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Feasibility Assessments for Comparative Evidence Generation: Building on the Cope et al. (2014) Framework in the Era of EU JCA
How should feasibility assessments for indirect treatment comparisons evolve in the era of EU JCA? Our expanded framework builds on Cope et al. (2014) and adds five new domains.
Trends in 12-Month Mortality and Statutory Health Insurance Costs in Incident Metastatic Bladder Cancer in Germany, 2011–2024
In incident metastatic bladder cancer in Germany, costs per patient rose from €32,245 to €43,042 between 2011 and 2024, without any improvement in 12-month survival.
Rising Drug Costs With Stable 12-Month Survival in Incident Metastatic Breast Cancer in Germany, 2011–2024
In incident metastatic breast cancer in Germany, 12-month survival remained broadly stable from 2011 to 2024, while costs rose by 22.9%, driven by outpatient drugs.
Trends in 12-Month Mortality and Healthcare Costs in Incident Metastatic Colorectal Cancer in Germany, 2011–2024
In incident metastatic colorectal cancer in Germany, costs rose moderately (+17.2%) between 2011 and 2024 without a consistent improvement in 12-month survival.
Increasing Costs and Limited Mortality Improvement in Incident Metastatic Lung Cancer in German Statutory Health Insurance Claims, 2011–2024
Costs for incident metastatic lung cancer in Germany rose by 87.5% between 2011 and 2024, while 12-month survival improved only modestly and inconsistently.
More Than Doubling of Costs With Unchanged 12-Month Mortality in Incident Metastatic Prostate Cancer in Germany, 2011–2024
Costs per patient with incident metastatic prostate cancer in Germany more than doubled between 2011 and 2024 – while 12-month survival remained nearly unchanged.
Epidemiology, Clinical Burden and Inflammatory Marker Testing in Atherosclerotic Cardiovascular Disease and Symptomatic Heart Failure in Germany: Insights from the ACHILLES Claims Data Analysis
How large is the burden of atherosclerotic cardiovascular disease (ASCVD) and symptomatic heart failure (HF) in Germany today – and how often is inflammation actually tested in routine care?
The ACHILLES claims data analysis, based on GWQ ServicePlus data from approximately 7.8 million individuals (2020–2024), identified 173,327 incident ASCVD and 121,208 incident symptomatic HF patients. In 2023, the age- and sex-adjusted incidence was 779 (ASCVD) and 668 (HF) per 100,000 individuals. Within 24 months, one in three ASCVD patients and almost one in two HF patients had a CV-related hospitalization – yet CRP testing was observed in only about 40% of patients in the first year after diagnosis.
ECA Feasibility Questionnaire: Quick Self-Evaluation
De-risk your evidence generation process by quickly assessing the feasibility of your External Comparator Arm (ECA). Identifying potential gaps early saves both time and financial resources.
This 24-question check evaluates three critical domains:
General Strategy (2 questions)
Data Feasibility (13 questions)
Design Feasibility (9 questions)
Clinical and economic benefits of seasonal COVID-19 vaccination in Germany: results from the ROUTINE COV19 Study, September 2022 to March 2024
Is there evidence for the benefit of COVID vaccinations in todays’ times? Recent study provides answers!
A team of scientists including GIPAM colleagues used GER claims data from GWQ Service Plus to explore what the impact of COVID-19 seasonal vaccinations between 1 September and 30 November 2023 is in an observational period of 4 months. A total of 146,132 individuals (73,066 vaccinated / 73,066 not vaccinated, 1:1 propensity score matching) were compared. All-cause mortality was 25% lower among COVID-19-vaccinated individuals (HR: 0.76; 95% CI: 0.70–0.82). Direct and indirect healthcare costs were found to be lower as well. These real-world findings support continued implementation of national immunisation recommendations during the endemic phase of SARS-CoV-2 circulation.
Barriers to Medication Adherence in Chronic Dermatological Diseases: A Validation Study of the Arabic Version of the Adherence Barriers Questionnaire and a Cross-Sectional Survey
📖عربي Arabic version of the unique ABQ questionnaire available!
In order to improve patients’ adherence to healthcare interventions such as long-term medication therapy in chronic diseases, there is one major challenge: Scientists as well as developers of adherence-promoting interventions and physicians need to know exactly WHY patients do not adhere with the interventions/prescriptions that were recommended to them.The ABQ is a unique and validated questionnaire to identify adherence barriers on a patient-level. It has now been validated in Arabic questionnaire:
The new discount on combination drug therapies in Germany: First numbers and assessment from a payor perspective
The “GKV Financial Stabilization Act” (GKV-FinStG), introduced in November 2022, brought several changes to the German pricing system for drugs, including a novel discount on pre-selected combination therapies. From October 2023 onwards, German statutory health insurance funds (SHIs) are entitled to a discount of 20 percent of the manufacturers’ prices on outpatient drugs that are prescribed in combination with another drug (for new drugs regulated by AMNOG) as designated by the “Gemeinsamer Bundesausschuss” (G-BA; §35a (3) sentence 4 SGB V). The German government expected medium-term savings of approximately €185 million per year.
Trends in Epidemiology and Mortality of Patients with Bladder Cancer in Germany: A Retrospective Study Using German Claims Data
Despite progress in the detection and treatment of bladder cancer (BC), it remains one of the common cancer diagnoses. Updated estimates of its epidemiology and mortality are needed to better understand the BC burden in Germany. This research aims to estimate the incidence/prevalence of BC in Germany and to describe trends in mortality in the last eleven years.
Monitoring the Burden of Lung Cancer in Germany: Trends in Incidence and Survival Using ZfKD Registry Data (2020–2023)
OBJECTIVES: To describe recent trends in lung cancer incidence, staging, morphology, and survival outcomes in Germany using comprehensive population-based data from the German Centre for Cancer Registry Data (ZfKD).
METHODS: This retrospective analysis included all lung cancer cases diagnosed from 2020 to 2023 in individuals aged 18 years or older. Anonymized data were sourced from the ZfKD, which compiles mandatory cancer notifications across the German federal states. Variables analyzed included patient demographics, tumor characteristics (histological subtype, stage), and Kaplan-Meier-based survival estimates stratified by cancer subtype and stage.
RESULTS: A total of 222,366 lung cancer cases were recorded, with incidence per 100 adults of 0.081, 0.082, 0.081, and 0.077 in 2020, 2021, 2022, and 2023, respectively. Non-small cell lung cancer (NSCLC) accounted for 82.6% of cases, while small cell lung cancer (SCLC) made up 13.8%. NSCLC patients were older at diagnosis than those with SCLC (mean 70.2 vs. 68.5 years). Stage IV was the most common at diagnosis (41% in NSCLC, 59% in SCLC). Median survival was 12.8 months for NSCLC and 8.1 months for SCLC, dropping to 6.5 and 6.8 months, respectively, in stage IV disease. Adenocarcinoma was the most frequent NSCLC subtype (40.5%), followed by squamous cell carcinoma (15.7%).
CONCLUSION: Late-stage lung cancer diagnosis remains common and contributes to poor short-term survival. These findings underscore the need for earlier detection strategies and continued research into treatment pathways and outcomes.
“Too Good to Be True?” Social Desirability Bias in Age-Related Patterns of Self-Reported Medication Adherence Among Patients with Atrial Fibrillation
OBJECTIVES: To investigate whether social desirability bias contributes to the paradox of older adults reporting high medication adherence despite a greater risk of non-adherence due to polypharmacy and comorbidities.
METHODS: We analyzed cross-sectional data from 308 anonymized adults with atrial fibrillation (AF), surveyed via online panels in the UK and the US, and during outpatient visits at a specialized stroke center in a German hospital. Patients suffering from AF and undertaking long-term treatment were included independently of the type, treatment, or duration of the disease. Participants completed the Adherence Assessment Questionnaire (AAQ), a validated self-report instrument that includes a two-item social desirability scale. Binomial logistic regression was used to estimate associations between age, social desirability, and their interaction with self-reported non-adherence, adjusting for gender, country, and number of medications. Sensitivity analyses using ordinal and linear regression models, as well as moderation estimates, were conducted to assess robustness.
RESULTS: The sample had a mean age of 67.0 years (SD: 13.2), and 33.8% were female. Increasing age and higher social desirability scores were associated with lower odds of reporting non-adherence (OR = 0.97, 95% CI: 0.94-0.99, p = .009 and OR = 0.80, 95% CI: 0.64-1.00, p = .051, respectively). The age-by-social desirability interaction was marginal in the binomial model (OR = 0.98, 95% CI: 0.96-1.00, p = .105), but significant in ordinal (p < .001) and linear (p = .002) regressions. Older adults with higher social desirability scores were especially likely to report better adherence. The moderation analysis (p = .016) confirmed that social desirability bias strengthened the association between age and adherence. No country-level differences were observed.
CONCLUSION: The apparent increase in self-reported adherence with age may reflect response bias rather than true behavioral differences. The tendency of socially desirable response behavior should be considered when interpreting self-reported adherence data.
GIPAM’s Unique Tool for Assessing the Feasibility of an External Control Arm Study
External control arms (ECAs) are used to generate comparative evidence (e.g., effectiveness) when only a single-arm trial has been conducted during the drug development process. However, key stakeholders often face substantial delays in determining the feasibility of an ECA; a responsive tool could streamline this process in a structured, rigorous manner.
Medical Chart Review (MCR) Studies Checklist
A structured tool to help teams plan and assess medical chart review studies with the rigour needed for HTA, regulatory, or publication use.
It highlights key design and operational considerations—bringing common pitfalls into focus before study initiation.