Digital therapeutics (DTx) are evidence-based therapeutic interventions, often developed in combination with a device and/or therapeutic agent, that are designed to prevent, manage, or treat a variety of medical conditions and address challenges such as medication adherence and disease control.¹

In this update, taken from the free report “Digital Therapeutics: Value, Evidence, and Access insight”, we discuss evidence generation to support optimal reimbursement of DTx.

Considerations for evidence that can be used to support the reimbursement of Digital Therapeutics

Many markets have mandatory requirements for demonstration of data security and data or technology ownership.

Development of DTx is underpinned by studies of their feasibility (usability, compliance, level of error), pilot studies, and demonstration of data control. Studies that are can be used to support reimbursement include those that describe the unmet need for DTx, the clinical benefit (safety and efficacy) achieved through their use, how DTx impact humanistic considerations (quality of life, adherence, behavior change, utility, user engagement, satisfaction or preference) and the economic impact of using DTx (healthcare resource use, budget impact, and costs).

The pace of publications suggests that research on digital therapeutics is particularly active in the areas of diabetes, cardiovascular health, and oncology

A targeted literature review of remote patient monitoring (RPM) devices and systems identified studies describing clinical, humanistic, and economic outcomes in cardiovascular disease (CVD). DTx were found to improve treatment outcomes and reduce healthcare costs by enabling timely, data-informed, personalized care decisions without the physical barrier of onsite clinical care in some types of CVD.² Specific findings included the following

• More than half of the studies identified in atrial fibrillation (AF) described improvements in the detection of AF compared to Holter monitoring or a control.
• In all the studies identified measuring blood pressure control, significant improvements from baseline were reported with remote patient monitoring.
• Studies reporting health-related quality of life (HRQL) were limited; however, 60% of the studies identified reported improvements in HRQL outcomes in patients using RPM compared with baseline or the standard of care treatment.
• Most economic studies identified reported healthcare resource utilization (HCRU).
• Of the studies of HCRU in arrhythmia/AF, half reported statistically significant reductions in HCRU, while the other half did not find a significant association between RPM and HCRU.
• Six studies were identified that reported statistically significant reductions in hospital admissions in patients with cardiac indications who used RPM.
• Cost savings of US$792 to US$7,274 per patient were reported for patients using RPM in Australia, Denmark, Germany, Spain, the United Kingdom, and the United States.

These findings indicate that the body of evidence being developed in the area of DTx characterizes the usability, clinical, humanistic, and economic outcomes for digital technologies. This evidence base is typical of that required for health technology assessment.

The path to reimbursement for digital technologies varies across markets, so what evidence is required to achieve optimal reimbursement and market access?

Digital technologies are actively being developed in the areas of both treatment and diagnostics. An estimated 47% of the global population has little or no access to diagnostics, with a potential for 1.1 million deaths in low-income and middle-income countries deemed to be avoided annually, through reduction in the diagnostic gap in diabetes, hypertension, HIV, and tuberculosis.³

Digital technologies are well-positioned to address unmet medical needs in the area of diagnostics, but equitable access to these emerging technologies will be driven by successful reimbursement.

Measurable demonstration of improved rates of diagnosis, although to be welcomed, needs to be supported by capacity to treat presenting patients within the healthcare system as well as evidence demonstrating that the diagnostic component has low rates of error and does not inadvertently increase HCRU burden.

Digital therapeutics provide evidence-based, software-driven therapeutic interventions for both the prevention and management of disease⁵

While real-world data (RWD) have a clear role to play in building evidence to support the efficacy of DTx in improving the management or treatment of a condition, these data may not be sufficient to replace a randomized controlled trial (RCT). RCTs demonstrating clinical benefit compared to the standard of care (clinical endpoints, quality of life, disease control), in combination with RWD indicating that the technology is usable in clinical practice and delivers cost or HCRU savings in a local market, would be very compelling for payers and would help support optimal reimbursement.

DTx launched in combination with new drug treatments will have the opportunity for incorporation of the DTx within the related RCTs, generating a differentiated product with a solid evidence base.⁵ Many DTx are being developed independently of drugs. This creates challenges when establishing benchmarks for pricing of the technology component alone. The costs of digital technologies can be wrapped up in the price of the drug, creating difficulty in demonstrating additional value or equitable comparison of the technology components.

In the absence of data from RCTs, there is a risk that manufacturer-developed evidence may not be consistent with evidence-based standards. This may lead to barriers to uptake of digital treatment options, reducing their general usage. Absence of data from RCTs also risks ineffective or harmful interventions being made available, with the potential for reputational damage and loss of patient confidence in DTx.⁴ In this context, it is not surprising that payers may prefer to reimburse DTx upon achieving better clinical outcomes within a given timeframe.

References:

1. Digital Therapeutics Alliance. https://dtxalliance.org [accessed January 12, 2023].
2. Chivers M., Fora B., Su J., The impact of remote patient monitoring devices and systems on clinical, humanistic and economic burden of disease: results from a targeted literature review, Poster id. 1426-034, American College of Cardiology annual meeting, March 4-6, 2023, New Orleans, LA, USA.
3. Fleming A., Horton S., Wilson M., et al., The Lancet Commission on diagnostics: transforming access to diagnostics, Lancet 2021; 398: 1997–2050.
4. Espie C., Firth J., Torous J., Evidence-informed is not enough: digital therapeutics also need to be evidence-based, World Psychiatry, 2022 Jun; 21 (2): 320–321.
5. Dang A., Arora D., Rane P., Role of digital therapeutics and the changing future of healthcare, J Family Med Prim Care 2020 May; 9 (5): 2207–2213.