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Introduction: Given the increasing clinical and economic burden of obesity, it is of major importance to identify cost-effective approaches for obesity management. Areas covered: This study aims to systematically review and compile an overview of published decision models for health economic assessments (HEA) in obesity, in order to summarize and compare their key characteristics as well as to identify, inform and guide future research. Of the 4,293 abstracts identified, 87 papers met our inclusion criteria. A wide range of different methodological approaches have been identified. Of the 87 papers, 69 (79%) applied unique /distinctive modelling approaches. Expert commentary: This wide range of approaches suggests the need to develop recommendations /minimal requirements for model-based HEA of obesity. In order to reach this long-term goal, further research is required. Valuable future research steps would be to investigate the predictiveness, validity and quality of the identified modelling approaches. [ABSTRACT FROM AUTHOR]

Background: Stratified Medicine (SM) is becoming a practical reality with the targeting of medicines by using a biomarker or genetic-based diagnostic to identify the eligible patient sub-population. Like any healthcare intervention, SM interventions have costs and consequences that must be considered by reimbursement authorities with limited resources. Methodological standards and guidelines exist for economic evaluations in clinical pharmacology and are an important component for health technology assessments (HTAs) in many countries. However, these guidelines have initially been developed for traditional pharmaceuticals and not for complex interventions with multiple components. This raises the issue as to whether these guidelines are adequate to SM interventions or whether new specific guidance and methodology is needed to avoid inconsistencies and contradictory findings when assessing economic value in SM. Objective: This article describes specific methodological challenges when conducting health economic (HE) evaluations for SM interventions and outlines potential modifications necessary to existing evaluation guidelines /principles that would promote consistent economic evaluations for SM. Results/Conclusions: Specific methodological aspects for SM comprise considerations on the choice of comparator, measuring effectiveness and outcomes, appropriate modeling structure and the scope of sensitivity analyses. Although current HE methodology can be applied for SM, greater complexity requires further methodology development and modifications in the guidelines. [ABSTRACT FROM AUTHOR]

A previous publication in this journal showed that the pricing matrix model (PMM) allows an assessment of the pricing potential of a new innovative product. When the PMM is going to be used for the determination of a drug price for a new drug in the strategic product planning process, it is important that this methodology is reliable. In the initial paper the PMM only yielded an expected price for the new antidepressant without generating an estimate of the probability that the new drug would indeed be listed at this expected price. In this manuscript we present various methodologies to deal with uncertainty in the PMM. We introduce the concept of price acceptability curves. The conclusion of this paper is that the incorporation of uncertainty into the PMM will lead to a more accurate assessment of the pricing potential of a new drug. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To assess the cost effectiveness of palivizumab (a preventative treatment against severe respiratory syncytial virus [RSV] infection) in children at high risk of hospitalisation, i.e. preterm infants ≤35 weeks gestation, children with bronchopulmonary dysplasia (BPD) and children with congenital heart disease (CHD).The analysis was based on a lifetime follow-up period in order to capture the impact of palivizumab on long-term morbidity and mortality resulting from an RSV infection. The primary efficacy outcome in the palivizumab clinical trials was the number of RSV hospitalisations avoided, which was extrapolated to effectiveness outcomes, i.e. number of life-years gained and number of QALYs. Costs and effects were discounted by 3.5%. METHODS: A decision tree model was developed employing data sources from the published literature, palivizumab clinical trials, official UK price/tariff lists and national population statistics. The comparator was no prophylaxis. The primary perspective of the study was that of the UK NHS. In a societal perspective scenario analysis, the future lost productivity of a child resulting from RSV-related mortality (indirect costs) was also included. The cost of administration of palivizumab, hospital care for RSV infections and the cost of asthma treatment were included.The analysis was based on a lifetime follow-up period in order to capture the impact of palivizumab on long-term morbidity and mortality resulting from an RSV infection. The primary efficacy outcome in the palivizumab clinical trials was the number of RSV hospitalisations avoided, which was extrapolated to effectiveness outcomes, i.e. number of life-years gained and number of QALYs. Costs and effects were discounted by 3.5%. RESULTS: In preterm infants and children with BPD, prophylaxis with palivizumab compared with no prophylaxis had an incremental cost-effectiveness ratio (ICER) of £7042/QALY without discounting outcomes, increasing to £16 720/QALY after discounting. In babies with CHD, the use of palivizumab resulted in an ICER of £2427/QALY without discounting outcomes and £6664/QALY after discounting. One-way sensitivity analyses and probabilistic sensitivity analyses confirmed the robustness of the model. A scenario analysis showed that the inclusion of indirect costs leads to further improvement in the cost-effectiveness outcomes for palivizumab. CONCLUSION: This study suggests that palivizumab prophylaxis against severe RSV infection in children at high risk may be cost effective from the NHS perspective (vs no prophylaxis), and that the positive clinical and economic benefits may persist beyond one RSV season. [ABSTRACT FROM AUTHOR]

Background: Reimbursement of new drugs is usually based on the budgetary impact of a new drug but there is also increasing demand for cost-effectiveness data on new drugs.Objective: To present a modelling technique (methodology) for an appropriate assessment of the budgetary impact of a new drug, which can simultaneously be used for a traditional cost-effectiveness analysis. DESIGN AND PERSPECTIVE: To illustrate the methodology, a model was constructed for a new hypothetical drug in Parkinson's disease, which allowed us to determine the budgetary impact and the cost effectiveness of this new antiparkinsonian drug from a societal perspective. The methodology consisted of two steps: (i) a simple population model (Markov model) was constructed to validate the epidemiological data by proving the consistency between the prevalence and incidence of Parkinson's disease for the Dutch population; (ii) this model was extended to a more complex model (semi-Markov model) by incorporation of disease progression for Parkinson's disease and all relevant economic and clinical measures. These included all drug utilisation associated with Parkinson's disease, as well as other resource utilisation patterns associated with outpatient and inpatient care for the treatment of Parkinson's disease.Results: The study showed that the difference in epidemiological data between a simple model and a complex model are substantial, which justifies the development of a complex model with a higher external validity. The complex model allowed an assessment of all potential candidates for the new drug and simultaneously allowed the assessment of the cost effectiveness of the new drug versus usual care.Conclusion: One model can be used for an appropriate assessment of the budgetary impact and the cost effectiveness of a new drug. [ABSTRACT FROM AUTHOR]

Presents a letter to the editor about the differing approaches to decision making adopted by clinicians and economists.

Abstract: Economic evaluations for medical nutrition, such as oral nutritional supplements (ONS), are relatively uncommon compared with other health technologies, and represent an area that has not been reviewed so far. In this systematic review, economic evaluations of enteral medical nutrition in the management of disease-related malnutrition (DRM) were reviewed and qualified to estimate the economic value. Initially, 481 studies were found, of which 37 full-text articles were assessed for eligibility and were rated on their quality using the Quality of Health Economic Studies (QHES) instrument. The final review focused on the high QHES quality economic evaluation studies. As both the studied medical nutrition intervention and the form of the economic evaluation varied, a quantitative synthesis (meta-analysis) was not attempted but a critical analysis and comparison of the individual study results were performed. ONS was the most studied intervention, covering several patient populations and different health care settings. Outcomes included cost savings (n = 3), no significant extra costs per unit of clinical and/or functional improvement (n = 1), or significantly higher costs per unit of clinical and/or functional improvement but still cost-effective for the used threshold (n = 4). This review shows that the use of enteral medical nutrition in the management of DRM can be efficient from a health economic perspective. [Copyright &y& Elsevier]