F.G. Sandmann

Decision making in Germany: Is health economic evaluation as a supporting tool a sleeping beauty?

For many years, the legal situation within the statutory health insurance (SHI) system in Germany has allowed for health economic evaluations. There are various reasons why health economic evaluations have played virtually no role in decision making until now: to begin with, a method for the evaluation of the relation between benefits and costs which needed to be in accordance with the legal requirements had to be developed, the outcome of which was the efficiency frontier approach. Subsequent health care reforms have led to changing objectives and strategies. Currently, price negotiations of newly launched drugs are based on an early benefit assessment of dossiers submitted by pharmaceutical manufacturers. Other reasons might be the presently very comfortable financial situation of the statutory health insurance system as well as a historically grown societal fear and discomfort towards what is perceived to be a rationing of medicinal products. For the time being, it remains open how long the German health care system can afford to continue neglecting the benefits of health economic evaluations for drug and non-drug interventions, and when it will be time to wake this sleeping beauty.

Factors that led to the implementation of the efficiency frontier approach in health economic evaluation in Germany: Do not avoid the elephant in the room. Comment on Klingler et al. (Health Policy 109 (2013) 270–280)

Klingler et al. claim that the following factors led to he adoption of the efficiency frontier (EF) approach in ermany: the rejection of a fixed threshold, focusing on linical benefit instead of cost-effectiveness as decision arameter, (avoiding) healthcare rationing, methodologial doubts regarding quality-adjusted life years (QALYs), nd associating QALYs with healthcare rationing [1]. In our opinion, the authors may overlook the factual aim f the EF-approach: justification of setting ceiling prices nstead of making reimbursement decisions. Furthermore, he role of a judicial review – a crucial veto point in the erman regulatory space – has not been discussed. Both ill briefly be explained below.

Burden, duration and costs of hospital bed closures due to acute gastroenteritis in England per winter, 2010/11–2015/16

Summary Background Bed closures due to acute gastroenteritis put hospitals under pressure each winter. In England, the National Health Service (NHS) has monitored the winter situation for all acute trusts since 2010/11. Aim To estimate the burden, duration and costs of hospital bed closures due to acute gastroenteritis in winter. Methods A retrospective analysis of routinely collected time-series data of bed closures due to diarrhoea and vomiting was conducted for the winters 2010/11 to 2015/16. Two key issues were addressed by imputing non-randomly missing values at provider level, and filtering observations to a range of dates recorded in all six winters. The lowest and highest values imputed were taken to represent the best- and worst-case scenarios. Bed-days were costed using NHS reference costs, and potential staff absence costs were based on previous studies. Findings In the best-to-worst case, a median of 88,000–113,000 beds were closed due to gastroenteritis each winter. Of these, 19.6–20.4% were unoccupied. On average, 80% of providers were affected, and had closed beds for a median of 15–21 days each winter. Hospital costs of closed beds were £5.7–£7.5 million, which increased to £6.9–£10.0 million when including staff absence costs due to illness. Conclusions The median number of hospital beds closed due to acute gastroenteritis per winter was equivalent to all general and acute hospital beds in England being unavailable for a median of 0.88–1.12 days. Costs for hospitals are high but vary with closures each winter.

Estimating the opportunity costs of bed-days.

Abstract Opportunity costs of bed‐days are fundamental to understanding the value of healthcare systems. They greatly influence burden of disease estimations and economic evaluations involving stays in healthcare facilities. However, different estimation techniques employ assumptions that differ crucially in whether to consider the value of the second‐best alternative use forgone, of any available alternative use, or the value of the actually chosen alternative. Informed by economic theory, this paper provides a taxonomic framework of methodologies for estimating the opportunity costs of resources. This taxonomy is then applied to bed‐days by classifying existing approaches accordingly. We highlight differences in valuation between approaches and the perspective adopted, and we use our framework to appraise the assumptions and biases underlying the standard approaches that have been widely adopted mostly unquestioned in the past, such as the conventional use of reference costs and administrative accounting data. Drawing on these findings, we present a novel approach for estimating the opportunity costs of bed‐days in terms of health forgone for the second‐best patient, but expressed monetarily. This alternative approach effectively re‐connects to the concept of choice and explicitly considers net benefits. It is broadly applicable across settings and for other resources besides bed‐days.

Estimating the Hospital Burden of Norovirus-Associated Gastroenteritis in England and Its Opportunity Costs for Nonadmitted Patients

Since the introduction of rotavirus vaccination in England in July 2013, norovirus has become the second-largest contributor of inpatient gastroenteritis, preventing 57800 patients from being admitted annually. Economic costs amount to £297.7 million, which translates into 6300 quality-adjusted life years.

Should NICE reconsider the 2016 UK guidelines on TB contact tracing? A cost-effectiveness analysis of contact investigations in London

Background In January 2016, clinical TB guidance in the UK changed to no longer recommend screening contacts of non-pulmonary, non-laryngeal (ETB) index cases. However, no new evidence was cited for this change, and there is evidence that screening these contacts may be worthwhile. The objective of this study was to estimate the cost-effectiveness of screening contacts of adult ETB cases and adult pulmonary or laryngeal TB (PTB) cases in London, UK. Methods We carried out a cross-sectional analysis of data collected on TB index cases and contacts in the London TB register and an economic evaluation using a static model describing contact tracing outcomes. Incremental cost-effectiveness ratios (ICERs) were calculated using no screening as the baseline comparator. All adult TB cases (≥15 years old) in London from 2012 to 2015, and their contacts, were eligible (2465/5084 PTB and 2559/6090 ETB index cases were included). Results Assuming each contact with PTB infects one person/month, the ICER of screening contacts of ETB cases was £78 000/quality-adjusted life-years (QALY) (95% CI 39 000 to 140 000), and screening contacts of PTB cases was £30 000/QALY (95% CI 18 000 to 50 000). The ICER of screening contacts of ETB cases was £30 000/QALY if each contact with PTB infects 3.4 people/month. Limitations of this study include the use of self-reported symptomatic periods and lack of knowledge about onward transmission from PTB contacts. Conclusions Screening contacts of ETB cases in London was almost certainly not cost-effective at any conventional willingness-to-pay threshold in England, supporting recent changes to National Institute for Health and Care Excellence national guidelines.

Estimation of Input Costs for a Markov Model in a German Health Economic Evaluation of Newer Antidepressants

Background: Estimating input costs for Markov models in health economic evaluations requires health state–specific costing. This is a challenge in mental illnesses such as depression, as interventions are not clearly related to health states. We present a hybrid approach to health state–specific cost estimation for a German health economic evaluation of antidepressants. Methods: Costs were determined from the perspective of the community of persons insured by statutory health insurance (“SHI insuree perspective”) and included costs for outpatient care, inpatient care, drugs, and psychotherapy. In an additional step, costs for rehabilitation and productivity losses were calculated from the societal perspective. We collected resource use data in a stepwise hierarchical approach using SHI claims data, where available, followed by data from clinical guidelines and expert surveys. Bottom-up and top-down costing approaches were combined. Results: Depending on the drug strategy and health state, the average input costs varied per patient per 8-week Markov cycle. The highest costs occurred for agomelatine in the health state first-line treatment (FT) (“FT relapse”) with €506 from the SHI insuree perspective and €724 from the societal perspective. From both perspectives, the lowest costs (excluding placebo) were €55 for selective serotonin reuptake inhibitors in the health state “FT remission.” Conclusion: To estimate costs in health economic evaluations of treatments for depression, it can be necessary to link different data sources and costing approaches systematically to meet the requirements of the decision-analytic model. As this can increase complexity, the corresponding calculations should be presented transparently. The approach presented could provide useful input for future models.

The efficiency-frontier approach for health economic evaluation versus cost-effectiveness thresholds and internal reference pricing: combining the best of both worlds?

ABSTRACT Introduction: The efficiency-frontier approach (EFA) to health economic evaluation aims to benchmark the relative efficiency of new drugs with the incremental cost-effectiveness ratios (ICERs) of non-dominated comparators. By explicitly considering any differences in health outcomes and costs, it enhances the internal reference pricing (IRP) policy that was officially endorsed by Germany as the first country worldwide in 1989. However, the EFA has been repeatedly criticized since its official endorsement in 2009. Areas covered: This perspective aims to stimulate the debate by discussing whether the main objections to the EFA are technically valid, irrespective of national contextual factors in Germany with reservations towards using cost-per-quality-adjusted life year (QALY) thresholds. Moreover, we comparatively assessed whether the objections are truly unique to the EFA or apply equally to IRP and cost-effectiveness thresholds. Expert commentary: The plethora of objections to the EFA (n = 20) has obscured that many objections are neither technically valid nor unique to the EFA. Compared with cost-effectiveness thresholds, only two objections apply uniquely to the EFA and concern intended key properties: (1) no external thresholds are needed and (2) the EFA is sensitive to price changes of comparators. Combining these policies and developing them further are under-utilized research areas.

Winter burden of hospital bed closures due to acute gastroenteritis in England, 2010–11 to 2015–16: a population-based observational study

Abstract Background Winter pressure on hospital beds is a recurring public health concern. We aimed to estimate and compare the extent of hospital bed closures due to gastroenteritis during the past six winters in England. Methods We obtained all available daily records of occupied and unoccupied hospital beds closed because of diarrhoea and vomiting for all acute Trusts in England for 2010–11 to 2015–16 from National Health Service (NHS) Englands winter situation reports. Because recording lengths differed in all six winters, we focused on an overlapping range of dates (Nov 30 to Feb 20—ie, 83 days or 11·9 weeks). About one-third of values were missing non-randomly (ie, all weekends and bank holidays), for which we imputed numbers at provider-level through last-observation carried forward and next-observation carried backward. We considered the lowest and highest value imputed as best and worst case estimates. We report numbers of all general and acute beds available in England and of all beds closed; the total number of beds closed per winter and the proportion unoccupied; and Pearsons correlation coefficient for occupied and unoccupied beds closed. Findings Total hospital capacity was a median 8·30 million beds (IQR 8·28–8·35 million) to 8·36 million beds (8·35–8·39 million) with the lowest and highest value imputed, respectively, corresponding to 100 000 (99 500–101 000) and 101 000 (99 900–102 000) beds per day. The median number of beds closed because of diarrhoea and vomiting was 88 300 (70 900–123 000) to 113 000 (88 300–151 000) with the lowest and highest value imputed, with totals for each of the six winters of 98 500 to 123 000 (2010–11), 135 000 to 168 000 (2011–12), 131 000 to 161 000 (2012–13), 68 600 to 83 800 (2013–14), 78 100 to 102 000 (2014–15), and 37 800 to 50 100 (2015–16). Respective proportions of beds closed unoccupied were 0·21 and 0·22, 0·19 and 0·20, 0·18 and 0·20, 0·19 and 0·21, 0·18 and 0·18, and 0·19 and 0·19. The number of occupied and unoccupied beds closed per day was strongly positively correlated (r=0·91 and r=0·89). Interpretation Bed closures were equivalent to all general and acute NHS beds in England being unavailable for a median of 0·88 to 1·12 days with the lowest and highest value imputed. 20% were lost when unoccupied. The peak bed closures in 2011–12 coincided with a novel norovirus strain and the decline after 2012–13 with rotavirus vaccine introduction in July, 2013. Funding This study originates from FGSs doctoral research that is jointly supported by a PhD studentship from the London School of Hygiene & Tropical Medicine and Public Health England.