Enhancing access to high-quality cancer care: empirical analyses of quality assurance initiatives in Germany

Cancer is the second leading cause of death in OECD countries. Over the past decades, patients have greatly benefited from advancements in diagnostic and treatment options, which have significantly reduced mortality rates by enhancing the quality and effectiveness of therapies. However, diffusion of innovation is clustered across regions, leading to disparities in access to advanced treatment. Ensuring the dissemination of quality standards and medical innovation in clinical practice has become a critical concern for health care policy, with the aim of providing all cancer patients with high-quality care. To achieve this goal, the German Cancer Society introduced the accreditation program for organ cancer centers in 2003. The program aims to ensure standardized, evidence-based care within networks of interdisciplinary inpatient and outpatient providers, covering the entire treatment process. Accreditation uptake varies across regions, limiting access for certain patient populations. While accreditation guidelines promote state-of-the-art cancer treatment, health care systems are increasingly burdened with rising costs related to medical innovation. Since 2011, Germany employs value-based pricing to contain pharmaceutical expenditures. Prices of innovative drugs are linked to their clinical value in relation to therapy standards. As a result, the reform has increased the requirements for manufacturers to provide scientific evidence for external assessments, potentially affecting innovation processes and access to innovative pharmaceuticals. As quality assurance initiatives gain importance, the question arises how these efforts and regional innovation activities influence each other, access to specialized care, medical innovation, and resulting health outcomes. This thesis addresses these research gaps, focusing on the accreditation program for organ cancer centers and the Pharmaceutical Market Restructuring Act (Arzneimittelmarktneuordnungsgesetz, or AMNOG) in Germany. Using a mixed-method approach, it covers organizational, regional and temporal differences in innovation activity and accreditation uptake. First, the thesis focusses on organizational and environmental determinants of accreditation decisions in hospitals and the impact of accreditation on organizational innovativeness and performance. While hospitals must adapt to constant changes in a dynamic health care market, standardization through accreditation poses the risk of limiting an organization’s dynamic capabilities. This is because standardization relies on different mechanisms and both activities compete for limited resources. In a comparative case study, 25 semi-structured interviews with physicians and quality managers from 19 accredited German hospitals were analyzed using an inductive grounded theory approach. The analysis resulted in a conceptual model illustrating the relationship between accreditation and innovation activities within the context of strategic decision-making. For quantitative analyses, data from various data sources were acquired and combined. In particular, the thesis applies metrics for regional innovation activity, measured by the number of clinical trials and scientific publications for different pharmaceuticals and cancer types. Merging regional-level data with patient-level data allows to map local health care markets and their development over time. To estimate the impact of regional innovation activity on the uptake of accreditation, district-level panel data from 1998 to 2018 for eight cancer types was analyzed using linear fixed effect regression models. As both innovation activity and accreditation uptake are clustered across regions, understanding their relationship is crucial to enable effective resource allocation towards the standardization of care. Innovation activity was measured by publication output, while cancer incidence, gross domestic product, and hospital competition were considered confounding variables. To quantify the effect of local access to accredited care providers on regional health outcomes, the thesis employs a retrospective cohort study. Treatment in accredited centers is associated with higher survival rates, prompting policy makers to advocate for greater centralization towards these centers, even though it may increase travel distances for patients. While studies suggest that accreditation affects the supply and demand side of local cancer care beyond direct treatment outcome, its population-level effect remains unknown. The study applies nearest neighbor matching, based on Mahalanobis distance, with replacement to 3.2 million patients of eight cancer types in the German cancer registry. Among these, 861,508 patients had local access to accredited initial treatment. These patients were matched with those who lacked accredited care in their vicinity. The matching process considered individual and regional determinants of treatment outcomes, including the presence of accreditation in neighboring districts. Cox proportional hazard models were used to estimate hazard ratios, while G-Computation was applied to estimate the average treatment effects on the treated for one-, three-, and five-year survival probabilities. Finally, an event study design was used to evaluate the impact of the 2011 German AMNOG reform on knowledge production for innovative cancer drugs. Although the reform is associated with launch delays, an increase in innovation activity and the availability of scientific evidence could accelerate the diffusion of innovation and improve health outcomes. Data from the U.S. National Library of Medicine was used to measure clinical trials and publication output for 29 cancer drugs launched in Germany between 2008 and 2013. The impact of the reform was analyzed, accounting for pre-existing trends and structural differences between innovation processes. Subgroup analyses were conducted to assess the reform's impact on research in Germany and industry involvement. The qualitative analysis reveals that, depending on the available resources and market environment, hospitals engage in innovation activities and accreditation to achieve quality and financial goals. For smaller hospitals, accreditation is considered a necessary condition to remain competitive in local markets. These hospitals benefit from a positive effect of accreditation on incremental process and product innovation. For larger hospitals, obtaining accreditation is a necessary condition to acquire additional funding, with a limited impact on innovation activities. Ideally, accreditation and innovation activities can be aligned to achieve superior quality and financial performance through organizational ambidexterity. Panel data shows that the diffusion of the accreditation program is affected by regional innovation activity. Districts with any cancer type specific publications have an 11.2 percentage points higher probability to have at least one related accredited cancer center. Diffusion rates vary by level of publication activity, timing after program launch and cancer type. For breast cancer, districts in the highest ten percent by publication activity had on average 0.385 accredited centers more one year and 0.671 accredited centers more three years after program initiation, compared to districts without publications. Breast, colon, and prostate cancer patients with access to accredited care benefit from higher survival probabilities with hazard ratios between 0.87 and 0.96. Five-year survival probabilities increased for five cancer types by 1.8 to 7.3 percentage points. Effects vary by severity of illness measured through UICC TNM staging. The analyses show regional spillover effects of accreditation in neighboring districts. The AMNOG reform increased knowledge production for innovative pharmaceuticals, potentially facilitating medical innovation diffusion and mitigating launch delays associated with the reform. The total number of completed clinical trials increased after 2012, with an average of 2.69 more trials per drug in 2016. After 2011, the total number of publications increased to up to 28.16 additional publications per year and drug. While changes in German innovation output remain non-significant, the data show decreasing industry sponsorship of clinical trials with German participation. The results allow one to derive recommendations for hospitals and political decision-makers. Before seeking accreditation, hospital decision-makers should assess resource availability and potential benefits. Especially in regions with high competition, innovation activity and standardization of care through accreditation can be aligned to achieve quality and financial goals. Organizational decision-makers have to ensure that resource use for accreditation does not impair patient care, for example, by overburdening medical staff with administrative tasks. To reduce regional disparities in cancer care, political decision-makers can promote both innovation activity and the uptake of accreditation in undersupplied regions. Financial incentive systems for providers, such as additional remuneration for accredited centers to offset accreditation costs, likely encourage more providers to seek accreditation. More innovative regions show higher accreditation uptake, suggesting that involving providers in undersupplied regions more closely in medical research could enhance their ability to adopt medical innovation and quality assurance measures such as accreditation. In light of the AMNOG reform, guidelines or incentives related to the generation of scientific evidence could direct innovation activity towards Germany. Supporting the treatment of patients in accredited centers might increase the benefit of accreditation for local patient populations. Given that the benefits of accreditation differ between patient groups, centralizing care in accredited centers could be worthwhile for those patients with the highest expected benefi