ARLINGTON, VA – December 14, 2022 – As the leading international organization on digital therapeutic (DTx) thought leadership and education, the Digital Therapeutics Alliance (DTA) welcomes the introduction of the ‘‘Medicaid and CHIP Access to Prescription Digital Therapeutics Act’’. This bipartisan legislation would provide guidance regarding coverage of prescription digital therapeutics under Medicaid and the State Children’s Health Insurance Program (CHIP).
This bipartisan legislation is championed by Senators Shelly Moore Capito (R-WV) and Jeanne Shaheen (D-NH) and reflects the growing recognition of the clinical and health economic value that digital therapeutics provide to patients, caregivers, and clinicians – especially given the increased barriers to care that Medicaid beneficiaries continue to face during and beyond the Covid-19 pandemic.
While Massachusetts and Oklahoma are already covering prescription digital therapeutics through their state Medicaid programs, this legislation provides much-needed clarity for other states intending to provide access to digital therapeutics and comes at a critical moment for patients, when many are unable to access other forms of necessary therapies. Using this guidance to leverage existing pathways to expand access to DTx products for Medicaid-covered populations will enable those with chronic and mental health conditions to access expanded care options that can make a tremendous difference in their quality of life and healthcare outcomes.
In addition to providing critical guidance to enable more standardized coverage decisions across the country, the Medicaid and CHIP Access to Prescription Digital Therapeutics Act (S.5238) would also allow the Secretary of Health and Human Services (HHS) to provide technical assistance to states considering coverage of FDA-approved or cleared prescription digital therapeutic products, and would define ‘prescription digital therapeutic’ within the context of Medicaid.
“Digital therapeutics hold particular value for Medicaid populations with convenient, accessible, and personalized treatment options to address many unmet medical needs,” says Andy Molnar, DTA Chief Executive Officer. “This legislation would establish more clarity and uniformity in how prescription digital therapeutics are covered by public programs from state to state and is a critical step toward ensuring that these evidence-based treatments get into the hands of those who need them most. We are grateful for the work of the bill sponsors and look forward to working with a broad coalition of patients, clinicians, and others to pass this into law.”
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About DTA
The Digital Therapeutics Alliance (DTA) is a global non-profit trade association of industry leaders and stakeholders with the mission of broadening the understanding, adoption, and integration of digital therapeutics into healthcare. DTA works to enable expanded access to high quality, evidence-based digital therapeutics for patients, clinicians, and payors to improve clinical and health economic outcomes. To learn more, please visit: www.dtxalliance.org or follow us on LinkedIn and Twitter.
Media Contact:
Hannah Fairman
Digital Therapeutics Alliance
hfairman@dtxalliance.org
Arlington, VA and San Francisco, CA – Tuesday, December 6, 2022 – The Digital Therapeutics Alliance (DTA), a global non-profit trade association with the mission of broadening the understanding, adoption, and integration of digital therapeutics into healthcare, in collaboration with DTA Resource Partner, Curebase, a company committed to democratizing access to clinical studies, today released a publication to provide a fit-for-purpose evidence standard for DTx product regulatory, reimbursement, and clinical acceptance.
The publication, “Setting the Stage for a Fit-For-Purpose DTx Evidentiary Standard”, outlines foundational principles specific to the DTx category of medicine and baseline expectations for healthcare decision makers (HCDMs) related to the types, quality, and timing of clinical trials necessary to evaluate and implement DTx therapies in real-world settings.
Given the profound growth of the DTx industry over the last decade, and as more HCDMs across the world embark on evaluating DTx products, it is important for clinicians, policymakers, and payors to have access to a harmonized, consistent set of study expectations to sufficiently demonstrate product safety, efficacy, and impact. Thus far, DTx products have been subject to the same clinical evidence standards that are used to assess the safety and effectiveness of other traditional medical devices and pharmaceuticals. However, given the unique nature of DTx products, it is increasingly clear that a fit-for-purpose evidence evaluation standard is required to account for the faster and iterative nature of DTx product life cycles, levels of potential risk, and their place in clinical therapy.
“For broader patient access to DTx therapies across the global marketplace, evaluation frameworks need to be clear, consistent, and specific to the unique characteristics of DTx products,” said Megan Coder, Chief Policy Officer of the Digital Therapeutics Alliance. “A fit-for-purpose DTx product evidence evaluation framework – reflective of how DTx products are designed and used in real-world settings – strengthens DTx evidentiary robustness and clarity, thereby preventing unnecessary delays in patient access to high-quality clinically-validated digital therapeutics.”
“Patients everywhere deserve access to high-quality care; having a fit-for-purpose evidence standard for DTx brings the industry one step closer to this,” says Whitney Stewart, Director of Clinical Project Management at Curebase. “By aligning the industry and providing the foundation for DTx studies, this paper paves the way for more thorough DTx studies, for a clearer path forward for DTx companies, and should result in overall better patient care.”
This publication provides evidence-based expectations for how DTx products should be validated by payors globally, building on principles from pharmaceutical and general medical device standards, while acknowledging digital therapeutics’ unique mechanisms of action, iterative development lifecycles, and clinical outcomes. To enable movement toward a fit-for-purpose DTx evidentiary standard, DTA will continue to engage with the broader healthcare ecosystem to develop harmonized and DTx-specific clinical evidence frameworks. For more information, and to download the paper, visit: https://dtxalliance.org/wp-content/uploads/2022/12/DTA-Clinical-Evidence-Paper_12.22.pdf.
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About DTA
The Digital Therapeutics Alliance (DTA) is a global non-profit trade association of industry leaders and stakeholders with the mission of broadening the understanding, adoption, and integration of digital therapeutics into healthcare. DTA works to enable expanded access to high quality, evidence-based digital therapeutics for patients, clinicians, and payors in order to improve clinical and health economic outcomes. To learn more, please visit: www.dtxalliance.org or follow us on LinkedIn and Twitter.
About Curebase
At Curebase, our mission is to bring quality medical innovations to patients faster and improve human well-being through more efficient clinical studies. We are proving that clinical research can be radically accelerated if we empower physicians everywhere to enroll patients in the communities where they live. By applying cutting-edge clinical software and remote study management techniques to the problem, we are reinventing clinical trials and research from the ground up. For more information, please visit www.curebase.com.