Value Assessment Frameworks and Health Preference Research in Digital Health Technologies
Axel Mühlbacher, PhD, Hochschule Neubrandenburg, Neubrandenburg, Germany; Volker Amelung, PhD, Medical University Hannover, Hannover, Germany; and Katarzyna Kolasa, PhD, Kozminski University, Warsaw, MZ, Poland
Introduction
The emergence of digital health technologies (DHTs) has precipitated a profound transformation in the delivery of healthcare, presenting unprecedented opportunities for customizing patient treatment and optimizing health service workflows. This technological evolution extends beyond mere enhancements in care quality; it represents a paradigm shift in the nexus between healthcare delivery and policy formulation.
The realm of DHTs has seen impressive advancements across various medical fields, with diabetes management standing out as one of the prime examples of how connected ecosystems and innovative applications can significantly improve patient care.
Continuous glucose monitoring (CGM) systems represent a leap forward, allowing patients to monitor their glucose levels in real time without the need for traditional finger-prick tests. Devices provide continuous, dynamic glucose data directly to the patient’s smartphone app. These real-time data can also be shared with healthcare providers, enabling more responsive and personalized diabetes management strategies.
Insulin management apps are another pivotal development. Apps integrated in CGM systems and insulin pumps offer personalized dosing recommendations based on real-time glucose readings and other patient inputs. This not only helps in optimizing glycemic control but also reduces the risk of hypoglycemia and hyperglycemia by adjusting insulin doses more accurately than conventional methods. By leveraging data analytics and machine learning algorithms, these apps can predict glucose fluctuations and suggest adjustments preemptively.
Platforms that integrate CGM data with electronic health records (EHRs) enable healthcare providers to monitor their patients’ glycemic control remotely, facilitating timely interventions without the need for in-person visits. Digital therapeutics platforms combine CGM data with behavioral health interventions to address the lifestyle and psychological aspects of diabetes management. Platforms offer personalized coaching, nutritional planning, and psychological support to help patients adopt healthier habits and cope with the challenges of managing diabetes.
"The emergence of digital health technologies has precipitated a profound transformation in the delivery of healthcare, presenting unprecedented opportunities for customizing patient treatment."
These examples illustrate not just the potential of DHTs to transform diabetes care but also the broader implications for healthcare delivery, evaluation, and policy. They demonstrate how advancements in digital health can lead to more personalized, effective, and patient-centered approaches to managing chronic conditions. This paper endeavors to dissect the pivotal roles played by value assessment frameworks and health preference research amid this transformative wave. Through an analytical lens, it scrutinizes the legislative and market mechanisms that either advance or curtail the assimilation of DHTs into the healthcare system. The aim is to unravel the complexities of legal structures, market receptivity, and the intrinsic value DHTs confer upon the health sector, with a view to shedding light on the overarching implications for health policy and the delivery of patient-centered care.
The Future of DHTs
In 2020, a paper1 with the bold title “Want to See the Future of Digital Health Tools? Look to Germany” was published in the Harvard Business Review, discussing the introduction and evaluation of digital health applications (DiGAs) in Germany. The authors assert that the introduction of DiGAs is expected to significantly influence the integration of DHTs into healthcare practices and patients’ daily routines. In late 2019, the German parliament passed the Digital Healthcare Act, aiming to catalyze the digital transformation of its healthcare system. This law marked a significant step for Germany, which historically lagged in digital health compared to its peers. A key provision of the Digital Healthcare Act is the formalization of DiGAs. DiGAs are intended to support the treatment or management of medical conditions and could be prescribed by healthcare professionals or by the health insurance company directly. Therefore, they are included in the basic benefit package in Germany. They are part of a broader trend toward incorporating digital technologies into healthcare to improve patient outcomes and provide more personalized care.
The law introduced a fast-track process, managed by the Federal Institute for Drugs and Medical Devices, allowing DiGAs to swiftly enter the market. Following a streamlined review, an app can be included in a central registry and prescribed by physicians and psychotherapists, with reimbursement from health insurance providers covering approximately 90% of the population. To be listed and remain in the DiGA registry, apps must meet specific standards, including data protection, information security, interoperability, and preliminary data on benefits. Additionally, they must be CE-certified in one of the European Union’s 2 lowest-risk classes. If an app demonstrates “positive care effects,” it can be directly listed; otherwise, it must show evidence of benefits within 12 months of being added to the registry. German healthcare policy was aware of the challenge and, as a first step, opted for medical devices at the lowest risk level to learn from experience. It is particularly noteworthy that a considerable number of manufacturers withdrew their applications after the consultation meetings because the evidence was insufficient. The next step, medical devices with slightly higher risk levels, will also be included from 2024. Also, the range of services will be extended to digital nursing applications.
"The introduction of digital health apps is expected to significantly influence the integration of digital health technologies into healthcare practices and patients’ daily routines."
Germany’s approach to digital health was viewed as a potential model for other healthcare systems seeking to embrace digital innovation. However, the initial optimism is gradually waning as the anticipated success among manufacturers is not materializing, and the challenges seem to overshadow the opportunities. The challenges faced by Germany in the adoption of DHTs, particularly around the aspects of withdrawals and bankruptcies of manufacturers, reflect a complex interplay of regulatory, market, and operational dynamics. DiGAs, initially approved and listed for reimbursement under the statutory health insurance system, are later removed from this list. For a DiGA to be included in the service catalogue, it must demonstrate a certain level of efficacy and safety. If the ongoing collection of evidence fails to support the initial claims of benefit, the application may be withdrawn. Some DiGAs may not achieve the anticipated level of user engagement or integration into clinical practice. This lack of adoption can undermine their financial viability and lead to withdrawal.
Developing and maintaining a DiGA that meets regulatory standards for safety, efficacy, and data security requires significant investment. Smaller companies or startups may struggle with the financial burden, particularly if they encounter delays in market acceptance or reimbursement. Navigating the regulatory landscape and achieving a spot in the health insurance catalogue is a complex and time-consuming process. Even after overcoming these hurdles, manufacturers may face challenges in market penetration and user adoption. The reimbursement rates set by health insurance may not cover the costs of development, marketing, and maintenance, especially for DiGAs that require continuous updates and support.
The experiences in Germany underline the importance of creating a supportive ecosystem for DHTs that balances innovation with patient safety and efficacy. In the German healthcare landscape, the inception of DiGAs has served as a catalyst, spurring a comprehensive discourse on the integration of technological innovation within health policy frameworks.
Developments in Value-Based Pricing
The discourse surrounding DHTs necessitates a robust understanding of the international discussion of value-based pricing. This investigation underscores the potential of value-based pricing to recalibrate the economic landscape of health technology prices. Despite its promise, the sector grapples with a discernible lack of uniformity in determining the precise value attributes and pricing methodologies appropriate for the evaluation of DHTs. Global efforts, specifically the initiatives of the ISPOR Special Task Force, alongside frameworks developed by leading entities such as American Society of Clinical Oncology, European Society for Medical Oncology, National Comprehensive Cancer Network, and Memorial Sloan Kettering Cancer Center, were implemented to integrate an extensive array of value determinants into healthcare evaluation.
The initial enthusiasm for introducing DHTs in Germany, driven by the Digital Healthcare Act, appears to have encountered challenges dampening initial expectations. Manufacturers, healthcare providers, and regulatory authorities face several difficulties:
Low user numbers and the absence of anticipated success suggest lower acceptance and demand for DiGAs than expected, possibly due to lack of user awareness, insufficient integration into existing reimbursement of healthcare providers, or challenges in demonstrating clinical benefits.
- Removal of DiGAs from health insurance catalogs may indicate failure to meet effectiveness and safety criteria or insufficient proof of benefits, reflecting flaws in the evaluation process or manufacturers’ difficulties in meeting required evaluation standards.
- Financial challenges and insolvencies among manufacturers may point to a tough market environment, high development costs, and regulatory hurdles.
- Given these challenges, revising the system for DiGA evaluation and integration might be needed to ensure its effectiveness in promoting innovative solutions while protecting patients and ensuring care quality.
This sheds light on the inherent challenges of implementing value-based pricing. An array of methodologies is deployed for quantifying a broad spectrum of value elements. The discourse dissects various value components utilized in value assessment frameworks, encompassing quantifiable measures like quality-adjusted life years, clinical outcomes, and productivity losses, as well as the more nuanced qualitative factors such as the value of hope and the real-option value. A critical examination of these valuation approaches ensues, considering their application across diverse disease areas and technologies, and assessing their potential for broader implementation in value-based pricing strategies.
"This investigation underscores the potential of value-based pricing to recalibrate the economic landscape of health technology prices."
New Assessment Approaches for DHTs
In the realm of DHTs, there’s a clear distinction between innovative new products from emerging companies, like symptom checkers and the digitalization of existing processes by established players. The former are often disruptive, while the latter tend to be more incremental.
The rise of DHTs calls for a significant shift in how we evaluate their worth, moving beyond traditional methods to new frameworks that better capture their unique value. Research by Haig et al2 and Main et al3 emphasizes the need for a combined approach of regulatory vision and value-based assessment, aligning with the dynamic nature of DHTs. This research highlights the urgency of evolving regulations at the same pace as DHTs.
This shift involves quickly adapting policies and balancing technological progress with patient safety. It requires engaging multiple stakeholders and integrating real-world evidence, which is crucial for understanding treatment effects from various sources, as noted by Kolasa and others4,5 in 2023. With the growing role of individuals in decision making, it’s also essential to include behavioral data in our assessments.
"The rise of DHTs calls for a significant shift in how we evaluate their worth, moving beyond traditional methods to new frameworks that better capture their unique value."
Challenges in the Valuation of DHTs
Even if there are currently few reliable figures, it is assumed that there are currently several hundred thousand DiGAs and that tens of thousands are added every year. A few of these have both a relevant and proven medical benefit and should therefore undoubtedly be part of the basic benefit package of a healthcare system.
The evaluation of DHT faces unique challenges due to its diverse range of products:
- DHTs are often part of complex interventions with effects that cannot be isolated.
- The value of DHTs often depends on multiple decision criteria, differently valued depending on the perspective (eg, clinician, patient, or payer).
- Technologies, rapid development demands swift market access.
- DHTs continually evolve, necessitating an adaptive evaluation model.
- Often developed by entities with limited resources, DHTs’ sustainability and long-term impact can be uncertain.
The central challenge is therefore to develop an evaluation grid that assists quick and accurate decision making. There are fundamental decisions with DHT that should be addressed by a value assessment framework: (1) market access, (2) reimbursement, and (3) pricing.
Pricing is a particularly difficult topic and depends largely on the positioning of the DHT. Three basic logics are conceivable:
- DHTs substitute “status quo” therapies and accordingly there are few arguments why these existing therapies should not be a comparator for pricing decisions (eg, digital physiotherapy versus analog physiotherapy).
- DHTs bridge the gap until existing therapies can begin or may no longer be necessary. This is often the case with psychotherapy, where waiting times are often very long.
DHTs complement existing therapies and should therefore be seen as an add-on. These include, for example, therapy support for oncological diseases or tinnitus.
The benefits of all 3 variants are unquestionable if the relevant studies are available but lead to fundamentally different approaches to pricing.
Strategic Recommendations
DHTs hold immense promise for transforming healthcare delivery, enhancing patient outcomes, and optimizing healthcare workflows. Their potential lies in enabling personalized medicine, improving chronic disease management (as seen in diabetes care), and facilitating remote patient monitoring. These technologies can lead to significant advancements in preventive healthcare, early disease detection, and patient engagement by providing digital tools that empower patients and healthcare providers with real-time data and analytics.
The challenges in DHT adoption often stem from issues related to reimbursement and market acceptance. Payers are crucial stakeholders in the healthcare ecosystem, and their caution towards new technologies can hinder DHT adoption. Challenges include proving the cost-effectiveness of DHTs, navigating diverse reimbursement policies, and demonstrating clear clinical benefits to justify their inclusion in healthcare plans.
Patient perception of and demand for DHTs are pivotal for their successful integration into healthcare systems. While there’s a growing interest among patients in technologies that offer convenience, better access to information, and personalized care, challenges remain in terms of usability, accessibility, and trust in digital solutions. Patient hesitance may arise from concerns over data privacy, the digital divide, or skepticism about the efficacy of digital interventions compared to traditional care methods.
Examining other markets that have successfully adopted DHTs and established regulatory frameworks for their assessment can provide valuable insights. Countries like the United States, with the US Food and Drug Administration’s Digital Health Innovation Action Plan, or the United Kingdom’s NHS Digital, showcase how supportive regulatory environments can foster innovation while ensuring patient safety and efficacy of digital health solutions. The ongoing discussion highlights the importance of clear regulatory pathways, stakeholder engagement, and evidence-based standards for technology validation and market access.
"While there’s a growing interest among patients in technologies that offer convenience, better access to information, and personalized care, challenges remain in terms of usability, accessibility, and trust in digital solutions."
In addressing the valuation of DHTs, it is essential to develop adaptive and innovative policies that match the emergent nature of these technologies. These policies should not only respond to current demands but also anticipate the future trajectory of DHTs, ensuring they are inclusive and resonate with the multidimensional aspects of digital health. The valuation complexity of DHTs arises from their inherent heterogeneity and the diverse impacts they have across the healthcare spectrum. Central to bridging the gaps in traditional assessment methods are real-world evidence and multiple criteria decision analysis. These methodologies enable a more nuanced and holistic appraisal of DHTs, capturing a range of benefits and risks not fully represented in conventional models. Moreover, health preference research is crucial in elucidating the value judgments of various stakeholders, providing structured insights into needs, preferences, and expectations.
A human-centric approach is imperative in the valuation of DHTs, addressing the unique spectrum of risks and benefits they present. Traditional methodologies often fall short in quantifying innovation and may not adequately capture the nuanced benefits of these technologies. This analysis must extend to the varied effects of DHTs on healthcare infrastructure, advocating for an approach that is both flexible and centered on patient needs.
Ultimately, the discussion underscores the need to forge new evidentiary benchmarks reflecting the evolving and dynamic lifecycle of DHTs. These benchmarks would facilitate the appraisal of current technologies and anticipate future innovations, ensuring a comprehensive and future-ready approach to valuing digital health technologies.
In support of the ongoing developments discussed, Value in Health announced a themed section, “Digital Health Technologies: Examining Value, Regulation, and Equity.” This issue aims to address the complex interplay between technological innovation, health economics, and policy within the rapidly evolving domain of digital health technologies.
We invite submissions that explore the changing paradigms of digital health valuation and contribute insights for the future of healthcare technology assessment and policy. Researchers and practitioners are encouraged to submit manuscripts through the journal’s online submission system by September 1, 2024, indicating in the cover letter that the submission is for the Digital Health Technologies theme.
This themed issue offers an opportunity to impact the discourse on the valuation, regulation, and equitable integration of digital health technologies into healthcare. We anticipate your contributions to shaping a more informed and effective approach to healthcare technology assessment and policy making.
References
1. Stern AD, Matthies H, Hagen J, Brönneke JB, Debatin JF. “Want to See the Future of Digital Health Tools? Look to Germany.” Harvard Business Review (website), December 2, 2020. https://hbr.org/2020/12/want-to-see-the-future-of-digital-health-tools-look-to-germany
2. Haig M, Main C, Chávez D, Kanavos P. A value framework to assess patient-facing digital health technologies that aim to improve chronic disease management: a Delphi approach. Value Health. 2023;26(10):1474-1484. https://doi.org/10.1016/j.jval.2023. 06.008
3. Main C, Haig M, Chávez D, Kanavos P. Assessing the value of provider-facing digital health technologies used in chronic disease management: towards a value framework based on multi-stakeholder perceptions. Med Decis Making. 2024;44(1):28-41. https://doi.org/10.1177/0272989X231206803
4. Kolasa K. The Digital Transformation of the Healthcare System: Healthcare 5.0. 1st ed. Routledge. 2023. https://doi.org/10.4324/b23291
5. Kolasa K, Admassu B, Hołownia-Voloskova M, Kędzior KJ, Poirrier JE, Perni S. Systematic reviews of machine learning in healthcare: a literature review. Expert Rev Pharmacoecon Outcomes Res. 2024;24(1):63-115. doi: 10.1080/14737167.2023.2279107.
