Incidence trend of type 2 diabetes from 2012 to 2021 in Germany: an analysis of health claims data of 11 million statutorily insured people.

AIMS/HYPOTHESIS: The aim of the study is to describe the time trend of type 2 diabetes incidence in the largest state of Germany, Bavaria, from 2012 to 2021, and to compare the incidence rates during the pandemic period (2020-2021) to the pre-pandemic period (2012-2019). METHODS: This secondary data analysis uses health claims data provided by the Bavarian Association of Statutory Health Insurance Physicians (KVB), covering approximately 11 million insurees, accounting for 85% of the total population of Bavaria, Germany. Newly diagnosed type 2 diabetes cases in adults (≥20 years) coded as E11 (Diabetes mellitus, Type 2) or E14 (Unspecified diabetes mellitus) under ICD-10, German modification (ICD-10-GM) for the study period 2012 to 2021 were included. Annual and quarterly age-standardised incidence rates (ASIR) stratified by sex, age and region were calculated using the European standard population. Sex-specific crude incidence rates (CIR) were calculated using 10-year age groups. Regression analyses adjusted for time trends, seasonal effects, and pandemic effects were used to analyse the incidence trend and to assess the effect of the pandemic. RESULTS: Overall, 745,861 new cases of type 2 diabetes were diagnosed between 2012 and 2021: 50.4% (376,193 cases) in women. The male/female ratio remained stable over the observation period, while the median age at diagnosis decreased from 61 to 58 years in men and from 66 years to 61 years in women. ASIR were consistently higher for men compared with women, with the yearly difference remaining stable over time (2012: 18%; 2021: 20%). An overall decreasing trend in ASIR was observed during the study period, with a strong decrease from 2012 to 2017, followed by a less pronounced decline from 2018 to 2021 for both sexes. For men, ASIR decreased from 1514 per 100,000 person-years in 2012 to 995 per 100,000 person-years in 2021 (4.6% average annual reduction), and for women from 1238 per 100,000 person-years in 2012 to 796 per 100,000 person-years in 2021 (4.8% average annual reduction). This downward trend was also observed for age groups above 50 years. Regression analyses showed no significant change in incidence rates during the pandemic period (2020 and 2021) compared with the pre-pandemic period. CONCLUSIONS/INTERPRETATION: For the first time, a 10-year incidence trend of type 2 diabetes is reported for Germany, showing a strong decline from 2012 to 2017, followed by a less pronounced decline from 2018 to 2021. The incidence trend of type 2 diabetes appears not to have been affected by the first 2 years of the COVID-19 pandemic. Despite an overall increasing prevalence, the incidence is decreasing, potentially resulting from robust screening by family physicians, reducing the median age at diagnosis by 3 to 5 years. However, further investigation is needed to fully identify the reasons for the declining incidence trend. Continued incidence monitoring is necessary to identify the long-term trend and the potential effect of the pandemic on diagnoses of type 2 diabetes.

Do Profit Margins of Pharmaceuticals Influence Reimbursement Decisions? A Discrete Choice Experiment Among Dutch Healthcare Decision Makers.

OBJECTIVES: This study aimed to investigate whether the profit margins of pharmaceuticals would influence the outcome of reimbursement decisions within the Dutch policy context. METHODS: We conducted a discrete choice experiment among 58 Dutch decision makers. In 20 choice sets, we asked respondents to indicate which of 2 pharmaceutical treatment options they would select for reimbursement. Options were described using 5 attributes (disease severity, incremental costs per quality-adjusted life-year, health gain, budget impact, and profit margin) with 3 levels each. Additionally, cognitive debriefing questions were presented, and for validation debriefing, interviews were conducted. Choice data were analyzed using mixed logit models, also to calculate marginal effects and choice probabilities. RESULTS: Results indicated that the specified levels of profit margins significantly influenced choices made. Decision makers were less likely to reimburse a product with a higher profit margin. The relative importance of profit margins was lower than that of the included traditional health technology assessment criteria, but not negligible. When asked directly, 61% of respondents indicated that profit margin should play a role in reimbursement decision making, although concerns about feasibility and the connection to price negotiations were voiced. CONCLUSIONS: Our results suggest that if available to decision makers the profit margin of pharmaceutical products would influence reimbursement decisions within the Dutch policy context. Higher profit margins would reduce the likelihood of reimbursement. Whether adding profit margin as an additional, explicit criterion to the health technology assessment decision framework would be feasible and desirable is open to further exploration.

Preferences of psychotherapists for blended care in Germany: a discrete choice experiment.

OBJECTIVES: Digital treatment formats are emerging within mental health care. Evidence suggests that mental health care providers and recipients prefer a combination of digital and traditional elements within psychotherapy treatment formats, also called blended care (BC), over standalone digital formats. We examined the attitudes and preferences of licensed psychotherapists in Germany regarding such BC applications. METHODS: We fielded a survey among psychotherapists, including questions about attitudes, previous experiences, and expectations regarding BC, as well as a discrete choice experiment. Attributes for the experiment were developed using a stepwise qualitative approach. A Bayesian D-efficient design was used to generate the choice tasks. The choice data were analyzed by applying mixed logit models. RESULTS: The survey was completed by 200 psychotherapists. Attitudes towards BC were mainly positive, with strong reported intentions to use BC formats. In the choice experiment, recommendation from a professional society for a BC online component was the most important characteristic. Greater effectiveness and a larger share of face-to-face vs. online time were also desired features, while a financial incentive to use BC was less relevant.

Preferences for e-Mental Health Interventions in Germany: A Discrete Choice Experiment.

OBJECTIVES: Recent evidence suggests that e-mental health interventions can be effective at improving mental health but that there is still a notable hesitation among patients to use them. Previous research has revealed that they are perceived by patients as being less helpful than face-to-face psychotherapy. The reasons for this unfavorable perception are, however, not yet well understood. The aim of our study was to address this question by eliciting preferences for individual components of e-mental health interventions in a discrete choice experiment. METHODS: Using a stepwise qualitative approach, we developed the following 5 attributes of eMHIs: introductory training, human contact, peer support, proven effectiveness, content delivery, and price. Additionally, we asked questions about respondents' demographics, attitudes, and previous experience of traditional psychotherapy, as well as their distress level. RESULTS: A total of 1984 respondents completed the survey. Using mixed logit models, we found that personal contact with a psychotherapist in blended care, proven effectiveness, and low price were highly valued by participants. Participants were indifferent toward the mode of content delivery but showed a slight preference for introductory training via phone, as well as for peer support via online forum alongside coach-led group meetings on site. DISCUSSION: Our results suggest a clear preference for blended care that includes face-to-face contact with a psychotherapist. This preference remained stable irrespective of sociodemographics, previous experience of psychotherapy, distress level, and the 2 context scenarios used in our discrete choice experiment. Further investigations looking at the potential benefits and risks of blended care are needed.

The value of health-Empirical issues when estimating the monetary value of a quality-adjusted life year based on well-being data.

Decisions on interventions or policy alternatives affecting health can be informed by economic evaluations, like cost-benefit or cost-utility analyses. In this context, there is a need for valid estimates of the monetary equivalent value of health (gains), which are often expressed in € per quality-adjusted life years (QALYs). Obtaining such estimates remains methodologically challenging, with a recent addition to the health economists' toolbox, which is based on well-being data: The well-being valuation approach. Using general population panel data from Germany, we put this approach to the test by investigating several empirical and conceptual challenges, such as the appropriate functional specification of income utility, the choice of health utility tariffs, or the health state dependence of consumption utility. Depending on specification, the bulk of estimated € per QALY values ranged from €20,000-60,000, with certain specifications leading to more considerable deviations, underlining persistent practical challenges when applying the well-being valuation methodology to health and QALYs. Based on our findings, we formulate recommendations for future research and applications.

Cost-effectiveness analysis of using dermatologists versus pediatricians to treat mild to moderate acne.

OBJECTIVE: To assess the cost-effectiveness from the payer perspective of using dermatologists versus pediatricians to treat acne in adolescents ages 10-18. METHODS: A Markov model was constructed to explore outcomes over a 2-year period from the US private payer perspective. Patients ages 10-18 with acne entered the model under the "dermatologist"and "pediatrician" conditions. In each 3-month cycle,each modeled patient received topical retinoids,benzoyl peroxide (BP), antibiotics, or no treatment,and could progress to an acne-free state or remain in an acne state. RESULTS: The average patient spent42.3% of the time in acne-free states under the dermatologist condition and 28.0% of the time in acne-free states under the pediatrician condition.The cohort of 1000 patients experienced 1900 total quality-adjusted life years (QALYs) at a cost of $2.33 million in the dermatologist condition and 1883 total QALYs at a cost of $1.62 million in the pediatrician condition, yielding an ICER of $40,000/QALY. Most sensitivity analyses confirmed the base case results. CONCLUSION: Dermatologist treatment appears cost-effective related to producing additional QALYs at a cost of less than $100,000 per QALY gained. Health plans should consider creating incentives to direct enrollees to dermatologists for acne treatment.

Estimating a Preference-Based Value Set for the Mental Health Quality of Life Questionnaire (MHQoL).

BACKGROUND: Health economic evaluations using common health-related quality of life measures may fall short in adequately measuring and valuing the benefits of mental health care interventions. The Mental Health Quality of Life questionnaire (MHQoL) is a standardized, self-administered mental health-related quality of life instrument covering 7 dimensions known to be relevant across and valued highly by people with mental health problems. The aim of this study was to derive a Dutch value set for the MHQoL to facilitate its use in cost-utility analyses. METHODS: The value set was estimated using a discrete choice experiment (DCE) with duration that accommodated nonlinear time preferences. The DCE was embedded in a web-based self-complete survey and administered to a representative sample (N = 1,308) of the Dutch adult population. The matched pairwise choice tasks were created using a Bayesian heterogeneous D-efficient design. The overall DCE design comprised 10 different subdesigns, with each subdesign containing 15 matched pairwise choice tasks. Each participant was asked to complete 1 of the subdesigns to which they were randomly assigned. RESULTS: The obtained coefficients indicated that "physical health,""mood," and "relationships" were the most important dimensions. All coefficients were in the expected direction and reflected the monotonic structure of the MHQoL, except for level 2 of the dimension "future." The predicted values for the MHQoL ranged from -0.741 for the worst state to 1 for the best state. CONCLUSIONS: This study derived a Dutch value set for the recently introduced MHQoL. This value set allows for the generation of an index value for all MHQoL states on a QALY scale and may hence be used in Dutch cost-utility analyses of mental healthcare interventions. HIGHLIGHTS: A discrete choice experiment was used to derive a Dutch value set for the MHQoL.This allows the use of the MHQoL in Dutch cost-utility analyses.The dimensions physical health, mood, and relationships were the most important.The utility values range from -0.741 for the worst state to 1 for the best state.

Experiences with and perception of patient-reported outcome measurement in patients undergoing knee and hip replacement in Germany.

BACKGROUND: Patient-reported outcome measures - PROMs - have been developed to provide an assessment of patients' physical function, symptoms, and health-related quality of life. With patient-centered care becoming increasingly important, several national strategies have been initiated for PROM measurement. However, Germany is only at the beginning of this process. The objective of this study is to assess patients' experience with and perception of completing PROMs in patients undergoing knee and hip replacement in Germany. METHODS: This study used survey data from patients undergoing hip or knee replacement surgery in a hospital in Germany. Before surgery, patients completed a PROMs survey. After at least 6 months, patients were re-contacted to fill in a questionnaire about their experiences with and perception of the PROMs data collection. RESULTS: Most patients either agreed or totally agreed that the time to fill in the questionnaire was appropriate (89%), that the purpose of the PROMs collection was clear (85%), that the questionnaire's content applied to their appointment (73%), and that this systematic assessment was beneficial (81%). The corresponding proportions were 54% for feeling productive while waiting and 50% for feeling that the information in the questionnaire affected the patient-doctor interaction positively. Only few significant associations were found between patient characteristics and the favorability of patients' ratings. There were no significant differences between hip and knee replacement surgery patients regarding the favorability rating on any survey question. CONCLUSIONS: The results of this study suggest that PROMs collection in the context of hip and knee replacement surgery is practicable and partly also perceived beneficial by patients. Orthopedic procedures could serve as a starting point for broader use and routine PROMs collection in Germany.

Willingness to pay for health gains from an international integrated early warning system for infectious disease outbreaks.

Recently, due to the corona virus outbreak, pandemics and their effects have been at the forefront of the research agenda. However, estimates of the perceived value of early warning systems (EWSs) for identifying, containing, and mitigating outbreaks remain scarce. This paper aims to show how potential health gains due to an international EWS might be valued. This paper reports on a study into willingness to pay (WTP) in six European countries for health gains due to an EWS. The context in which health is gained, those affected, and the reduction in risk of contracting the disease generated by the EWS are varied across seven scenarios. Using linear regression, we analyse this 'augmented' willingness to pay for a QALY (WTP-Q) for each of the scenarios, where 'augmented' refers to the possible inclusion of context specific elements of value, such as feelings of safety. An initial WTP-Q estimate for the basic scenario is €17,400. This can be interpreted as a threshold for investment per QALY into an EWS. Overall, WTP estimates move in the expected directions (e.g. higher risk reduction leads to higher WTP). However, changes in respondents' WTP for reductions in risk were not proportional to the magnitude of the change in risk reduction. This study provided estimates of the monetary value of health gains in the context of a pandemic under seven scenarios which differ in terms of outcome, risk reduction and those affected. It also highlights the importance of future research into optimal ways of eliciting thresholds for investments in public health interventions.

Braving the waves: exploring capability well-being patterns in seven European countries during the COVID-19 pandemic.

The COVID-19 pandemic considerably impacted the lives of European citizens. This study aims to provide a nuanced picture of well-being patterns during the pandemic across Europe with a special focus on relevant socio-economic sub-groups. This observational study uses data from a repeated, cross-sectional, representative population survey with nine waves of data from seven European countries from April 2020 to January 2022. The analysis sample contains a total of 25,062 individuals providing 64,303 observations. Well-being is measured using the ICECAP-A, a multi-dimensional instrument for approximating capability well-being. Average levels of ICECAP-A index values and sub-dimension scores were calculated across waves, countries, and relevant sub-groups. In a fixed effects regression framework, associations of capability well-being with COVID-19 incidence, mortality, and the stringency of the imposed lockdown measures were estimated. Denmark, the Netherlands, and France experienced a U-shaped pattern in well-being (lowest point in winter 2020/21), while well-being in the UK, Germany, Portugal, and Italy followed an M-shape, with increases after April 2020, a drop in winter 2020, a recovery in the summer of 2021, and a decline in winter 2021. However, observed average well-being reductions were generally small. The largest declines were found in the well-being dimensions attachment and enjoyment and among individuals with a younger age, a financially unstable situation, and lower health. COVID-19 mortality was consistently negatively associated with capability well-being and its sub-dimensions, while stringency and incidence rate were generally not significantly associated with well-being. Further investigation is needed to understand underlying mechanisms of presented patterns.

Did the COVID-19 pandemic change the willingness to pay for an early warning system for infectious diseases in Europe?

The COVID-19 pandemic highlights the need for effective infectious disease outbreak prevention. This could entail installing an integrated, international early warning system, aiming to contain and mitigate infectious diseases outbreaks. The amount of resources governments should spend on such preventive measures can be informed by the value citizens attach to such a system. This was already recognized in 2018, when a contingent valuation willingness to pay (WTP) experiment was fielded, eliciting the WTP for such a system in six European countries. We replicated that experiment in the spring of 2020 to test whether and how WTP had changed during an actual pandemic (COVID-19), taking into account differences in infection rates and stringency of measures by government between countries. Overall, we found significant increases in WTP between the two time points, with mean WTP for an early warning system increasing by about 50% (median 30%), from around €20 to €30 per month. However, there were marked differences between countries and subpopulations, and changes were only partially explained by COVID-19 burden. We discuss possible explanations for and implication of our findings.

Estimating an anchored utility tariff for the well-being of older people measure (WOOP) for the Netherlands.

OBJECTIVE: Health economic evaluations using common health-related quality of life measures may fall short in adequately incorporating all relevant benefits of health and social care interventions targeted at older people. The Well-being of Older People measure (WOOP) is a broader well-being measure that comprises nine well-being domains. The objective of this study was to estimate a utility tariff for the WOOP, to facilitate its application in cost-utility analyses. METHODS: A discrete choice experiment (DCE) with duration approach was set up and fielded among 2,012 individuals from the Netherlands aged 65 years and above. Matched pairwise choice tasks, colour-coding and level overlap were used to reduce the cognitive burden of the DCE. The choice tasks were created using a Bayesian heterogeneous D-efficient design. The estimation procedure accommodated for nonlinear time preferences via an exponential discounting function. RESULTS: The estimation results showed that 'physical health', 'mental health', and 'making ends meet' were the most important well-being domains for older people, followed by 'independence' and 'living situation'. Of somewhat lesser importance were domains like 'social life', 'receiving support' and 'feeling useful'. The generated utility tariffs can be used to translate well-being states described with the WOOP to a utility score between -0.616 and 1. CONCLUSIONS: This study established a tariff for the WOOP, which will facilitate its use in economic evaluations of health and social care interventions targeted at older people, first of all in the Netherlands.

The societal impact of a biologic treatment of ankylosing spondylitis: a case study based on secukinumab.

Aim: This study estimates the societal benefits of using biologics like secukinumab (SEC) instead of nonsteroidal anti-inflammatory drugs for treating patients with ankylosing spondylitis in Germany. Materials & methods: A Markov and a population model were used to predict the functional impairment of German ankylosing spondylitis patients using SEC or nonsteroidal anti-inflammatory drugs. This was translated into avoided productivity losses, which were valued according to gross value added. Results: The productivity impairment of SEC users was predicted to decrease by 20 percentage points, corresponding to 12.8 and 32.7 million hours in paid and unpaid work and a monetary value of €1.6 billion from 2016 to 2030. Accounting for economic spillover effects increases the societal value to € 3.3 billion. Conclusion: The improvements in functional impairment due to biologics could lead to sizable productivity effects.

Happy with Your Capabilities? Valuing ICECAP-O and ICECAP-A States Based on Experienced Utility Using Subjective Well-Being Data.

Background. The ICECAP-O and the ICECAP-A are validated capability well-being instruments. To be used in economic evaluations, multidimensional instruments require weighting of the distinguished well-being states. These weights are usually obtained through ex ante preference elicitation (i.e., decision utility) but could also be based on experienced utility. Objective. This article describes the development of value sets for ICECAP-O and ICECAP-A based on experienced utility and compares them with current decision utility weights. Methods. Data from 2 cross-sectional samples corresponding to the target groups of ICECAP-O and ICECAP-A were used in 2 separate analyses. The utility impacts of ICECAP-O and ICECAP-A levels were assessed through regression models using a composite measure of subjective well-being as a proxy for experienced utility. The observed utility impacts were rescaled to match the 0 to 1 range of the existing value set. Results. The calculated experienced utility values were similar to the decision utility weights for some of the ICECAP dimensions but deviated for others. The largest differences were found for weights of the ICECAP-O dimension enjoyment and the ICECAP-A dimensions attachment and autonomy. Conclusions. The results suggest a different weighting of ICECAP-O and ICECAP-A levels if experienced utility is used instead of decision utility.

Estimating the monetary value of health and capability well-being applying the well-being valuation approach.

BACKGROUND: Quality of life measures going beyond health, like the ICECAP-A, are gaining importance in health technology assessment. The assessment of the monetary value of gains in this broader quality of life is needed to use these measurements in a cost-effectiveness framework. METHODS: We applied the well-being valuation approach to calculate a first monetary value for capability well-being in comparison to health, derived by ICECAP-A and EQ-5D-5L, respectively. Data from an online survey administered in February 2018 to a representative sample of UK citizens aged 18-65 was used (N = 1512). To overcome the endogeneity of income, we applied an instrumental variable regression. Several alternative model specifications were calculated to test the robustness of the results. RESULTS: The base case empirical estimate for the implied monetary value of a year in full capability well-being was £66,597. The estimate of the monetary value of a QALY, obtained from the same sample and using the same methodology amounted to £30,786, which compares well to previous estimates from the willingness to pay literature. Throughout the conducted robustness checks, the value of capability well-being was found to be between 1.7 and 2.6 times larger than the value of health. CONCLUSION: While the applied approach is not without limitations, the generated insights, especially concerning the relative magnitude of valuations, may be useful for decision-makers having to decide based on economic evaluations using the ICECAP-A measure or, to a lesser extent, other (capability) well-being outcome measures.

A case study applying a novel approach to estimate the social impact of a medical innovation - the use of secukinumab for psoriatic arthritis in Germany.

OBJECTIVES: Psoriatic arthritis (PsA) is associated with serious productivity impairment. Secukinumab, a fully human IL-17A inhibitor, provides sustained relief from PsA symptoms. This study estimates the societal economic benefits of using secukinumab instead of conventional disease-modifying anti-rheumatic drugs (DMARDs) for treating patients with active PsA in Germany from 2016 to 2030. METHODS: A Markov and a population model simulated the functional impairment of German PsA patients. The relationship between functional impairment and work productivity was used to determine the productivity difference in the populations treated with secukinumab and csDMARDs. The corresponding gains in productive time were allocated to paid and unpaid activities and valued according to gross value added (GVA). Since increased productivity has the potential to stimulate greater macroeconomic effects, indirect and induced GVA effects were calculated as well. RESULTS: The use of secukinumab reduces the productivity impairment in the target population on average by 13 percentage points. This difference could generate 32 million active and productive hours until the year 2030, which translates to GVA equivalents of €1.3 billion. Including indirect and induced effects yield an economic estimate of €2.7 billion GVA equivalent. CONCLUSIONS: The improvements in PsA-related functional impairment could lead to sizable productivity effects within the economy.

Willingness to pay for an early warning system for infectious diseases.

Early warning systems for infectious diseases and foodborne outbreaks are designed with the aim of increasing the health safety of citizens. As a first step to determine whether investing in such a system offers value for money, this study used contingent valuation to estimate people's willingness to pay for such an early warning system in six European countries. The contingent valuation experiment was conducted through online questionnaires administered in February to March 2018 to cross-sectional, representative samples in the UK, Denmark, Germany, Hungary, Italy, and The Netherlands, yielding a total sample size of 3140. Mean willingness to pay for an early warning system was €21.80 (median €10.00) per household per month. Pooled regression results indicate that willingness to pay increased with household income and risk aversion, while they decreased with age. Overall, our results indicate that approximately 80-90% of people would be willing to pay for an increase in health safety in the form of an early warning system for infectious diseases and food-borne outbreaks. However, our results have to be interpreted in light of the usual drawbacks of willingness to pay experiments.

The societal impact of obinutuzumab in the first-line treatment of patients with follicular lymphoma in Germany.

In this study, we assessed the productivity gains associated with the use of obinutuzumab in combination with chemoimmunotherapy (G-chemo) in first-line treatment among follicular lymphoma patients. Health benefits, measured as an increase in progression-free survival, were translated into productivity gains in both paid and unpaid work using gross value added as productivity measure. From 2017 to 2030, 11,870 overall progression-free years can be gained by utilizing obinutuzumab. These progression-free years correspond to undiscounted productivity gains of about €187.9 million in paid work and about €535.9 million in unpaid work. Our study shows that the benefits of the use of obinutuzumab in the first-line treatment of follicular lymphoma extend beyond clinical advantages.

Long-term health benefits of stroke prevention with apixaban versus vitamin K antagonist warfarin in patients with non-valvular atrial fibrillation in Germany: a population-based modelling study.

BACKGROUND: Patients with non-valvular atrial fibrillation (NVAF) have a five times higher stroke risk. For more than 50 years, vitamin K antagonists (VKAs) have been the primary medication for stroke prevention. Apixaban, a non-vitamin K oral anticoagulant (NOAC), has demonstrated better efficacy and safety characteristics than the VKA warfarin in the ARISTOTLE trial. This study aims to quantify the potential societal effects of using apixaban instead of VKA in the German NVAF population from 2017 to 2030. METHODS: Using an existing Markov model and a dynamic population approach, we modelled the health benefits of apixaban in patients with NVAF compared to VKA therapy in the German population from 2017 to 2030. RESULTS: The results represent the extrapolated direct long-term health benefits of apixaban over VKA therapy for the German NVAF population. From 2017 until 2030, the use of apixaban instead of a VKA could avoid 52,185 major clinical events. This includes 15,383 non-fatal strokes or SEs, 22,483 non-fatal major bleeds, and 14,319 all-cause deaths, which correspond to 109,887 life years gained. CONCLUSION: This study demonstrated that using apixaban instead of VKA for stroke prevention can lead to considerable reduction in cardiovascular events.