Harmonizing regulatory market approval of products with high safety requirements: Evidence from the European pharmaceutical market.

We causally analyzed whether being a member of the European Union (EU) and having access to a centralized marketing authorization procedure (centralized procedure [CP]) affects availability and time to launch of new pharmaceuticals. We employed multiple difference-in-differences models, exploiting the eastern enlargement of the EU as well as changes in the indications that fall within the compulsory or voluntary scope of the CP. Results showed that countries experienced a mean decrease in launch delay of 10.9 months (p = 0.004) after joining the EU. Effects were higher among pharmaceuticals that belong to indications that might voluntarily participate in the CP but are not obliged to. These are often financially less attractive to manufacturers than pharmaceuticals within the compulsory scope. Availability of new pharmaceuticals launched remained unaffected. We found signs that the magnitude of the country-specific effect of centralized marketing authorization on launch delay may be influenced by strategic decisions of manufacturers at the national level (e.g., parallel trade or reference pricing).

From Health to Well-Being: Toward a Monetary Valuation of a Well-Being-Adjusted Life-Year.

OBJECTIVES: Economic evaluations using broader measures to capture benefits beyond improved health can inform policy making, but only if the monetary value of gains measured using these instruments is understood. This study explored contingent valuation as a method to estimate the monetary value of a well-being-adjusted life-year (WALY) as measured by ICEpop Capability Measure for Adults (ICECAP-A). METHODS: In a large online survey of representative samples from 7 European countries, participants valued a change in the ICECAP-A from their current health state to a randomly assigned hypothetical state. Participants were instructed that an unspecified treatment could avoid a loss or produce a gain in well-being and were asked for their willingness to pay (WTP) for this treatment. WTP per WALY was calculated using an aggregated approach that used ICECAP-A tariffs from the United Kingdom. RESULTS: We analyzed a sample of 7428 observations, focusing on avoided losses (n = 6002) because the results for gains were not theoretically valid. Different cutoff points for a marginal change were explored. Depending on the definition of a marginal change, WTP per WALY averaged between €13 323.28 and €61 375.63 for avoided losses between [0, 0.5] and [0, 0.1], respectively, for 1 month. Mean WTP per WALY varied across the countries as follows: Denmark (€17 867.93-€88 634.14), France (€10 278.35-€45 581.28), Germany (€12 119.39-€54 566.56), Italy (€11 753.69-€52 161.25), The Netherlands (€14 612.88-€58 951.74), Spain (€11 904.12-€57 909.17), and United Kingdom (€13 133.75-€68 455.85). CONCLUSION: Despite the inherent limitations of our study, it offers valuable insights into methods for eliciting the WTP for changes in capability well-being as measured with ICECAP-A.

Inflammatory bowel disease (IBD) patients with impaired quality of life on biologic therapy benefit from the support of an IBD nurse specialist: Results of a randomised controlled trial in Germany (IBDBIO-ASSIST study).

BACKGROUND: IBDBIO-ASSIST was a randomised controlled trial assessing the efficacy of care provided by IBD nurse specialists in Germany in improving health-related quality of life (QoL) in IBD patients on biologic therapy. AIM: To evaluate patient-related outcomes and economic consequences associated with integrating IBD nurses into usual care. METHODS: We randomly assigned 1086 patients with IBD on biologic therapy to a control group (CG) receiving usual care or an intervention group (IG) receiving additional care from an IBD nurse specialist. The primary outcome was disease-specific QoL (sIBDQ) assessed at 6, 12 and 18 months. RESULTS: At baseline, patients in both groups were highly satisfied with their treatment situation and had relatively high sIBDQ values (range: 1-7; CG: 5.12; IG: 4.92). In the intention-to-treat (ITT) analysis of the overall sample, there was no significant difference in sIBDQ between groups at the assessment time points. However, a per-protocol analysis of patients with impaired QoL at baseline (EQ-VAS < 75 [median]), showed improvement in sIBDQ over 6 months that became significant at month 12 and remained significant through month 18 (baseline: IG 4.24; CG 4.31; 18 months: IG 5.02; CG 4.76; p = 0.017). CONCLUSION: High baseline satisfaction of IBD patients with treatment and the relatively high baseline sIBDQ values may have contributed to the lack of significant difference in sIBDQ scores for the overall sample. However, patients with impaired QoL derived significant benefit from additional care provided by an IBD nurse specialist, leading to meaningful improvements in sIBDQ over the long term.

Mapping from SIBDQ to EQ-5D-5L for patients with inflammatory bowel disease.

OBJECTIVE: Clinical studies commonly use disease-specific measures to assess patients' health-related quality of life. However, economic evaluation often requires preference-based utility index scores to calculate cost per quality-adjusted life-year (QALY). When utility index scores are not directly available, mappings are useful. To our knowledge, no mapping exists for the Short Inflammatory Bowel Disease Questionnaire (SIBDQ). Our aim was to develop a mapping from SIBDQ to the EQ-5D-5L index score with German weights for inflammatory bowel disease (IBD) patients. METHODS: We used 3856 observations of 1055 IBD patients who participated in a randomised controlled trial in Germany on the effect of introducing regular appointments with an IBD nurse specialist in addition to standard care with biologics. We considered five data availability scenarios. For each scenario, we estimated different regression and machine learning models: linear mixed-effects regression, mixed-effects Tobit regression, an adjusted limited dependent variable mixture model and a mixed-effects regression forest. We selected the final models with tenfold cross-validation based on a model subset and validated these with observations in a validation subset. RESULTS: For the first four data availability scenarios, we selected mixed-effects Tobit regressions as final models. For the fifth scenario, mixed-effects regression forest performed best. Our findings suggest that the demographic variables age and gender do not improve the mapping, while including SIBDQ subscales, IBD disease type, BMI and smoking status leads to better predictions. CONCLUSION: We developed an algorithm mapping SIBDQ values to EQ-5D-5L index scores for different sets of covariates in IBD patients. It is implemented in the following web application: https://www.bwl.uni-hamburg.de/hcm/forschung/mapping.html .

Treatment patterns of individualized real-life tapering approaches based on shared decision-making in rheumatoid arthritis.

OBJECTIVE: To provide real-world evidence on patient-individual tapering patterns of disease-modifying antirheumatic drugs (DMARDs) in rheumatoid arthritis (RA) patients in daily clinical practice. METHODS: Data obtained through a controlled prospective cohort study in Germany conducted from July 2018 to March 2021 were analyzed. Participants consist of RA patients in sustained remission who were eligible for DMARD tapering at enrolment. Data from RA patients who experienced tapering of DMARDs at least once during the observational period (n = 200) were used. Descriptive analyses of medical outcomes at baseline and at time of first tapering, time to first tapering, tapering patterns by substance group, and tapering intensity were documented. RESULTS: We did not observe meaningful differences in either disease activity or quality of life measures between substance groups at enrolment, time of first tapering, and at 6 or 12 months after tapering. Median time until first tapering varied between substance groups (csDMARDs: 108 days; bDMARDs: 189 days; combination: 119 days). Most patients received one iteration of tapering only (147/200 patients, 73.5%). Dose reduction was applied for patients treated with csDMARDs (79/86 patients, 91.8%), spacing of interval was the most frequent strategy for patients treated with bDMARDs only (43/48 patients, 89.5%). Necessity for increased DMARD dosage was observed in only 10% of patients (20/200). Tapering intensity by substance was overall heterogenous, indicating high individualization. CONCLUSION: We identify highly heterogeneous tapering patterns between substance groups and within substances. Identification and recognition of patient-individual approaches of tapering will help to further improve the management of RA for both patients and rheumatologists.

Socioeconomic Disparities In Mortality And Health Care Use During The COVID-19 Pandemic: Evidence From Germany.

Across the globe, populations with low socioeconomic status have borne a disproportionate burden of the COVID-19 pandemic. This article examines the relationship between two socioeconomic factors (education and income) and all-cause mortality and health care use to improve understanding of the impact of the pandemic on socioeconomic disparities in Germany, a high-income country with a universal health care system. We used mortality rates from the period 2011-21 and hospitalizations from the period 2014-21. We examined rates of all-cause mortality and all hospital admissions as well as admissions for respiratory, emergency, cancer surgery, elective, and ambulatory care-sensitive care. Although the use of some health care services was affected by the pandemic, our findings suggest that Germany endured COVID-19 without amplifying socioeconomic disparities in all-cause mortality and large segments of inpatient utilization.

Vaccine hesitancy comes in waves: Longitudinal evidence on willingness to vaccinate against COVID-19 from seven European countries.

AIM: This paper investigates the prevalence and determinants of three main states of people's willingness to be vaccinated (WTBV) against COVID-19 - willing, unwilling and hesitant - and the occurrence and predictors of shifts between these states over time. Understanding the dynamics of vaccine intentions is crucial for developing targeted campaigns to increase uptake and emergency response preparedness. STUDY DESIGN: A panel survey consisting of 9 quarterly waves of data collected between April 2020 and January 2022. Baseline data included 24 952 adults from Germany, UK, Denmark, the Netherlands, France, Portugal, and Italy recruited from online panels to construct census-matched nationally representative samples. METHODS AND MEASURES: Self-reported COVID-19 vaccine intention was the main outcome. Multinomial logit random effects models were used to analyze the relationships of interest. All results reported as relative risk ratios (RRR). RESULTS: Hesitancy to get vaccinated was the most unstable vaccine intention, with on average 42% of ever hesitant respondents remaining in this state through future waves, followed by the 'unwilling' (53%) and 'willing (82%). Following COVID-19 news, trust in information from the government, GPs and the WHO, risk preferences, risk perceptions, and confidence in vaccines (or lack thereof) predicted vaccination intention reversals. Risk preferences acted both as an impediment and as a facilitator for the vaccine uptake depending on the initial vaccine intention. CONCLUSIONS AND RELEVANCE: This study revealed the dynamic nature of COVID-19 vaccine intentions and its predictors in 7 European countries. The findings provide insights to policymakers for designing more effective communication strategies, particularly targeted at hesitant and unwilling to vaccinate population groups, to increase vaccine uptake for future public health emergencies.

Cooperation Improvement in an Integrated Healthcare Network: A Social Network Analysis.

Background: Cooperation is a core feature of integrated healthcare systems and an important link in their value-creating mechanism. The premise is that providers who cooperate can promote more efficient use of health services while improving health outcomes. We studied the performance of an integrated healthcare system in improving regional cooperation. Methods: Using claims data and social network analysis, we constructed the professional network from 2004 to 2017. Cooperation was studied by analyzing the evolution of network properties at network and physician practice (node) level. The impact of the integrated system was studied with a dynamic panel model that compared practices that participated in the integrated system versus nonparticipants. Results: The regional network evolved favourably towards cooperation. Network density increased 1.4% on average per year, while mean distance decreased 0.78%. At the same time, practices participating in the integrated system became more cooperative compared to other practices in the region: Degree (1.64e-03, p = 0.07), eigenvector (3.27e-03, p = 0.06) and betweenness (4.56e-03, p < 0.001) centrality increased more for participating practices. Discussion: Findings can be explained by the holistic approach to patients' care needs and coordination efforts of integrated healthcare. The paper provides a valuable design for performance assessment of professional cooperation. Highlights: Using claims data and social network analysis, we identify a regional cooperation network and conduct a panel analysis to measure the impact of an integrated care initiative on enhancing professional cooperation.Physician practices participating in the integrated system became more cooperative and improved their influence in the regional network more than non-participating practices.Integrated healthcare systems effectively incentivize cooperation through a holistic approach to patient care needs and coordination efforts.

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.

Jumping the Queue:Willingness to Pay for Faster Access to COVID-19 Vaccines in Seven European Countries.

INTRODUCTION: Given the initial shortage of vaccines to protect against coronavirus disease 2019 (COVID-19), many countries set up priority lists, implying that large parts of the population had to wait. We therefore elicited the willingness to pay (WTP) for access to two hypothetical COVID-19 vaccines. METHODS: Respondents were asked how much they would be willing to pay to get an immediate COVID-19 vaccination rather than waiting for one through the public system. We report data collected in January/February 2021 from the European COVID Survey (ECOS) comprising representative samples of the population in Denmark, France, Germany, Italy, Portugal, the Netherlands, and the UK (N = 7068). RESULTS: In total, 73% (68.5%) of respondents were willing to pay for immediate access to a 100% (60%) effective vaccine, ranging from 66.4% (59.4%) in the Netherlands to 83.3% (81.1%) in Portugal. We found a mean WTP of 54.36 euros (median 37 euros) for immediate access to the 100% effective COVID-19 vaccine and 43.83 euros (median 31 euros) for the 60% effective vaccine. The vaccines' effectiveness, respondents' age, country of residence, income, health state and well-being were significant determinants of WTP. Willingness to be vaccinated (WTV) was also strongly associated with WTP, with lower WTV being associated with lower WTP. A higher perceived risk of infection, higher health risk, more trust in the safety of vaccines, and higher expected waiting time for the free vaccination were all associated with a higher WTP. CONCLUSION: We find that most respondents would have been willing to pay for faster access to COVID vaccines (jumping the queue), suggesting welfare gains from quicker access to these vaccines. This is an important result in light of potential future outbreaks and vaccines.

Does health technology assessment compromise access to pharmaceuticals?

In response to rapidly rising pharmaceutical costs, many countries have introduced health technology assessment (HTA) as a 'fourth hurdle'. We evaluated the causal effect of HTA based regulation on access to pharmaceuticals by using the introduction of Germany's HTA system (AMNOG) in 2011. We obtained launch data on pharmaceuticals for 30 European countries from the IQVIA (formerly IMS) database. Using difference-in-difference models, we estimated the effect of AMNOG on launch delay, the ranking order of launch delays and the availability of pharmaceuticals. We then compared the results for Germany to Austria, Czechia, Italy, Portugal and the UK. Across all six countries, launch delay decreased from the pre-AMNOG period (25.01 months) to the post-AMNOG period (14.34 months). However, the introduction of AMNOG consistently reduced the magnitude of the decrease in launch delay in Germany compared to the comparator countries (staggered DiD: + 4.31 months, p = 0.05). Our logit results indicate that the availability of pharmaceuticals in Germany increased as a result of AMNOG (staggered logit: + 5.78%, p = 0.009). We provide evidence on the trade-off between regulation and access. This can help policymakers make better informed decisions to strike the right balance between cost savings achieved through HTA based regulation and access to pharmaceuticals.

10 Years of AMNOG: What is the Willingness-to-Pay for Pharmaceuticals in Germany?

OBJECTIVES: The German Pharmaceutical Market Restructuring Act (AMNOG, 2011) is a two-stage process to regulate the price of new pharmaceuticals in which price negotiations are conducted based on evidence-based medical benefit assessments using data from prior clinical trials. Although the act does not explicitly set a willingness-to-pay (WTP) threshold, the process itself implicitly establishes a WTP for health improvement. We evaluated the implicit WTP for prescription pharmaceuticals post-AMNOG in the German healthcare system from the decision-maker/payer perspective. METHODS: We extracted data on patient-group-specific annual treatment costs and endpoints from 2011 to 2021 from the dossiers assessed by the German Federal Joint Committee (FJC; Gemeinsamer Bundesausschuss). Using incremental cost-effectiveness ratios (ICERs), we calculated a WTP for the indications (I) diabetes, (II) cardiovascular disease, and (III) psoriasis weighted according to patient group size, first from the perspective of the decision-maker (approach A), and second from the perspective of the industry (approach B). To put clinical outcome measures into relation to one another, minimum clinically important differences (MCIDs) were derived from the literature and compared. RESULTS: The annual treatment costs of newly authorized drugs were substantially higher (both pre- and post-negotiation) than that of their comparators (e.g., psoriasis, pre-negotiation: €20,601.59, post-negotiation: €16,763.57; comparators: €5178.00). However, although newly launched drugs were more expensive than their comparators, they brought greater medical benefits and were more aligned with value (r = 0.59, P < 0.001) than older drugs. We estimated WTP to vary widely by indication group [€33,814.08 per 1 percentage point hemoglobin A1c (HbA1c) reduction for diabetes, €10,970.83 per life year gained for cardiovascular disease, and €663.46 per 1% PASI decrease for psoriasis; approach A]. WTP was converted to MCID thresholds: diabetes: €16,907.04; cardiovascular drugs: no MCID existent to convert; and psoriasis: €33,173.00. WTP remained constant over time for diabetes and cardiovascular drugs but increased for psoriasis drugs. CONCLUSION: This paper is one of the first to estimate the implicit WTP for prescription pharmaceuticals post-AMNOG and suggests that the WTP may vary between different therapeutic areas. Additionally, making different assumptions (approach A versus approach B) with regard to the assumed effectiveness in indication areas that had been declared as having no additional benefit by the FJC may explain the different perspectives of decision-makers and of the pharmaceutical industry on the value of a pharmaceutical.

Market diffusion of biosimilars in off-patent biologic drug markets across Europe.

Biologics are among the most expensive pharmaceuticals but have begun to lose their exclusivity rights over the past 15 years, offering the possibility for biosimilar competition. Therefore, we examine the market diffusion of biosimilars across Europe. Using revenues and sales data from IQVIA, we identified 12 biologic substances facing first biosimilar competition between 2014 and 2020 in 25 European countries. We investigated biosimilar market share depending on product and market characteristics with beta regression. Moreover, we compared market diffusion across countries using multilevel modelling. The average market share of biosimilars at first biosimilar entry was about seven percent in the retail and hospital market and grew to 34.69% and 38.29% after 16 quarters, respectively. Quarters since first biosimilar entry had a positive but decreasing effect on biosimilar market share (p<.001 for both markets). Quarterly growth ranged from 0.006 (Netherlands) to 0.026 (Slovakia) in the retail market and from 0.007 (Hungary) to 0.040 (United Kingdom) in the hospital market. The diffusion increased over time across all European markets, although at different rates. Biosimilar market share was higher in the hospital market. Compared to generics, diffusion of biosimilars is much slower. If policymakers desire to increase biosimilar diffusion, they should aim at policies that increase competition and use countries with the highest diffusion rates as benchmarks.

Does prospective payment influence quality of care? A systematic review of the literature.

In the light of rising health expenditures, the cost-efficient provision of high-quality inpatient care is on the agenda of policy-makers worldwide. In the last decades, prospective payment systems (PPS) for inpatient care were used as an instrument to contain costs and increase transparency of provided services. It is well documented in the literature that prospective payment has an impact on structure and processes of inpatient care. However, less is known about its effect on key outcome indicators of quality of care. In this systematic review, we synthesize evidence from studies investigating how financial incentives induced by PPS affect indicators of outcome quality domains of care, i.e. health status and user evaluation outcomes. We conduct a review of evidence published in English, German, French, Portuguese and Spanish language produced since 1983 and synthesize results of the studies narratively by comparing direction of effects and statistical significance of different PPS interventions. We included 64 studies, where 10 are of high, 18 of moderate and 36 of low quality. The most commonly observed PPS intervention is the introduction of per-case payment with prospectively set reimbursement rates. Abstracting evidence on mortality, readmission, complications, discharge disposition and discharge destination, we find the evidence to be inconclusive. Thus, claims that PPS either cause great harm or significantly improve the quality of care are not supported by our findings. Further, the results suggest that reductions of length of stay and shifting treatment to post-acute care facilities may occur in the course of PPS implementations. Accordingly, decision-makers should avoid low capacity in this area.

Health-related quality of life in seven European countries throughout the course of the COVID-19 pandemic: evidence from the European COvid Survey (ECOS).

PURPOSE: To investigate health-related quality of life (HRQoL) over the course of the COVID-19 pandemic in seven European countries and its association with selected sociodemographic as well as COVID-19-related variables. METHODS: We used longitudinal data from nine quarterly waves collected between April 2020 and January 2022 (sample size per wave ranging from N = 7025 to 7300) of the European COvid Survey (ECOS), a representative survey of adults in Germany, United Kingdom, Denmark, Netherlands, France, Portugal and Italy. HRQoL was measured using the EQ-5D-5L. The association of self-reported COVID-19 infection, perceived health risk from COVID-19, selected sociodemographic variables and the COVID-19 stringency index with HRQoL was analyzed by logistic and linear fixed effects regressions. RESULTS: On average across all nine waves, the proportion of respondents reporting any problems in at least one of the EQ-5D dimensions ranged between 63.8% (Netherlands) and 71.0% (Denmark). Anxiety/depression was the most frequently affected EQ-5D dimension in four countries (Portugal: 52.0%; United Kingdom: 50.2%; Italy: 49.2%; France: 49.0%), whereas pain/discomfort ranked first in three countries (Denmark: 58.3%; Germany: 55.8%; Netherlands: 49.0%). On average across all nine waves, the EQ-VAS score ranged from 70.1 in the United Kingdom to 78.4 in Portugal. Moreover, the EQ-5D-5L index ranged from .82 in Denmark to .94 in France. The occurrence of COVID-19 infection, changes in the perceived risk to one's own health from COVID-19, the occurrence of income difficulties and an increase in the COVID-19 stringency index were associated with increased likelihood of problems in EQ-5D dimensions, reduced EQ-VAS score and reduced EQ-5D-5L index. CONCLUSIONS: Across seven European countries, we found large proportions of respondents reporting problems in HRQoL dimensions throughout the pandemic, especially for anxiety/depression. Various sociodemographic and COVID-19-related variables were associated with HRQoL in longitudinal analysis.

Cost-utility analysis of early versus delayed endovascular intervention in critical limb-threatening ischemia patients with rest pain.

OBJECTIVE: The prevalence of chronic limb-threatening ischemia (CLTI) and poor health outcomes are high in Germany. Serious consequences of CLTI such as amputation and mortality can be effectively prevented by the early use of evidence-based therapeutic measures such as endovascular intervention. We have developed a cost-utility analysis to compare endovascular intervention with bare metal stents (BMSs) and endovascular intervention after conservative treatment from the German payer perspective. METHODS: A Markov model, with a 5-year time horizon and seven states, was developed: (1) intervention, (2) stable 1, (3) major amputation, (4) reintervention, (5) stable 2, (6) care, and (7) all-cause death. Transition probabilities were obtained by pooling the outcomes from multiple clinical studies. The costs were estimated using data from the German diagnosis-related group system, the German rehabilitation fund, and related literature. Health-state utilities were obtained from the reported data. The primary outcomes were the quality-adjusted life-years (QALYs) and costs. RESULTS: Early BMS intervention after 5 years resulted in a cost of €23,913 and an increase of 2.5 QALYs per patient, and endovascular intervention with BMS after conservative treatment after 5 years resulted in a cost of €18,323 and an increase of 2 QALYs per patient. The incremental cost-effectiveness ratio was €12,438. The number of major amputations was reduced by 6%. The results of the structural, deterministic, and probabilistic sensitivity analyses were robust. CONCLUSIONS: Early endovascular intervention with BMS resulted in more QALYs and a reduced risk of major amputation for early-stage CLTI patients. Our results showed that early endovascular intervention is very cost-effective according to World Health Organization recommended cost-effectiveness thresholds. However, the clinical decision regarding the use of early endovascular intervention should be determined by individual patient-level eligibility and the physician's judgment.

Economic Effects of Fixed-Dose Versus Loose-Dose Combination Therapy for Type 2 Diabetes Patients.

OBJECTIVE: We examined the effects of fixe-dose combinations (FDCs) versus loose-dose combinations (LDCs) on costs from the payer and patient perspective and investigated potential channels contributing to differences in costs between the two modes of treatment. METHODS: We investigated administrative data from 2017 to 2020 on diabetes patients in Germany. After using prospensity-score matching to remove dissimilarities between FDC and LDC patients, we compared changes in costs with a difference-in-differences approach. We analyzed pharmaceutical costs, inpatient and outpatient costs, other costs and total healthcare costs from the payer perspective, and co-payments from the patient perspective. RESULTS: The sample comprised 1117 FDC and 1272 LDC patients. Regression analysis revealed that FDC therapy significantly increased antidiabetic pharmaceutical spending in the first year by 5.5% (p < 0.01), but decreased co-payments by 33% (p < 0.01) in the first and 44% (p < 0.01) in the second year. We also observed a trend towards higher outpatient spending in the first year. No significant differences were found with respect to inpatient or other costs. The increase in antidiabetic pharmaceutical spending did not contribute to a significant increase in total healthcare expenditure. We identified a shift of co-payments to the payer and higher adherence as possible mechanisms behind the increase in antidiabetic pharmaceutical spending. CONCLUSION: Although FDC therapy increased disease-specific pharmaceutical spending in the short term, this increase did not lead to differences in total healthcare costs from the payer perspective. From the patient perspective, FDC therapy may be the preferred treatment approach, because of significant saving in co-payments, which is likely attributable to the elimination of one co-payment and therefore a shift in costs to the payer.

An econometric approach to aggregating multiple cardiovascular outcomes in German hospitals.

OBJECTIVE: Development of an aggregate quality index to evaluate hospital performance in cardiovascular events treatment. METHODS: We applied a two-stage regression approach using an accelerated failure time model based on variance weights to estimate hospital quality over four cardiovascular interventions: elective coronary bypass graft, elective cardiac resynchronization therapy, and emergency treatment for acute myocardial infarction. Mortality and readmissions were used as outcomes. For the estimation we used data from a statutory health insurer in Germany from 2005 to 2016. RESULTS: The precision-based weights calculated in the first stage were higher for mortality than for readmissions. In general, teaching hospitals performed better in our ranking of hospital quality compared to non-teaching hospitals, as did private not-for-profit hospitals compared to hospitals with public or private for-profit ownership. DISCUSSION: The proposed approach is a new method to aggregate single hospital quality outcomes using objective, precision-based weights. Likelihood-based accelerated failure time models make use of existing data more efficiently compared to widely used models relying on dichotomized data. The main advantage of the variance-based weights approach is that the extent to which an indicator contributes to the aggregate index depends on the amount of its variance.