A Round-up of 5 Expert Insights from the HealthXL Community
This past month, 138 of our HealthXL community members met across 14 meetings to discuss companion DTx in oncology, commercialization models for RPM, and evidence requirements for DTx reimbursement, among other topics. We’ve put together a snapshot of 5 expert insights from these meetings.
#1 On DTx in Oncology: There are huge gaps in the cancer patient journey that can be addressed by DTx products (e.g. side effects management, comorbidities, etc.). However, one of the challenges to developing solutions in this space is the variation in drugs, treatments, comorbidities and patient needs. Building a solution that covers all needs in oncology can be very difficult. In this case niche solutions may be more successful for this TA.
#2 On commercialization models for RPM: Hospital and Payer partnerships stood out as the most scalable and sustainable commercialization strategies for RPM. However, partnerships with other digital health companies will be uniquely positioned to give clinicians a full picture of their patients. Other important factors for success will be the solution’s integration with teleconsultation services, patient support programs and the existence of reimbursement codes.
#3 On Evidence for Reimbursement: RCTs might not be necessary to get reimbursed, but they really help. In Germany, you are not required to show RCT results to be listed in the DiGA directory, nevertheless, most companies are using RCTs as these are the industry gold standard for showing efficacy and safety. However, having clinical evidence may not be enough for payers. Economic evidence will be needed to get buy-in to the cost-reduction potential of a solution. In many cases, this data will need to be demonstrated time and time again rather than in a one-time study.
#4 On defining populations for RCTs: It is important to have a representative population in your RCT in order to meet different users' needs/requirements. If the cohort studied is not diverse enough, health plans may not see the value of the solution if their generalized population is not represented in the results. Decentralized Clinical Trials are anticipated to be a valuable tool for increasing diversity and inclusion in clinical trials where barriers have previously existed.
#5: On DH for Depression & Anxiety: There are a number of solutions in the mental health space, therefore for solutions that address depression and anxiety, product terminology and clarity is critical. PDT solutions for major depressive disorder (MDD) generalized anxiety disorder (GAD) are FDA cleared products and have high evidence requirements that are compared to the current standard of care. However, we are only starting to see RCTs for these products. These have not been extensively completed yet as they require larger sample sizes and are labeled as higher risk, making the expense of these trials often too high for small start-ups.
Want to join the conversation? Check out our website for upcoming meetings and events.
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