Capturing the value of vaccination within health technology assessment and health economics:Literature review and novel conceptual framework

Background: Vaccination provides significant health gains to individuals and society and can potentially improve health equity, healthcare systems and national economies. Policy decisions, however, are rarely informed by comprehensive economic evaluations (EE) including vaccination's wide-ranging value. The objective of this analysis was to focus on health technology assessment systems to identify relevant value concepts in order to improve current EE of non-pandemic vaccines. Methods: Following a literature review, a novel Value of Vaccination (VoV) framework was developed with experts in vaccine EE from developed countries with established health technology assessment systems. Results: Forty-four studies presenting value frameworks or concepts applicable to vaccination were included. Eighteen unique value concepts relevant to EE were identified and defined. These were categorised within the VoV framework using three dimensions, moving from a narrow payer perspective to a more expansive and societal perspective. The dimensions were: (I) conventional payer perspective concepts (e.g., health gains in vaccinees, direct medical costs); (II) conventional societal perspective concepts (e.g., indirect health/economic gains to caregivers/households, productivity in vaccinees); and (III) novel societal concepts (e.g., financial risk protection, peace of mind, societal health gains, healthcare systems security, political stability, social equity and macroeconomic gains). While good quality evidence and methods are available to support concepts in Dimensions I and II, further work is needed to generate the required evidence for vaccination impact on Dimension III concepts. Conclusions: The devastating effect on nations of the COVID-19 pandemic has helped to highlight the potential far-reaching benefits that many vaccination programmes can offer. This VoV framework is particularly relevant to policy decisions considering EE, and the potential future expansion of non-pandemic vaccination value considerations. The framework helps to understand and compare current value considerations across countries and payer versus societal perspectives. It provides decision-makers with a transparent and logical path to broaden consideration of VoV in EE. (C) 2022 GlaxoSmithKline Biologicals S.A. Published by Elsevier Ltd

Reform of Prescription Drug Reimbursement and Pricing in the German Social Health Insurance Market: A Comparison of Three Scenarios

We review regulation of two important parameters for third-party payers and manufacturers of prescription drugs: regulation of reimbursement and pricing. We find that centralised regulation of reimbursement and pricing prevails in the 15 original EU member countries (EU-15) and in European Free Trade Association (EFTA) countries. Compared with countries such as Switzerland, The Netherlands, France and England, regulation in the German social health insurance system is rather unique. First, market approval is nearly always equivalent to reimbursement. Second, manufacturers are free to determine prices but internal reference prices restrict them from actually doing so for generics and therapeutic substitutes. In order to contain rising expenditures for prescription drugs in Germany, and to set incentives for physicians to consider the costs as well as the benefits of prescriptions, three reform scenarios are feasible. The first scenario maintains centralised reimbursement and centralised pricing; the second maintains centralised reimbursement but switches to decentralised pricing (similar to social health insurance in Israel and Medicare in the US). Third-party payers would be able to negotiate with manufacturers about discounts and market shares for genetic and therapeutic substitutes. In the third scenario, pricing and reimbursement would be decentralised (similar to private health insurance in the US). We suggest that the second scenario is a viable compromise between consumer protection and a more competitive and cost-effective market for prescription drugs in German social health insurance and other similar markets for prescription drugs.Health-insurance, Pricing, Regulatory-process, Reimbursement

The budgetary impact of genetic testing for hereditary breast cancer for the statutory health insurance

Objectives: Potential opportunities and challenges of predictive genetic risk classification of healthy persons are currently discussed. However, the budgetary impact of rising demand is uncertain. This project aims to evaluate budgetary consequences of predictive genetic risk classification for statutory health insurance in Germany. Methods: A Markov model was developed in the form of a cohort simulation. It analyzes a population of female relatives of hereditary breast cancer patients. Mutation carriers are offered intensified screening, women with a BRCA1 or BRCA2 mutation can decide on prophylactic mastectomy and/or ovarectomy. The model considers the following scenarios: (a) steady demand for predictive genetic testing, and (b) rising demand. Most input parameters are based on data of the German Consortium for Hereditary Breast and Ovarian Cancer. The model contains 49 health states, starts in 2015, and runs for 10 years. Prices were evaluated from the perspective of statutory health insurance. Results: Steady demand leads to an expenditure of euro49.8 million during the 10-year period. Rising demands lead to additional expenses of euro125.5 million. The model reveals the genetic analysis to be the main cost driver while cost savings in treatment costs of breast and ovarian cancer are indicated. Conclusions: The results contribute to close the knowledge gap concerning the budgetary consequences due to genetic risk classification. A rising demand leads to additional costs especially due to costs for genetic analysis. The model indicates budget shifts with cost savings due to breast and ovarian cancer treatment in the scenario of rising demands

Clinical Effectiveness and Cost Effectiveness of Tailoring Chronic Hepatitis C Treatment with Peginterferon Alpha-2b Plus Ribavirin to HCV Genotype and Early Viral Response: A Decision Analysis Based on German Guidelines

Background Recently developed German guidelines for antiviral treatment in patients with chronic hepatitis C recommend basing drug dosage, intended treatment duration and early stopping rules on the genotype of the hepatitis C virus and early viral responses to treatment. Abstract: Objectives To evaluate effectiveness and cost effectiveness of different antiviral treatment strategies including the German guidelines, for chronic hepatitis C. Abstract: Methods A validated lifetime Markov model was used to project life expectancy, QALYs and lifetime costs for the following strategies: (i) no antiviral therapy (NoAVT); (ii) interferon-α-2b plus ribavirin for 48 weeks (IFN + R); (iii) peginterferon-α-2b plus weight-based ribavirin for 48 weeks (PEG + R); (iv) peginterferon-α-2b plus ribavirin according to German guidelines with genotype-dependent treatment duration, dosage and 12-week viral response evaluation (GUIDE). Clinical and resource utilization data were derived from a clinical trial, the published literature and a survey of German hepatologists. Incremental cost-effectiveness ratios (ICERs) were calculated adopting the German societal perspective. Costs (in €, year 2005 values) and health outcomes were discounted at 3% annually. Uncertainty was assessed using deterministic and probabilistic sensitivity analyses. Abstract: Results Compared with NoAVT, PEG + R increased undiscounted life expectancy by 5.0 life-years (5.2 QALYs) and GUIDE increased undiscounted life expectancy by 4.9 years (5.1 QALYs). Compared with PEG + R, GUIDE saved 13% of hepatitis C virus-related lifetime costs per patient. GUIDE dominated IFN + R. Compared with NoAVT, discounted ICERs were €1500 per QALY for GUIDE and €3200 per QALY for PEG + R. Abstract: Conclusion Administering GUIDE should allow tailoring treatment efficiently to genotype, bodyweight and early viral response in patients with chronic hepatitis C, and appears cost effective compared with other well accepted medical interventions.

Quality of life and healthcare costs of patients with allergic respiratory diseases: a cross-sectional study

Hillerich V, Valbert F, Neusser S, et al. Quality of life and healthcare costs of patients with allergic respiratory diseases: a cross-sectional study. European Journal of Health Economics. 2023.BACKGROUND: Allergic rhinitis (AR) and allergic asthma (AA) are chronic respiratory diseases that represent a global health problem. One aim of this study was to analyze the Health-related Quality of Life (HRQoL) of the patients in order to identify statistically significant influencing factors that determine HRQoL. Another aim was to assess and analyze data on cost-of-illness from a statutory health insurance perspective.; METHODS: The EQ-5D-5L was used to evaluate the patients' HRQoL. To identify the factors influencing the HRQoL, a multinomial logistic regression analysis was conducted using groups based on the EQ-5D-5L index value as dependent variable. Routine data were analyzed to determine total healthcare costs.; RESULTS: The average EQ-5D-5L index was 0.85 (SD 0.20). A high age, the amount of disease costs, low internal health-related control beliefs and high ozone exposure in the residential area were found to be statistically significant influencing factors for a low HRQoL, whereas low age, male sex and a good possibility to avoid the allergens were found to be statistically significant factors influencing a high HRQoL. On average, the study participants incurred annual costs of 3072 (SD: 3485), of which 699 (SD: 743) could be assigned to allergic respiratory diseases.; CONCLUSIONS: Overall, the patients in the VerSITA study showed a high level of HRQoL. The identified influencing factors can be used as starting points for improving the HRQoL of patients with allergic respiratory diseases. From the perspective of a statutory health insurance, per person expenditures for allergic respiratory diseases are rather low. © 2023. The Author(s)

Resiliency in the Age of COVID-19: A Policy Toolkit

Twenty-nine LBJ School authors have come together to craft interdisciplinary and resilience-based policy solutions in one toolkit called Resiliency in the Age of COVID-19. In 18 articles that span public management, climate change, economic development, national security and more, LBJ School policy authors provide a forward-thinking lens on what went wrong and what leadership, public policies and initiatives it will take to fix the system flaws exposed by the pandemic. Published during the LBJ School’s 50th anniversary year, the toolkit also provides a snapshot of the school’s depth and breadth of policy and research engagement at this moment in time.Public Affair