Determining the societal value of a prospective drug for ME/CFS in Germany.

BACKGROUND: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) imposes a substantial societal and economic burden. The aim of this study is to ascertain the optimal level of public research and development (R&D) investment in Germany for a prospective drug, given the pressing need for effective treatments. METHODS: This study calculates the societal value from a German perspective by integrating health and economic outcomes in the context of public R&D investment for ME/CFS. It considers factors such as direct medical costs, productivity loss, and the effectiveness of a prospective drug. RESULTS: The anticipated introduction of a prospective drug is estimated to yield a quality-adjusted life year (QALY) gain of approximately 29,000 and a societal value of about €2.6 billion. The optimal R&D investment in Germany is estimated at €676 million, which represents about a quarter of the total investment required to bring a significant drug to market, considering diminishing returns and market constraints. Results were confirmed in the sensitivity analysis. CONCLUSIONS: The study concludes that a coordinated international approach is imperative to address the funding and market size limitations effectively in developing treatments for ME/CFS and to realize the substantial societal and economic benefits.

Value-based pricing of cognitive behavioral therapy for depression in primary care: an economic evaluation.

OBJECTIVES: Value-based pricing (VBP) determines product prices based on their perceived benefits. In healthcare, VBP prices medical technologies considering health outcomes and other relevant factors. This study applies VBP using economic evaluation to provider-patient communication, taking cognitive behavioral therapy (CBT) for adult primary care patients with depressive disorders as a case study. METHODS: A 12-week decision-tree model was developed from the German social health insurance system's perspective, comparing CBT against the standard of care. The influence of an extended time horizon on VBP was assessed using a theoretical model and long-term data spanning 46 months. RESULTS: Using a willingness-to-pay threshold of €88,000 per quality-adjusted life year gained, the base-case 50-minute compensation rate for CBT was €45. Assuming long-term effects of CBT significantly affected the value-based compensation, increasing it to €226. CONCLUSIONS: This study showcases the potential of applying VBP to CBT. However, significant price variability is highlighted, contingent upon assumptions regarding CBT's long-term impacts.

Optimal allocation of scarce PCR tests during the COVID-19 pandemic.

BACKGROUND/AIM: During the coronavirus disease (COVID-19) pandemic, Germany and various other countries experienced a shortage of polymerase chain reaction (PCR) laboratory tests due to the highly transmissible SARS-CoV-2 Omicron variant that drove an unprecedented surge of infections. This study developed a mathematical model that optimizes diagnostic capacity with lab-based PCR testing. METHODS: A mathematical model was constructed to determine the value of PCR testing in relation to the pre-test probability of COVID-19. Furthermore, the model derives the lower and upper bounds for the threshold pre-test probability of the designated priority group. The model was applied in a German setting using the PCR test-positivity rate at the beginning of February 2022. RESULTS: The value function of PCR testing is bell-shaped with respect to the pre-test probability, reaching a maximum at a pre-test probability of 0.5. Based on a PCR test-positivity rate of 0.3 and assuming that at least two thirds of the tested population have a pre-test probability below, lower and higher pre-test probability thresholds are ≥ 0.1 and 0.7, respectively. Therefore, individuals who have a 25% likelihood of testing positive because they exhibit symptoms should be a higher priority for PCR testing. Furthermore, a positive rapid antigen test in asymptomatic individuals with no known exposure to COVID-19 should be confirmed using PCR. Yet, symptomatic individuals with a positive RAT should be excluded from PCR testing. CONCLUSION: A mathematical model that allows for the optimal allocation of scarce PCR tests during the COVID-19 pandemic was developed.

Long COVID: Costs for the German economy and health care and pension system.

BACKGROUND: Patients with acute COVID-19 can develop persistent symptoms (long/post COVID-19 syndrome). This study aimed to project the economic, health care, and pension costs due to long/post-COVID-19 syndrome with new onset in Germany in 2021. METHODS: Using secondary data, economic costs were calculated based on wage rates and the loss of gross value-added. Pension payments were determined based on the incidence, duration, and amount of disability pensions. Health care expenditure was calculated based on rehabilitation expenses. RESULTS: The analysis estimated a production loss of 3.4 billion euros. The gross value-added loss was calculated to be 5.7 billion euros. The estimated financial burden on the health care and pension systems due to SARS-CoV-2 infection was approximately 1.7 billion euros. Approximately 0.4 percent of employees are projected to be wholly or partially withdrawn from the labor market in the medium term due to long/post-COVID with new onset in 2021. CONCLUSION: Costs of long/post-COVID-19 syndrome with new onset in 2021 are not negligible for the German economy and health care and pension systems but may still be manageable.

A Model-Based Estimate of the Cost-Effectiveness Threshold in Germany.

PURPOSE: Value-based pricing of new, innovative health technologies defined as pricing through economic evaluation requires the use of a basic cost-effectiveness threshold. This study presents a cost-effectiveness model that determines the cost-effectiveness threshold for life-extending new, innovative technologies based on health system opportunity costs. METHODS: To estimate health system opportunity costs, the study used German data and examined the period between 1896 and 2014. To this end, it determined intertemporal differences in the remaining lifetime spending and life expectancy by age and gender. To account for the age composition of the population, it weighted age-specific intertemporal changes in the remaining lifetime spending and life expectancy by the age-specific population size. To estimate life expectancy gains solely attributable to the health care system, it used aggregated data on amenable mortality. It calculated the cost-effectiveness ratio of health care spending in the German health care system on average and at the margin. RESULTS: Based on the cost-effectiveness ratio of health care spending at the margin, the threshold value for life-prolonging new, innovative technologies was at least €42,634 per life-year gained, with a point estimate of €88,107 per life-year gained. Based on the average ratio, the threshold value dropped below €34,000 per life-year gained. CONCLUSION: This study provides new evidence on the cost-effectiveness threshold for value-based pricing of new, innovative technologies. Data from Germany suggest that a threshold value based on health care spending at the margin is considerably higher than that based on the average ratio.

Cost-effectiveness of future lockdown policies against the COVID-19 pandemic.

AIM: While the European Union (EU) has approved several COVID-19 vaccines, new variants of concern may be able to escape immunity. The purpose of this study is to project the cost-effectiveness of future lockdown policies in conjunction with a variant-adapted vaccine booster. The exemplary scenario foresees a 25% decline in the vaccine protection against severe disease. METHODS: A decision model was constructed using, for example, information on age-specific fatality rates, intensive care unit (ICU) costs and outcomes, and herd protection threshold. The costs and benefits of a future lockdown strategy were determined from a societal viewpoint under three future scenarios-a booster shot's efficacy of 0%, 50%, and 95%. RESULTS: The cost-effectiveness ratio of a lockdown policy in conjunction with a booster dose with 95% efficacy is €44,214 per life year gained. A lockdown is cost-effective when the probability of approving a booster dose with 95% efficacy is at least 48% (76% when considering uncertainty in input factors). CONCLUSION: In this exemplary scenario, a future lockdown policy appears to be cost-effective if the probability of approving a variant-adapted vaccine booster with an efficacy of 95% is at least 48%.

COVID-19 and the forgone health benefits of elective operations.

BACKGROUND AND AIM: The first SARS-CoV-2 pandemic wave in Germany involved a tradeoff between saving the lives of COVID-19 patients by providing sufficient intensive care unit (ICU) capacity and foregoing the health benefits of elective procedures. This study aims to quantify this tradeoff. METHODS: The analysis is conducted at both the individual and population levels. The analysis calculates quality-adjusted life years (QALYs) to facilitate a comparison between the health gains from saving the lives of COVID-19 patients in the ICU and the health losses associated with postponing operative procedures. The QALYs gained from saving the lives of COVID-19 patients are calculated based on both the real-world ICU admissions and deaths averted from flattening the first wave. Scenario analysis was used to account for variation in input factors. RESULTS: At the individual level, the resource-adjusted QALY gain of saving one COVID-19 life is predicted to be 3 to 15 times larger than the QALY loss of deferring one operation (the average multiplier is 9). The real-world QALY gain at the population level is estimated to fall within the range of the QALY loss due to delayed procedures. The modeled QALY gain by flattening the first wave is 3 to 31 times larger than the QALY loss due to delayed procedures (the average multiplier is 17). CONCLUSION: During the first wave of the pandemic, the resource-adjusted health gain from treating one COVID-19 patient in the ICU was found to be much larger than the health loss from deferring one operation. At the population level, flattening the first wave led to a much larger health gain than the health loss from delaying operative procedures.

Was EU's COVID-19 vaccine procurement strategy irrational? A re-analysis based on cost-effectiveness considerations.

AIM: The European Union (EU) has received criticism for being slow to secure coronavirus disease (COVID-19) vaccine contracts in 2020 before the approval of the first COVID-19 vaccine. This study aimed to retrospectively analyze the EU's COVID-19 vaccine procurement strategy. To this end, the study retrospectively determined the minimum vaccine efficacy that made vaccination cost-effective from a societal perspective in Germany before clinical trial announcements in late 2020. The results were compared with the expected vaccine efficacy before the announcements. METHODS: Two strategies were analyzed: vaccination followed by the complete lifting of mitigation measures and a long-term mitigation strategy. A decision model was constructed using, for example, information on age-specific fatality rates, intensive care unit costs and outcomes, and herd protection thresholds. The base-case time horizon was 5 years. Cost-effectiveness of vaccination was determined in terms of the costs per life-year gained. The value of an additional life-year was borrowed from new, innovative oncological drugs, as cancer is a condition with a perceived threat similar to that of COVID-19. RESULTS: A vaccine with 50% efficacy against death due to COVID-19 was not clearly cost-effective compared with a long-term mitigation strategy if mitigation measures were planned to be lifted after vaccine rollout. The minimum vaccine efficacy required to achieve cost-effectiveness was 40% in the base case. The sensitivity analysis showed considerable variation around the minimum vaccine efficacy, extending above 50% for some of the input variables. CONCLUSIONS: This study showed that vaccine efficacy levels expected before clinical trial announcements did not clearly justify lifting mitigation measures from a cost-effectiveness standpoint. Hence, the EU's sluggish procurement strategy still appeared to be rational at the time of decision making.

Benefits, risks, and cost-effectiveness of COVID-19 self-tests from a consumer's perspective.

BACKGROUND: The aim of this study is to quantify the health benefits, risks, and cost-effectiveness of COVID-19 self-tests from a consumer's perspective in Germany. METHODS: The analysis is based on a modelling approach using secondary data. The clinical endpoints considered in this analysis are avoided SARS-CoV-2 infections and secondary severe clinical events (death, intensive care unit (ICU) admission, and long COVID syndrome). The study determines the number of self-tests that need to be conducted under a 7-day incidence of 75 per 100,000 population to prevent one infection or severe clinical event. Furthermore, the study calculates the cost of testing per avoided clinical event and quality-adjusted life year (QALY) gained from a consumer perspective. RESULTS: Disregarding the rate of unreported COVID-19 cases, 4556 self-tests need to be conducted (over 12 years) in order to avoid one undesirable event (death, intensive care unit stay, or long COVID syndrome). Ninety percent of infections are not avoided among direct contacts but along the chain of infection. The costs per quality-adjusted life year gained from a consumer's perspective are €5870. This ratio is particularly sensitive to the 7-day incidence, effective reproduction number, and the age of contacts. CONCLUSIONS: The benefits of self-testing in the general population at a 7-day incidence rate of 75 per 100,000 appear to be minor. Nevertheless, cost-effectiveness may still be acceptable in the presence of higher-risk contacts given the low costs of self-test kits in Germany.

Value-based pricing of a COVID-19 vaccine.

AIM: The purpose of this study is to determine the value-based price of a COVID-19 vaccine from a societal perspective in Germany. METHODS: A decision model was constructed using, e.g., information on age-specific fatality rates, intensive care unit (ICU) costs and outcomes, and the full vaccination rate. Three strategies were analysed: vaccination (with 95 % and 50 % efficacy against death), a mitigation strategy, and no intervention. The base-case time horizon was 5 years. The value of a vaccine includes savings from avoiding COVID-19 mitigation measures and productivity loss, as well as health benefits from preventing COVID-19 related mortality. The value of an additional life year was borrowed from new, innovative oncological drugs, as cancer reflects a condition with a similar morbidity and mortality burden in the general population in the short term as COVID-19. RESULTS: A vaccine with a 95 % efficacy dominates the mitigation strategy strictly. The value-based price (€6,431) is thus determined by the comparison between vaccination and no intervention. The price is particularly sensitive to the full vaccination rate and the duration of vaccine protection. In contrast, the value of a vaccine with 50 % efficacy is more ambiguous. CONCLUSION: This study yields a value-based price for a COVID-19 vaccine with 95 % efficacy, which is considerably greater than the purchasing price.

The clinical and economic value of a successful shutdown during the SARS-CoV-2 pandemic in Germany.

Background and aim: A shutdown of businesses enacted during the SARS-CoV-2 pandemic can serve different goals, e.g., preventing the intensive care unit (ICU) capacity from being overwhelmed ('flattening the curve') or keeping the reproduction number substantially below one ('squashing the curve'). The aim of this study was to determine the clinical and economic value of a shutdown that is successful in 'flattening' or 'squashing the curve' in Germany. Methods: In the base case, the study compared a successful shutdown to a worst-case scenario with no ICU capacity left to treat COVID-19 patients. To this end, a decision model was developed using, e.g., information on age-specific fatality rates, ICU outcomes, and the herd protection threshold. The value of an additional life year was borrowed from new, innovative oncological drugs, as cancer reflects a condition with a similar morbidity and mortality burden in the general population in the short term as COVID-19. Results: A shutdown that is successful in 'flattening the curve' is projected to yield an average health gain between 0.01 and 0.05 life years (0.1 to 0.6 months) per capita in the German population. The corresponding economic value ranges between €616 and €4797 per capita or, extrapolated to the total population, 1%-12% of the gross domestic product (GDP) in 2019. A shutdown that is successful in 'squashing the curve' is expected to yield a minimum health gain of 0.08 life years (1 month) per capita, corresponding to 19 % of the GDP in 2019. Results are particularly sensitive to mortality data and the prevalence of undetected cases. Conclusion: A successful shutdown is forecasted to yield a considerable gain in life years in the German population. Nevertheless, questions around the affordability and underfunding of other parts of the healthcare system emerge.