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.

Evaluating the Usefulness of Population-Wide COVID-19 Testing in the Omicron Era: Insights from a German Model.

BACKGROUND: The Omicron variant of SARS-CoV-2, which has become dominant worldwide since late 2021, presents a unique challenge due to its high rate of asymptomatic transmission. This study evaluates the efficacy and value of population-wide testing, including self-testing, in the context of COVID-19, particularly under the Omicron variant, using data from Germany. METHODS: A decision-analytical model and secondary data was used for assessing the impact of systematic screening and testing for COVID-19. Various scenarios were taken into consideration including seasonal patterns of COVID-19 transmission and the potential for annual waves. The model assessed the clinical benefits of testing against the backdrop of vaccine effectiveness, transmission rates, and the potential to prevent severe clinical events, including death, ICU admission, and long COVID syndrome. RESULTS: The study found that the value of mass testing and self-testing for private use was highly contingent on the transmission rate and the scenario of COVID-19 waves (seasonal vs. continuous). For winter waves, a very high incidence rate was required to justify testing, while for continuous waves, testing could be valuable for those in contact with individuals in their last decade of life. The analysis highlighted the limitations of mass testing when community transmission rates were low and the potential value of testing in high-risk contacts or amidst new outbreaks. DISCUSSION: The findings suggest that the resumption of testing during winter waves is unlikely to provide significant clinical benefits given the current understanding of Omicron's transmission and immunity waning. This study underscores the need for a nuanced approach to COVID-19 testing policies, considering both the epidemiological context and the practical implications of testing strategies.

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.

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.

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.

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.

The price of curing cancer.

BACKGROUND: Health care systems around the world struggle with high prices for new cancer drugs. The purpose of this study was to conduct a gedankenexperiment and calculate how much health expenditures would change if a cure for cancer through pharmaceutical treatment were made available. The cancer cure was conceived to eliminate both cancer deaths and the underlying morbidity burden of cancer. Furthermore, the cure was hypothesized to arrive in incremental steps but at infinitesimally small time intervals (resulting, effectively, in an immediate cure). METHODS: The analysis used secondary data and was conducted from the viewpoint of the German social health insurance. As its underlying method, it used a cause-elimination life-table approach. To account for the age distribution of the population, the study weighted age-specific increases in remaining life expectancy by age-specific population sizes. It considered drug acquisition costs as well as savings and life extension costs from eliminating cancer. All cancer drugs that underwent a mandatory early benefit assessment in Germany between 2011 and 2015/16 and were granted an added benefit were included. Data on age- and gender-specific probabilities of survival, population sizes, causes of death, and health expenditures, as well as data on cancer costs were taken from the German Federal Office of Statistics and the German Federal Social Insurance Office. RESULTS: Based on the cause-elimination life-table approach and accounting for the age structure of the German population, curing cancer in Germany yields an increase in average remaining life expectancy by 2.66 life years. Based on the current incremental cost-effectiveness ratio of new cancer drugs, which is on average €101,493 per life year gained (€39,751/0.39 life years), the German social health insurance would need to pay €280,497 per insuree to eliminate cancer. Dividing this figure by current average remaining lifetime health expenditures yields a ratio of 2.07, which represents a multiplier of current health expenditures. CONCLUSIONS: Eliminating cancer at current price levels would more than triple total health expenditures in Germany. As the current price of a cure requires a drastic reduction of non-health consumption, it appears that current prices for cancer drugs already on the market (i.e., small steps towards a cure) need careful reconsideration.

A parsimonious model to validate cost-effectiveness analyses on preventive health care.

BACKGROUND: The effect of preventive health care on health expenditures is ambiguous. On the one hand, prevention reduces the costs of future morbidity. On the other hand, prevention leads to costs of life extension. The purpose of this paper is to develop a parsimonious model that determines for a preventive measure of interest whether savings from preventing morbidity are more than offset by the costs of living longer, resulting in a net expenditure increase. METHODS: A theoretical model was built based on a Weibull survival function. It includes savings and life extension costs over the remaining lifetime. The model was applied to the example of obesity prevention. RESULTS: The model shows that the cost consequences of prevention are essentially driven by two factors: i) the relative reduction of morbidity-related costs, which determines the amount of savings from avoiding morbidity; and ii) the hazard ratio of death, which determines the amount of life extension costs. In the application example, the model is able to validate the results of a more complex cost-effectiveness model on obesity prevention. CONCLUSIONS: This work provides new insight into the lifetime cost consequences of prevention. The model can be used both to check plausibility of the results of other models and to conduct an independent analysis.

Autonomy, Coercion, and Public Healthcare Guarantees: The Uptake of Sofosbuvir in Germany.

Health insurance coverage for incarcerated citizens is generally acceptable by Western standards. However, it creates internal tensions with the prevailing justifications for public healthcare. In particular, a conceptualization of medical care as a source of autonomy enhancement does not align with the decreased autonomy of incarceration and the needs-based conceptualization of medical care in cases of imprisonment; and rejecting responsibility as a criterion for assigning medical care conflicts with the use of responsibility as a criterion for assigning punishment. The recent introduction of sofosbuvir in Germany provides a particularly instructive illustration of such tensions. It requires searching for a refined reflective equilibrium regarding the scope, limits, and justifications of publicly guaranteed care.

A proportional rule for setting reimbursement prices of new drugs and its mathematical consistency.

BACKGROUND: Value-based pricing (VBP) of new drugs has been suggested both as a way to control health expenditures and to maximize health benefits based on the available resources. The purpose of this work is to present a simple mathematical proof showing that prices of new drugs are set in a mathematically consistent way when the sum of intervention and downstream costs is proportional to the size of health benefits. Such proportional relationship underlies the efficiency-frontier method used by the German Institute for Quality and Efficiency in Health Care (IQWiG). METHODS: A proof by contradiction is presented that is based upon the following three premises: 1) total costs (intervention plus downstream costs) of existing non-dominated drugs and interventions are acceptable to decision-making bodies; 2) new drugs with health benefits in-between those of the most and second most effective existing interventions are not automatically excluded from reimbursement and are acceptable if prices are sufficiently low; and 3) value is measured on a cardinal scale. RESULT: The proof shows that a proportional rule sets reimbursement prices of new drugs in a mathematically consistent way. CONCLUSION: Based on the proof and the underlying assumptions a proportional relationship between costs and health benefits ensures mathematical consistency in VBP of drugs.

Willingness to pay for new medicines: a step towards narrowing the gap between NICE and IQWiG.

BACKGROUND: The question of how to set the cost-effectiveness threshold for new, innovative medicines is a matter of ongoing controversy. One prominent proposal suggests that the cost-effectiveness threshold adopted by the U.K. National Institute for Health and Care Excellence (NICE) should represent the opportunity cost for the U.K. National Health Service resulting from the adoption of new medicines. The purpose of this article is to compare this proposal for the U.K. with the approach chosen by the Institute for Quality and Efficiency in Health Care (IQWiG) in Germany, which relies on indication-specific cost-effectiveness thresholds. MAIN TEXT: The 'ideal' NICE and IQWiG surprisingly share the fundamental principle of inferring the willingness to pay from existing care. For this and other reasons, indication-specific thresholds based on IQWiG's methodology do not lead to more inefficiency at the health system's level than a generic threshold based on the 'ideal' NICE (keeping other conditions the same). Also, applying either decision rule to one country will yield a similar long-term growth in population spending. Assuming that everything else is equal, both decision rules are predicted to decrease long-term expenditure growth. Convergence of the two decision rules would require, among others, ruling out waste in the 'ideal' NICE's approach and, for IQWiG's approach, using the same relative weights for life expectancy and health-related quality of life as the quality-adjusted-life-year model. CONCLUSION: This article shows that both decision rules have notable commonalities in terms of inferring the willingness to pay from existing care and the projected impact on long-term growth in population spending.

Pharmaceutical expenditure and gross domestic product: Evidence of simultaneous effects using a two-step instrumental variables strategy.

This paper estimates the income elasticity of government pharmaceutical spending and assesses the simultaneous effect of such spending on gross domestic product (GDP). Using a panel dataset for 136 countries from 1995 to 2006, we employ a two-step instrumental variable procedure where we first estimate the effect of GDP on public pharmaceutical expenditure using tourist receipts as an instrument for GDP. In the second step, we construct an adjusted pharmaceutical expenditure series where the response of public pharmaceutical expenditure to GDP is partialled out and use this endogeneity adjusted series as an instrument for pharmaceutical expenditure. Our estimations show that GDP has a strong positive impact on pharmaceutical spending with elasticity in excess of unity in countries with low spending on pharmaceuticals and countries with large economic freedom. In the second step, we find that when the quantitatively large reverse effect of GDP is accounted for, public pharmaceutical spending has a negative effect on GDP per capita particularly in countries with limited economic freedom.

Budgetary Impact and Cost Drivers of Drugs for Rare and Ultrarare Diseases.

OBJECTIVES: To review recent studies reporting health care expenditures (budgetary impact) for orphan medicinal products (OMPs) in Europe and to contribute to our understanding of the cost drivers of nononcological OMPs by means of an empirical analysis in Germany. METHODS: A systematic search for relevant studies on rare diseases was conducted in PubMed and Embase (until December 2016). In addition, annual treatment costs of nononcological OMPs in Germany were analyzed with respect to five explanatory variables: total prevalence of disease, prevalence with added benefit, availability of alternative treatments for the same indication, extent/probability of treatment benefit, and evidence for a treatment effect on mortality. RESULTS: A total of nine studies with specific estimates of the budget impact of OMPs for a total of 11 countries were identified; one study addressed specifically ultrarare diseases. Annual per-capita spending for OMPs ranges from €1.32 in Latvia to €16 in France. Per-patient annual treatment costs vary between €27,811 and €1,647,627 in Germany. On the basis of the German data set, the regression analysis shows that log prevalence has a significant inverse relationship with log annual treatment cost. In this model, doubling the prevalence leads to a 43% decrease in annual treatment cost. CONCLUSIONS: Despite per-patient annual treatment costs ranging up to several hundreds of thousands of euros for some OMPs, per-capita spending for OMPs is relatively small. In this study an inverse relationship between prevalence and annual treatment costs was found.

Should Cost-Effectiveness Analysis Include the Cost of Consumption Activities? AN Empirical Investigation.

There has been a debate on whether cost-effectiveness analysis should consider the cost of consumption and leisure time activities when using the quality-adjusted life year as a measure of health outcome under a societal perspective. The purpose of this study was to investigate whether the effects of ill health on consumptive activities are spontaneously considered in a health state valuation exercise and how much this matters. The survey enrolled patients with inflammatory bowel disease in Germany (n = 104). Patients were randomized to explicit and no explicit instruction for the consideration of consumption and leisure effects in a time trade-off (TTO) exercise. Explicit instruction to consider non-health-related utility in TTO exercises did not influence TTO scores. However, spontaneous consideration of non-health-related utility in patients without explicit instruction (60% of respondents) led to significantly lower TTO scores. Results suggest an inclusion of consumption costs in the numerator of the cost-effectiveness ratio, at least for those respondents who spontaneously consider non-health-related utility from treatment. Results also suggest that exercises eliciting health valuations from the general public may include a description of the impact of disease on consumptive activities.