Over the past month, our HealthXL community members discussed the value of DTx-generated RWD, DTx Reimbursement in the US-Value- Based Contracting (VBC) Basics, and Remote Patient Monitoring programs for Pharma, among other topics. We’ve put together a snapshot of five expert insights from these meetings.
#1 On DTx-generated RWD: What is the Value for Pharma?: What pharma does with real world data (RWD) and real world evidence (RWE) depends on the use case and the team. Commercial teams will want the output, whereas, marketing teams and R&D will want the raw data. Pharma should have clearly defined objectives and specific data points to target, to enable the digital company to collect and analyze data more rigorously, resulting in higher output quality. With tight regulation and restrictive models, pharma may struggle to incorporate RWD and RWE, processes may need to be adapted, which needs to be in hand with changes in the regulatory bodies. As business models develop and processes are updated, RWD and RWE will become increasingly valuable.
#2 On sustainable business models for DTx in the US: In digital health, the best business model depends on the product. For prescription DTx, reimbursement from a payer organization is a must, taking into account the size of patient population, as well as the level of clinical and economic evidence available. Smaller patient population DTx companies might target healthcare providers, using bundled payments in treating these smaller patient populations. Hybrid models can use their user base to extract data to expand to other markets. Partnering with pharma companies that can add the DTx product as part of their drug label may make regulation and negotiations with payers easier.
#3 On what’s in Remote Patient Monitoring programs for Pharma: For Pharma, companies don’t get paid to decrease overall healthcare costs, which means the commercial imperative for Remote Patient Monitoring (RPM) must come from another avenue. Outside of use in clinical trials, the commercial merits of integrating RPM into day-to-day care are tricky. To show value, an RPM must demonstrate the potential to cut costs, enable new revenue lines or create revenue protecting data in an area such as adherence. For RPM to have an impact, it must successfully integrate both from a patient and healthcare perspective, and be effortless for the patient to ensure compliance.
#4 On DTx Reimbursement in the US-Value- Based Contracting Basics: Value-based contracts (VBCs) can be an opportunity to meet the interests of a number of health ecosystem stakeholders. They can be linked to clinical and/or financial outcomes, including adherence, prevalence of events, total costs of care, capitation, among others, and can be structured to solve many different commercial and access objectives. DTx will likely accelerate the US VBC environment due to: 24/7 therapeutic usage understanding, ease of access to other product specific patient and physician reported data; payer perception of need to de-risk clinical, coverage decisions more so than drugs, and PDT/DTx having more latitude in contracting and pricing than biopharma.
#5 On how to design a clinical trial for your digital health product: Proving clinical efficacy through clinical trials is one of the biggest challenges for digital health companies. Trials need developers and clinical teams to work together to create studies with better results. Real world data and evidence (RWD and RWE) in trials can have many benefits, including cost savings when designed to work in parallel with randomized controlled clinical trials (RCTs). RCTs are difficult to implement as they need a comparator which is difficult in the digital health space. In the absence of a comparator, the goal is to compare to the current standard of care whether it is a drug or another treatment. Patient recruitment can still be successful when the eligibility parameters are more relaxed, but patients need meaningful endpoints and effective communications. Furthermore, the industry needs to work on digital health literacy to get patient, caregiver and physician buy-in for these trials.
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