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Priority-setting policy-makers often face moral and political pressure to balance the conflicting motivations of efficiency and rescue/non-abandonment. Using the conflict between these motivations as a case study can enrich the understanding of institutional design in developed democracies. This essay presents a cognitive-psychological account of the conflict between efficiency and rescue/non-abandonment in health care priority-setting. It then describes three sets of institutional arrangements—in Australia, England/Wales, and Germany, respectively—that contend with this conflict in interestingly different ways. The analysis yields at least three implications for institutional design in developed democracies: (1) indeterminacy at the level of moral psychology can increase the probability of indeterminacy at the level of institutional design; (2) situational constraints in effect require priority-setting policy-makers to adopt normative-moral pluralism; and (3) the U.S. health care system may be in an anti-priority-setting equilibrium. [ABSTRACT FROM AUTHOR]

Abstract Aims The long‐term cost‐effectiveness of MitraClip in heart failure patients with secondary mitral regurgitation is still unclear. This study aimed to evaluate the long‐term cost‐effectiveness of MitraClip added to guideline‐directed medical therapy vs. guideline‐directed medical therapy alone in heart failure patients with secondary mitral regurgitation from the perspective of the healthcare systems of mainland China, the United Kingdom, Germany, and the United States. Methods and results A two‐stage (decision + Markov) model was built. Health utilities were defined by the New York Heart Association class, heart failure re‐hospitalization, and death and were calculated based on the 5 year follow‐up results of the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation trial. Direct healthcare costs were derived from the nationally representative data. Future utilities and costs were discounted at country‐specific rates. The primary outcome was the lifetime incremental cost‐effectiveness ratio. The mean age of the base case in our model was 72.2 years. Over a lifetime horizon, treatment with MitraClip was associated with 829 fewer heart failure re‐hospitalizations per 1000 treated patients. The MitraClip treatment was associated with incremental quality‐adjusted life‐year gains of 0.71, 0.76, 0.78, and 0.78, as well as incremental cost‐effectiveness ratios of ¥468 462, £28 910, €26 045, and $71 199 per quality‐adjusted life‐year for a lifetime horizon in mainland China, the United Kingdom, Germany, and the United States, respectively. In probabilistic sensitivity analysis, 0.2%, 59.4%, 99.6%, and 84.7% of patients were cost‐effective in mainland China, the United Kingdom, Germany, and the United States at the country‐specific willingness‐to‐pay thresholds. Conclusions MitraClip + guideline‐directed medical therapy was cost‐effective in heart failure patients with secondary mitral regurgitation in the United Kingdom, Germany, and the United States, but not in mainland China from the perspective of the national healthcare system.

Aims: The long‐term cost‐effectiveness of MitraClip in heart failure patients with secondary mitral regurgitation is still unclear. This study aimed to evaluate the long‐term cost‐effectiveness of MitraClip added to guideline‐directed medical therapy vs. guideline‐directed medical therapy alone in heart failure patients with secondary mitral regurgitation from the perspective of the healthcare systems of mainland China, the United Kingdom, Germany, and the United States. Methods and results: A two‐stage (decision + Markov) model was built. Health utilities were defined by the New York Heart Association class, heart failure re‐hospitalization, and death and were calculated based on the 5 year follow‐up results of the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation trial. Direct healthcare costs were derived from the nationally representative data. Future utilities and costs were discounted at country‐specific rates. The primary outcome was the lifetime incremental cost‐effectiveness ratio. The mean age of the base case in our model was 72.2 years. Over a lifetime horizon, treatment with MitraClip was associated with 829 fewer heart failure re‐hospitalizations per 1000 treated patients. The MitraClip treatment was associated with incremental quality‐adjusted life‐year gains of 0.71, 0.76, 0.78, and 0.78, as well as incremental cost‐effectiveness ratios of ¥468 462, £28 910, €26 045, and $71 199 per quality‐adjusted life‐year for a lifetime horizon in mainland China, the United Kingdom, Germany, and the United States, respectively. In probabilistic sensitivity analysis, 0.2%, 59.4%, 99.6%, and 84.7% of patients were cost‐effective in mainland China, the United Kingdom, Germany, and the United States at the country‐specific willingness‐to‐pay thresholds. Conclusions: MitraClip + guideline‐directed medical therapy was cost‐effective in heart failure patients with secondary mitral regurgitation in the United Kingdom, Germany, and the United States, but not in mainland China from the perspective of the national healthcare system. [ABSTRACT FROM AUTHOR]

Background: Because health resources are limited, health programs should be compared to allow the most efficient ones to emerge. To that aim, health utility instruments have been developed to allow the calculation of quality-adjusted life-year (QALY). However, generic instruments, which can be used by any individual regardless of their health profile, typically consider the preferences of the general population when developing their value set. Consequently, they are often criticized for lacking sensitivity in certain domains, such as cancer. In response, the latest version of the Short Form 6-Dimension (SF-6Dv2) has been adapted to suit the preferences of patients with breast or colorectal cancer in the Canadian province of Quebec. By extension, our study's aim was to determine cancer population norms of utility among patients with breast or colorectal cancer in Quebec using the SF-6Dv2. Method: To determine the cancer population norms, we exploited the data that were used in the development of a new value set for the SF-6Dv2. This value set was developed considering the preferences of patients with breast or colorectal cancer. Stratification by time of data collection (i.e., T1 and T2), sociodemographic variables (i.e., age, sex, body mass index, and self-reported health problems affecting quality of life), and clinical aspects (i.e., cancer site, histopathological classification, cancer stage at diagnosis, modality, and treatment characteristics) was performed. Results: In 353 observations, patients were more likely to have negative utility scores at T1 than at T2. Males had higher mean utility scores than females considering type of cancer and comorbidities. Considering the SF-6Dv2's dimensions, more females than males reported having health issues, most which concerned physical functioning. Significant differences by sex surfaced for all dimensions except "Role Limitation" and "Mental health." Patients with multifocal cancer had the highest mean and median utility values in all cancer sites considered. Conclusion: Cancer population norms can serve as a baseline for interpreting the scores obtained by a given population in comparison to the situation of another group. In this way, our results can assist in comparing utility scores among cancer patients with different sociodemographic groups to other patients/populations groups. To our knowledge, our identified utility norms are the first for patients with breast or colorectal cancer from Quebec. [ABSTRACT FROM AUTHOR]

Critics of quality-adjusted life-years argue that it discriminates against older individuals. However, little empirical evidence has been produced to inform this debate. This study aimed to compare published cost-effectiveness analyses (CEAs) on patients aged ≥65 years and those aged <65 years. We used the Tufts Cost-Effectiveness Analysis Registry to identify CEAs published in MEDLINE between 1976 and 2021. Eligible CEAs were categorized according to age (≥65 years vs <65 years). The distributions of incremental cost-effectiveness ratios (ICERs) were compared between the age groups. We used logistic regression to assess the association between age groups and the cost-effectiveness conclusion adjusted for confounding factors. We conducted sensitivity analyses to explore the impact of mixed age and age-unknown groups and all ICERs from the same CEAs. Subgroup analyses were also conducted. A total of 4445 CEAs categorized according to age <65 years (n = 3784) and age ≥65 years (n = 661) were included in the primary analysis. The distributions of ICERs and the likelihood of concluding that the intervention was cost-effective were similar between the 2 age groups. Adjusted odds ratios ranged from 1.132 (95% CI 0.930-1.377) to 1.248 (95% CI 0.970-1.606) (odds ratio >1 indicating that CEAs for age ≥65 years were more likely to conclude the intervention was cost-effective than those for age <65 years). Sensitivity and subgroup analyses found similar results. Our analysis found no systematic differences in published ICERs using quality-adjusted life-years between CEAs for individuals aged ≥65 years and those for individuals aged <65 years. • Critics argue that quality-adjusted life-years discriminate against older people and those with disabilities or receiving palliative care. • Analyses of published cost-effectiveness analyses found no systematic differences in cost-effectiveness conclusions between cost-effectiveness analyses focused on individuals aged ≥65 years and those for individuals aged <65 years. • This empirical evidence can be used to inform debates about the use of quality-adjusted life-years in drug price negotiations, reimbursement, and coverage policy making. [ABSTRACT FROM AUTHOR]

Aim: The cost-effectiveness of treatment options (anticholinergics, β3-adrenoceptor agonists, onabotulinumtoxinA, sacral nerve stimulation and percutaneous tibial stimulation [the latter two including new rechargeable neurostimulators]) for the management of overactive bladder (OAB) were compared with best supportive care (BSC) using a previously published Markov model. Materials & methods: Cost-effectiveness was evaluated over a 15-year time horizon, and sensitivity analyses were performed using 2- and 5-year horizons. Discontinuation rates, resource utilization, and costs were derived from published sources. Results: Using Medicare and commercial costs over a 15-year time period, onabotulinumtoxinA 100U had incremental cost-effectiveness ratios (ICERs) gained of $39,591/quality-adjusted life-year (QALY) and $42,255/QALY, respectively, versus BSC, which were the lowest ICERs of all assessed treatments. The sensitivity analyses at 2- and 5-year horizons also showed onabotulinumtoxinA to be the most cost-effective of all assessed treatments versus BSC. Conclusion: OnabotulinumtoxinA 100U is currently the most cost-effective treatment for OAB.

This study generates VILL-UI (Vision Impairment in Low Luminance - Utility Index), a preference-weighted measure (PWM) derived from the VILL-33 measure for use in patients with age-related macular degeneration (AMD) and valued to generate United Kingdom and German preference weights. A PWM consists of a classification system to describe health and utility values for every state described by the classification. The classification was derived using existing data collected as part of the MACUSTAR study, a low-interventional study on AMD, conducted at 20 clinical sites across Europe. Items were selected using psychometric and Rasch analyses, published criteria around PWM suitability, alongside instrument developer views and concept elicitation work that informed VILL-33 development. An online discrete choice experiment (DCE) with duration of the health state was conducted with the United Kingdom and German public. Responses were modeled to generate utility values for all possible health states. The classification system has 5 items across the 3 domains of VILL-33: reading and accessing information, mobility and safety, and emotional well-being. The DCE samples (United Kingdom: n = 1004, Germany: n = 1008) are broadly representative and demonstrate good understanding of the tasks. The final DCE analyses produce logically consistent and significant coefficients. This study enables responses to VILL-33 to be directly used to inform economic evaluation in AMD. The elicitation of preferences from both United Kingdom and Germany enables greater application of VILL-UI for economic evaluation throughout Europe. VILL-UI fills a gap in AMD in which generic preference-weighted measures typically lack sensitivity. • The Vision Impairment in Low Luminance-33 (VILL-33) patient-reported outcome measure is psychometrically valid and captures vision-related quality of life in age-related macular degeneration but cannot be used in its current form to inform economic evaluation because it does not have preference weights. • This study generates VILL-UI, a preference-weighted measure derived from the VILL-33 measure for use in patients with age-related macular degeneration, with both United Kingdom and German preference weights. • This study generates a new preference-weighted measure VILL-UI, which enables prospective and retrospective data sets with VILL-33 data to be directly used to inform economic evaluation. [ABSTRACT FROM AUTHOR]

This study aimed to assess whether recently proposed alternatives to the quality-adjusted life-year (QALY), intended to address concerns about discrimination, are suitable for informing resource allocation decisions. We consider 2 alternatives to the QALY: the health years in total (HYT), recently proposed by Basu et al, and the equal value of life-years gained (evLYG), currently used by the Institute for Clinical and Economic Review. For completeness we also consider unweighted life-years (LYs). Using a hypothetical example comparing 3 mutually exclusive treatment options, we consider how calculations are performed under each approach and whether the resulting rankings are logically consistent. We also explore some further challenges that arise from the unique properties of the HYT approach. The HYT and evLYG approaches can result in logical inconsistencies that do not arise under the QALY or LY approaches. HYT can violate the independence of irrelevant alternatives axiom, whereas the evLYG can produce an unstable ranking of treatment options. HYT have additional issues, including an implausible assumption that the utilities associated with health-related quality of life and LYs are "separable," and a consideration of "counterfactual" health-related quality of life for patients who are dead. The HYT and evLYG approaches can result in logically inconsistent decisions. We recommend that decision makers avoid these approaches and that the logical consistency of any approaches proposed in future be thoroughly explored before considering their use in practice. • A common criticism of the quality-adjusted life-year (QALY) is that life extensions generate fewer QALYs for those with poorer health-related quality of life. The equal value of life-years gained (evLYG) approach addresses this by assigning equal value to life extensions of similar length; however, this does not incentivize development of technologies that also improve health-related quality of life during life extension. The recently proposed health years in total (HYT) approach attempts to overcome both these issues. • We assess whether these recently proposed alternatives to the QALY are suitable for informing healthcare resource allocation decisions. Using a hypothetical example comparing 3 mutually exclusive treatment options, we consider how calculations are performed under each approach and whether the resulting rankings satisfy some basic tenets of rational choice theory. We also explore some further challenges that arise from the unique properties of the HYT approach. • We find that the HYT and evLYG approaches can result in logical inconsistencies that do not arise when using QALYs. HYT can violate the "independence" axiom, whereas the evLYG can produce an unstable ranking of treatment options. We recommend that policy makers exercise caution and avoid adopting any approaches that violate fundamental principles of rational decision making or that rely upon assumptions that lack credibility. [ABSTRACT FROM AUTHOR]

Background: The aging process can lead to knee pain in the elderly, which negatively impacts their quality of life by decreasing their physical functioning and potentially affecting their psychological well-being over time. This study aimed to determine the association between knee pain and the quality of life of the elderly. Methods: This analytical study involved elderly patients aged 60 years and over who presented with complaints of knee pain at the Geriatric Outpatient Clinic of Universitas Airlangga Hospital, Surabaya, Indonesia, from September 2022 to March 2023. The participants were selected by consecutive sampling until a total of 50 samples were collected using the interview method. The independent variable was knee pain, while the dependent variable was quality of life. The instruments used were the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) to measure knee pain and the Barthel Index for Activities of Daily Living (ADL) to assess the quality of life. The data were analyzed using Spearman's rho, with p

Abstract Background The partitioned survival model (PSM) and the state transition model (STM) are widely used in cost-effectiveness analyses of anticancer drugs. Using different modeling approaches with or without consideration of brain metastasis, we compared the quality-adjusted life-year (QALY) estimates of Osimertinib and pemetrexed-platinum in advanced non-small cell lung cancer with epidermal growth factor receptor mutations. Methods We constructed three economic models using parametric curves fitted to patient-level data from the National Health Insurance Review and Assessment claims database from 2009 to 2020. PSM and 3-health state transition model (3-STM) consist of three health states: progression-free, post-progression, and death. The 5-health state transition model (5-STM) has two additional health states (brain metastasis with continuing initial therapy, and with subsequent therapy). Time-dependent transition probabilities were calculated in the state transition models. The incremental life-year (LY) and QALY between the Osimertinib and pemetrexed-platinum cohorts for each modeling approach were estimated over seven years. Results The PSM and 3-STM produced similar incremental LY (0.889 and 0.899, respectively) and QALY (0.827 and 0.840, respectively). However, 5-STM, which considered brain metastasis as separate health states, yielded a slightly higher incremental LY (0.910) but lower incremental QALY (0.695) than PSM and 3-STM. Conclusions Our findings indicate that incorporating additional health states such as brain metastases into economic models can have a considerable impact on incremental QALY estimates. To ensure appropriate health technology assessment decisions, comparison and justification of different modeling approaches are recommended in the economic evaluation of anticancer drugs.

Introduction Studies on economic evaluations of the 13-valent pneumococcal conjugate vaccine (PCV13) have been increasing over the last decade. No systematic reviews have synthesized the evidence of economic evaluations of the PCV13. Areas covered We systematically searched the literature which published on peer-reviewed journals from January 2010 to June 2022. The literature search was conducted in the following electronic databases: PubMed, Web of Science, Embase, the Cochrane Library, CNKI, Wanfang database, VIP database. We identified 1827 records from the database search. After excluding 511 duplicates, 1314 records were screened, of which 156 records were retained for the full-text reviews. A total of 44 studies were included in the review. Among the included studies, 33 studies were economic evaluations of PCV13 among children, and 11 studies were conducted among adults. The literature search initiated in April, 2022, and updated in June 2022. Expert opinion Vaccination with PCV13 was found to significantly reduce the mortality and morbidity of pneumococcal diseases and was cost-effective compared to no vaccine or several other pneumococcal vaccines (e.g. PCV10, PPV23). Future research is advised to expand economic evaluations of PCV13 combined with dynamic model to enhance methodologic rigor and prediction accuracy.

Background: The partitioned survival model (PSM) and the state transition model (STM) are widely used in cost-effectiveness analyses of anticancer drugs. Using different modeling approaches with or without consideration of brain metastasis, we compared the quality-adjusted life-year (QALY) estimates of Osimertinib and pemetrexed-platinum in advanced non-small cell lung cancer with epidermal growth factor receptor mutations. Methods: We constructed three economic models using parametric curves fitted to patient-level data from the National Health Insurance Review and Assessment claims database from 2009 to 2020. PSM and 3-health state transition model (3-STM) consist of three health states: progression-free, post-progression, and death. The 5-health state transition model (5-STM) has two additional health states (brain metastasis with continuing initial therapy, and with subsequent therapy). Time-dependent transition probabilities were calculated in the state transition models. The incremental life-year (LY) and QALY between the Osimertinib and pemetrexed-platinum cohorts for each modeling approach were estimated over seven years. Results: The PSM and 3-STM produced similar incremental LY (0.889 and 0.899, respectively) and QALY (0.827 and 0.840, respectively). However, 5-STM, which considered brain metastasis as separate health states, yielded a slightly higher incremental LY (0.910) but lower incremental QALY (0.695) than PSM and 3-STM. Conclusions: Our findings indicate that incorporating additional health states such as brain metastases into economic models can have a considerable impact on incremental QALY estimates. To ensure appropriate health technology assessment decisions, comparison and justification of different modeling approaches are recommended in the economic evaluation of anticancer drugs. [ABSTRACT FROM AUTHOR]

BackgroundTreatment outcomes after pelvic organ prolapse surgery are often presented as dichotomous "success or failure" based on anatomic and symptom criteria. However, clinical experience suggests that some women with outcome "failures" are asymptomatic and perceive their surgery to be successful and that other women have anatomic resolution but continue to report symptoms. Characterizing failure types could be a useful step to clarify definitions of success, understand mechanisms of failure, and identify individuals who may benefit from specific therapies.ObjectiveThis study aimed to identify clusters of women with similar failure patterns over time and assess associations among clusters and the Pelvic Organ Prolapse Distress Inventory, Short-Form Six-Dimension health index, Patient Global Impression of Improvement, patient satisfaction item questionnaire, and quality-adjusted life-year.Study designOutcomes were evaluated for up to 5 years in a cohort of participants (N=709) with stage ≥2 pelvic organ prolapse who underwent surgical pelvic organ prolapse repair and had sufficient follow-up in 1 of 4 multicenter surgical trials conducted by the Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Surgical success was defined as a composite measure requiring anatomic success (Pelvic Organ Prolapse Quantification system points Ba, Bp, and C of ≤0), subjective success (absence of bothersome vaginal bulge symptoms), and absence of retreatment for pelvic organ prolapse. Participants who experienced surgical failure and attended ≥4 visits from baseline to 60 months after surgery were longitudinally clustered, accounting for similar trajectories in Ba, Bp, and C and degree of vaginal bulge bother; moreover, missing data were imputed. Participants with surgical success were grouped into a separate cluster.ResultsSurgical failure was reported in 276 of 709 women (39%) included in the analysis. Failures clustered into the following 4 mutually exclusive subgroups: (1) asymptomatic intermittent anterior wall failures, (2) symptomatic intermittent anterior wall failures, (3) asymptomatic intermittent anterior and posterior wall failures, and (4) symptomatic all-compartment failures. Each cluster had different bulge symptoms, anatomy, and retreatment associations with quality of life outcomes. Asymptomatic intermittent anterior wall failures (n=150) were similar to surgical successes with Ba values that averaged around -1 cm but fluctuated between anatomic success (Ba≤0) and failure (Ba>0) over time. Symptomatic intermittent anterior wall failures (n=82) were anatomically similar to asymptomatic intermittent anterior failures, but women in this cluster persistently reported bothersome bulge symptoms and the lowest quality of life, Short-Form Six-Dimension health index scores, and perceived success. Women with asymptomatic intermittent anterior and posterior wall failures (n=28) had the most severe preoperative pelvic organ prolapse but the lowest symptomatic failure rate and retreatment rate. Participants with symptomatic all-compartment failures (n=16) had symptomatic and anatomic failure early after surgery and the highest retreatment of any cluster.ConclusionIn particular, the following 4 clusters of pelvic organ prolapse surgical failure were identified in participants up to 5 years after pelvic organ prolapse surgery: asymptomatic intermittent anterior wall failures, symptomatic intermittent anterior wall failures, asymptomatic intermittent anterior and posterior wall failures, and symptomatic all-compartment failures. These groups provide granularity about the nature of surgical failures after pelvic organ prolapse surgery. Future work is planned for predicting these distinct outcomes using patient characteristics that can be used for counseling women individually.

Background: Hip fractures are a common and costly health problem, resulting in significant morbidity and mortality, as well as high costs for healthcare systems, especially for the elderly. Implementing surgical preventive strategies has the potential to improve the quality of life and reduce the burden on healthcare resources, particularly in the long term. However, there are currently limited guidelines for standardizing hip fracture prophylaxis practices. Methods: This study used a cost-effectiveness analysis with a finite-state Markov model and cohort simulation to evaluate the primary and secondary surgical prevention of hip fractures in the elderly. Patients aged 60 to 90 years were simulated in two different models (A and B) to assess prevention at different levels. Model A assumed prophylaxis was performed during the fracture operation on the contralateral side, while Model B included individuals with high fracture risk factors. Costs were obtained from the Centers for Medicare & Medicaid Services, and transition probabilities and health state utilities were derived from available literature. The baseline assumption was a 10% reduction in fracture risk after prophylaxis. A sensitivity analysis was also conducted to assess the reliability and variability of the results. Results: With a 10% fracture risk reduction, model A costs between $8,850 and $46,940 per quality-adjusted life-year ($/QALY). Additionally, it proved most cost-effective in the age range between 61 and 81 years. The sensitivity analysis established that a reduction of ≥ 2.8% is needed for prophylaxis to be definitely cost-effective. The cost-effectiveness at the secondary prevention level was most sensitive to the cost of the contralateral side's prophylaxis, the patient's age, and fracture treatment cost. For high-risk patients with no fracture history, the cost-effectiveness of a preventive strategy depends on their risk profile. In the baseline analysis, the incremental cost-effectiveness ratio at the primary prevention level varied between $11,000/QALY and $74,000/QALY, which is below the defined willingness to pay threshold. Conclusion: Due to the high cost of hip fracture treatment and its increased morbidity, surgical prophylaxis strategies have demonstrated that they can significantly relieve the healthcare system. Various key assumptions facilitated the modeling, allowing for adequate room for uncertainty. Further research is needed to evaluate health-state-associated risks. [ABSTRACT FROM AUTHOR]

Stopping smoking has proven benefits in nearly all illnesses but the impact and health economic benefits of stopping smoking after a diagnosis of lung cancer are less well defined. We assessed the cost-effectiveness of smoking cessation (SC) services for patients with newly diagnosed lung cancer against current usual care, where patients are unlikely to receive SC service referral. A health economic model was constructed in Excel. The modelled population comprised of patients with a new diagnosis of non–small cell lung cancer (NSCLC). Data from the LungCast data set (Clinical Trials Identifier NCT01192256) were used to estimate model inputs. A structured search of published literature identified inputs not represented in LungCast, including healthcare resource use and costs. Costs were estimated from a 2020/2021 UK National Health Service and Personal Social Services perspective. The model estimated the incremental quality-adjusted life-year (QALY) gained in patients with newly diagnosed NSCLC receiving targeted SC intervention than those receiving no intervention. Extensive one-way sensitivity analyses explored input and data set uncertainty. In the 5-year base case, the model estimated an incremental cost of £14 904 per QALY gained through SC intervention. Sensitivity analysis estimated an outcome range of between £9935 and £32 246 per QALY gained. The model was most sensitive to the estimates of relative quit rates and expected healthcare resource use. This exploratory analysis indicates that SC intervention for smokers with patients with newly diagnosed NSCLC should be a cost-effective use of UK National Health Service resources. Additional research with focused costing is needed to confirm this positioning. • This study is the first to explore the potential cost-effectiveness of targeted SC intervention in currently smoking patients with newly diagnosed non–small cell lung cancer (a high-risk population proven to benefit from quitting smoking). • The LungCast trial (Clinical Trials Identifier NCT01192256) is a real-world data set exploring the prevalence and survival impact of smoking in a cohort of patients with newly diagnosed lung cancer with > 2400 patients tracked for up to 2 years (or until death). • This exploratory analysis can support commissioners in assessing the potential value of investing in dedicated SC services at the point of diagnosis of non–small cell lung cancer. [ABSTRACT FROM AUTHOR]

This study aimed to quantify the association between the loss of health state utilities (LHSU) and obesity, considering different obesity categories. This is relevant to interventions economic evaluations and for public policy decision planning. Using data from the Chilean National Health Survey, this study uses linear regression models and counterfactual scenarios to calculate the prevalent burden, population averages, and total sum of LHSU attributable to obesity for the Chilean national level on people older than 15 years, year 2017. Adjustments for socioeconomic status and associated noncommunicable diseases (NCDs) are considered. Calculating the LHSU using these methods enables the approximation of loss of prevalent quality-adjusted life-years (QALYs). The raw obesity LHSU burden was 9.1% (95% uncertainty interval [UI] 5.1-13). When adjustment is considered, the LHSU attributable to obesity reaches 4.6% (95% UI 0.6-8.5) being responsible for 121 045 prevalent QALYs. Socioeconomic status adjusted analysis of higher body mass index (BMI, in kg/m2) categories of obesity shows a dose-response effect for LHSU, being the BMI ≥ 40 category with the highest population average of attributable LHSU (10.1; 95% UI 5.5-14.5, scale 0 [full health] to 100 [dead]). Burden for BMI ≥ 35 categories showed the biggest change after NCD adjustment. Obesity carries a significant burden of QALY loss. Policy decision-making addressing obesity should focus specially on the BMI ≥ 40 group. NCD comorbidity should be considered for policies addressing the BMI ≥ 35 group. • Studies show that the losses of health state utilities (LHSUs) associated to obesity are in the range 0.6 to 5.0 (anchored from 0 to 100; health to dead, respectively). • Adjusted, the burden of LHSU attributable to obesity is 4.6% (95% uncertainty interval 0.6-8.5). • The LHSU burden and the total prevalent quality-adjusted life-year losses form a "U" shape, where body mass index ≥ 40 and 30 to 35 kg/m2 categories show higher values. • These results support considering different strategies for tackling the obesity public health problem. • The methods used here can contribute to find new ways to make fruitful work with public cross-sectional information at national level. [ABSTRACT FROM AUTHOR]

Abstract Chronic disease can cause tissue and organ damage constituting the largest obstacle to therapy which, in turn, reduces patients’ quality-adjusted life-year. Degenerative diseases such as osteoporosis, Alzheimer’s disease, Parkinson’s disease, and infectious conditions such as hepatitis, cause physical injury to organs. Moreover, damage resulting from chronic conditions such as diabetes can also culminate in the loss of organ function. In these cases, organ transplantation constitutes the therapy of choice, despite the associated problems of immunological rejection, potential disease transmission, and high morbidity rates. Tissue regeneration has the potential to heal or replace tissues and organs damaged by age, disease, or trauma, as well as to treat disabilities. Stem cell use represents an unprecedented strategy for these therapies. However, product availability and mass production remain challenges. A novel therapeutic alternative involving amniotic mesenchymal stem cell metabolite products (AMSC-MP) has been developed using metabolites from stem cells which contain cytokines and growth factors. Its potential role in regenerative therapy has recently been explored, enabling broad pharmacological applications including various gastrointestinal, lung, bladder and renal conditions, as well as the treatment of bone wounds, regeneration and skin aging due to its low immunogenicity and anti-inflammatory effects. The various kinds of growth factors present in AMSC-MP, namely bFGF, VEGF, TGF-β, EGF and KGF, have their respective functions and activities. Each growth factor is formed by different proteins resulting in molecules with various physicochemical properties and levels of stability. This knowledge will assist in the manufacture and application of AMSC-MP as a therapeutic agent.

Introduction: The objective of this study was to evaluate the cost-effectiveness of lisocabtagene maraleucel (liso-cel) versus other available chimeric antigen receptor T-cell therapies, including axicabtagene ciloleucel (axi-cel) and tisagenlecleucel (tisa-cel), in patients who had received at least two prior therapies from a United States (US) commercial third-party payer perspective. Methods: To capture this heterogeneity in survival outcomes, we used mixture cure models to extrapolate progression-free survival (PFS) and overall survival (OS). Patient-level data from TRANSCEND NHL 001 for liso-cel and reconstructed patient-level data from ZUMA-1 for axi-cel, JULIET for tisa-cel, and SCHOLAR-1 for salvage chemotherapy, derived using the Guyot method, were used for OS and PFS. The model included adverse events associated with liso-cel, axi-cel, and tisa-cel. Results: Liso-cel was less costly (incremental cost of − $74,980) and marginally more effective (0.002 incremental quality-adjusted life-years [QALY]) than axi-cel and had an incremental cost of $67,925 and 2.02 incremental QALYs over tisa-cel in the base case. Results remained consistent in sensitivity analyses, with the liso-cel OS cure fraction being the main driver of cost-effectiveness compared with both axi-cel and tisa-cel. Conclusion: This analysis estimated that liso-cel is cost-effective compared with tisa-cel and axi-cel from a commercial US payer perspective. [ABSTRACT FROM AUTHOR]

Chronic disease can cause tissue and organ damage constituting the largest obstacle to therapy which, in turn, reduces patients' quality-adjusted life-year. Degenerative diseases such as osteoporosis, Alzheimer's disease, Parkinson's disease, and infectious conditions such as hepatitis, cause physical injury to organs. Moreover, damage resulting from chronic conditions such as diabetes can also culminate in the loss of organ function. In these cases, organ transplantation constitutes the therapy of choice, despite the associated problems of immunological rejection, potential disease transmission, and high morbidity rates. Tissue regeneration has the potential to heal or replace tissues and organs damaged by age, disease, or trauma, as well as to treat disabilities. Stem cell use represents an unprecedented strategy for these therapies. However, product availability and mass production remain challenges. A novel therapeutic alternative involving amniotic mesenchymal stem cell metabolite products (AMSC-MP) has been developed using metabolites from stem cells which contain cytokines and growth factors. Its potential role in regenerative therapy has recently been explored, enabling broad pharmacological applications including various gastrointestinal, lung, bladder and renal conditions, as well as the treatment of bone wounds, regeneration and skin aging due to its low immunogenicity and anti-inflammatory effects. The various kinds of growth factors present in AMSC-MP, namely bFGF, VEGF, TGF-β, EGF and KGF, have their respective functions and activities. Each growth factor is formed by different proteins resulting in molecules with various physicochemical properties and levels of stability. This knowledge will assist in the manufacture and application of AMSC-MP as a therapeutic agent. [ABSTRACT FROM AUTHOR]

Objectives: This study aims to compare the cost-effectiveness of oral prednisolone and adrenocorticotropic hormone injection in West syndrome patients, the two most common hormonal therapies used for this condition. Materials and Methods: In this prospective and observational study, we documented sociodemographic, epilepsy, and development-related variables at baseline and up to 6 months after starting hormonal therapy, in all consecutive eligible patients of WS between August 2019 and June 2021, apart from the direct medical and non-medical costs and indirect health-care costs. We selected cost per quality-adjusted life-year (QALY) gained, per one patient with spasm freedom, one positive responder (>50% reduction in spasms), one relapse-free patient, and one patient with development gain. We determined whether incremental cost-effectiveness ratio for these parameters crossed the threshold value in base-case analysis and alternate scenario analysis. Results: Out of 52 patients screened, 38 and 13 patients enrolled in ACTH and prednisolone group. On D28, 76% and 71% achieved spasm cessation (P = 0.78) and the total cost of treatment was INR 19783 and 8956 (P = 0.01), in ACTH and prednisolone group respectively. For all pre-specified parameters, the cost/effectiveness ratios including cost/QALY gain were higher in ACTH group and the corresponding ICER values for all these parameters crossed the threshold cost value of INR 148,777 in base-case analysis and also in alternative scenario analysis. Conclusion: Treatment with oral prednisolone is more cost-effective as compared to ACTH injection for children with WS. [ABSTRACT FROM AUTHOR]

Studies on economic evaluations of the 13-valent pneumococcal conjugate vaccine (PCV13) have been increasing over the last decade. No systematic reviews have synthesized the evidence of economic evaluations of the PCV13. We systematically searched the literature which published on peer-reviewed journals from January 2010 to June 2022. The literature search was conducted in the following electronic databases: PubMed, Web of Science, Embase, the Cochrane Library, CNKI, Wanfang database, VIP database. We identified 1827 records from the database search. After excluding 511 duplicates, 1314 records were screened, of which 156 records were retained for the full-text reviews. A total of 44 studies were included in the review. Among the included studies, 33 studies were economic evaluations of PCV13 among children, and 11 studies were conducted among adults. The literature search initiated in April, 2022, and updated in June 2022. Vaccination with PCV13 was found to significantly reduce the mortality and morbidity of pneumococcal diseases and was cost-effective compared to no vaccine or several other pneumococcal vaccines (e.g. PCV10, PPV23). Future research is advised to expand economic evaluations of PCV13 combined with dynamic model to enhance methodologic rigor and prediction accuracy. [ABSTRACT FROM AUTHOR]

Background and objectives: The estimation of a cost- Effectiveness (CE) threshold from the perspective of those who have experienced a lifethreatening disease can provide empirical evidence for health policy makers to make the best allocation decisions on limited resources. The aim of the current study was to empirically determine the CE threshold for cancer interventions from the perspective of cancer patients in Iran. Methods: A composite time trade-off (cTTO) task for deriving quality adjusted life-year (QALY) and a double-bounded dichotomous choice (DBDC) approach followed by open-ended question for examining patients’ willingness-to-pay were performed. A nationally representative sample of 580 cancer patients was recruited from the largest governmental cancer centers in Iran between June 2021 and January 2022, and data were gathered using face-to-face interviews. The CE threshold was calculated using the nonparametric Turnbull model and parametric interval-censored Weibull regression model. Furthermore, the factors that affect the CE threshold were determined using the parametric model. Results: The estimated CE threshold using the nonparametric Turnbull model and parametric interval-censored Weibull regression model was IRR 440,410,000 (USD 10,485.95) and IRR 595,280,000 (USD 14,173.33) per QALY, respectively. Gender, age, education, income, type of cancer, and current treatment status were significantly associated with the estimated CE threshold. Conclusions: The value of parametric model-based threshold in this study was 1.98 times the Iranian GDP per capita, which was lower than the CE threshold value recommended by the WHO (i.e., 3 times the GDP per capita) for low-and middle-income countries. [ABSTRACT FROM AUTHOR]

• Combination chemotherapy with sugemalimab may be cost-effectiveness. • Cost of sugemalimab has a large impact on Markov model results. • Reshaping first-line treatment of lung cancer with sugemalimab in China. Because of its low immunogenicity and associated risk of toxicity, sugemalimab is expected to reshape the first-line treatment landscape for non-small cell lung cancer (NSCLC) in China. However, it remains unclear whether the use of expensive sugemalimab is cost-effective in this population. A Markov model was constructed based on the GEMSTONE-302 study to assess the efficacy of sugemalimab in combination with chemotherapy for first-line treatment of metastatic NSCLC. Efficacy and safety data were entered, with costs and utility values derived from the literature, and incremental cost-effectiveness ratios (ICERs) were estimated, and univariate sensitivity analyses and probabilistic sensitivity analyses were performed. We also considered cost-effectiveness in two different treatment regimen scenarios after disease progression. Compared with the placebo plus platinum-based chemotherapy, patients with metastatic NSCLC treated with sugemalimab plus platinum-based chemotherapy saw an increase of 0.56 life-years (LYs) and 0.41 quality-adjusted life-years (QALYs), and patients with squamous NSCLC resulted in an ICER per QALY of $45,280.02. Patients with nonsquamous metastatic NSCLC resulted in an ICER of $45,294.15 per QALY. Univariate sensitivity analysis showed that disease-free survival utility had the greatest impact on the results. Probabilistic sensitivity analysis (PSA) showed that when the willingness-to-pay (WTP) for QALYs was $27,354/QALY, sugemalimab, in combination with platinum-based chemotherapy, was more cost-effective than the placebo. From a Chinese health care system perspective, first-line treatment of squamous or nonsquamous metastatic NSCLC with sugemalimab plus platinum-based chemotherapy may have cost-effectiveness compared with placebo plus platinum-based chemotherapy at a WTP threshold of $27,354/QALY. [ABSTRACT FROM AUTHOR]

Aim: The cost–effectiveness of treatment options (anticholinergics, β3-adrenoceptor agonists, onabotulinumtoxinA, sacral nerve stimulation and percutaneous tibial stimulation [the latter two including new rechargeable neurostimulators]) for the management of overactive bladder (OAB) were compared with best supportive care (BSC) using a previously published Markov model. Materials & methods: Cost–effectiveness was evaluated over a 15-year time horizon, and sensitivity analyses were performed using 2- and 5-year horizons. Discontinuation rates, resource utilization, and costs were derived from published sources. Results: UsingMedicare and commercial costs over a 15-year time period, onabotulinumtoxinA 100U had incremental cost–effectiveness ratios (ICERs) gained of $39,591/qualityadjusted life-year (QALY) and $42,255/QALY, respectively, versus BSC, which were the lowest ICERs of all assessed treatments. The sensitivity analyses at 2- and 5-year horizons also showed onabotulinumtoxinA to be the most cost-effective of all assessed treatments versus BSC. Conclusion: OnabotulinumtoxinA 100U is currently the most cost-effective treatment for OAB.

Background and objectivesThe estimation of a cost- Effectiveness (CE) threshold from the perspective of those who have experienced a life-threatening disease can provide empirical evidence for health policy makers to make the best allocation decisions on limited resources. The aim of the current study was to empirically determine the CE threshold for cancer interventions from the perspective of cancer patients in Iran.MethodsA composite time trade-off (cTTO) task for deriving quality adjusted life-year (QALY) and a double-bounded dichotomous choice (DBDC) approach followed by open-ended question for examining patients’ willingness-to-pay were performed. A nationally representative sample of 580 cancer patients was recruited from the largest governmental cancer centers in Iran between June 2021 and January 2022, and data were gathered using face-to-face interviews. The CE threshold was calculated using the nonparametric Turnbull model and parametric interval-censored Weibull regression model. Furthermore, the factors that affect the CE threshold were determined using the parametric model.ResultsThe estimated CE threshold using the nonparametric Turnbull model and parametric interval-censored Weibull regression model was IRR 440,410,000 (USD 10,485.95) and IRR 595,280,000 (USD 14,173.33) per QALY, respectively. Gender, age, education, income, type of cancer, and current treatment status were significantly associated with the estimated CE threshold.ConclusionsThe value of parametric model-based threshold in this study was 1.98 times the Iranian GDP per capita, which was lower than the CE threshold value recommended by the WHO (i.e., 3 times the GDP per capita) for low-and middle-income countries.

Objectives: This study aimed to investigate how multicriteria decision analysis (MCDA) could complement cost-effectiveness analysis (CEA) to support investment decisions in elderly care at local level.Methods: We used an integrated elderly care program in The Netherlands as a case study to demonstrate the application of both methods. In a 12-month quasi-experimental study (n = 384), data on the following outcome measures were collected: quality-adjusted life-years (CEA) and physical functioning, psychological well-being, social relationships and participation, enjoyment of life, resilience, person centeredness, continuity of care, and costs (MCDA). We performed regression analysis on inversed probability weighted data and controlled for potential confounders to obtain a double robust estimate of the outcomes. Probabilistic sensitivity analyses determined uncertainty for both methods.Results: The integrated elderly care program was not likely (ie, 36%) to be cost-effective according to the CEA (incremental cost-effectiveness ratios: €88 249 from a societal perspective) using the conventional Dutch willingness-to-pay threshold (ie, €50 000). The MCDA demonstrated that informal caregivers and professionals slightly preferred the intervention over usual care, driven by enjoyment of life and person centeredness. Patients did not prefer either the intervention or usual care, whereas payers and policy makers slightly preferred usual care, mainly due to higher costs of the intervention.Conclusions: MCDA could provide local-level decision makers with a broader measurement of effectiveness by including outcomes beyond health and longevity and the preferences of multiple stakeholders. This additional information could foster the acceptability and implementability of cost-effective innovations in elderly care. [ABSTRACT FROM AUTHOR]

Background: We evaluated the cost-effectiveness of the screening in mainland China for Alzheimer's disease (AD) patients aged over 60. Methods: Individuals in mainland China, received an initial screening by questionnaire on mental state, and those with scores deemed suspicious for AD were referred to diagnostic tests. A 9-state Markov model was developed to simulate the disease progression of a cohort of 100,000 subjects aging from 60 to 80. In addition, several scenarios were analyzed to assess the robustness under different screening frequency, starting age, the duration of drug effects, and the health status of subjects. Results: The ICER of AD screening was 26413.77 USD per QALY [quality-adjusted life-year (QALY)] compared with no screening. The number of deaths and severe AD cases who did not receive treatment averted by screening accounted for 0.076 and 0.006% of the total population, respectively, and the net monetary benefit was 128.29 USD per capita. Under the thresholds of one and three times the gross domestic product per capita, the probability of screening being cost-effective was approximately 18 and 77%, respectively. The ICER decreased to 18132.96USD per QALY when the drug effect was prolonged, and increased when the frequency of screening was increased, the starting age was postponed, and patients suffering from comorbidities were more. However, the number of severe AD cases and deaths declined when the screening frequency increased. Conclusion: Screening for AD in individuals over 60 can reduce the numbers of severe AD cases and deaths and may be cost-effective, depending on factors such as screening frequency, starting age of screening, and duration of drug effects. Additionally, mild cognitive impairment (MCI) is an important stage at which the burden of progression to AD may be reduced and the cost-effectiveness of screening may be improved. [ABSTRACT FROM AUTHOR]

Health-related quality of life is expressed in utilities, also referred to as utility estimates or parameters. Considerations about the source and type of utility values are especially important in a modeling context, where the lack of transparency, including the lack of a hierarchy for utility data sources, is a major issue to any estimation and can potentially compromise model reliability. This document aims to present the first version of the Brazilian guidelines for utility measurement to support economic analysis. A virtual workshop and a modified Delphi panel with 10 health technology specialists followed a rapid evaluation of 110 technical documents and indexed publications. The recommendations are based on the proposition that has received the most votes, although contentious issues are addressed in the suggestion or discussion. The rationale for the final decision is included in the text. The consensus includes 50 recommendations with the following topics: Transparency and Reliability, Model Design, Conditions Under Which Generic Questionnaires Are Not Sensible or Valid, Utility Evidence Hierarchy, Utility Data Searching, Modeling Utility Values, Extrapolating Quality Adjusted Life-Years for Models With Lifetime Horizons, Caregiver Utility, Utility Data Synthesis, Quality/Certainty of the Evidence, and Utility Estimates in End-of-Life Conditions. The goal of this project is to create unified national standards for using utility metrics in economic analysis in Brazil. This set of recommendations is not obligatory, but it is meant to serve as a guide and lead to the development of better and more transparent economic models in the country. [ABSTRACT FROM AUTHOR]

Samuel F Hunter,1 Jas Bindra,2 Ishveen Chopra,3 John Niewoehner,4 Mary P Panaccio,4 George J Wan4 1Advanced Neurosciences Institute, Franklin, TN, USA; 2Falcon Research Group, North Potomac, MD, USA; 3Manticore Consultancy, Bethesda, MD, USA; 4Mallinckrodt Pharmaceuticals, Hampton, NJ, USACorrespondence: George J WanMallinckrodt Pharmaceuticals, 53 I-78 Frontage Road, Hampton, NJ, 08827, USAEmail george.wan@mnk.comBackground: Relapses are common among patients with multiple sclerosis (MS) despite treatment with disease-modifying therapies. Repository corticotropin injection (RCI, Acthar® Gel), plasmapheresis (PMP), and intravenous immunoglobulin (IVIg) are alternative therapies for MS relapse. There is a dearth of economic assessments of these therapies for the acute exacerbations of MS. This study estimated the cost-effectiveness of RCI compared to PMP or IVIg.Methods: A Markov state-transition model compared outcomes (costs, relapses, remission, and utilities) with RCI versus PMP or IVIg for the acute exacerbations in MS. The model was developed from the United States (US) payer and societal perspectives over one to three years. Patients initiated on alternative therapies were evaluated in one-day increments for the first 30 days during treatment. The model assumes the natural history of MS after treatment in the first month, adjusting for the effect of treatment. Incremental cost-effectiveness ratios (ICERs) were estimated as cost per quality-adjusted life-year (QALY) gained. The uncertainty in model parameters was evaluated in probabilistic sensitivity analyses.Results: In the base case, RCI has an ICER of USD 42,078 per QALY compared to PMP over one year from the payer perspective and is dominant over two and three years; RCI is dominant compared to PMP from the societal perspective over all three years. Compared to IVIg, RCI is a dominant strategy from both payer and societal perspectives over all three years. Probabilistic sensitivity analysis supports the base case findings, suggesting that RCI may be cost-effective versus PMP and IVIg for acute exacerbations in MS.Conclusion: RCI is a cost-effective alternative treatment for MS relapses compared to PMP and IVIg from the US payer and societal perspectives.Keywords: Acthar® Gel, cost-effectiveness analysis, acute exacerbation, multiple sclerosis, quality-adjusted life-year, repository corticotropin injection

Objectives: Following protocol, adults value EQ-5D-Y-3L health states from the perspective of a 10-year-old child. It remains unclear why adults value health states differently for themselves than for a 10-year-old child and whether the latter perspective is representative of adults' preferences for the 8 to 15 years age range of the EQ-5D-Y-3L. This study examines the reasons underlying (potential) differences in adults' health-state preferences for themselves, a 10-year-old child, and 15-year-old adolescent.Methods: We conducted semistructured interviews using a think-aloud protocol with 25 participants who performed valuation tasks in July 2020 to August 2020. Using the Framework Method, we developed 28 categories grouped under 5 themes that illustrated the differences emerging from the interviews.Results: Participants (A) deemed it more straining to perform valuation tasks for a 10-year-old child and 15-year-old adolescent than for themselves, (B) had a stable self-image, but varied in whom they imagined as 10-year-old child and 15-year-old adolescent, (C) focused on different dimensions and levels for a 15-year-old adolescent than for a 10-year-old child and themselves, (D) had various thoughts about nonhealth-related factors that influenced their preferences, and (E) gave up relatively few life-years for a 10-year-old child and 15-year-old adolescent, also to avoid others bearing a grudge against them.Conclusions: Our results indicate that differences in adults' health-state preferences for themselves and a 10-year-old child largely result from differences in thoughts about nonhealth-related factors. They further indicate that health-state preferences for a 10-year-old child may not be representative of such preferences for the full EQ-5D-Y-3L age range. [ABSTRACT FROM AUTHOR]

Objectives: The Patient-Reported Outcome Measurement Information System (PROMIS) Preference score (PROPr) can be used to assess health state utility (HSU) and estimate quality-adjusted life-years in cost-effectiveness analyses. It is based on item response theory and promises to overcome limitations of existing HSU scores such as ceiling effects. The PROPr contains 7 PROMIS domains: cognitive abilities, depression, fatigue, pain, physical function, sleep disturbance, and ability to participate in social roles and activities. We aimed to compare the PROPr with the 5-level EQ-5D (EQ-5D-5L) in terms of psychometric properties using data from 3 countries.Methods: We collected PROMIS-29 profile and EQ-5D-5L data from 3 general population samples (United Kingdom = 1509, France = 1501, Germany = 1502). Given that cognition is not assessed by the PROMIS-29, it was predicted by the recommended linear regression model. We compared the convergent validity, known-groups construct validity, and ceiling and floor effects of the PROPr and EQ-5D-5L.Results: The mean PROPr (0.48, 0.53, 0.48; P<.01) and EQ-5D-5L scores (0.82, 0.85, 0.83; P<.01) showed significant differences of similar magnitudes (d = 0.34; d = 0.32; d = 0.35; P<.01) across all samples. The differences were invariant to sex, income, occupation, education, and most conditions but not for age. The Pearson correlation coefficients between both scores were r = 0.74, r = 0.69, and r = 0.72. PROPr's ceiling and floor effects both were minor to moderate. The EQ-5D-5L's ceiling (floor) effects were major (negligible).Conclusions: Both the EQ-5D-5L and the PROPr assessed by the PROMIS-29 show high validity. The PROPr yields considerably lower HSU values than the EQ-5D-5L. Consequences for quality-adjusted life-year measurements should be investigated in future research. [ABSTRACT FROM AUTHOR]

The technological advancement in the field of orthopedics has initiated better healthcare service that equates to the need of cost-effectiveness approach. We propose a model for estimating the simultaneous effect of health and cost involved in an orthopedic surgery implants by using seemingly unrelated regression equations models. The simultaneous equations represent a relationship between the health status of a group of individuals and their expenditures related to the cost of surgical procedure/treatment undertaken in an orthopedic department of a hospital. We define model specification, estimation, and statistical tests in simultaneous equation models. This is further used to estimate the utility function that indeed helps in the computation of quality-adjusted life-year (QALY) values. Using the seemingly unrelated regression equation models for the seasonal data in 2018 and 2019, we have obtained the seasonal QALY values. Furthermore, the measurement of seasonal changes in QALY values is done by using a method of simple averages. We analyze the health conditions in orthopedics by the formation of health and expenditure relationship for the inpatients and outpatients undertaking a treatment. A framework has been setup for computing quality of life-year values by including the direct and the indirect costs. The patient-reported outcome measures are also useful in detecting the change in disease states and important difference in minimal clinical changes that further adds value to the computation of quality of life. • We propose an econometric approach for estimating the simultaneous effect of health and cost by using seemingly unrelated regression equations models. • Quality-adjusted life-year (QALY) is an important metric of health outcome that gives the value of QALYs on the scale of 0 to 1. • Seasonal QALY indices are obtained by expressing the monthly average as a percentage of the QALY values. [ABSTRACT FROM AUTHOR]

Objectives: The EQ Health and Wellbeing Short (EQ-HWB-S) is a new broad generic measure of health and wellbeing for use in economic evaluations of interventions across healthcare, social care, and public health. This measure conceptually overlaps with the 5-level version EQ-5D (EQ-5D-5L), while expanding on the coverage of health and social care related dimensions. This study aims to examine the extent to which the EQ-HWB-S and EQ-5D-5L overlap and are different.Methods: A sample of US-based respondents (n = 903; n = 400 cancer survivors and n = 503 general population) completed a survey administered via an online panel. The survey included the EQ-HWB item pool (62 items, including 11 items used in this analysis), EQ-5D-5L, and questions about sociodemographic and health characteristics. The analysis included (Spearman's) correlations, the comparison of patterns of response (distributions and ceiling effects), and the ability to discriminate between known groups.Results: Moderate to strong associations were found between conceptually overlapping dimensions of the EQ-5D-5L and the EQ-HWB-S (rs > 0.5, P < .001). Among respondents reporting full health on the EQ-5D-5L (n = 161, 18.23%), the EQ-HWB-S identified ceiling effects, particularly with the item "feeling exhausted." Most EQ-5D-5L and EQ-HWB-S items demonstrated discriminative ability among those with and without physical and mental conditions, yielding medium (> 0.5) to large effect sizes (> 0.8). Nevertheless, only EQ-HWB-S items distinguished between caregivers and noncaregivers and those with low and high caregiver burden, albeit with small effect sizes (0.2-0.5).Conclusions: Results indicate a convergence between the measures, especially between overlapping dimensions, lending support to the validity of the EQ-HWB-S. The EQ-HWB-S performed similarly or better than the EQ-5D-5L among patient groups and is better able to differentiate among caregivers and respondents closer to full health. [ABSTRACT FROM AUTHOR]

Objectives: This study aimed to present the face validity and psychometric stages performed in Spanish in Argentina, the only Spanish-speaking country of an international collaboration that undertook the construction of a new measure that can be used in economic evaluation across health, social care, and public health, the EQ EQ-HWB (EQ Health and Wellbeing). We also explored the relationship among 3-level version EQ-5D (EQ-5D-3L), 5-level version EQ-5D (EQ-5D-5L), and EQ-HWB.Methods: Face validity was based on semistructured face to face interviews of a purposive sample to explore translatability of language and concepts of 97 candidate items, translated into Argentina Spanish. The psychometric evaluation using an online panel assessed the psychometric properties of 64 items that were carried forward (floor and ceiling effects, item correlations, known-group differences in relevant prespecified subgroups by the international and local teams, exploratory and confirmatory factor analysis, and item response theory). EQ-5D-3L, EQ-5D-5L, and EQ-HWB correlations were explored.Results: In the face validity stage, 24 interviews with carers, general public, patients, and users of social services were included. Most items showed adequate face validity. In the psychometric assessment, 497 participants were recruited (64% reporting a long-term health condition). Most of the items showed adequate psychometrics in an Argentinian context. EQ-5D-3L and EQ-5D-5L had strong correlations, and EQ-HWB was moderately correlated to EQ visual analog scale. The Argentina team recommended 23 of the final 25 items.Conclusions: The assessment of Spanish items contributed to the overall development of EQ-HWB and helped inform the design of an internationally relevant 25-item and a short 9-item measure intended to be used in economic evaluations. [ABSTRACT FROM AUTHOR]

Objectives: The development of measures such as the EQ-HWB (EQ Health and Wellbeing) requires selection of items. This study explored the psychometric performance of candidate items, testing their validity in patients, social carer users, and carers.Methods: Article and online surveys that included candidate items (N = 64) were conducted in Argentina, Australia, China, Germany, United Kingdom, and the United States. Psychometric assessment on missing data, response distributions, and known group differences was undertaken. Dimensionality was explored using exploratory and confirmatory factor analysis. Poorly fitting items were identified using information functions, and the function of each response category was assessed using category characteristic curves from item response theory (IRT) models. Differential item functioning was tested across key subgroups.Results: There were 4879 respondents (Argentina = 508, Australia = 514, China = 497, Germany = 502, United Kingdom = 1955, United States = 903). Where missing data were allowed, it was low (UK article survey 2.3%; US survey 0.6%). Most items had responses distributed across all levels. Most items could discriminate between groups with known health conditions with moderate to large effect sizes. Items were less able to discriminate across carers. Factor analysis found positive and negative measurement factors alongside the constructs of interest. For most of the countries apart from China, the confirmatory factor analysis model had good fit with some minor modifications. IRT indicated that most items had well-functioning response categories but there was some evidence of differential item functioning in many items.Conclusions: Items performed well in classical psychometric testing and IRT. This large 6-country collaboration provided evidence to inform item selection for the EQ-HWB measure. [ABSTRACT FROM AUTHOR]

Background. Stroke and epilepsy are the most common neurologic conditions affecting individuals. The Short Form Six-Dimension Health Index (SF-6D) is a preference-based measure of health developed to estimate utility values from the SF-36. This study estimated utility values for health states of Nigerian individuals with stroke or epilepsy using the SF-36. Methods. SF-36 responses from 125 and 69 individuals with stroke and persons with epilepsy, respectively, were transformed into health state utility values using the SF-6D algorithm. The Excel program developed by Brazier and colleagues was used to generate the SF-6D utility score estimated using a set of parametric preference weights. The health state utility values were determined using ordinal health state and standard gamble valuation techniques. Results. Mean ( s ) ages of the stroke and epilepsy participants were 63.1 (11) and 39.6 (16) y, respectively. The mean ( s ) utility scores for stroke and epilepsy were 0.52 (0.10) and 0.65 (0.1) for standard gamble and 0.48 (0.13) and 0.68 (0.11), respectively, using the ordinal health state paradigm. The mean ( s ) utility of stroke (female = 0.46 [0.15]; male = 0.50 [0.12]) and epilepsy (female = 0.65 [0.13], male = 0.69 [0.11]) participants were reported. The mean ( s ) annual episodes of seizure was 18.7 (39). Conclusions. To our knowledge, this is the first study to suggest that females with stroke and those with epilepsy considered their health to be poorer than that of their male counterparts. The significance of our findings is that they may be helpful for researchers, policy makers, and clinicians by providing input into economic evaluations to facilitate resource allocation for stroke survivors and people living with epilepsy to improve their health outcomes and reduce the huge burden associated with the conditions., Highlight: We estimated a health state utility value for stroke and epilepsy to aid researchers and public health policy makers in conducting health economic analysis and outcomes research., (© The Author(s) 2024.)

Objectives: Patients waking up with stroke symptoms are often excluded from intravenous thrombolysis with alteplase (IV-tpa). The WAKE-UP trial, a European multicenter randomized controlled trial, proved the clinical effectiveness of magnetic resonance imaging-guided IV-tpa for these patients. This analysis aimed to assess the cost-effectiveness of the intervention compared to placebo.Methods: A Markov model was designed to analyze the cost-effectiveness over a 25-year time horizon. The model consisted of an inpatient acute care phase and a rest-of-life phase. Health states were defined by the modified Rankin Scale (mRS). Initial transition probabilities to mRS scores were based on WAKE-UP data and health state utilities on literature search. Costs were based on data from the University Medical Center Hamburg-Eppendorf, literature, and expert opinion. Incremental costs and effects over the patients' lifetime were estimated. The analysis was conducted from a formal German healthcare perspective. Univariate and probabilistic sensitivity analyses were performed.Results: Treatment with IV-tpa resulted in cost savings of €51 009 and 1.30 incremental gains in quality-adjusted life-years at a 5% discount rate. Univariate sensitivity analysis revealed incremental cost-effectiveness ratio being sensitive to the relative risk of favorable outcome on mRS for placebo patients after stroke, the costs of long-term care for patients with mRS 4, and patient age at initial stroke event. In all cases, IV-tpa remained cost-effective. Probabilistic sensitivity analysis proved IV-tpa cost-effective in >95% of the simulations results.Conclusions: Magnetic resonance imaging-guided IV-tpa compared to placebo is cost-effective in patients with ischemic stroke with unknown time of onset. [ABSTRACT FROM AUTHOR]

Objectives: Tofacitinib is an oral, small molecule Janus kinase (JAK) inhibitor for the treatment of ulcerative colitis (UC). This study assessed the cost-effectiveness of tofacitinib versus other available treatments for patients with moderate to severe UC following an inadequate response to conventional treatment and who are either naïve to or have failed previous biologics in Germany. Methods: A Markov cohort model was developed to evaluate the differences in long-term costs and outcomes between tofacitinib and its comparators from the perspective of German statutory health insurance (SHI) for patients either naïve or exposed to biologics. Tofacitinib was compared to infliximab, infliximab biosimilar, adalimumab, adalimumab biosimilar, golimumab, vedolizumab, ustekinumab, and conventional therapy. Health states modeled were remission, treatment response, active UC, and post-colectomy. Patients not responding to treatment could switch to a different treatment. Treatment efficacy for induction and maintenance phases were assessed by a systematic literature review (SLR) and network meta-analysis (NMA). The model included costs associated with drug administration, adverse events, and medical resource use. Extensive deterministic and probabilistic sensitivity analyses (DSA and PSA) were conducted. Results: Over a life-time horizon, patients treated with tofacitinib gained 0.035-0.083 quality-adjusted life-years (QALYs) and had direct cost savings to the SHI of e4,228-e17,184 compared to biologic treatments other than adalimumab biosimilar. When compared to adalimumab biosimilar, treatment with tofacitinib resulted in an incremental cost-effectiveness ratio (ICER) of e17,497 per QALY gained and can be considered a cost-effective alternative. Compared with conventional therapy, tofacitinib resulted in a lower ICER than all other biologics. The DSA showed that the model results were most influenced by differences in treatment efficacy. The PSA suggested confidence in the base-case results considering uncertainty around parameters. Conclusions: The results of this economic model suggest tofacitinib is a cost-effective treatment option for patients with moderate to severe UC in Germany. [ABSTRACT FROM AUTHOR]

PurposeDipeptidylpeptidase-4 (DPP-4) inhibitors, including linagliptin, alogliptin, saxagliptin, sitagliptin, and vildagliptin, are used for the treatment of type 2 diabetes mellitus (T2DM) patients in China. This study assessed the economic outcomes of different DPP-4 inhibitors in patients with T2DM inadequately controlled with metformin in the Chinese context.Materials and MethodsIn this study, the validated Chinese Outcomes Model for T2DM (COMT) was conducted to project economic outcomes from the perspective of Chinese healthcare service providers. Efficacy and safety, medical expenditure, and utility data were derived from the literature, which were assigned to model variables. The primary outputs of the model included the lifetime costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio (ICER). One-way and probability sensitivity analysis was conducted to assess the potential uncertainties of parameters.ResultsOf the five competing strategies, alogliptin 25 mg strategy yielded the most significant health outcome, which associated with improvements in discounted QALY of 0.007, 0.014, 0.011, and 0.022 versus linagliptin 5 mg, saxagliptin 5 mg, sitagliptin 100 mg and vildagliptin50 mg, respectively. The sitagliptin 100 mg strategy was the cheapest option. The ICER of alogliptin 25 mg against sitagliptin 100 mg strategy was $6,952 per additional QALY gained, and the rest of the strategies were dominated or extended dominated. The most influential parameters were the cost of DPP-4 inhibitors and their treatment efficacy.ConclusionsThese results suggested that alogliptin was a preferred treatment option compared with other DPP-4 inhibitors for Chinese patients whose T2DM are inadequately controlled on metformin monotherapy.

Purpose: Dipeptidylpeptidase-4 (DPP-4) inhibitors, including linagliptin, alogliptin, saxagliptin, sitagliptin, and vildagliptin, are used for the treatment of type 2 diabetes mellitus (T2DM) patients in China. This study assessed the economic outcomes of different DPP-4 inhibitors in patients with T2DM inadequately controlled with metformin in the Chinese context. Materials and Methods: In this study, the validated Chinese Outcomes Model for T2DM (COMT) was conducted to project economic outcomes from the perspective of Chinese healthcare service providers. Efficacy and safety, medical expenditure, and utility data were derived from the literature, which were assigned to model variables. The primary outputs of the model included the lifetime costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio (ICER). One-way and probability sensitivity analysis was conducted to assess the potential uncertainties of parameters. Results: Of the five competing strategies, alogliptin 25 mg strategy yielded the most significant health outcome, which associated with improvements in discounted QALY of 0.007, 0.014, 0.011, and 0.022 versus linagliptin 5 mg, saxagliptin 5 mg, sitagliptin 100 mg and vildagliptin50 mg, respectively. The sitagliptin 100 mg strategy was the cheapest option. The ICER of alogliptin 25 mg against sitagliptin 100 mg strategy was $6,952 per additional QALY gained, and the rest of the strategies were dominated or extended dominated. The most influential parameters were the cost of DPP-4 inhibitors and their treatment efficacy. Conclusions: These results suggested that alogliptin was a preferred treatment option compared with other DPP-4 inhibitors for Chinese patients whose T2DM are inadequately controlled on metformin monotherapy. [ABSTRACT FROM AUTHOR]

Objectives: To develop a cancer-specific multi-attribute utility instrument derived from the Functional Assessment of Cancer Therapy - General (FACT-G) health-related quality of life (HRQL) questionnaire.Methods: We derived a descriptive system based on a subset of the 27-item FACT-G. Item selection was informed by psychometric analyses of existing FACT-G data (n = 6912) and by patient input (n = 82). We then conducted an online valuation survey, with participants recruited via an Australian general population online panel. A discrete choice experiment (DCE) was used, with attributes being the HRQL dimensions of the descriptive system and survival duration, and 16 choice-pairs per participant. Utility decrements were estimated with conditional logit and mixed logit modeling.Results: Eight HRQL dimensions were included in the descriptive system: pain, fatigue, nausea, sleep, work, social support, sadness, and future health worry; each with 5 levels. Of 1737 panel members who accessed the valuation survey, 1644 (95%) completed 1 or more DCE choice-pairs and were included in analyses. Utility decrements were generally monotonic; within each dimension, poorer HRQL levels generally had larger utility decrements. The largest utility decrements were for the highest levels of pain (-0.40) and nausea (-0.28). The worst health state had a utility of -0.54, considerably worse than dead.Conclusions: A descriptive system and preference-based scoring approach were developed for the FACT-8D, a new cancer-specific multi-attribute utility instrument derived from the FACT-G. The Australian value set is the first of a series of country-specific value sets planned that can facilitate cost-utility analyses based on items from the FACT-G and related FACIT questionnaires containing FACT-G items. [ABSTRACT FROM AUTHOR]

Manabu Akazawa,1 Ataru Igarashi,2 Nozomi Ebata,3 Tatsunori Murata,4 Shigeki Zeniya,4 Yuri Haga,5 Kazutaka Nozawa,3 Koichi Fujii,3 Toshihiko Taguchi6 1Public Health and Epidemiology, Meiji Pharmaceutical University, Tokyo, Japan; 2Health Economics and Outcomes Research, Graduate School of Pharmaceutical Sciences, The University of Tokyo, Tokyo, Japan; 3Medical Affairs, Pfizer Japan Inc., Tokyo, Japan; 4CRECON Medical Assessment Inc., Tokyo, Japan; 5Clinical Research Division, Clinical Study Support, Inc., Nagoya, Japan; 6Yamaguchi Rosai Hospital, Yamaguchi, JapanCorrespondence: Nozomi EbataMedical Affairs, Pfizer Japan Inc., 3-22-7 Yoyogi, Shibuya-ku, Tokyo 151-8589 JapanTel +81 3 80 3393 0745Fax +81 3 5309 9198Email nozomi.ebata@pfizer.comPurpose: To evaluate the cost-effectiveness of pregabalin versus other analgesics among patients with chronic cervical pain with neuropathic components during routine clinical practice in Japan.Patients and methods: The analysis considered patients with chronic cervical pain with a neuropathic pain component (radiating pain to the upper limb) and who were treated with pregabalin with or without other analgesics (pregabalin-containing treatments) or other analgesics alone (usual care) for 8 weeks. Other analgesics included non-steroidal anti-inflammatory drugs (NSAIDs), weak opioids, antidepressants, and antiepileptic drugs. A Markov cohort simulation model was constructed to estimate costs and effectiveness (in terms of quality-adjusted life-years, QALYs) of each treatment over a 12-month time horizon. In the model, patients transitioned among three states of pain severity (no/mild, moderate, and severe). Data were derived from a previous observational study (pregabalin-containing treatments, n = 138; usual care, n = 211). Cost inputs included medical costs and productivity losses. QALYs were calculated using the EuroQol five-dimensional, five-level questionnaire. The cost-effectiveness was evaluated using incremental cost-effectiveness ratios (ICERs). Sensitivity analyses were conducted to assess the robustness of results.Results: From the payer’s perspective, pregabalin-containing treatments were more costly (JPY 61,779 versus JPY 26,428) but also more effective (0.763 QALYs versus 0.727 QALYs) than the usual care, with an ICER of JPY 970,314 per QALY gained. From the societal perspective, which also included productivity losses, the ICER reduced to JPY 458,307 per QALY gained. One-way sensitivity analyses demonstrated the robustness of the results. Given a hypothetical threshold value of one additional QALY of JPY 5,000,000, the probability of pregabalin-containing treatments being cost-effective was 100%.Conclusion: Compared with using other analgesics alone, the use of pregabalin, alone or in addition to other analgesics, was cost-effective for the treatment of chronic cervical pain with a neuropathic pain component in Japan.Keywords: neuropathic pain, quality-adjusted life-year, incremental cost-effectiveness ratio, health economics

Background: Cataract surgery is one of the most common operations. Femtosecond laser-assisted cataract surgery (FLACS) is a technique that automates a number of operative steps. Objectives: To compare FLACS with phacoemulsification cataract surgery (PCS). Design: Multicentre, outcome-masked, randomised controlled non-inferiority trial. Setting: Three collaborating NHS hospitals. Participants: A total of 785 patients with age-related cataract in one or both eyes were randomised between May 2015 and September 2017. Intervention: FLACS (n = 392 participants) or PCS (n = 393 participants). Main outcome measures: The primary outcome was uncorrected distance visual acuity in the study eye after 3 months, expressed as the logarithm of the minimum angle of resolution (logMAR): 0.00 logMAR (or 6/6 if expressed in Snellen) is normal (good visual acuity). Secondary outcomes included corrected distance visual acuity, refractive outcomes (within 0.5 dioptre and 1.0 dioptre of target), safety and patient-reported outcome measures at 3 and 12 months, and resource use. All trial follow-ups were performed by optometrists who were masked to the trial intervention. Results: A total of 353 (90%) participants allocated to the FLACS arm and 317 (81%) participants allocated to the PCS arm attended follow-up at 3 months. The mean uncorrected distance visual acuity was similar in both treatment arms [0.13 logMAR, standard deviation 0.23 logMAR, for FLACS, vs. 0.14 logMAR, standard deviation 0.27 logMAR, for PCS, with a difference of –0.01 logMAR (95% confidence interval –0.05 to 0.03 logMAR; p = 0.63)]. The mean corrected distance visual acuity values were again similar in both treatment arms (–0.01 logMAR, standard deviation 0.19 logMAR FLACS vs. 0.01 logMAR, standard deviation 0.21 logMAR PCS; p = 0.34). There were two posterior capsule tears in the PCS arm. There were no significant differences between the treatment arms for any secondary outcome at 3 months. At 12 months, the mean uncorrected distance visual acuity was 0.14 logMAR (standard deviation 0.22 logMAR) for FLACS and 0.17 logMAR (standard deviation 0.25 logMAR) for PCS, with a difference between the treatment arms of –0.03 logMAR (95% confidence interval –0.06 to 0.01 logMAR; p = 0.17). The mean corrected distance visual acuity was 0.003 logMAR (standard deviation 0.18 logMAR) for FLACS and 0.03 logMAR (standard deviation 0.23 logMAR) for PCS, with a difference of –0.03 logMAR (95% confidence interval –0.06 to 0.01 logMAR; p = 0.11). There were no significant differences between the arms for any other outcomes, with the exception of the mean binocular corrected distance visual acuity with a difference of –0.02 logMAR (95% confidence interval –0.05 to 0.00 logMAR) (p = 0.036), which favoured FLACS. There were no significant differences between the arms for any health, social care or societal costs. For the economic evaluation, the mean cost difference was £167.62 per patient higher for FLACS (95% of iterations between –£14.12 and £341.67) than for PCS. The mean QALY difference (FLACS minus PCS) was 0.001 (95% of iterations between –0.011 and 0.015), which equates to an incremental cost-effectiveness ratio (cost difference divided by QALY difference) of £167,620. Limitations: Although the measurement of outcomes was carried out by optometrists who were masked to the treatment arm, the participants were not masked. Conclusions: The evidence suggests that FLACS is not inferior to PCS in terms of vision after 3 months’ follow-up, and there were no significant differences in patient-reported health and safety outcomes after 12 months’ follow-up. In addition, the statistically significant difference in binocular corrected distance visual acuity was not clinically significant. FLACS is not cost-effective. Future work: To explore the possible differences in vision in patients without ocular co-pathology. Trial registration: Current Controlled Trials ISRCTN77602616. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 6. See the NIHR Journals Library website for further project information. Moorfields Eye Charity (grant references GR000233 and GR000449 for the endothelial cell counter and femtosecond laser used).

Antihypertensive drug treatment is cost-effective for adults at high risk of developing cardiovascular disease (CVD). However, the cost-effectiveness in people with stage 1 hypertension (140-159 mm Hg systolic blood pressure) at lower CVD risk remains unclear. The objective was to establish the 10-year CVD risk threshold where initiating antihypertensive drug treatment for primary prevention in adults, with stage 1 hypertension, becomes cost-effective. A lifetime horizon Markov model compared antihypertensive drug versus no treatment, using a UK National Health Service perspective. Analyses were conducted for groups ranging between 5% and 20% 10-year CVD risk. Health states included no CVD event, CVD and non-CVD death, and 6 nonfatal CVD morbidities. Interventions were compared using cost-per-quality-adjusted life-years. The base-case age was 60, with analyses repeated between ages 40 and 75. The model was run separately for men and women, and threshold CVD risk assessed against the minimum plausible risk for each group. Treatment was cost-effective at 10% CVD risk for both sexes (incremental cost-effectiveness ratio £10 017/quality-adjusted life-year [$14 542] men, £8635/QALY [$12 536] women) in the base-case. The result was robust in probabilistic and deterministic sensitivity analyses but was sensitive to treatment effects. Treatment was cost-effective for men regardless of age and women aged >60. Initiating treatment in stage 1 hypertension for people aged 60 is cost-effective regardless of 10-year CVD risk. For other age groups, it is also cost-effective to treat regardless of risk, except in younger women. [ABSTRACT FROM AUTHOR]

Introduction: Many patients with major depressive disorder (MDD) do not achieve remission with their first antidepressant (AD), resulting in a high burden due to treatment failure. Vortioxetine is a valid treatment option for patients with MDD only partially responding to their first AD. Characterization of vortioxetine's potential benefits versus other approved treatments is important. Areas covered: The cost-effectiveness of vortioxetine, including cognitive outcomes, was modeled in comparison with levomilnacipran and vilazodone for patients switched to these medications after inadequate responses to a first AD. Expert opinion: Vortioxetine was associated with incremental quality-adjusted life-year (QALY) gains versus levomilnacipran (0.008) or vilazodone (0.009). Vortioxetine was dominant versus levomilnacipran and cost-effective versus vilazodone (incremental cost-effectiveness ratio [ICER],33,829 USD/QALY). In sensitivity analyses using residual cognitive dysfunction rates (vortioxetine, 49%; levomilnacipran, 58%, and vilazodone, 64%), incremental QALY gains for vortioxetine versus levomilnacipran (0.0085) or vilazodone (0.0109) were found. Vortioxetine remained dominant versus levomilnacipran and cost-effective versus vilazodone (ICER, 27,633 USD/QALY). ICER reduction was found with cognition outcomes inclusion. This model provides additional support for considering vortioxetine for patients requiring a switch of MDD treatments, although its conclusions are limited by the data available for inclusion. Additional research and real-world trials are needed to confirm the findings. [ABSTRACT FROM AUTHOR]

Background: The lack of a value set allowing the calculation of QALY is an important limitation when establishing the value of emerging therapies to treat food allergy. The aim of this study was to develop a Short‐Form Six‐Dimension version 2 (SF‐6Dv2) preference value set for the calculation of health utility from the Canadian food‐allergic population. Methods: Two hundred ninety‐five parents of patients aged 0‐17 years old and 154 patients aged 12 years old and above with food allergy were recruited in clinic and online. Participants were asked to complete a self‐administered online questionnaire including generic health‐related quality of life questionnaires. Various health states described by the SF‐6Dv2 were valued with time‐trade‐off and discrete choice experiments. Data from elicitation techniques were combined using the hybrid regression model. Results: A total of 241 parents and 125 patients performed 3904 time‐trade‐off and 5112 discrete choice experiments. Utility decrements were estimated for each level of each SF‐6Dv2 dimension. Utility values calculated based on the validated preference set were in average 0.15 lower (95%CI: 0.12‐0.18) and were poorly correlated (R2 = 0.46) with those derived from the EQ‐5D‐5L generic questionnaire in the same cohort. Conclusion: A representative preference value set for patients with food allergy was determined using the SF‐6Dv2 generic questionnaire. This adapted preference set will contribute to improve the validity of future utility estimates in this population for the appraisal of upcoming potentially impactful but sometimes costly therapies. [ABSTRACT FROM AUTHOR]

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Objective: To analyze the health-related quality of life (HRQoL) and survival of real-world prostate cancer (PC) patients and to calculate quality-adjusted life-years (QALYs) experienced under different treatment strategies. Materials and Methods: PC patients undergoing active surveillance (n = 226), radiation treatment (n = 280), surgery (n = 299), or hormonal treatment (n = 62) responded to the generic 15-dimensional (15D) HRQoL questionnaire at the time of the diagnosis and were followed up 3, 6, 12, and 24 months later. QALYs experienced during the follow-up were calculated for each treatment group, and variables associated with survival were analyzed using Cox proportional hazards models. Results: HRQoL was stable during the first 2 years after diagnosis in all other treatment groups, except in patients treated with hormonal therapy. The overall survival within 6.5-year follow-up time was 84.4%. The number of QALYs experienced during the 2-year follow-up was similar in patients in active surveillance (1.790), surgery (1.784), and radiation groups (1.767), but significantly lower in the hormonal therapy group (1.665). Conclusions: Patients receiving hormonal treatment had significantly impaired HRQoL and survival compared with other treatments. Although the number of QALYs experienced was similar in the 3 other treatment lines, there were marked differences between treatment lines on some 15D dimensions. [ABSTRACT FROM AUTHOR]