Market access update
Digital therapeutics: what are the challenges for reimbursement?
Digital therapeutics are quickly becoming one of the fastest-growing fields in healthcare. Innovation by regulators, policy-makers, and payers is needed to ensure that patients can access and benefit from these technologies. Successful market access is key to delivering individual patient benefits, potential healthcare system gains, and a meaningful integration of digital therapeutics into our healthcare infrastructure at a population level.
In this update, taken from the free report “Digital Therapeutics: Value, Evidence, and Access insight”, we summarize:
- What are digital therapeutics and how are they commonly used?
- Demonstrating safety, efficacy, and economic benefit for digital therapeutics
- The role of data protection in reimbursement
- Examples of reimbursement of digital therapeutics for diabetes and cardiology
- The importance of understanding how payers propose to attribute value for digital therapeutics
- Considerations for user adoption and infrastructure integration of digital therapeutics.
What are digital therapeutics and how are they commonly used?
Digital therapeutics 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 poor disease control.1
Digital therapeutic use is most commonly reported in the therapy areas of diabetes, cardiovascular disease, and oncology – conditions which benefit from close monitoring of risk factors and better management of the disease, treatment, and comorbidities to improve disease management and prevent disease progression.2–4 Remote monitoring of patients combines digital technologies that collect patients’ physiological data at home, empowering patients to play a greater role in the management of their conditions and enabling transmission of data to healthcare providers for rapid assessment and interventions.5
For reimbursement, digital therapeutics must demonstrate safety, efficacy, and economic benefit
In most markets, digital therapeutics must conform to the therapeutic standard of demonstrating safety, efficacy, and economic benefit (cost-consequences, cost-minimization, budget impact) when compared with existing treatments to meet payer requirements for reimbursement. The unmet need and additional value of digital therapeutics can be presented from the viewpoint of the patient, caregiver, healthcare professional, healthcare system or payer perspective.
Digital therapeutics have been shown to improve treatment outcomes and reduce healthcare costs by enabling timely data-informed, personalized care decisions without the physical barrier of attending appointments in a clinical setting in some types of cardiovascular disease (for example, representing benefits for healthcare resource utilization).4,6,7 Digital technologies are not directly associated with the toxicity-related adverse events of conventional therapeutics.
The role of data protection in reimbursement for digital therapeutics
In addition to the requirement to demonstrate safety and efficacy, digital therapeutics collect and store patient information and must comply with data privacy and security regulations ensuring patient data is protected from unauthorized access and patients are informed of how their data will be used. Digital therapeutics are subject to Data Protection Regulation and other regional regulations governing data control.
Reimbursement for digital therapeutics can take multiple pathways
There is no single pathway for reimbursement for digital therapeutics. Digital therapeutics are typically subject to the reimbursement routes of a device, with digital application-specific routes to reimbursement being defined in limited markets.8–10
The heterogeneity of approaches to reimbursement of digital therapeutics being applied across markets creates a challenge for manufacturers when identifying the optimal route to reimbursement, but also when determining the evidence requirements to achieve optimal reimbursement for their technology.
In the current landscape, digital technologies may be reimbursed where they demonstrate equivalence to the standard of care; however, in many disease states, this is unlikely to represent a price premium, as historical comparator technologies are often relatively low-cost. For example, in diabetes and cardiology:
Diabetes: the cost of existing pen delivery systems is typically incorporated within the reimbursement of an insulin-device therapeutic, representing no visible additional cost to the payer. For digital therapeutics in the diabetes space, this presents a challenge when determining price of a new digital therapeutic in the context of a comparator with no associated reimbursement cost.
Cardiology: a digital therapeutic may reflect a new cost compared with current practice, with the benefit being that the patient may be more regularly monitored at home rather than in a healthcare setting.
The importance of understanding how payers propose to attribute value for digital therapeutics
These examples illustrate the complexity of demonstrating the value of digital therapeutics when applying the existing pricing and reimbursement frameworks. Manufacturers require better insight into how payers propose to attribute value when considering the benefits of digital therapeutics: considerations for the evidence requirements are different when considering the value of this technology for an individual patient (clinical endpoints) versus a wider healthcare system perspective (healthcare resource utilization).
Increasingly, the manufacturers of digital therapeutics are embarking on the generation of high‑quality clinical studies to better support reimbursement at a premium price. This is a high-cost activity and, to demonstrate value to payers, careful consideration of the target patient demographic is needed, with difficult-to-treat subgroups having the potential to benefit most from digital therapeutics translating to a more clinically significant efficacy benefit when compared with standard of care.
In the absence of equitable reimbursement mechanisms at a national level, digital therapeutics are likely fueling healthcare disparity, with health equity differences becoming more pronounced by socioeconomic status. In the absence of clear and equitable reimbursement pathways, in many markets, patients will continue to access digital therapeutics by paying out of pocket. Ensuring digital therapeutics are reimbursed requires demonstration of their clinical and economic value. Greater market access should ultimately deliver better and more affordable technologies to the patients who will benefit from them most.
Considerations for user adoption and infrastructure integration of digital therapeutics
Further considerations for digital therapeutics uptake in clinical practice will include the requirement for the user to be technology-enabled and the need to better integrate data systems with existing healthcare IT infrastructures. For example:
- Manufacturers must plan for efficient training of healthcare professionals to ensure technology adoption of better clinical outcomes
- Healthcare professionals increasingly operate under significant time constraints and may consider the time requirements to train patient-users a significant barrier to technology adoption
- Manufacturers must carefully consider the user-interface of the technology and how patient training is efficiently managed for optimal use of the technology
- Mapping of how patient data will be used and shared with healthcare professionals efficiently is a technological infrastructure challenge.
The challenges of education and IT infrastructure mapping may become increasingly differentiating or burdensome technology characteristics as competing technologies present to the market.
Read the full report: “Digital therapeutics: policy, access, value, and evidence”
In the next section of the free report, we discuss pathways to reimbursement for digital therapeutics. We also explore evidence requirements and highlight perspectives for access in the Asia-Pacific region and the US.
References
Digital Therapeutics Alliance. https://dtxalliance.org.
Kendir C et al., Eur J Gen Pract. 2018;(1):45–50.
Shufelt C et al., NPJ Digit Med. 2019;(2):84.
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.
Zhang Y et al., JBI Evid Synth. 2022;20(6):1585–1592.
Dang A et al., J Family Med Prim Care. 2020;9(5):2207–2213.
Vegesna A et al., Telemedicine and e-Health. 2017;23(1)3–17.
https://www.bundesgesundheitsministerium.de/en/digital-healthcare-act.html.
https://www.fda.gov/medical-devices/digital-health-center-excellence.
