A Transparency Checklist for Carbon Footprint Calculations Applied within a Systematic Review of Virtual Care Interventions.

Increasing concerns about climate change imply that decisions on the digitization of healthcare should consider evidence about its carbon footprint (CF). This study aims to develop a transparency catalogue for reporting CF calculations, to compare results, and to assess the transparency (reporting quality) of the current evidence of virtual care (VC) intervention. We developed a checklist of transparency criteria based on the consolidation of three established standards/norms for CF calculation.

Reporting Quality of Discrete Event Simulations in Healthcare-Results From a Generic Reporting Checklist.

Objectives: The aims of this study were to formulate a generic reporting checklist for healthcare-related discrete event simulation (DES) studies and to critically appraise the existing studies.

Methods: Based on the principles of accessibility and generality, assessment items were derived from the International Society for Pharmacoeconomics and Outcomes Research (ISPOR)-Society for Medical Decision Making (SMDM) Task Force reports. The resulting checklist was applied to all 211 DES studies identified in a previous review.

Evaluation as institution: a contractarian argument for needs-based economic evaluation.

Background: There is a gap between health economic evaluation methods and the value judgments of coverage decision makers, at least in Germany. Measuring preference satisfaction has been claimed to be inappropriate for allocating health care resources, e.g.

Health Care Costs Associated With Incident Complications in Patients With Type 2 Diabetes in Germany.

Objective: The aim of this study is to provide reliable regression-based estimates of costs associated with different type 2 diabetes complications.

Research Design And Methods: We used nationwide statutory health insurance (SHI) data from 316,220 patients with type 2 diabetes. Costs for inpatient and outpatient care, pharmaceuticals, rehabilitation, and nonmedical aids and appliances were assessed in the years 2013-2015.

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.

Reporting Guidelines for the Use of Expert Judgement in Model-Based Economic Evaluations.

Introduction: Expert judgement has a role in model-based economic evaluations (EEs) of healthcare interventions. This study aimed to produce reporting criteria for two types of study design to use expert judgement in model-based EE: (i) an expert elicitation (quantitative) study; and (ii) a Delphi study to collate (qualitative) expert opinion.

Methods: A two-round online Delphi process identified the degree of consensus for four core definitions (expert; expert parameter values; expert elicitation study; expert opinion) and two sets of reporting criteria in a purposive sample of experts.

USING CLAIMS DATA FOR EVIDENCE GENERATION IN MANAGED ENTRY AGREEMENTS.

Objectives: This study assesses the use of routinely collected claims data for managed entry agreements (MEA) in the illustrative context of German statutory health insurance (SHI) funds.

Methods: Based on a nonsystematic literature review, the data needs of different MEA were identified. A value-based typology to classify MEA on the basis of these data needs was developed.

Early decision-analytic modeling - a case study on vascular closure devices.

Background: As economic considerations become more important in healthcare reimbursement, decisions about the further development of medical innovations need to take into account not only medical need and potential clinical effectiveness, but also cost-effectiveness. Already early in the innovation process economic evaluations can support decisions on development in specific indications or patient groups by anticipating future reimbursement and implementation decisions. One potential concept for early assessment is value-based pricing.

The cost-effectiveness of UGT1A1 genotyping before colorectal cancer treatment with irinotecan from the perspective of the German statutory health insurance.

Background: The evidence concerning the cost-effectiveness of UGT1A1*28 genotyping is ambiguous and does not allow drawing valid conclusions for Germany. This study evaluates the cost-effectiveness of UGT1A1 genotyping in patients with metastatic colorectal cancer undergoing irinotecan-based chemotherapy compared to no testing from the perspective of the German statutory health insurance.

Material And Methods: A decision-analytic Markov model with a life time horizon was developed.

Cost-Effectiveness of an Individualized First-Line Treatment Strategy Offering Erlotinib Based on EGFR Mutation Testing in Advanced Lung Adenocarcinoma Patients in Germany.

Background: Lung cancer is among the top causes of cancer-related deaths. Epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitors can increase progression-free survival compared with standard chemotherapy in patients with EGFR mutation-positive advanced non-small cell lung cancer (NSCLC).

Objective: The aim of the study was to evaluate the cost-effectiveness of EGFR mutation analysis and first-line therapy with erlotinib for mutation-positive patients compared with non-individualized standard chemotherapy from the perspective of German statutory health insurance.

Using needs-based frameworks for evaluating new technologies: an application to genetic tests.

Given the multitude of newly available genetic tests in the face of limited healthcare budgets, the European Society of Human Genetics assessed how genetic services can be prioritized fairly. Using (health) benefit maximizing frameworks for this purpose has been criticized on the grounds that rather than maximization, fairness requires meeting claims (e.g.

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.

Funding decisions for newborn screening: a comparative review of 22 decision processes in Europe.

Decision-makers need to make choices to improve public health. Population-based newborn screening (NBS) is considered as one strategy to prevent adverse health outcomes and address rare disease patients' needs. The aim of this study was to describe key characteristics of decisions for funding new NBS programmes in Europe.

Is individualized medicine more cost-effective? A systematic review.

Background: Individualized medicine (IM) is a rapidly evolving field that is associated with both visions of more effective care at lower costs and fears of highly priced, low-value interventions. It is unclear which view is supported by the current evidence.

Objective: Our objective was to systematically review the health economic evidence related to IM and to derive general statements on its cost-effectiveness.

What is personalized medicine: sharpening a vague term based on a systematic literature review.

Background: Recently, individualized or personalized medicine (PM) has become a buzz word in the academic as well as public debate surrounding health care. However, PM lacks a clear definition and is open to interpretation. This conceptual vagueness complicates public discourse on chances, risks and limits of PM.

Criteria for fairly allocating scarce health-care resources to genetic tests: which matter most?

The use of genetic tests is expanding rapidly. Given limited health-care budgets throughout Europe and few national coverage decisions specifically for genetic tests, decisions about allocating scarce resources to genetic tests are frequently ad hoc and left to lower-level decision makers. This study assesses substantive ethical and economic criteria to prioritize genetic services in a reasonable and fair manner.

Link between process and appraisal in coverage decisions: an analysis with structural equation modeling.

Background: To achieve fair-coverage decision making, both material criteria and criteria of procedural justice have been proposed. The relationship between these is still unclear.

Objective: To analyze hypotheses underlying the assumption that more assessment, transparency, and participation have a positive impact on the reasonableness of coverage decisions.

Transparency vs. closed-door policy: do process characteristics have an impact on the outcomes of coverage decisions? A statistical analysis.

The aim of this study was to analyze influences of process- and technology-related characteristics on the outcomes of coverage decisions. Using survey data on 77 decisions from 13 countries, we examined whether outcomes differ by 14 variables that describe components of decision-making processes and the technology. We analyzed the likelihood of committees covering a technology, i.

Eliciting preferences for priority setting in genetic testing: a pilot study comparing best-worst scaling and discrete-choice experiments.

Given the increasing number of genetic tests available, decisions have to be made on how to allocate limited health-care resources to them. Different criteria have been proposed to guide priority setting. However, their relative importance is unclear.

The role of health technology assessment in coverage decisions on newborn screening.

Objectives: The role and impact of health technology assessment (HTA) in health policy has been widely discussed. Researchers have started to analyze how decisions on coverage of new technologies are made. Although the involvement of HTA may be an indicator of a well established decision process, this hypothesis requires validation.

A structured tool to analyse coverage decisions: development and feasibility test in the field of cancer screening and prevention.

Objectives: The comparison of fourth hurdle processes is challenging because they are heterogeneous and decision practice may deviate from formal process rules. This study applies a published framework consisting of key steps of coverage decision processes to the area of cancer prevention.

Methods: A research design was developed for analysis of case studies on past decision processes.

Points to consider in assessing and appraising predictive genetic tests.

The use of predictive genetic tests is expanding rapidly. Given limited health care budgets and few national coverage decisions specifically for genetic tests, evidence of benefits and harms is a key requirement in decision making; however, assessing the benefits and harms of genetic tests raises a number of challenging issues. Frequently, evidence of medical benefits and harms is limited due to practical and ethical limitations of conducting meaningful clinical trials.

Challenges of translating genetic tests into clinical and public health practice.

Research in genetics and genomics has led to an expanding list of molecular genetic tests, which are increasingly entering health care systems. However, the evidence surrounding the benefits and harms of these tests is frequently weak. Here we present the main challenges to the successful translation of new research findings about genotype-phenotype associations into clinical practice.

The cost-effectiveness of screening for hereditary hemochromatosis in Germany: a remodeling study.

Objective: Genetic tests for hereditary hemochromatosis (HH) are currently included in the German ambulatory care reimbursement scheme but only for symptomatic individuals and the offspring of HH patients. This study synthesizes the most current evidence to examine whether screening in the broader population is cost-effective and to identify the best choice of initial and follow-up screening tests.

Methods: A probabilistic decision-analytic model was constructed to calculate cost per life year gained (LYG) for HH screening among male Caucasians aged 30.