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OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
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Calidad de Vida , Valor de la Vida , Humanos , Análisis Costo-Beneficio , Años de Vida Ajustados por Calidad de Vida , Asignación de Recursos/métodosRESUMEN
OBJECTIVES: The objective of this Prospective Register of Systematic Reviews (CRD42022384192) registered systematic review and meta-analysis was to determine whether prophylactic peritoneal dialysis (PD) catheter insertion at the time of pediatric cardiac surgery is associated with improved short-term outcomes. DATA SOURCES: Databases search of the MEDLINE, EMBASE, CINAHL, and Cochrane Library completed in April 2021 and updated October 2023. STUDY SELECTION: Two reviewers independently completed study selection, data extraction, and bias assessment. Inclusion criteria were randomized controlled trials (RCTs) and observational studies of children (≤ 18 yr) undergoing cardiac surgery with cardiopulmonary bypass. We evaluated use of prophylactic PD catheter versus not. DATA EXTRACTION: The primary outcome was in-hospital mortality, as well as secondary short-term outcomes. Pooled random-effect meta-analysis odds ratio with 95% CI are reported. DATA SYNTHESIS: Seventeen studies met inclusion criteria, including four RCTs. The non-PD catheter group received supportive care that included diuretics and late placement of PD catheters in the ICU. Most study populations included children younger than 1 year and weight less than 10 kg. Cardiac surgery was most commonly used for arterial switch operation. In-hospital mortality was reported in 13 studies; pooled analysis showed no association between prophylactic PD catheter placement and in-hospital mortality. There were mixed results for ICU length of stay and time to negative fluid balance, with some studies showing shortened duration associated with use of prophylactic PD catheter insertion and others showing no difference. Overall, the studies had high risk for bias, mainly due to small sample size and lack of generalizability. CONCLUSIONS: In this meta-analysis, we have failed to demonstrate an association between prophylactic PD catheter insertion in children and infants undergoing cardiac surgery and reduced in-hospital mortality. Other relevant short-term outcomes, including markers of fluid overload, require further study.
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Procedimientos Quirúrgicos Cardíacos , Mortalidad Hospitalaria , Diálisis Peritoneal , Niño , Preescolar , Humanos , Lactante , Recién Nacido , Procedimientos Quirúrgicos Cardíacos/efectos adversos , Diálisis Peritoneal/métodos , Complicaciones Posoperatorias/prevención & control , Complicaciones Posoperatorias/epidemiología , AdolescenteRESUMEN
We explored how investments in housing for vulnerable populations (including those experiencing homelessness) are described as leading to cost containment for the health, justice, and social service systems; the nature of any costs and benefits; and variations by housing type and over time. A structured search of peer-reviewed academic research focused on the core concepts of economic benefit, public housing programs, and vulnerable populations. Findings from 42 articles reporting on cost containment specific to health, justice, and social service systems at the municipal, regional, and/or state/provincial level were synthesized. Most of the studies focused on supportive housing interventions, targeted adults (mainly men) experiencing chronic homelessness in the USA, and reported results over 1-5 years. Approximately half of the articles reported on the costs required to house vulnerable populations. About half reported on funding sources, which is critical information for leadership decisions in cost containment for supportive housing. Most of the studies assessing program cost or cost-effectiveness reported a reduction in service costs and/or greater cost-effectiveness. Studies mostly reported impacts on health services, with hospital/inpatient care and emergency service use typically decreasing across the intervention types. All the studies that assessed cost impacts on the justice system reported a decrease in expenditures. Housing vulnerable populations was also found to decrease shelter service use and engagement with the foster care/welfare systems. Housing interventions may offer cost-savings in the short- and medium-term, with a limited evidence base also demonstrating long term benefit.
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Vivienda , Personas con Mala Vivienda , Adulto , Femenino , Humanos , Masculino , Gastos en Salud , Servicio Social , Poblaciones VulnerablesRESUMEN
Gene expression profiling (GEP) testing using 12-gene recurrence score (RS) assay (EndoPredict®), 58-gene RS assay (Prosigna®), and 21-gene RS assay (Oncotype DX®) is available to aid in chemotherapy decision-making when traditional clinicopathological predictors are insufficient to accurately determine recurrence risk in women with axillary lymph node-negative, hormone receptor-positive, and human epidermal growth factor-receptor 2-negative early-stage breast cancer. We examined the cost-effectiveness of incorporating these assays into standard practice. A decision model was built to project lifetime clinical and economic consequences of different adjuvant treatment-guiding strategies. The model was parameterized using follow-up data from a secondary analysis of the Anastrozole or Tamoxifen Alone or Combined randomized trial, cost data (2017 Canadian dollars) from the London Regional Cancer Program (Canada) and secondary Canadian sources. The 12-gene, 58-gene, and 21-gene RS assays were associated with cost-effectiveness ratios of $36,274, $48,525, and $74,911/quality-adjusted life year (QALY) gained and resulted in total gains of 379, 284.3, and 189.5 QALYs/year and total budgets of $12.9, $14.2, and $16.6 million/year, respectively. The total expected-value of perfect information about GEP assays' utility was $10.4 million/year. GEP testing using any of these assays is likely clinically and economically attractive. The 12-gene and 58-gene RS assays may improve the cost-effectiveness of GEP testing and offer higher value for money, although prospective evidence is still needed. Comparative field evaluations of GEP assays in real-world practice are associated with a large societal benefit and warranted to determine the optimal and most cost-effective assay for routine use.
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Neoplasias de la Mama/tratamiento farmacológico , Neoplasias de la Mama/genética , Quimioterapia Adyuvante/métodos , Análisis Costo-Beneficio/métodos , Perfilación de la Expresión Génica/métodos , Neoplasias de la Mama/economía , Quimioterapia Adyuvante/economía , Femenino , Perfilación de la Expresión Génica/economía , Humanos , Cadenas de Markov , Invasividad Neoplásica/genéticaRESUMEN
In July 2018, the UK Minister of Public Health announced that human papillomavirus vaccination would be extended to 12-year-old boys. This decision was informed by updated evidence from the Joint Committee on Vaccination and Immunisation (JCVI) published earlier that month. Vaccination of boys had been found not to be cost-effective in a series of analyses conducted for the JCVI, including the most recent assessment prior to the minister's announcement. These analyses were conducted under the standard methods for cost-effectiveness analysis recommended by the JCVI, which are primarily based on guidelines from the National Institute of Health and Care Excellence. Although the JCVI concluded they were unable to advise extending vaccination on the basis of standard appraisal methods, their most recent round of assessment also considered analyses using nonstandard appraisal methods. In particular, the JCVI noted that vaccination of boys was likely to be cost-effective when a lower discount rate of 1.5% is applied to costs and health effects, as opposed to the 3.5% rate usually employed. The JCVI stated that they were supportive of applying such alternative methods, and on this basis, they would advise extending vaccination to boys. This commentary explains the JCVI's application of nonstandard appraisal methods and considers whether it was justified. We conclude that the JCVI was not justified in applying the lower discount rate. We voice concerns that a willingness to endorse a politically popular intervention may have driven the JCVI to depart from a fair and consistent application of healthcare rationing.
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Infecciones por Papillomavirus/economía , Infecciones por Papillomavirus/prevención & control , Vacunas contra Papillomavirus/administración & dosificación , Vacunas contra Papillomavirus/economía , Vacunación/economía , Vacunación/normas , Niño , Análisis Costo-Beneficio , Asignación de Recursos para la Atención de Salud , Humanos , Masculino , Modelos Económicos , Guías de Práctica Clínica como Asunto , Años de Vida Ajustados por Calidad de Vida , Medicina Estatal , Reino UnidoRESUMEN
OBJECTIVES: This paper introduces a framework with which to conceptualize the decision-making process in health technology assessment for new interventions with high budgetary impacts. In such circumstances, the use of a single threshold based on the marginal productivity of the healthcare system is inappropriate. The implications of this for potential partial implementation, horizontal equity, and pharmaceutical pricing are illustrated using this framework. RESULTS: Under the condition of perfect divisibility and given an objective of maximizing health, a large budgetary impact of a new treatment may imply that optimal implementation is partial rather than full, even at a given incremental cost-effectiveness ratio that would nevertheless mean the decision to accept the treatment in full would not lead to a net reduction in health. In a one-shot price-setting game, this seems to give rise to potential horizontal equity concerns. When the assumption of fixity of the incremental cost-effectiveness ratio (arising from the assumed exogeneity of the manufacturer's price) is relaxed, it can be shown that the threat of partial implementation may be sufficient to give rise to an incremental cost-effectiveness ratio at which cost the entire potential population is treated, maximizing health at an increased level, and with no contravention of the horizontal equity principle.
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Costos y Análisis de Costo/métodos , Toma de Decisiones , Medicamentos bajo Prescripción/economía , Evaluación de la Tecnología Biomédica/métodos , Presupuestos , Análisis Costo-Beneficio , Costos y Análisis de Costo/normas , Humanos , Modelos Económicos , Años de Vida Ajustados por Calidad de Vida , Medicina Estatal , Reino UnidoRESUMEN
INTRODUCTION: Enzalutamide (Enza) is an effective treatment for metastatic castrate-resistant prostate cancer (mCPRC). However, Enza is not cost-effective (CE) at willingness to pay (WTP) thresholds from $0-$125 000/quality adjusted life years (QALYs) and is therefore a strain on valuable health care dollars. Metformin (Met) is inexpensive (~$8.00/month) and is thought to improve prostate cancer specific and overall survival compared to those not taking Met. We hypothesized that there must be an added effect Met could provide that would make Enza CE thereby alleviating this financial strain on government health care budgets. MATERIALS AND METHODS: We constructed a Markov model and performed a threshold analysis to narrow in on the added effect needed to make such a combination therapy cost-effective at various WTP thresholds. RESULTS: At a WTP threshold of $50 000/QALY Enza + Met is unlikely to be CE unless it increases Enza's efficacy by more than 30%. At a WTP threshold of $100 000, Enza + Met could be CE barring Met adds 18.73% to the efficacy of Enza. CONCLUSIONS: Enza + Met is unlikely to be CE at WTP thresholds less than $100 000/QALY; these results make sense because a therapy that is not CE at these WTP thresholds by itself is unlikely to be CE with an adjuvant therapy that keep a patient on such a treatment for even longer. Finally, our model suggests that the mCRPC setting is not the optimal place to trial adding Met as the relative costs are high and utility values low.
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Antineoplásicos/uso terapéutico , Metformina/uso terapéutico , Feniltiohidantoína/análogos & derivados , Neoplasias de la Próstata Resistentes a la Castración/tratamiento farmacológico , Antineoplásicos/economía , Benzamidas , Análisis Costo-Beneficio , Quimioterapia Combinada/economía , Humanos , Masculino , Cadenas de Markov , Metformina/economía , Nitrilos , Feniltiohidantoína/economía , Feniltiohidantoína/uso terapéutico , Neoplasias de la Próstata Resistentes a la Castración/economía , Neoplasias de la Próstata Resistentes a la Castración/secundario , Neoplasias de la Próstata Resistentes a la Castración/terapia , Resultado del TratamientoRESUMEN
BACKGROUND: Due to high survival rates and the relatively small benefit of adjuvant therapy, the application of personalized medicine (PM) through risk stratification is particularly beneficial in early breast cancer (BC) to avoid unnecessary harms from treatment. The new 21-gene assay (OncotypeDX, ODX) is a promising prognostic score for risk stratification that can be applied in conjunction with Adjuvant!Online (AO) to guide personalized chemotherapy decisions for early BC patients. Our goal was to evaluate risk-group specific cost effectiveness of adjuvant chemotherapy for women with early stage BC in Austria based on AO and ODX risk stratification. METHODS: A previously validated discrete event simulation model was applied to a hypothetical cohort of 50-year-old women over a lifetime horizon. We simulated twelve risk groups derived from the joint application of ODX and AO and included respective additional costs. The primary outcomes of interest were life-years gained, quality-adjusted life-years (QALYs), costs and incremental cost-effectiveness (ICER). The robustness of results and decisions derived were tested in sensitivity analyses. A cross-country comparison of results was performed. RESULTS: Chemotherapy is dominated (i.e., less effective and more costly) for patients with 1) low ODX risk independent of AO classification; and 2) low AO risk and intermediate ODX risk. For patients with an intermediate or high AO risk and an intermediate or high ODX risk, the ICER is below 15,000 EUR/QALY (potentially cost effective depending on the willingness-to-pay). Applying the AO risk classification alone would miss risk groups where chemotherapy is dominated and thus should not be considered. These results are sensitive to changes in the probabilities of distant recurrence but not to changes in the costs of chemotherapy or the ODX test. CONCLUSIONS: Based on our modeling study, chemotherapy is effective and cost effective for Austrian patients with an intermediate or high AO risk and an intermediate or high ODX risk. In other words, low ODX risk suggests chemotherapy should not be considered but low AO risk may benefit from chemotherapy if ODX risk is high. Our analysis suggests that risk-group specific cost-effectiveness analysis, which includes companion prognostic tests are essential in PM.
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Neoplasias de la Mama/tratamiento farmacológico , Neoplasias de la Mama/epidemiología , Análisis Costo-Beneficio , Recurrencia Local de Neoplasia/tratamiento farmacológico , Austria , Neoplasias de la Mama/genética , Neoplasias de la Mama/patología , Quimioterapia Adyuvante/métodos , Terapia Combinada/economía , Femenino , Regulación Neoplásica de la Expresión Génica/genética , Humanos , Proteínas de Neoplasias/genética , Recurrencia Local de Neoplasia/genética , Recurrencia Local de Neoplasia/patología , Estadificación de Neoplasias , Medicina de Precisión , Pronóstico , Años de Vida Ajustados por Calidad de Vida , Factores de RiesgoRESUMEN
Non-invasive prenatal testing (NIPT) is an exciting technology with the potential to provide a variety of clinical benefits, including a reduction in miscarriages, via a decline in invasive testing. However, there is also concern that the economic and near-future clinical benefits of NIPT have been overstated and the potential limitations and harms underplayed. NIPT, therefore, presents an opportunity to explore the ways in which a range of social pressures and policies can influence the translation, implementation, and use of a health care innovation. NIPT is often framed as a potential first tier screen that should be offered to all pregnant women, despite concerns over cost-effectiveness. Multiple forces have contributed to a problematic translational environment in Canada, creating pressure towards first tier implementation. Governments have contributed to commercialization pressure by framing the publicly funded research sector as a potential engine of economic growth. Members of industry have an incentive to frame clinical value as beneficial to the broadest possible cohort in order to maximize market size. Many studies of NIPT were directly funded and performed by private industry in laboratories lacking strong independent oversight. Physicians' fear of potential liability for failing to recommend NIPT may further drive widespread uptake. Broad social endorsement, when combined with these translation pressures, could result in the "routinization" of NIPT, thereby adversely affecting women's reproductive autonomy. Policymakers should demand robust independent evidence of clinical and public health utility relevant to their respective jurisdictions before making decisions regarding public funding for NIPT.
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Pruebas de Detección del Suero Materno , Obstetricia/tendencias , Femenino , Humanos , Obstetricia/legislación & jurisprudencia , Embarazo , Transferencia de Tecnología , Investigación Biomédica TraslacionalRESUMEN
PURPOSE: To develop an evidence-based guideline for the management of grades I-III neck pain and associated disorders (NAD). METHODS: This guideline is based on recent systematic reviews of high-quality studies. A multidisciplinary expert panel considered the evidence of effectiveness, safety, cost-effectiveness, societal and ethical values, and patient experiences (obtained from qualitative research) when formulating recommendations. Target audience includes clinicians; target population is adults with grades I-III NAD <6 months duration. RECOMMENDATION 1: Clinicians should rule out major structural or other pathologies as the cause of NAD. Once major pathology has been ruled out, clinicians should classify NAD as grade I, II, or III. RECOMMENDATION 2: Clinicians should assess prognostic factors for delayed recovery from NAD. RECOMMENDATION 3: Clinicians should educate and reassure patients about the benign and self-limited nature of the typical course of NAD grades I-III and the importance of maintaining activity and movement. Patients with worsening symptoms and those who develop new physical or psychological symptoms should be referred to a physician for further evaluation at any time during their care. RECOMMENDATION 4: For NAD grades I-II ≤3 months duration, clinicians may consider structured patient education in combination with: range of motion exercise, multimodal care (range of motion exercise with manipulation or mobilization), or muscle relaxants. In view of evidence of no effectiveness, clinicians should not offer structured patient education alone, strain-counterstrain therapy, relaxation massage, cervical collar, electroacupuncture, electrotherapy, or clinic-based heat. RECOMMENDATION 5: For NAD grades I-II >3 months duration, clinicians may consider structured patient education in combination with: range of motion and strengthening exercises, qigong, yoga, multimodal care (exercise with manipulation or mobilization), clinical massage, low-level laser therapy, or non-steroidal anti-inflammatory drugs. In view of evidence of no effectiveness, clinicians should not offer strengthening exercises alone, strain-counterstrain therapy, relaxation massage, relaxation therapy for pain or disability, electrotherapy, shortwave diathermy, clinic-based heat, electroacupuncture, or botulinum toxin injections. RECOMMENDATION 6: For NAD grade III ≤3 months duration, clinicians may consider supervised strengthening exercises in addition to structured patient education. In view of evidence of no effectiveness, clinicians should not offer structured patient education alone, cervical collar, low-level laser therapy, or traction. RECOMMENDATION 7: For NAD grade III >3 months duration, clinicians should not offer a cervical collar. Patients who continue to experience neurological signs and disability more than 3 months after injury should be referred to a physician for investigation and management. RECOMMENDATION 8: Clinicians should reassess the patient at every visit to determine if additional care is necessary, the condition is worsening, or the patient has recovered. Patients reporting significant recovery should be discharged.
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Antiinflamatorios no Esteroideos/uso terapéutico , Terapia por Ejercicio , Dolor de Cuello/terapia , Rango del Movimiento Articular , Yoga , Análisis Costo-Beneficio , Humanos , Terapia por Luz de Baja Intensidad , Masaje , Ontario , Examen Físico , Terapia por RelajaciónRESUMEN
The National Institute for Health and Clinical Excellence (NICE) recently recommended differential discounting of costs and health effects in the economic appraisal of health care interventions in certain circumstances. The recommendation was published in an amendment to NICE's Guide to the Methods of Technology Appraisal. The amendment states that differential discounting should be applied where "treatment effects are both substantial in restoring health and sustained over a very long period (normally at least 30 years)." Renewed interest in differential discounting from NICE is welcome; however, the recommendation's selective application of differential discounting raises a number of concerns. The stated criteria for applying differential discounting are ambiguous. The rationale for the selective application of differential discounting has not been articulated by NICE and is questionable. The selective application of differential discounting leads to several inconsistencies, the most concerning of which is the lower valuation of health gains for those with less than 30 years remaining life expectancy, which can be interpreted as age discrimination. Furthermore, the discount rates chosen by NICE do not appear to be informed by recent advances in the theoretical understanding of differential discounting. NICE's apparent motivation for recommending differential discounting was to ensure a favorable cost-effectiveness ratio for a pediatric oncology drug. While flexibility may be appropriate to allow some interventions that exceed conventional cost-effectiveness thresholds to be adopted, the selective adjustment of appraisal methods is problematic and without justification.
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Atención a la Salud/economía , Años de Vida Ajustados por Calidad de Vida , Evaluación de la Tecnología Biomédica/métodos , Análisis Costo-Beneficio/métodos , Análisis Costo-Beneficio/normas , Humanos , Evaluación de la Tecnología Biomédica/economía , Reino UnidoRESUMEN
BACKGROUND: The study was conducted to determine the clinical and cost effectiveness of enhanced multi-disciplinary teams (EMDTs) vs. 'usual care' for the treatment of pressure ulcers in long term care (LTC) facilities in Ontario, Canada METHODS: We conducted a multi-method study: a pragmatic cluster randomized stepped-wedge trial, ethnographic observation and in-depth interviews, and an economic evaluation. Long term care facilities (clusters) were randomly allocated to start dates of the intervention. An advance practice nurse (APN) with expertise in skin and wound care visited intervention facilities to educate staff on pressure ulcer prevention and treatment, supported by an off-site hospital based expert multi-disciplinary wound care team via email, telephone, or video link as needed. The primary outcome was rate of reduction in pressure ulcer surface area (cm2/day) measured on before and after standard photographs by an assessor blinded to facility allocation. Secondary outcomes were time to healing, probability of healing, pressure ulcer incidence, pressure ulcer prevalence, wound pain, hospitalization, emergency department visits, utility, and cost. RESULTS: 12 of 15 eligible LTC facilities were randomly selected to participate and randomized to start date of the intervention following the stepped wedge design. 137 residents with a total of 259 pressure ulcers (stage 2 or greater) were recruited over the 17 month study period. No statistically significant differences were found between control and intervention periods on any of the primary or secondary outcomes. The economic evaluation demonstrated a mean reduction in direct care costs of $650 per resident compared to 'usual care'. The qualitative study suggested that onsite support by APN wound specialists was welcomed, and is responsible for reduced costs through discontinuation of expensive non evidence based treatments. Insufficient allocation of nursing home staff time to wound care may explain the lack of impact on healing. CONCLUSION: Enhanced multi-disciplinary wound care teams were cost effective, with most benefit through cost reduction initiated by APNs, but did not improve the treatment of pressure ulcers in nursing homes. Policy makers should consider the potential yield of strengthening evidence based primary care within LTC facilities, through outreach by APNs. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT01232764.
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Grupo de Atención al Paciente/economía , Úlcera por Presión/terapia , Telemedicina/economía , Adulto , Anciano , Análisis por Conglomerados , Análisis Costo-Beneficio , Femenino , Investigación sobre Servicios de Salud , Hospitalización/estadística & datos numéricos , Humanos , Incidencia , Entrevistas como Asunto , Masculino , Persona de Mediana Edad , Ontario/epidemiología , Úlcera por Presión/epidemiología , Prevalencia , Resultado del Tratamiento , Cicatrización de HeridasRESUMEN
As high-cost medicines put increasing pressure on public health care budgets, the need to identify 'fair' prices for medicines has never been greater. This paper proposes a framework, built upon fundamental economic principles, that allows for the consideration of 'fair' prices for medicines. The framework incorporates key considerations from conventional supply-side and demand-side approaches for specifying a cost-effectiveness 'threshold', including the health opportunity cost borne by other patients ([Formula: see text]) and society's willingness to pay for marginal improvements in population health ([Formula: see text]). The costs incurred by manufacturers in developing and supplying new medicines are also considered, as are the incentives for manufacturers to strategically price up to any common price per unit of benefit (cost-effectiveness 'threshold') specified by the payer. The framework finds that, at any 'fair' price, a medicine's dynamically calculated incremental cost-effectiveness ratio (ICER) lies below [Formula: see text]. When pricing medicines collectively, the framework finds that a common price below [Formula: see text] is required to maximize population health (consumer surplus) or to maximize total welfare (consumer and producer surplus). This framework has important policy implications for payers who wish to improve population health outcomes from constrained health care budgets. In particular, existing approaches to 'value-based pricing' should be reconsidered to ensure that patients receive a 'fair' share of the resulting economic surplus.
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Costos de los Medicamentos , Costos de la Atención en Salud , Humanos , Presupuestos , Análisis Costo-BeneficioRESUMEN
OBJECTIVES: Adjuvant chemotherapy decisions in early breast cancer are complex. The 21-gene assay can potentially aid such decisions, but costs US $4175 per patient. Adjuvant! Online is a freely available decision aid. We evaluate the cost-effectiveness of using the 21-gene assay in conjunction with Adjuvant! Online, and of providing adjuvant chemotherapy conditional upon risk classification. METHODS: A probabilistic Markov decision model simulated risk classification, treatment, and the natural history of breast cancer in a hypothetical cohort of 50-year-old women with lymph node-negative, estrogen receptor- and/or progesterone receptor-positive, human epidermal growth factor receptor 2/neu-negative early breast cancer. Cost-effectiveness was considered from an Ontario public-payer perspective by deriving the lifetime incremental cost (2012 Canadian dollars) per quality-adjusted life-year (QALY) for each strategy, and the probability each strategy is cost-effective, assuming a willingness-to-pay of $50,000 per QALY. RESULTS: The 21-gene assay has an incremental cost per QALY in patients at low, intermediate, or high Adjuvant Online! risk of $22,440 (probability cost-effective 78.46%), $2,526 (99.40%), or $1,111 (99.82%), respectively. In patients at low (high) 21-gene assay risk, adjuvant chemotherapy increases (reduces) costs and worsens (improves) health outcomes. For patients at intermediate 21-gene assay risk and low, intermediate, or high Adjuvant! Online risk, chemotherapy has an incremental cost per QALY of $44,088 (50.59%), $1,776 (77.65%), or $1,778 (82.31%), respectively. CONCLUSIONS: The 21-gene assay appears cost-effective, regardless of Adjuvant! Online risk. Adjuvant chemotherapy appears cost-effective for patients at intermediate or high 21-gene assay risk, although this finding is uncertain in patients at intermediate 21-gene assay and low Adjuvant! Online risk.
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Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Neoplasias de la Mama/tratamiento farmacológico , Técnicas de Apoyo para la Decisión , Transcriptoma , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/economía , Neoplasias de la Mama/genética , Neoplasias de la Mama/terapia , Quimioterapia Adyuvante , Análisis Costo-Beneficio , Femenino , Humanos , Cadenas de Markov , Persona de Mediana Edad , Modelos Económicos , Guías de Práctica Clínica como Asunto , Años de Vida Ajustados por Calidad de Vida , Medición de RiesgoRESUMEN
It is acknowledged that health technology assessment (HTA) is an inherently value-based activity that makes use of normative reasoning alongside empirical evidence. But the language used to conceptualise and articulate HTA's normative aspects is demonstrably unnuanced, imprecise, and inconsistently employed, undermining transparency and preventing proper scrutiny of the rationales on which decisions are based. This paper - developed through a cross-disciplinary collaboration of 24 researchers with expertise in healthcare priority-setting - seeks to address this problem by offering a clear definition of key terms and distinguishing between the types of normative commitment invoked during HTA, thus providing a novel conceptual framework for the articulation of reasoning. Through application to a hypothetical case, it is illustrated how this framework can operate as a practical tool through which HTA practitioners and policymakers can enhance the transparency and coherence of their decision-making, while enabling others to hold them more easily to account. The framework is offered as a starting point for further discussion amongst those with a desire to enhance the legitimacy and fairness of HTA by facilitating practical public reasoning, in which decisions are made on behalf of the public, in public view, through a chain of reasoning that withstands ethical scrutiny.
RESUMEN
Appropriate decisions based on cost-effectiveness evaluations of health-care technologies depend upon the cost-effectiveness threshold and its rate of growth as well as some social rate of time preference for health. A more traditional approach to this problem is outlined before a social decision-making approach is developed, which demonstrates that social time preference for health is revealed through the budget allocations made by a socially legitimate higher authority. The relationship between the social time preference rate for health, the growth rate of the cost-effectiveness threshold and the rate at which the higher authority can borrow or invest is then examined. We establish that the social time preference rate for health is implied by the budget allocation and the health production functions in each period. As such, the social time preference rate for health depends not on the social time preference rate for consumption or growth in the consumption value of health but on growth in the cost-effectiveness threshold and the rate at which the higher authority can save or borrow between periods. The implications for discounting and the policies of bodies such as NICE are then discussed.
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Presupuestos , Toma de Decisiones , Servicios de Salud/estadística & datos numéricos , Tecnología Biomédica , Análisis Costo-Beneficio , Humanos , Modelos Econométricos , Reino UnidoRESUMEN
BACKGROUND: Multi-disciplinary heart failure (HF) clinics have been shown to improve outcomes for HF patients in randomized clinical trials. However, it is unclear how widely available specialized HF clinics are in Ontario. Also, the service models of current clinics have not been described. It is therefore uncertain whether the efficacy of HF clinics in trials is generalizable to the HF clinics currently operating in the province. METHODS: As part of a comprehensive evaluation of HF clinics in Ontario, we performed an environmental scan to identify all HF clinics operating in 2010. A semi-structured interview was conducted to understand the scope of practice. The intensity and complexity of care offered were quantified through the use of a validated instrument, and clinics were categorized as high, medium or low intensity clinics. RESULTS: We identified 34 clinics with 143 HF physicians. We found substantial regional disparity in access to care across the province. The majority of HF physicians were cardiologists (81%), with 81% of the clinics physically based in hospitals, of which 26% were academic centers. There was a substantial range in the complexity of services offered, most notably in the intensity of education and medication management services offered. All the clinics focused on ambulatory care, with only one having an in-patient focus. None of the HF clinics had a home-based component to care. CONCLUSIONS: Multiple HF clinics are currently operating in Ontario with a wide spectrum of care models. Further work is necessary to understand which components lead to improved patient outcomes.
Asunto(s)
Centros Comunitarios de Salud/organización & administración , Insuficiencia Cardíaca/terapia , Garantía de la Calidad de Atención de Salud , Centros Comunitarios de Salud/economía , Financiación Gubernamental , Insuficiencia Cardíaca/epidemiología , Humanos , Entrevistas como Asunto , Ontario/epidemiologíaRESUMEN
BACKGROUND: Decisions based on cost-effectiveness analyses (CEAs) using equal discount rates for health and cost outcomes are consistent with using a constant cost-effectiveness threshold over time. We sought to analyze trends in author-reported cost per quality-adjusted life-year (QALY) thresholds from CEAs published for the US setting over 24 y to retrospectively assess whether the recommended equal discount rates for costs and health were consistent with trends in the CEA literature. METHODS: We used the Tufts CEA Registry to assess whether author-reported cost-effectiveness thresholds changed in CEAs published for the US setting between 1995 and 2018 and back-calculated the implied discount rate for health based on these trends for inflation-adjusted cost-effectiveness thresholds and an annual discount rate for costs of 3%. RESULTS: We found 1995 CEAs published for the US setting and found that average nominal and inflation-adjusted cost-effectiveness thresholds increased over that time period. The discount rate for health would need to equal 2.43% to 2.48% (depending on the subset of CEAs analyzed) to be consistent with the observed trends in inflation-adjusted author-reported cost-effectiveness thresholds. We also found that restricting our analysis to currency years between 1995 and 2014 would result in a back-calculated discount rate for health of 2.99% to 3.28%. CONCLUSIONS: We found that CEA researchers have implicitly assumed that inflation-adjusted cost-effectiveness thresholds in the United States have been increasing over time (1995-2018), which is inconsistent with the recommended and prevailing choice of equal discount rates for health and cost outcomes. Our results are sensitive to the cutoff year used in the analysis. HIGHLIGHTS: We show visually and through equations that the recommended and prevailing practice of using equal discount rates for cost and health outcomes in cost-effectiveness analyses (CEAs) logically implies a constant inflation-adjusted cost-effectiveness threshold over time.Using data from the Tufts CEA Registry, we found that author-reported cost-effectiveness thresholds used in CEAs published for the US setting with currency years between 1995 and 2018 increased over time (both with and without adjustment for inflation).Assuming an annual discount rate for costs equal to 3%, the discount rate for health would need to equal approximately 2.5% to preserve consistency across decisions taken at different dates given the observed trends in inflation-adjusted author-reported cost-effectiveness thresholds.This finding depends on the cutoff year used in the analysis (data from currency years 1995-2014 would support use of equal discount rates, whereas data after 2014 would suggest a sharper trend toward increasing cost-effectiveness thresholds).
Asunto(s)
Análisis Costo-Beneficio , Humanos , Años de Vida Ajustados por Calidad de Vida , Sistema de Registros , Estudios Retrospectivos , Estados UnidosRESUMEN
BACKGROUND: The quality of reporting of health economic evaluations for rehabilitation services has been questioned, limiting the ability to provide accurate recommendations for health decisions. PURPOSE: To document current overall reporting quality of the published literature for economic evaluations of rehabilitation services using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS), and to identify factors that could influence the quality of reporting. DATA SOURCES: Electronic literature searches were performed using MEDLINE and the NHS Economic Evaluations Database via the Cochrane Library. STUDY SELECTION: Prospective rehabilitation economic evaluation articles from 2013 to 2020 were selected. DATA EXTRACTION: Data were extracted by one reviewer and independently verified by a second reviewer. DATA SYNTHESIS/RESULTS: Title and abstracts of 3,454 papers were reviewed. 204 papers were selected for a full text screening. From those, 129 potential papers were identified to be included in this study. LIMITATIONS: Only two databases were used in data collection, and papers were selected from 2013 to 2020 only. CONCLUSIONS: Inconsistent reporting in health economic evaluations of rehabilitation services has continued, despite the availability of the CHEERS checklist. The methods of the analyzed studies were frequently under-reported, thereby creating challenges in determining whether the results reported were valid.IMPLICATIONS FOR REHABILITATIONVariable quality of reporting has been identified in rehabilitation research assessing cost-effectiveness.To grow as an area of expertise, the field of rehabilitation must produce research demonstrating its cost-effectiveness.Both rehabilitation clinicians and funders would benefit from full and transparent information to identify optimal solutions for effective and efficient care.