the health care providers.
#5 On clinical and economic evidence for standalone digital therapeutics (DTx)
As software solutions, DTx will require ongoing monitoring and updates to fix bugs or improve features. As the industry evolves, there needs to be recognition that DTx products will be iterative - similar to other tech companies in sectors such as entertainment or banking. Non-prescription Standalone DTx, in particular, needs to be heavily consumer-focused and updated regularly to stay relevant. This creates issues as it may require multiple updates and resubmissions with regulators.
Want to join the conversation? Check out our website for upcoming meetings and events.
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