Rapid review on the incentives of digital health apps for physicians and psychotherapists: A German perspective.

Objective: The Digital Healthcare Act introduced the prescription of digital health applications under specific circumstances in 2019 in Germany. They are funded through the social security system. In market access of prescribed digital health applications, Germany is pioneering the market. There remains a gap in understanding the views of medical professionals on the incentives of using these applications. As prescription of digital health applications starts emerging in other European countries, we sought to generate an overview of incentives and barriers that affect the caregivers in their decision of promoting and prescribing them in Germany. Methods: A Rapid Review of the Web of Science database for the years 2017-2023 was performed using sensitive search strings. Two reviewers conducted a three-phase selection via title, abstract and full-text independently from each other. The quality of studies was assessed systematically by both reviewers. Both quantitative and qualitative studies with primary data were included, and study quality was assessed using a standardised form. Results: Out of 1643 initial results, 12 studies with information from 9302 physicians and psychotherapists were identified. Eight quantitative and four qualitative studies were included in the analysis. Key findings suggest that while between 40% and 60% of caregivers see relevant incentives mainly based on patients' benefits, 20-40% see relevant barriers. For the physicians' daily work, there were slightly more barriers than incentives identified in the quantitative synthesis. The qualitative studies revealed no relevant incentives that were not attributed to patients. Conclusion: While digital health solutions offer promising avenues for enhancing patient care, their acceptance among healthcare professionals hinges on addressing prevailing concerns. Continuous research and dialogues with the medical community are pivotal to harness the full potential of digital health applications in healthcare.

A sociotechnical framework to assess patient-facing eHealth tools: results of a modified Delphi process.

Among the thousands of eHealth tools available, the vast majority do not get past pilot phases because they cannot prove value, and only a few have been systematically assessed. Although multiple eHealth assessment frameworks have been developed, these efforts face multiple challenges. This study aimed to address some of these challenges by validating and refining an initial list of 55 assessment criteria based on previous frameworks through a two-round modified Delphi process with in-between rounds of interviews. The expert panel (n = 57) included participants from 18 countries and 9 concerned parties. A consensus was reached on 46 criteria that were classified into foundational and contextual criteria. The 36 foundational criteria focus on evaluating the eHealth tool itself and were grouped into nine clusters: technical aspects, clinical utility and safety, usability and human centricity, functionality, content, data management, endorsement, maintenance, and developer. The 10 contextual criteria focus on evaluating the factors that vary depending on the context the tool is being evaluated for and were grouped into seven clusters: data-protection compliance, safety regulatory compliance, interoperability and data integration, cultural requirements, affordability, cost-benefit, and implementability. The classification of criteria into foundational and contextual helps us assess not only the quality of an isolated tool, but also its potential fit in a specific setting. Criteria subscales may be particularly relevant when determining the strengths and weaknesses of the tool being evaluated. This granularity enables different concerned parties to make informed decisions about which tools to consider according to their specific needs and priorities.

Economic Evaluation Associated With Clinical-Grade Mobile App-Based Digital Therapeutic Interventions: Systematic Review.

BACKGROUND: Digital therapeutics (DTx), a class of software-based clinical interventions, are promising new technologies that can potentially prevent, manage, or treat a spectrum of medical disorders and diseases as well as deliver unprecedented portability for patients and scalability for health care providers. Their adoption and implementation were accelerated by the need for remote care during the COVID-19 pandemic, and awareness about their utility has rapidly grown among providers, payers, and regulators. Despite this, relatively little is known about the capacity of DTx to provide economic value in care. OBJECTIVE: This study aimed to systematically review and summarize the published evidence regarding the cost-effectiveness of clinical-grade mobile app-based DTx and explore the factors affecting such evaluations. METHODS: A systematic review of economic evaluations of clinical-grade mobile app-based DTx was conducted following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) 2020 guidelines. Major electronic databases, including PubMed, Cochrane Library, and Web of Science, were searched for eligible studies published from inception to October 28, 2022. Two independent reviewers evaluated the eligibility of all the retrieved articles for inclusion in the review. Methodological quality and risk of bias were assessed for each included study. RESULTS: A total of 18 studies were included in this review. Of the 18 studies, 7 (39%) were nonrandomized study-based economic evaluations, 6 (33%) were model-based evaluations, and 5 (28%) were randomized clinical trial-based evaluations. The DTx intervention subject to assessment was found to be cost-effective in 12 (67%) studies, cost saving in 5 (28%) studies, and cost-effective in 1 (6%) study in only 1 of the 3 countries where it was being deployed in the final study. Qualitative deficiencies in methodology and substantial potential for bias, including risks of performance bias and selection bias in participant recruitment, were identified in several included studies. CONCLUSIONS: This systematic review supports the thesis that DTx interventions offer potential economic benefits. However, DTx economic analyses conducted to date exhibit important methodological shortcomings that must be addressed in future evaluations to reduce the uncertainty surrounding the widespread adoption of DTx interventions. TRIAL REGISTRATION: PROSPERO International Prospective Register of Systematic Reviews CRD42022358616; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022358616.

Differential discounting in the economic evaluation of healthcare programs.

BACKGROUND: The question of appropriate discount rates in health economic evaluations has been a point of continuous scientific debate. Today, it is widely accepted that, under certain conditions regarding the social objective of the healthcare decision maker and the fixity of the budget for healthcare, a lower discount rate for health gains than for costs is justified if the consumption value of health is increasing over time. To date, however, there is neither empirical evidence nor a strong theoretical a priori supporting this assumption. Given this lack of evidence, we offer an additional approach to check the appropriateness of differential discounting. METHODS: Our approach is based on a two-goods extension of Ramsey's optimal growth model which allows accounting for changing relative values of goods explicitly. Assuming a constant elasticity of substitution (CES) utility function, the growth rate of the consumption value of health depends on three variables: the growth rate of consumption, the growth rate of health, and the income elasticity of the willingness to pay for health. Based on a review of the empirical literature on the monetary value of health, we apply the approach to obtain an empirical value of the growth rate of the consumption value of health in Germany. RESULTS: The empirical literature suggests that the income elasticity of the willingness to pay for health is probably not larger but rather smaller than 1 and probably not smaller but rather larger than 0.2. Combining this finding with reasonable values of the annual growth rates in consumption (1.5-1.6%) and health (0.1%) suggests, for Germany, an annual growth rate of the consumption value of health between 0.3 and 1.5%. CONCLUSION: In the light of a two-goods extension of Ramsey's optimal growth model, the available empirical evidence makes the case for a growing consumption value of health. Therefore, the current German practice of applying the same discount rate to costs and health gains introduces a systematic bias against healthcare technologies with upfront costs and long-term health effects. Differential discounting with a lower rate for health effects appears to be a more appropriate discounting model.

A DELPHI study on aspects of study design to overcome knowledge gaps on the burden of disease caused by serogroup B invasive meningococcal disease.

BACKGROUND: Value assessment of vaccination programs against serogroup B invasive meningococcal disease (IMD) is on the agenda of public health authorities. Current evidence on the burden due to IMD is unfit for pinning down the nature and magnitude of the full social and economic costs of IMD for two reasons. First, the concepts and components that need to be studied are not agreed, and second, measures of the concepts that have been studied are weak and inconsistent. Thus, the economic evaluation of the available serogroup B meningococcal (MenB) vaccines is difficult. The aims of this DELPHI study are to: (1) agree on the concepts and components determining the burden of MenB diseases that need to be studied; and (2) seek consensus on appropriate methods and study designs to measure quality of life (QoL) associated with MenB induced long-term sequelae in future studies. METHODS: We designed a DELPHI questionnaire based on the findings of a recent systematic review on the QoL associated with IMD-induced long-term sequelae, and iteratively interviewed a panel of international experts, including physicians, health economists, and patient representatives. Experts were provided with a controlled feedback based on the results of the previous round. RESULTS: Experts reached consensus on all questions after two DELPHI rounds. Major gaps in the literature relate (i) to the classification of sequelae, which allows differentiation of severity levels, (ii) to the choice of QoL measures, and (iii) to appropriate data sources to examine long-term changes and deficits in patients' QoL. CONCLUSIONS: Better conceptualisation of the structure of IMD-specific sequelae and of how their diverse forms of severity might impact the QoL of survivors of IMD as well as their family network and care-providers is needed to generate relevant, reliable and generalisable data on QoL in the future. The results of this DELPHI panel provide useful guidance on how to choose the study design, target population and appropriate QoL measures for future research and hence, help promote the appropriateness and consistency in study methodology and sample characteristics.

The cost-of-illness for invasive meningococcal disease caused by serogroup B Neisseria meningitidis (MenB) in Germany.

INTRODUCTION: Invasive meningococcal disease (IMD) is a severe disease mainly affecting infants and young children. The most common serogroup causing IMD in Germany is the serogroup type B Neisseria meningitidis (MenB). The aim of the present study is to estimate the economic burden of MenB-related IMD in Germany. METHOD: A bottom-up, model-based costing approach has been used to calculate the diagnose- and age-specific yearly lifetime costs of a hypothetical cohort of MenB-related IMD cases. Direct costs contain the treatment cost for the acute phase of the disease, long-term sequelae, costs for rehabilitation, and public health response. Indirect costs are calculated for the human-capital approach and the friction-cost approach considering productivity losses of patients or parents for the acute phase and long-term sequelae. Publicly available databases from the Federal Statistical Office, the SOEP panel data set, literature, and expert opinion were used as data sources. All future costs beyond the reference year of 2015 were discounted at 3%. RESULTS: The total costs for the hypothetical cohort (343 patients) from a societal perspective are €19.6 million (€57,100/IMD case) using the friction-cost approach and €58.8 million (€171,000/IMD case) using the human-capital approach. Direct costs amount to €18.6 million or €54,300 €/case. Sequelae are responsible for 81% of the direct costs/case. DISCUSSION: The elevated costs/MenB-related IMD case reflect the severity of the disease. The total costs are sensitive to the productivity-loss estimation approach applied. MenB is an uncommon but severe disease; The costs/case reflect the severity of the disease and is within the same magnitude as for human papilloma virus infections. The available literature on sequelae is due to the uncommonness limited and heterogeneous.

Systematic Review of Invasive Meningococcal Disease: Sequelae and Quality of Life Impact on Patients and Their Caregivers.

INTRODUCTION: Invasive meningococcal disease (IMD, septicaemia and/or meningitis) has a severe acute and long-term burden: 5-10% of patients die within 48 h, and long-term sequelae have been reported in 10-20% of survivors. Health-related quality of life (HRQoL) is increasingly but inconsistently assessed. METHODS: A systematic literature review on Neisseria meningitidis IMD sequelae and HRQoL in survivors of all ages and their caregivers, including family, was conducted for high-income countries from 2001 to 2016 (in Medline and Embase, following Cochrane and PRISMA guidelines). RESULTS: A total of 31 studies, mostly of childhood IMD cases, were included. A broad range of physical, neurological and psychological IMD sequelae were identified. The literature has evolved, with more types of sequelae reported in more recent studies; however, meningococcal disease-specific and sequelae-specific HRQoL data are lacking, and existing studies used a wide variety of instruments. Physical sequelae included: amputations (up to 8% of children, 3% adolescents/adults) and skin scars (up to 55% of children, 18% adolescents, 2% adults). Neurologic sequelae included: hearing loss (up to 19% of infants, 13% children, 12% adolescents, 8% adults). Psychological sequelae included: anxiety, learning difficulties, emotional and behavioural difficulties. IMD negatively affects HRQoL in patients and also in their family and close caregiver network, both in the short- and long-term. Even IMD survivors without sequelae experienced an adverse impact on HRQoL after many years, affecting self-esteem, physical, mental and psychosocial health, and HRQoL was worse in those with cognitive and behavioural sequelae. CONCLUSION: A high proportion of IMD survivors are affected by a broad range of sequelae and reduced HRQoL that persists years after infection. Childhood IMD survivors had more sequelae and more severe sequelae compared with adult survivors. HRQoL was affected in patients and also in their families, caregivers and surrounding network over the long term. More research is needed to resolve data gaps and to standardise HRQoL assessment. FUNDING: GlaxoSmithKline Biologicals SA (Rixensart, Belgium).

Costs of conservative management of early-stage prostate cancer compared to radical prostatectomy-a claims data analysis.

BACKGROUND: Due to widespread PSA testing incidence rates of localized prostate cancer increase but curative treatment is often not required. Overtreatment imposes a substantial economic burden on health care systems. We compared the direct medical costs of conservative management and radical therapy for the management of early-stage prostate cancer in routine care. METHODS: An observational study design is chosen based on claims data of a German statutory health insurance fund for the years 2008-2011. Three hundred fifty-three age-matched men diagnosed with prostate cancer and treated with conservative management and radical prostatectomy, are included. Individuals with diagnoses of metastases or treatment of advanced prostate cancer are excluded. In an excess cost approach direct medical costs are considered from an insured community perspective for in- and outpatient care, pharmaceuticals, physiotherapy, and assistive technologies. Generalized linear models adjust for comorbidity by Charlson comorbidity score and recycled predictions method calculates per capita costs per treatment strategy. RESULTS: After follow-up of 2.5 years per capita costs of conservative management are €6611 lower than costs of prostatectomy ([-9734;-3547], p < 0.0001). Complications increase costs of assistive technologies by 30% (p = 0.0182), but do not influence any other costs. Results are robust to cost outliers and incidence of prostate cancer diagnosis. The short time horizon does not allow assessing long-term consequences of conservative management. CONCLUSIONS: At a time horizon of 2.5 years, conservative management is preferable to radical prostatectomy in terms of costs. Claims data analysis is limited in the selection of comparable treatment groups, as clinical information is scarce and bias due to non-randomization can only be partly mitigated by matching and confounder adjustment.

Points to consider for prioritizing clinical genetic testing services: a European consensus process oriented at accountability for reasonableness.

Given the cost constraints of the European health-care systems, criteria are needed to decide which genetic services to fund from the public budgets, if not all can be covered. To ensure that high-priority services are available equitably within and across the European countries, a shared set of prioritization criteria would be desirable. A decision process following the accountability for reasonableness framework was undertaken, including a multidisciplinary EuroGentest/PPPC-ESHG workshop to develop shared prioritization criteria. Resources are currently too limited to fund all the beneficial genetic testing services available in the next decade. Ethically and economically reflected prioritization criteria are needed. Prioritization should be based on considerations of medical benefit, health need and costs. Medical benefit includes evidence of benefit in terms of clinical benefit, benefit of information for important life decisions, benefit for other people apart from the person tested and the patient-specific likelihood of being affected by the condition tested for. It may be subject to a finite time window. Health need includes the severity of the condition tested for and its progression at the time of testing. Further discussion and better evidence is needed before clearly defined recommendations can be made or a prioritization algorithm proposed. To our knowledge, this is the first time a clinical society has initiated a decision process about health-care prioritization on a European level, following the principles of accountability for reasonableness. We provide points to consider to stimulate this debate across the EU and to serve as a reference for improving patient management.

The cost-utility of open prostatectomy compared with active surveillance in early localised prostate cancer.

BACKGROUND: There is an on-going debate about whether to perform surgery on early stage localised prostate cancer and risk the common long term side effects such as urinary incontinence and erectile dysfunction. Alternatively these patients could be closely monitored and treated only in case of disease progression (active surveillance). The aim of this paper is to develop a decision-analytic model comparing the cost-utility of active surveillance (AS) and radical prostatectomy (PE) for a cohort of 65 year old men with newly diagnosed low risk prostate cancer. METHODS: A Markov model comparing PE and AS over a lifetime horizon was programmed in TreeAge from a German societal perspective. Comparative disease specific mortality was obtained from the Scandinavian Prostate Cancer Group trial. Direct costs were identified via national treatment guidelines and expert interviews covering in-patient, out-patient, medication, aids and remedies as well as out of pocket payments. Utility values were used as factor weights for age specific quality of life values of the German population. Uncertainty was assessed deterministically and probabilistically. RESULTS: With quality adjustment, AS was the dominant strategy compared with initial treatment. In the base case, it was associated with an additional 0.04 quality adjusted life years (7.60 QALYs vs. 7.56 QALYs) and a cost reduction of €6,883 per patient (2011 prices). Considering only life-years gained, PE was more effective with an incremental cost-effectiveness ratio of €96,420/life year gained. Sensitivity analysis showed that the probability of developing metastases under AS and utility weights under AS are a major sources of uncertainty. A Monte Carlo simulation revealed that AS was more likely to be cost-effective even under very high willingness to pay thresholds. CONCLUSION: AS is likely to be a cost-saving treatment strategy for some patients with early stage localised prostate cancer. However, cost-effectiveness is dependent on patients' valuation of health states. Better predictability of tumour progression and modified reimbursement practice would support widespread use of AS in the context of the German health care system. More research is necessary in order to reliably quantify the health benefits compared with initial treatment and account for patient preferences.

Early evaluation and value-based pricing of regenerative medicine technologies.

Since the first pioneering scientists explored the potential of using human cells for therapeutic purposes the branch of regenerative medicine has evolved to become a mature industry. The focus has switched from 'what can be done' to 'what can be commercialized'. Timely health economic evaluation supports successful marketing by establishing the value of a product from a healthcare system perspective. This article reports results from a research project on early health economic evaluation in collaboration with developers, clinicians and manufacturers. We present an approach to determine an early value-based price for a new treatment of cartilage defects of the knee from the area of regenerative medicine. Examples of using evaluation results for the purpose of business planning, market entry, preparing the coverage decision and managed entry are discussed.