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Baid D, Lakdawalla DN, Finkelstein EA. Societal Preferences for Subsidizing Treatments Targeting Patients With Advanced Illness: A Discrete Choice Experiment. Value Health Reg Issues 2024; 43:101003. [PMID: 38838425 DOI: 10.1016/j.vhri.2024.101003] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/23/2023] [Revised: 04/10/2024] [Accepted: 04/23/2024] [Indexed: 06/07/2024]
Abstract
OBJECTIVES Cost-effectiveness analyses are increasingly used to inform subvention decisions for moderately life extending treatments but apply several simplifying assumptions that may be inconsistent with public preferences. Contrary to standard assumptions, we hypothesize that societal willingness to allocate public funding toward these treatments is (1) diminishing for incremental improvements in survival and quality of life (QoL) and (2) greater for subvention policies that exclude the oldest old (>80 years). METHODS We tested these hypotheses using a web-based discrete choice experiment (n = 425) in Singapore. In each of 5 questions, respondents were shown 2 hypothetical treatments targeting patients with an expected prognosis of 2 months at very poor QoL and asked which treatment they wanted the government to subsidize, if any. Treatments were defined by 4 attributes: cost to the government, age of beneficiaries, expected gain in survival (2-12 months), and QoL (poor, fair, and good). RESULTS Latent class models were used to analyze results. Results revealed 2 classes. In the majority class (69.7% of sample), respondents value incremental gains in survival and QoL at a diminishing rate. Their willingness to allocate public funding estimates (Singapore dollars 16 825-91 027 per patient per month) were much higher than traditional cost-effectiveness thresholds. In the second class, respondents were unwilling to subsidize treatments offering less than 2 months of life extension or poor QoL. Neither class preferred subvention policies that exclude the oldest old. CONCLUSIONS These findings suggest that the Singapore government should consider cost-effectiveness thresholds that rise with increases in life extension. Age-based restrictions should not be imposed.
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Affiliation(s)
- Drishti Baid
- Sol Price School of Public Policy, University of Southern California, Los Angeles, CA, USA; Leonard D. Schaeffer Center for Health Policy and Economics, University of Southern California, Los Angeles, CA, USA.
| | - Darius N Lakdawalla
- Sol Price School of Public Policy, University of Southern California, Los Angeles, CA, USA; Leonard D. Schaeffer Center for Health Policy and Economics, University of Southern California, Los Angeles, CA, USA
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Reeves GEM, Shepherd J, Collins NJ, Twaddell S, Harjit Singh R. Assessing quality of life in pulmonary arterial hypertension: An independent prognostic marker. Pulm Circ 2024; 14:e12380. [PMID: 38827380 PMCID: PMC11144421 DOI: 10.1002/pul2.12380] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/15/2023] [Revised: 04/10/2024] [Accepted: 04/13/2024] [Indexed: 06/04/2024] Open
Abstract
Pulmonary arterial hypertension (PAH, or PH Group 1), a disease of aberrant pulmonary vascular remodeling, causing progressive right heart failure (RHF) due to elevation of pulmonary vascular resistance (PVR). Patient mortality risk stratification guides choice and intensity of pharmacological intervention and is assessed by haemodynamics (especially PVR) as well as noninvasive tools including WHO functional class (FC), 6-min walk distance (6MWD), and NT-proBNP levels. Quality of life (QOL) assessment is acknowledged as a central aspect of patient-centered care, but our study sought to extend QOL's role as an additional noninvasive risk marker that could further refine risk stratification and hence therapeutic choices within a "treatment to target" paradigm (aiming to achieve low-risk status). This study found that QOL assessment using the PAH-SYMPACT© physical activity tool provided enhanced, independent mortality risk information, with one unit rise in this score associated with a 41% increase in likelihood risk (odds ratio 1.41, 95% confidence interval: 1.01-1.98 (p < 0.05)) of falling within intermediate versus low-group category. We therefore found further support for additional prognostic value being conferred by measurement of QOL as part of routine PAH evaluation, reinforcing its critical role.
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Affiliation(s)
- Glenn Edward Malcolm Reeves
- John Hunter Hospital, NSW Health HNELHD, Hunter Regional Mail CentreWarabrookNew South WalesAustralia
- School of Medicine and Public HealthUniversity of NewcastleCallaghanNew South WalesAustralia
| | - Julie Shepherd
- Immune & Clinical Trials Unit, John Hunter HospitalNewcastleNew South WalesAustralia
| | - Nicholas John Collins
- John Hunter Hospital, NSW Health HNELHD, Hunter Regional Mail CentreWarabrookNew South WalesAustralia
| | - Scott Twaddell
- John Hunter Hospital, NSW Health HNELHD, Hunter Regional Mail CentreWarabrookNew South WalesAustralia
| | - Rajinder Harjit Singh
- John Hunter Hospital, NSW Health HNELHD, Hunter Regional Mail CentreWarabrookNew South WalesAustralia
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van Beers E, Melisse B, de Jonge M, Peen J, van den Berg E, de Beurs E. Web-based guided self-help cognitive behavioral therapy-enhanced versus treatment as usual for binge-eating disorder: a randomized controlled trial protocol. Front Psychiatry 2024; 15:1332360. [PMID: 38435976 PMCID: PMC10904459 DOI: 10.3389/fpsyt.2024.1332360] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/09/2023] [Accepted: 01/29/2024] [Indexed: 03/05/2024] Open
Abstract
Binge-eating disorder (BED) is a psychiatric disorder characterized by recurrent episodes of eating a large amount of food in a discrete period of time while experiencing a loss of control. Cognitive behavioral therapy-enhanced (CBT-E) is a recommended treatment for binge-eating disorder and is typically offered through 20 sessions. Although binge-eating disorder is highly responsive to CBT-E, the cost of treating these patients is high. Therefore, it is crucial to evaluate the efficacy of low-intensity and low-cost treatments for binge-eating disorder that can be offered as a first line of treatment and be widely disseminated. The proposed noninferiority randomized controlled trial aims to determine the efficacy of web-based guided self-help CBT-E compared to treatment-as-usual CBT-E. Guided self-help will be based on a self-help program to stop binge eating, will be shorter in duration and lower intensity, and will require fewer therapist hours. Patients with binge-eating disorder (N = 180) will be randomly assigned to receive guided self-help or treatment-as-usual. Assessments will take place at baseline, mid-treatment, at the end of treatment, and at 20- and 40-weeks post-treatment. Treatment efficacy will be measured by examining the reduction in binge-eating days in the previous 28 days between baseline and the end of treatment between groups, with a noninferiority margin (Δ) of 1 binge-eating day. Secondary outcomes will include full remission, body shape dissatisfaction, therapeutic alliance, clinical impairment, health-related quality of life, attrition, and an economic evaluation to assess cost-effectiveness and cost-utility. The moderators examined will be baseline scores, demographic variables, and body mass index. It is expected that guided self-help is noninferior in efficacy compared to treatment-as-usual. The proposed study will be the first to directly compare the efficacy and economically evaluate a low-intensity and low-cost binge-eating disorder treatment compared to treatment-as-usual. If guided self-help is noninferior to treatment-as-usual in efficacy, it can be widely disseminated and used as a first line of treatment for patients with binge-eating disorder. The Dutch trial register number is R21.016. The study has been approved by the Medical Research Ethics Committees United on May 25th, 2021, case number NL76368.100.21.
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Affiliation(s)
- Ella van Beers
- Novarum Center for Eating Disorders & Obesity, Amstelveen, Netherlands
| | - Bernou Melisse
- Novarum Center for Eating Disorders & Obesity, Amstelveen, Netherlands
- Utrecht University, Department of Clinical Psychology, Utrecht, Netherlands
| | - Margo de Jonge
- Novarum Center for Eating Disorders & Obesity, Amstelveen, Netherlands
| | - Jaap Peen
- Department of Research, Arkin Mental Health Institute, Amsterdam, Netherlands
| | - Elske van den Berg
- Novarum Center for Eating Disorders & Obesity, Amstelveen, Netherlands
- Department of Research, Arkin Mental Health Institute, Amsterdam, Netherlands
| | - Edwin de Beurs
- Department of Research, Arkin Mental Health Institute, Amsterdam, Netherlands
- Leiden University, Department of Clinical Psychology, Leiden, Netherlands
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Cresswell K, Anderson S, Montgomery C, Weir CJ, Atter M, Williams R. Evaluation of Digitalisation in Healthcare and the Quantification of the "Unmeasurable". J Gen Intern Med 2023; 38:3610-3615. [PMID: 37715095 PMCID: PMC10713954 DOI: 10.1007/s11606-023-08405-y] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/12/2023] [Accepted: 08/29/2023] [Indexed: 09/17/2023]
Abstract
Evaluating healthcare digitalisation, where technology implementation and adoption transforms existing socio-organisational processes, presents various challenges for outcome assessments. Populations are diverse, interventions are complex and evolving over time, meaningful comparisons are difficult as outcomes vary between settings, and outcomes take a long time to materialise and stabilise. Digitalisation may also have unanticipated impacts. We here discuss the limitations of evaluating the digitalisation of healthcare, and describe how qualitative and quantitative approaches can complement each other to facilitate investment and implementation decisions. In doing so, we argue how existing approaches have focused on measuring what is easily measurable and elevating poorly chosen values to inform investment decisions. Limited attention has been paid to understanding processes that are not easily measured even though these can have significant implications for contextual transferability, sustainability and scale-up of interventions. We use what is commonly known as the McNamara Fallacy to structure our discussions. We conclude with recommendations on how we envisage the development of mixed methods approaches going forward in order to address shortcomings.
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Affiliation(s)
| | - Stuart Anderson
- School of Informatics, The University of Edinburgh, Edinburgh, UK
| | - Catherine Montgomery
- Institute for the Study of Science, Technology and Innovation, The University of Edinburgh, Edinburgh, UK
| | - Christopher J Weir
- Edinburgh Clinical Trials Unit, Usher Institute, The University of Edinburgh, Edinburgh, UK
| | - Marek Atter
- Edinburgh Clinical Trials Unit, Usher Institute, The University of Edinburgh, Edinburgh, UK
| | - Robin Williams
- Institute for the Study of Science, Technology and Innovation, The University of Edinburgh, Edinburgh, UK
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Health Technology Assessment Process for Oncology Drugs: Impact of CADTH Changes on Public Payer Reimbursement Recommendations. Curr Oncol 2022; 29:1514-1526. [PMID: 35323327 PMCID: PMC8947453 DOI: 10.3390/curroncol29030127] [Citation(s) in RCA: 20] [Impact Index Per Article: 6.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/28/2022] [Revised: 02/25/2022] [Accepted: 02/26/2022] [Indexed: 11/17/2022] Open
Abstract
Public reimbursement systems face the challenge of balancing provision of needed treatments and the reality of limited resources. Canada has a complex system for drug approval and public reimbursement, with jurisdiction divided between the federal government and the provinces/territories. A pivotal role is that of health technology assessment (HTA), which relies primarily on health economic principles to analyze the value of drugs on a population health basis and make recommendations about public reimbursement. The Canadian Agency for Drugs and Technologies in Health (CADTH) provides recommendations to all provinces but Quebec. This article provides an overview of Canada’s approval and public reimbursement pathway, including the role of HTA and the economic principles on which it relies. Starting in late 2020, CADTH reduced the cost per quality-adjusted life year (QALY) threshold, the metric relied upon in making recommendations to public payers. An analysis of all 56 oncology drug final recommendations issued from January 2020 to January 2022 was conducted and confirms this reduction in the cost per QALY threshold. As a result of this threshold reduction, recommendations to the provinces include, in a number of cases, substantially greater price reductions. The potential implications for successful price negotiation with the pan-Canadian Pharmaceutical Alliance (pCPA), the public negotiating body for the provinces, are discussed.
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Yan T, Ortendahl JD, Chang E, Wessler Z, Harmon AL, Broder MS. Real-world impact of disease on functioning and activity: what is missed when using general instruments to estimate quality-adjusted life years. Curr Med Res Opin 2022; 38:165-170. [PMID: 34775901 DOI: 10.1080/03007995.2021.2006535] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 10/19/2022]
Abstract
OBJECTIVE Economic evaluations conducted to inform healthcare resource allocation often rely on quality-adjusted life years (QALYs) to measure therapeutic benefit. However, QALYs, with underlying health utilities estimated using the EQ-5D or SF-36, may fail to capture the impact of disease for all patients. How well-being and heath utility differ across several common conditions was explored. METHODS This study examined eight diseases: arthritis, asthma, cancer, depression, diabetes, heart disease, lung disease and stroke. Health utilities for each disease were obtained from published literature. Other measures of disease burden, including physical functioning, cognitive functioning and physical activity, were estimated from the National Health and Nutrition Examination Survey (NHANES). Group rankings by these measures were compared to rankings by health utility. RESULTS Health utilities were lowest for patients with depression (0.44), and highest for those with cancer (0.81). Physical functioning was most limited (higher score) among those with stroke (28.2) and had the least impact for cancer (24.4). Physical activity was most impacted by heart disease (27.3) and least impacted by depression (40.7). Cognitive functioning was lowest in stroke (41.6) and highest in asthma (52.0). CONCLUSION Differences in rankings of disease severity by metric indicate that the results of cost-utility analyses might be biased against treatments for certain diseases. As patient preferences for clinical outcomes vary, the full burden of disease should be considered in evaluations. Restricting access to treatments based on an incomplete estimate of burden could lead to misallocation of resources and a withholding of therapies that patients find valuable.
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Affiliation(s)
- Tingjian Yan
- Partnership for Health Analytic Research LLC, Beverly Hills, CA, USA
| | - Jesse D Ortendahl
- Partnership for Health Analytic Research LLC, Beverly Hills, CA, USA
| | - Eunice Chang
- Partnership for Health Analytic Research LLC, Beverly Hills, CA, USA
| | | | - Amanda L Harmon
- Partnership for Health Analytic Research LLC, Beverly Hills, CA, USA
| | - Michael S Broder
- Partnership for Health Analytic Research LLC, Beverly Hills, CA, USA
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Kocot E, Kotarba P, Dubas-Jakóbczyk K. The application of the QALY measure in the assessment of the effects of health interventions on an older population: a systematic scoping review. Arch Public Health 2021; 79:201. [PMID: 34794496 PMCID: PMC8600812 DOI: 10.1186/s13690-021-00729-7] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/22/2021] [Accepted: 11/05/2021] [Indexed: 11/23/2022] Open
Abstract
BACKGROUND One of the most commonly used types of evaluation methods is cost-utility analysis (CUA), using the Quality Adjusted Life Year (QALY) indicator as a preference-based measure for assessing effects of a given programme. Such assessments are often translated into health-care provision priorities; therefore, effectively choosing the method of outcome evaluation is crucial for ensuring the best possible allocation of scarce resources. The main objective of this scoping review is to identify what kinds of problems and limitations may occur when the QALY indicator is used to assess the effects of health interventions in the older population. METHODS To identify literature in a scoping review, the databases MEDLINE via PubMed and Scopus were searched. A manual search on relevant organizations' and associations' websites was also conducted (EUnetHTA, ISPOR and national governmental agencies responsible for allocation decisions). No limits concerning publication dates were set. All relevant data were extracted and analyzed, then a narrative summary was prepared. RESULTS The database search identified 10,832 relevant items, finally 32 studies were included in the analysis. The main types of issues indicated in the studies were as follows: (1) lower life expectancy in the older population causes lower QALY gains; (2) an equal value of one QALY is used regardless of age; (3) poorer average health state causes lower QALY gains; (4) inadequate instruments to measure quality of life (QoL); (5) attributes of QoL used regardless of age; and (6) no beyond-health QoL aspects taken into account. CONCLUSIONS This review shows clearly that many problems of different types are connected with using QALY for the older population, but there is no consensus as to whether QALY discriminates against the older population or not - an opinion regarding this issue depends strongly on accepted principles, particularly the approach to equity and how one understands fairness. Health care resources should not be allocated solely on the basis of the health maximization rule because this can lead to discrimination against certain groups (e.g., older, disabled, and/or chronically ill people). To maintain the balance between efficiency and equity, the issues connected with age-based rationing should be widely discussed.
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Affiliation(s)
- Ewa Kocot
- Health Economics and Social Security Department, Institute of Public Health, Faculty of Health Sciences, Jagiellonian University Medical College, Krakow, Poland
| | - Paulina Kotarba
- Department of Health, Małopolska Provincial Office in Krakow, Krakow, Poland
| | - Katarzyna Dubas-Jakóbczyk
- Health Economics and Social Security Department, Institute of Public Health, Faculty of Health Sciences, Jagiellonian University Medical College, Krakow, Poland
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Beresniak A, Malfertheiner P, Franceschi F, Liebaert F, Salhi H, Gisbert JP. Helicobacter pylori "Test-and-Treat" strategy with urea breath test: A cost-effective strategy for the management of dyspepsia and the prevention of ulcer and gastric cancer in Spain-Results of the Hp-Breath initiative. Helicobacter 2020; 25:e12693. [PMID: 32285569 DOI: 10.1111/hel.12693] [Citation(s) in RCA: 23] [Impact Index Per Article: 4.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/16/2019] [Revised: 03/08/2020] [Accepted: 03/09/2020] [Indexed: 12/11/2022]
Abstract
BACKGROUND Data from clinical trials comparing Helicobacter pylori (H. pylori) management strategies in patients with dyspepsia are limited. Cost-effectiveness simulation models might help to identify the optimal strategy. OBJECTIVE To assess the cost-effectiveness of the H. pylori "Test and Treat" (T&T) strategy including the use of urea breath test (UBT) vs symptomatic treatment (ST) and vs upper gastrointestinal endoscopy (UGE) as a first procedure in patients with dyspepsia. METHODS Three main strategies: "T&T" strategy including the use of UBT, "UGE" and "ST" have been compared using cost-effectiveness models developed in accordance with the Spanish medical practice. For the model simulations, a time horizon of 4 weeks was considered for the endpoint "Dyspepsia symptoms relief" and 10 years when using "Peptic ulcer avoided" and "Gastric cancer avoided" endpoints. RESULTS For the endpoint "Dyspepsia symptoms relief", T&T strategy appears to be the most cost-effective (883€/success) compared to UGE strategy and to ST strategy (respectively 1628€ and 990€/success). For the endpoint "Probability of peptic ulcer", the T&T strategy appears to be the most cost-effective (421€/peptic ulcer avoided/y) compared to UGE strategy and ST strategy (respectively 728€ and 632€/peptic ulcer avoided/y). For the endpoint "Gastric cancer avoided", the T&T strategy appears to be the most cost-effective (524€/gastric cancer avoided/y) compared to UGE strategy and "ST" strategy (respectively 716€ and 696€/gastric cancer avoided/y). CONCLUSIONS T&T strategy including the use of UBT is the most cost-effective medical approach for management of dyspepsia and for the prevention of ulcer and gastric cancer.
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Affiliation(s)
| | - Peter Malfertheiner
- Department of Gastroenterology, Hepatology and Infectious Diseases, Otto-von-Guericke University Hospital, Magdeburg, Germany.,Department of Medicine II, University Hospital, LMU, Munich, Germany
| | - Francesco Franceschi
- Department of Gastroenterology and Internal Medicine, Catholic University, Rome, Italy
| | | | | | - Javier P Gisbert
- Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP), Universidad Autónoma de Madrid, and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain
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9
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Huang M, ElTayeby O, Zolnoori M, Yao L. Public Opinions Toward Diseases: Infodemiological Study on News Media Data. J Med Internet Res 2018; 20:e10047. [PMID: 29739741 PMCID: PMC5964307 DOI: 10.2196/10047] [Citation(s) in RCA: 21] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/08/2018] [Revised: 04/01/2018] [Accepted: 04/22/2018] [Indexed: 01/07/2023] Open
Abstract
Background Society always has limited resources to expend on health care, or anything else. What are the unmet medical needs? How do we allocate limited resources to maximize the health and welfare of the people? These challenging questions might be re-examined systematically within an infodemiological frame on a much larger scale, leveraging the latest advancement in information technology and data science. Objective We expanded our previous work by investigating news media data to reveal the coverage of different diseases and medical conditions, together with their sentiments and topics in news articles over three decades. We were motivated to do so since news media plays a significant role in politics and affects the public policy making. Methods We analyzed over 3.5 million archive news articles from Reuters media during the periods of 1996/1997, 2008 and 2016, using summary statistics, sentiment analysis, and topic modeling. Summary statistics illustrated the coverage of various diseases and medical conditions during the last 3 decades. Sentiment analysis and topic modeling helped us automatically detect the sentiments of news articles (ie, positive versus negative) and topics (ie, a series of keywords) associated with each disease over time. Results The percentages of news articles mentioning diseases and medical conditions were 0.44%, 0.57% and 0.81% in the three time periods, suggesting that news media or the public has gradually increased its interests in medicine since 1996. Certain diseases such as other malignant neoplasm (34%), other infectious diseases (20%), and influenza (11%) represented the most covered diseases. Two hundred and twenty-six diseases and medical conditions (97.8%) were found to have neutral or negative sentiments in the news articles. Using topic modeling, we identified meaningful topics on these diseases and medical conditions. For instance, the smoking theme appeared in the news articles on other malignant neoplasm only during 1996/1997. The topic phrases HIV and Zika virus were linked to other infectious diseases during 1996/1997 and 2016, respectively. Conclusions The multi-dimensional analysis of news media data allows the discovery of focus, sentiments and topics of news media in terms of diseases and medical conditions. These infodemiological discoveries could shed light on unmet medical needs and research priorities for future and provide guidance for the decision making in public policy.
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Affiliation(s)
- Ming Huang
- Department of Health Sciences Research, Mayo Clinic, Rochester, MN, United States
| | - Omar ElTayeby
- Department of Computer Science, University of North Carolina at Charlotte, Charlotte, NC, United States
| | - Maryam Zolnoori
- Department of Health Sciences Research, Mayo Clinic, Rochester, MN, United States
| | - Lixia Yao
- Department of Health Sciences Research, Mayo Clinic, Rochester, MN, United States
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Willke RJ, Neumann PJ, Garrison LP, Ramsey SD. Review of Recent US Value Frameworks-A Health Economics Approach: An ISPOR Special Task Force Report [6]. VALUE IN HEALTH : THE JOURNAL OF THE INTERNATIONAL SOCIETY FOR PHARMACOECONOMICS AND OUTCOMES RESEARCH 2018; 21:155-160. [PMID: 29477393 DOI: 10.1016/j.jval.2017.12.011] [Citation(s) in RCA: 48] [Impact Index Per Article: 6.9] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 11/21/2017] [Accepted: 12/07/2017] [Indexed: 05/05/2023]
Abstract
The sixth section of our Special Task Force (STF) report reviews and comments on recent US-oriented value assessment frameworks, specifically those published by the American College of Cardiology/American Heart Association, the Institute for Clinical and Economic Research, the American Society of Clinical Oncology, the National Comprehensive Cancer Network, and the Memorial Sloan Kettering Cancer Center. We review published commentaries that address the validity, reliability, and conceptual underpinnings of these frameworks. We find common themes of critique regarding the strengths and limitations across frameworks. Particular shortcomings of some frameworks pose greater threats to their face validity and utility compared with others. The most significant limitations include lack of clear perspective (e.g., patient vs. health plan) and poor transparency in accounting for costs and benefits. We then review how each framework adheres to core STF recommendations, with particular emphasis on whether the framework can be used to support coverage decisions by health insurers, and whether it adheres to core principles of cost-effectiveness analysis. The Institute for Clinical and Economic Research framework most closely adheres to core STF recommendations. Others have significant limitations that vary widely from framework to framework. We also review how the frameworks follow STF recommendations for addressing potentially relevant issues beyond cost-effectiveness analysis - for example, equity in resource allocation and patient heterogeneity. Finally, we review whether and how each framework uses value thresholds and addresses affordability concerns. We conclude with suggestions for further research, particularly in the areas of testing the measurement and use of novel elements of value and deliberative processes.
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Affiliation(s)
- Richard J Willke
- International Society for Pharmacoeconomics and Outcomes Research, Lawrenceville, NJ, USA.
| | - Peter J Neumann
- Center for the Evaluation of Value and Risk in Health, Tufts Medical Center, Boston, MA, USA
| | - Louis P Garrison
- The Comparative Health Outcomes, Policy, and Economics Institute, University of Washington, Seattle, WA, USA
| | - Scott D Ramsey
- Department of General Internal Medicine, University of Washington, Seattle, WA, USA
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Agapova M, Bresnahan BB, Higashi M, Kessler L, Garrison LP, Devine B. A proposed approach for quantitative benefit-risk assessment in diagnostic radiology guideline development: the American College of Radiology Appropriateness Criteria Example. J Eval Clin Pract 2017; 23:128-138. [PMID: 27762080 DOI: 10.1111/jep.12635] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/28/2016] [Revised: 07/24/2016] [Accepted: 07/26/2016] [Indexed: 12/20/2022]
Abstract
The American College of Radiology develops evidence-based practice guidelines to aid appropriate utilization of radiological procedures. Panel members use expert opinion to weight trade-offs and consensus methods to rate appropriateness of imaging tests. These ratings include an equivocal range, assigned when there is disagreement about a technology's appropriateness and the evidence base is weak or for special circumstances. It is not clear how expert consensus merges with the evidence base to arrive at an equivocal rating. Quantitative benefit-risk assessment (QBRA) methods may assist decision makers in this capacity. However, many methods exist and it is not clear which methods are best suited for this application. We perform a critical appraisal of QBRA methods and propose several steps that may aid in making transparent areas of weak evidence and barriers to consensus in guideline development. We identify QBRA methods with potential to facilitate decision making in guideline development and build a decision aid for selecting among these methods. This study identified 2 families of QBRA methods suited to guideline development when expert opinion is expected to contribute substantially to decision making. Key steps to deciding among QBRA methods involve identifying specific benefit-risk criteria and developing a state-of-evidence matrix. For equivocal ratings assigned for reasons other than disagreement or weak evidence base, QBRA may not be needed. In the presence of disagreement but the absence of a weak evidence base, multicriteria decision analysis approaches are recommended; and in the presence of weak evidence base and the absence of disagreement, incremental net health benefit alone or combined with multicriteria decision analysis is recommended. Our critical appraisal further extends investigation of the strengths and limitations of select QBRA methods in facilitating diagnostic radiology clinical guideline development. The process of using the decision aid exposes and makes transparent areas of weak evidence and barriers to consensus.
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Affiliation(s)
- Maria Agapova
- Pharmaceutical Outcomes Research and Policy Program, University of Washington, Seattle, Washington, USA
| | - Brian B Bresnahan
- Department of Radiology, University of Washington, Seattle, Washington, USA
| | | | - Larry Kessler
- Department of Health Services, University of Washington, Seattle, Washington, USA
| | - Louis P Garrison
- Pharmaceutical Outcomes Research and Policy Program, University of Washington, Seattle, Washington, USA
| | - Beth Devine
- Pharmaceutical Outcomes Research and Policy Program, University of Washington, Seattle, Washington, USA.,Department of Health Services, University of Washington, Seattle, Washington, USA
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12
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Beresniak A, Dupont D. Is there an alternative to quality-adjusted life years for supporting healthcare decision making? Expert Rev Pharmacoecon Outcomes Res 2016; 16:351-7. [DOI: 10.1080/14737167.2016.1184975] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/21/2022]
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13
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Beresniak A, Caruba T, Sabatier B, Juillière Y, Dubourg O, Danchin N. Cost-effectiveness modelling of percutaneous coronary interventions in stable coronary artery disease. World J Cardiol 2015; 7:594-602. [PMID: 26516413 PMCID: PMC4620070 DOI: 10.4330/wjc.v7.i10.594] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/27/2015] [Revised: 03/06/2015] [Accepted: 09/30/2015] [Indexed: 02/06/2023] Open
Abstract
The objective of this study is to develop a cost-effectiveness model comparing drug eluting stents (DES) vs bare metal stent (BMS) in patients suffering of stable coronary artery disease. Using a 2-years time horizon, two simulation models have been developed: BMS first line strategy and DES first line strategy. Direct medical costs were estimated considering ambulatory and hospital costs. The effectiveness endpoint was defined as treatment success, which is the absence of major adverse cardiac events. Probabilistic sensitivity analyses were carried out using 10000 Monte-Carlo simulations. DES appeared slightly more efficacious over 2 years (60% of success) when compared to BMS (58% of success). Total costs over 2 years were estimated at 9303 € for the DES and at 8926 € for bare metal stent. Hence, corresponding mean cost-effectiveness ratios showed slightly lower costs (P < 0.05) per success for the BMS strategy (15520 €/success), as compared to the DES strategy (15588 €/success). Incremental cost-effectiveness ratio is 18850 € for one additional percent of success. The sequential strategy including BMS as the first option appears to be slightly less efficacious but more cost-effective compared to the strategy including DES as first option. Future modelling approaches should confirm these results as further comparative data in stable coronary artery disease and long-term evidence become available.
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Leverkus F, Chuang-Stein C. Implementation of AMNOG: An industry perspective. Biom J 2015; 58:76-88. [PMID: 26332597 PMCID: PMC4737288 DOI: 10.1002/bimj.201300256] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/31/2013] [Revised: 06/13/2015] [Accepted: 06/18/2015] [Indexed: 11/08/2022]
Abstract
In 2010, the Federal Parliament (Bundestag) of Germany passed a new law (Arzneimittelmarktneuordnungsgesetz, AMNOG) on the regulation of medicinal products that applies to all pharmaceutical products with active ingredients that are launched beginning January 1, 2011. The law describes the process to determine the price at which an approved new product will be reimbursed by the statutory health insurance system. The process consists of two phases. The first phase assesses the additional benefit of the new product versus an appropriate comparator (zweckmäßige Vergleichstherapie, zVT). The second phase involves price negotiation. Focusing on the first phase, this paper investigates requirements of benefit assessment of a new product under this law with special attention on the methods applied by the German authorities on issues such as the choice of the comparator, patient relevant endpoints, subgroup analyses, extent of benefit, determination of net benefit, primary and secondary endpoints, and uncertainty of the additional benefit. We propose alternative approaches to address the requirements in some cases and invite other researchers to help develop solutions in other cases.
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Beresniak A, Medina-Lara A, Auray JP, De Wever A, Praet JC, Tarricone R, Torbica A, Dupont D, Lamure M, Duru G. Validation of the underlying assumptions of the quality-adjusted life-years outcome: results from the ECHOUTCOME European project. PHARMACOECONOMICS 2015; 33:61-9. [PMID: 25230587 DOI: 10.1007/s40273-014-0216-0] [Citation(s) in RCA: 34] [Impact Index Per Article: 3.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 05/20/2023]
Abstract
BACKGROUND Quality-adjusted life-years (QALYs) have been used since the 1980s as a standard health outcome measure for conducting cost-utility analyses, which are often inadequately labeled as 'cost-effectiveness analyses'. This synthetic outcome, which combines the quantity of life lived with its quality expressed as a preference score, is currently recommended as reference case by some health technology assessment (HTA) agencies. While critics of the QALY approach have expressed concerns about equity and ethical issues, surprisingly, very few have tested the basic methodological assumptions supporting the QALY equation so as to establish its scientific validity. OBJECTIVES The main objective of the ECHOUTCOME European project was to test the validity of the underlying assumptions of the QALY outcome and its relevance in health decision making. METHODS An experiment has been conducted with 1,361 subjects from Belgium, France, Italy, and the UK. The subjects were asked to express their preferences regarding various hypothetical health states derived from combining different health states with time durations in order to compare observed utility values of the couples (health state, time) and calculated utility values using the QALY formula. RESULTS Observed and calculated utility values of the couples (health state, time) were significantly different, confirming that preferences expressed by the respondents were not consistent with the QALY theoretical assumptions. CONCLUSIONS This European study contributes to establishing that the QALY multiplicative model is an invalid measure. This explains why costs/QALY estimates may vary greatly, leading to inconsistent recommendations relevant to providing access to innovative medicines and health technologies. HTA agencies should consider other more robust methodological approaches to guide reimbursement decisions.
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Affiliation(s)
- Ariel Beresniak
- Data Mining International, Route de l'Aéroport, 29-31, CP 221, 1215, Geneva 15, Switzerland,
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Leverkus F. [Methodology for analysing quality-of-life data in the benefit assessment of pharmaceuticals]. ZEITSCHRIFT FUR EVIDENZ, FORTBILDUNG UND QUALITAT IM GESUNDHEITSWESEN 2014; 108:111-9. [PMID: 24780708 DOI: 10.1016/j.zefq.2014.02.008] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/29/2022]
Abstract
Early benefit assessment aims to prove a benefit of a new pharmaceutical over the appropriate comparator based on patient-relevant endpoints. In addition to mortality and morbidity, quality of life is a patient-relevant endpoint. Thus, phase III clinical trials are the basis of evidence. But HTA and health authorities attach different importance to quality of life. Using the example of oncology, the challenges with study design and analysis will be discussed. A particular challenge to the analysis of quality-of-life data is varying observation times in treatment arms with different effectiveness. Based on the example of Crizotinib possible solutions will be presented.
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Sumner W, Ding E, Fischer ID, Hagen MD. Methods for Performing Survival Curve Quality-of-Life Assessments. Med Decis Making 2014; 34:787-99. [PMID: 24449432 DOI: 10.1177/0272989x13514775] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/18/2013] [Accepted: 11/02/2013] [Indexed: 11/15/2022]
Abstract
BACKGROUND Many medical decisions involve an implied choice between alternative survival curves, typically with differing quality of life. Common preference assessment methods neglect this structure, creating some risk of distortions. METHODS Survival curve quality-of-life assessments (SQLA) were developed from Gompertz survival curves fitting the general population's survival. An algorithm was developed to generate relative discount rate-utility (DRU) functions from a standard survival curve and health state and an equally attractive alternative curve and state. A least means squared distance algorithm was developed to describe how nearly 3 or more DRU functions intersect. These techniques were implemented in a program called X-Trade and tested. RESULTS SQLA scenarios can portray realistic treatment choices. A side effect scenario portrays one prototypical choice, to extend life while experiencing some loss, such as an amputation. A risky treatment scenario portrays procedures with an initial mortality risk. A time trade scenario mimics conventional time tradeoffs. Each SQLA scenario yields DRU functions with distinctive shapes, such as sigmoid curves or vertical lines. One SQLA can imply a discount rate or utility if the other value is known and both values are temporally stable. Two SQLA exercises imply a unique discount rate and utility if the inferred DRU functions intersect. Three or more SQLA results can quantify uncertainty or inconsistency in discount rate and utility estimates. Pilot studies suggested that many subjects could learn to interpret survival curves and do SQLA. LIMITATIONS SQLA confuse some people. Compared with SQLA, standard gambles quantify very low utilities more easily, and time tradeoffs are simpler for high utilities. When discount rates approach zero, time tradeoffs are as informative and easier to do than SQLA. CONCLUSIONS SQLA may complement conventional utility assessment methods.
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Affiliation(s)
- Walton Sumner
- Department of Internal Medicine, Washington University School of Medicine, St. Louis, MO, USA (WS, IDF)
| | - Eric Ding
- American Board of Family Medicine, Inc., Lexington, KY, USA (ED, MDH)
| | - Irene D Fischer
- Department of Internal Medicine, Washington University School of Medicine, St. Louis, MO, USA (WS, IDF)
| | - Michael D Hagen
- American Board of Family Medicine, Inc., Lexington, KY, USA (ED, MDH),Department of Family and Community Medicine, University of Kentucky College of Medicine, Lexington, KY, USA (MDH)
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18
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Bryła M, Burzyńska M, Maniecka-Bryła I. Self-rated quality of life of city-dwelling elderly people benefitting from social help: results of a cross-sectional study. Health Qual Life Outcomes 2013; 11:181. [PMID: 24168471 PMCID: PMC3819270 DOI: 10.1186/1477-7525-11-181] [Citation(s) in RCA: 29] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/22/2013] [Accepted: 10/24/2013] [Indexed: 11/21/2022] Open
Abstract
Background The percentage of people aged 65 or older living in Poland is 13.6%, but 17.2% in Łódź. The aim of the study was to identify factors correlating with the self-rated quality of life of elderly inhabitants of cities applying for social help, on the basis of a cross-sectional study. Methods The study was conducted in Łódź, a large Polish city, between September 2011 and February 2012 in a group of people applying for help in the Municipal Social Welfare Centre. Four hundred and sixty-six respondents aged 65 or older were included in the study. The tool used in the study was an interview questionnaire. The respondents answered questions on their demographic situation, living conditions, financial, health and social situation. The authors also applied the WHOQOL-BREF Questionnaire, the Activities of Daily Living Scale (ADL) and the Geriatric Depression Scale (GSOD). For statistical purposes, the authors used single- and multiple-factor regression and the Statistica 9.0 Program. The results were presented as an odds ratio (OR) with a 95% confidence interval (CI); the adopted significance level was p < 0.05. The authors applied the Pearson’s x2 test in order to evaluate the structure of the studied group and the subpopulation, who were aged 65 or older and using social help, throughout the city. Results Logistic regression confirmed that a high quality of life depends on the following variables: university education (OR = 2.31; p < 0.05), an income which is sufficient to live (OR = 1.63; p < 0.05), no heart palpitations (OR = 2.32; p < 0.05), stable blood pressure (OR = 2.32; p < 0.05), no headaches (OR = 1.55; p < 0.05), no pain in the chest (OR = 1.51; p < 0.01), no shortness of breath (OR = 1.51; p < 0.01), no tiredness (OR = 2.08; p < 0.05), a score on the Geriatric Depression Scale pointing to a lack of suspected depression (OR = 9.88; p < 0.001 if the person does not suffer from depression and OR = 6.33; p < 0.001 if there is uncertain depression) as well as not using nursing services, a score on the ADL Scale confirming the person’s fitness and participation in family gatherings. Conclusions A subjective evaluation of the quality of life of the elderly depends on many factors. An identification of these factors might be helpful in implementing steps aimed at improving the quality of life of elderly people who, as a consequence, will need less social help: particularly nursing services.
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Esser A, Gube M, Schettgen T, Kraus T, Lang J. QALY as evaluation tool in a health surveillance program. Int J Hyg Environ Health 2013; 217:399-404. [PMID: 24054544 DOI: 10.1016/j.ijheh.2013.07.014] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/15/2012] [Revised: 07/17/2013] [Accepted: 07/29/2013] [Indexed: 10/26/2022]
Abstract
BACKGROUND Quality adjusted life years (QALYs), based on health related quality of life (HRQL), are a commonly used concept in health economics. The aim of this study was to apply the concept of QALY to the evaluation of a surveillance program for health related effects of PCB exposure and measure the impact of occupational PCB-exposure on the remaining QALYs of participants. METHODS The internal PCB exposure was determined by gas chromatography with mass spectrometry in plasma. The HRQOL was assessed via the EQ-5D-3L instrument and combined with the remaining lifetime (RLE) at the time point of cessation of exposure. For comparative reasons we used both the linear calculation and the complex-number-model from Prieto and Sacristan. The impact of several PCB congeners was regressed on the percentage of discounted QALYs on RLE via hierarchical multiple regression, controlling for gender, relational and educational status. RESULTS Findings were able to detect a small but significant effect of elevated plasma levels of PCB on QALY for the linear calculation and partially for the complex number calculation. This means that an internal exposure to PCB reduced HRQOL in the RLE of participants in the surveillance program. CONCLUSION QALYs can be applied successfully to monitor HRQL effects in surveillance programs. The exposure to a hazardous substance has an influence on QALYs. Findings have to be interpreted as a first hint. In the following assessment it has to be monitored whether there is an improvement or worsening of HRQL.
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Affiliation(s)
- André Esser
- Institute for Occupational Medicine and Social Medicine, RWTH Aachen University, Aachen, Germany(1).
| | - Monika Gube
- Institute for Occupational Medicine and Social Medicine, RWTH Aachen University, Aachen, Germany(1)
| | - Thomas Schettgen
- Institute for Occupational Medicine and Social Medicine, RWTH Aachen University, Aachen, Germany(1)
| | - Thomas Kraus
- Institute for Occupational Medicine and Social Medicine, RWTH Aachen University, Aachen, Germany(1)
| | - Jessica Lang
- Institute for Occupational Medicine and Social Medicine, RWTH Aachen University, Aachen, Germany(1)
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Beresniak A, Sabatier B, Achouh P, Menasché P, Fabiani JN. Cost-effectiveness of mitral valve repair versus replacement by biologic or mechanical prosthesis. Ann Thorac Surg 2012; 95:98-104. [PMID: 23063201 DOI: 10.1016/j.athoracsur.2012.08.005] [Citation(s) in RCA: 12] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/22/2012] [Revised: 07/26/2012] [Accepted: 08/01/2012] [Indexed: 11/18/2022]
Abstract
BACKGROUND Surgical treatment strategies for mitral valve disease have progressively shifted toward repair given the better survival outcomes with this type of intervention. However, valve repairs and valve replacement may require reoperations with time. In the absence of clinical trials assessing the effectiveness of various mitral surgical treatments with time, we propose to develop cost-effectiveness models to compare sequential treatment strategies. METHODS Three simulation models were carried out to assess the cost-effectiveness of mitral valve repair as first-line treatment, compared with either mechanical or biologic valve replacements. Efficacy data were derived from both the published literature and from a specific clinical cohort of 582 patients treated for this condition. Using the French public health care system perspective, relevant direct costs were derived using a local resource utilization assessment and official costing data sources. RESULTS Over 10 years, costs per success were significantly lower (p < 0.01) for the mitral valve repair strategy versus biologic or mechanical valve replacements (€35,550, €49,492, and €54,634 per success, respectively). Over 20 years, costs per success were significantly lower (p < 0.01) for the mechanical valve replacement strategy compared with the mitral valve repair and biologic valve replacement (€94,763, €100,053, and €147,484 per success, respectively). CONCLUSIONS Considering the increased referral rate in older patients with degenerative mitral valve disease, and their shorter life expectancy, these results show that when medically required and technically practicable, mitral valve repair should be considered as the first-line strategy.
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21
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Bosanquet N, Domenighetti G, Beresniak A, Auray JP, Crivelli L, Richard L, Howard P. Equity, Access and Economic Evaluation in Rare Diseases. ACTA ACUST UNITED AC 2012. [DOI: 10.1007/bf03257374] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/27/2022]
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Lucidarme O, Cadi M, Berger G, Taieb J, Poynard T, Grenier P, Beresniak A. Cost-effectiveness modeling of colorectal cancer: Computed tomography colonography vs colonoscopy or fecal occult blood tests. Eur J Radiol 2012; 81:1413-9. [DOI: 10.1016/j.ejrad.2011.03.027] [Citation(s) in RCA: 11] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/21/2011] [Accepted: 03/07/2011] [Indexed: 11/28/2022]
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Puolakka K, Blåfield H, Kauppi M, Luosujärvi R, Peltomaa R, Leikola-Pelho T, Sennfalt K, Beresniak A. Cost-effectiveness modelling of sequential biologic strategies for the treatment of moderate to severe rheumatoid arthritis in Finland. Open Rheumatol J 2012; 6:38-43. [PMID: 22582103 PMCID: PMC3349947 DOI: 10.2174/1874312901206010038] [Citation(s) in RCA: 18] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/21/2011] [Revised: 02/20/2012] [Accepted: 02/28/2012] [Indexed: 11/25/2022] Open
Abstract
Objective:
The main objective was to compare the cost-effectiveness of therapeutic options in moderate or severe rheumatoid arthritis (RA) when a clinical response to a first TNF-blocker, either etanercept (ETA), adalimumab (ADA), or infliximab (INF), is insufficient. Methods:
Effectiveness criteria were defined as remission (RS), low disease activity (LDAS), and moderate to high disease activity (MHDAS). Cost-effectiveness was derived as cost per day in RS and in LDAS using simulation modelling to assess six sequential biologic strategies over 2 years. Each sequential treatment strategy was composed of three biologic agents and included a first anti-TNF agent, ETA, ADA or INF, followed by either abatacept (ABA) or rituximab (RTX) as a second therapeutic option in case of an insufficient response, followed by another anti-TNF agent in case of further insufficient response. Results:
Over two years and taking into account biologic costs, the following estimated mean costs per day in RS and LDAS were respectively of €829 and €428 for the biologic sequence composed of ADA-ABA-ETA, €1292 and €516 for the sequence ADA-RTX-ETA, €829 and €429 for the sequence ETA-ABA-ADA, €1292 and €517 for the sequence ETARTX- ADA, €840 and €434 for the sequence INF-ABA-ETA, and €1309 and €523 for the sequence INF-RTX-ETA. Conclusion:
The treatment sequences including ABA as the second biologic option appear more cost-effective than those including RTX in a patients with moderate to severe RA and an insufficient response to a first anti-TNF agent.
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Affiliation(s)
- K Puolakka
- Lappeenranta Central Hospital, Lappeenranta, Finland
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Beresniak A, Ariza-Ariza R, Garcia-Llorente JF, Ramirez-Arellano A, Dupont D. Modelling cost-effectiveness of biologic treatments based on disease activity scores for the management of rheumatoid arthritis in Spain. Int J Inflam 2011; 2011:727634. [PMID: 21785694 PMCID: PMC3139138 DOI: 10.4061/2011/727634] [Citation(s) in RCA: 24] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/14/2011] [Accepted: 05/02/2011] [Indexed: 12/03/2022] Open
Abstract
Background. The objective of this simulation model was to assess the cost-effectiveness of different biological treatment strategies based on levels of disease activity in Spain, in patients with moderate to severe active RA and an insufficient response to at least one anti-TNF agent. Methods. Clinically meaningful effectiveness criteria were defined using DAS28 scores: remission and Low Disease Activity State (LDAS) thresholds. Monte-Carlo simulations were conducted to assess cost-effectiveness over 2 years of four biological sequential strategies composed of anti-TNF agents (adalimumab, infliximab), abatacept or rituximab, in patients with moderate to severe active RA and an insufficient response to etanercept as first biological agent. Results. The sequential strategy including etanercept, abatacept and adalimumab appeared more efficacious over 2 years (102 days in LDAS) compared to the same sequence including rituximab as second biological option (82 days in LDAS). Cost-effectiveness ratios showed lower costs per day in LDAS with abatacept (427 €) compared to rituximab as second biological option (508 €). All comparisons were confirmed when using remission criteria. Conclusion. Model results suggest that in patients with an insufficient response to anti-TNF agents, the biological sequences including abatacept appear more efficacious and cost-effective than similar sequences including rituximab or cycled anti-TNF agents.
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Weyler EJ, Gandjour A. Empirical validation of patient versus population preferences in calculating QALYs. Health Serv Res 2011; 46:1562-74. [PMID: 21517837 DOI: 10.1111/j.1475-6773.2011.01268.x] [Citation(s) in RCA: 10] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/29/2022] Open
Abstract
A fundamental assumption of the quality-adjusted life year model is mutual utility independence between life years and health status. However, this assumption may not hold for severe health states: living in a severe health state may cause disutility beyond a so-called maximal endurable time (MET). It is unknown, however, whether persons without experience of a disease, who are often used in health state valuation exercises, account for MET. Using data from 159 respondents from two convenience samples in Germany who were presented a health state description of depression, this study shows that persons without experience of depression had a lower rate of MET than persons with a history of depression. Furthermore, they had more preference reversals in case of MET, thus violating a fundamental principle of rational choice theory. While these findings suggest that severe health states should be assessed by patients rather than the community, confirmation in additional studies outside Germany and based on other health-state valuation techniques and diseases is recommended.
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Affiliation(s)
- Eva-Julia Weyler
- Faculty of Management, Economics, and Social Sciences, University of Cologne, Cologne, Germany
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26
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Fennessy FM, Kong CY, Tempany CM, Swan JS. Quality-of-life assessment of fibroid treatment options and outcomes. Radiology 2011; 259:785-92. [PMID: 21364084 DOI: 10.1148/radiol.11100704] [Citation(s) in RCA: 27] [Impact Index Per Article: 1.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/11/2022]
Abstract
PURPOSE To obtain utilities (a unit of measure of a person's relative preferences for different health states compared with death or worst possible outcome) for uterine fibroids before and after treatment and to measure short-term utilities for the following uterine fibroid treatments: abdominal hysterectomy, magnetic resonance (MR) imaging-guided focused ultrasound surgery, and uterine artery embolization (UAE). MATERIALS AND METHODS This retrospective study was approved by the institutional review board and was HIPAA compliant. The waiting trade-off (WTO) method, a variation on the time trade-off (TTO) method, is used to obtain utilities for diagnostic procedures on the basis of the fact that people wait longer to avoid noxious tests and/or procedures. The WTO method provides short-term quality of life tolls in terms of quality-adjusted life-weeks by scaling wait times with pre- and posttreatment utilities. Utilities for uterine fibroids before and after treatment were obtained with the TTO method and a visual analog scale (VAS) by using a questionnaire administered by means of a phone interview. WTO wait times were adjusted for quality of life with VAS and TTO utilities and a transformation of VAS. Wait times were compared by using nonparametric tests. The study participants included 62 patients who had undergone abdominal hysterectomy, 74 who had undergone UAE, and 61 who had undergone MR imaging-guided focused ultrasound surgery. RESULTS Quality of life increased with all treatments. The median WTO wait time was higher for hysterectomy (21.6 weeks) than for UAE or MR imaging-guided focused ultrasound surgery (14.1 weeks for both) (P < .05). Quality-adjusted life-week tolls were smaller when scaled according to TTO than when scaled according to VAS or transformation of VAS. CONCLUSION Quality of life increased after all fibroid treatments. WTO is feasible for assessing the quality-adjusted morbidity of treatment procedures. SUPPLEMENTAL MATERIAL http://radiology.rsna.org/lookup/suppl/doi:10.1148/radiol.11100704/-/DC1.
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Affiliation(s)
- Fiona M Fennessy
- Department of Radiology, Brigham and Women's Hospital, Harvard Medical School, 75 Francis St, Boston, MA 02115, USA.
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Brentani A, de Castro G, Federico MH. Cost-effectiveness analysis of cisplatin-based chemoradiation to treat patients with unresectable, nonmetastatic head and neck cancer in Brazil. Head Neck 2010; 33:1199-205. [DOI: 10.1002/hed.21601] [Citation(s) in RCA: 9] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/07/2010] [Revised: 07/26/2010] [Accepted: 07/29/2010] [Indexed: 11/10/2022] Open
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Cost-effectiveness modelling of biological treatment sequences in moderate to severe rheumatoid arthritis in France. Rheumatology (Oxford) 2010; 49:733-40. [DOI: 10.1093/rheumatology/kep434] [Citation(s) in RCA: 29] [Impact Index Per Article: 1.9] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/15/2022] Open
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Bensmail D, Ward AB, Wissel J, Motta F, Saltuari L, Lissens J, Cros S, Beresniak A. Cost-effectiveness modeling of intrathecal baclofen therapy versus other interventions for disabling spasticity. Neurorehabil Neural Repair 2009; 23:546-52. [PMID: 19228818 DOI: 10.1177/1545968308328724] [Citation(s) in RCA: 42] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/16/2022]
Abstract
OBJECTIVE To assess by simulation the cost-effectiveness of intrathecal baclofen (ITB) therapy compared with conventional medical treatments for patients with disabling spasticity and functional dependence caused by any neurological disease. METHODS Two models were created to simulate therapeutic strategies for managing severe spasticity, one with and one without the use of ITB, to assess various treatment sequences over 2 years based on current medical practices in France. Successful treatment at each evaluation was defined as a combination of: (1) the increased patient and caregiver satisfaction as assessed by goal attainment scaling (GAS), and (2) a decrease of at least 1 point on the Ashworth score. Probabilistic sensitivity analyses were performed using 5000 Monte-Carlo simulations taking into account specific distribution curves for direct costs and effectiveness parameters in each treatment option. RESULTS The model simulations suggest that including ITB as a first option strategy in the management of function of severely impaired patients with disabling spasticity results in a higher success rate (78.7% vs 59.3%; P < .001). In addition, the ITB therapy model revealed a lower cost (pound 59,391 vs pound 88,272; P < .001) and an overall more favorable cost-effectiveness ratio (pound 75,204/success vs pound 148,822/success; P < .001), compared with conventional medical management without ITB. CONCLUSION Within the assumptions of our modeling, ITB therapy evaluated by a combination of treatment success criteria at 6-month intervals over a 2-year period may be a cost-effective strategy compared to conventional medical management alone.
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Affiliation(s)
- D Bensmail
- Department of Physical Medicine and Rehabilitation, Groupe Hospitalier R. Poincaré-Hôpital Maritime de Berck, AP-HP, Versailles-Saint Quentin University, Garches, France
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Felli JC, Noel RA, Cavazzoni PA. A Multiattribute Model for Evaluating the Benefit-Risk Profiles of Treatment Alternatives. Med Decis Making 2009; 29:104-15. [DOI: 10.1177/0272989x08323299] [Citation(s) in RCA: 46] [Impact Index Per Article: 2.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/15/2022]
Abstract
The assessment of the benefits and risks associated with a medicine's use requires careful consideration of a wealth of information of varying format and quality, ranging from efficacy and safety data derived from randomized clinical trials to statistical results from health outcomes studies to spontaneously reported adverse events. Contrary to the expectations of patients, physicians, and regulators, the literature offers little guidance as to how to strike an appropriate balance between benefit and risk. Although a qualitative listing of a medicine's benefits and risks is useful, much could be gained from a systematic and transparent process to evaluate a medicine's pre- and postmarketing performance. The authors propose a representational model based on multicriteria decision analysis that can incorporate both evaluative judgments from different perspectives (e.g., physician, patient) and quantitative data to inform tradeoffs between multiple benefit and multiple risk elements in a logically consistent and transparent manner. The model is designed to highlight the relative merits and deficits of treatment alternatives in well-defined and specific contexts. It is intended to serve as a common platform to facilitate focused benefit-risk tradeoff discussions between scientists, physicians, regulatory authorities, and pharmaceutical companies, and to assist in the communication of clear and consistent messages regarding those tradeoffs.
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Gabbay E, Meyer KB. Identifying critically ill patients with acute kidney injury for whom renal replacement therapy is inappropriate: an exercise in futility? NDT Plus 2008; 2:97-103. [PMID: 25949304 PMCID: PMC4421337 DOI: 10.1093/ndtplus/sfn196] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/27/2008] [Accepted: 11/27/2008] [Indexed: 01/05/2023] Open
Abstract
Clinicians treating critically ill patients must consider the possibility that painful and expensive aggressive treatments might confer negligible benefit. Such treatments are often described as futile or inappropriate. We discuss the problem of deciding whether to initiate renal replacement therapy (RRT) for critically ill patients with acute kidney injury (AKI) in the context of the debate surrounding medical futility. The main problems in deciding when such treatment would be futile are that the concept itself is controversial and eludes quantitative definition, that available outcome data do not allow confident identification of patients who will not benefit from treatment and that the decision on RRT in a critically ill patient with AKI is qualitatively different from decisions on other modalities of intensive care and resuscitation, as well as from decisions on dialysis for chronic kidney disease. Despite these difficulties, nephrologists need to identify circumstances in which continued aggressive care would be futile before proceeding to initiate RRT.
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Affiliation(s)
- Ezra Gabbay
- Division of Nephrology, Tufts Medical Center, Boston, MA, 02111 , USA
| | - Klemens B Meyer
- Division of Nephrology, Tufts Medical Center, Boston, MA, 02111 , USA
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Cost-effectiveness modeling of abatacept versus other biologic agents in DMARDS and anti-TNF inadequate responders for the management of moderate to severe rheumatoid arthritis. Clin Rheumatol 2008; 28:403-12. [DOI: 10.1007/s10067-008-1060-4] [Citation(s) in RCA: 24] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/05/2008] [Revised: 10/02/2008] [Accepted: 11/18/2008] [Indexed: 10/21/2022]
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Cohen SY, Bremond-Gignac D, Quentel G, Mimoun G, Citterio T, Bisot-Locard S, Beresniak A. Cost-effectiveness sequential modeling of ranibizumab versus usual care in age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol 2008; 246:1527-34. [PMID: 18642019 DOI: 10.1007/s00417-008-0890-8] [Citation(s) in RCA: 14] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/14/2008] [Revised: 06/09/2008] [Accepted: 06/11/2008] [Indexed: 10/21/2022] Open
Abstract
AIMS To assess effectiveness, cost, and cost-effectiveness of ranibizumab versus the current medical practices of treating age-related macular degeneration in France. METHODS A simulation decision framework over 1 year compared ranibizumab versus the usual care using two effectiveness criteria: the "visual acuity improvement rate" (greater than 15 letters on the ETDRS scale) and the "rate of legal blindness avoided". Two decision trees included various sequences of current treatments, with or without ranibizumab. RESULTS Ranibizumab appeared significantly more effective than the usual care (p < 0.001), providing greater treatment success rate of visual acuity improvement (48.8% versus 33.9%). The cost of the ranibizumab strategy was higher (9,123 euros over 1 year for ranibizumab versus 7,604 euros for the usual care) but the average cost-effectiveness was lower--18,721 euros/success for ranibizumab versus 22,543 euros/success for usual care (p < 0.001). Considering the "legal blindness avoided" success criterion, the ranibizumab strategy appeared significantly more effective (p < 0.001), providing greater treatment success rate for of legal blindness avoided than usual care (99.7% versus 93.1%) although it was more expensive (9,196 euros over 1 year for ranibizumab versus 5,713 euros for the usual care). CONCLUSION Ranibizumab significantly improved the rate of visual acuity improvement and reduced the rate of legal blindness. Ranibizumab appeared significantly more cost-effective than the usual treatments in terms of visual acuity improvement.
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Affiliation(s)
- S Y Cohen
- Centre Ophtalmologique d'Imagerie et de Laser, Paris, France
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Bansback N, Harrison M, Brazier J, Davies L, Kopec J, Marra C, Symmons D, Anis A. Health state utility values: a description of their development and application for rheumatic diseases. ARTHRITIS AND RHEUMATISM 2008; 59:1018-26. [PMID: 18576311 DOI: 10.1002/art.23813] [Citation(s) in RCA: 20] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [MESH Headings] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/09/2022]
Affiliation(s)
- Nick Bansback
- Centre for Health Evaluation and Outcome Sciences, Vancouver, British Columbia, Canada
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Abstract
Rheumatoid arthritis (RA) is a chronic and lifelong autoimmune disorder that results in significant pain, disability and excess mortality if untreated or inadequately treated. Quality-of-life (QOL) assessments are particularly important in the absence of a cure for RA. Generic and disease-specific patient-reported QOL instruments, such as the Health Assessment Questionnaire (HAQ) Disability Index and the SF-36, have proven validity and sensitivity for assessment of changes in QOL in clinical trials of disease-modifying anti-rheumatic drugs (DMARDs). However, these instruments are rarely utilized in clinical practice, and patients have reported that the actual clinical assessments alone do not address important parameters, such as fatigue and disturbed sleep, which significantly affect QOL.New biological DMARDs have shown significant efficacy in improving clinical and QOL parameters in randomized controlled trials. However, the high cost of biological DMARDs compared with non-biological DMARDs is a factor in the increasing health costs associated with the treatment of RA. Generic health utility instruments that measure QOL parameters enable calculation of the increased QALYs associated with more costly treatment in patients with RA. The costs per QALY associated with biological DMARDs in RA appear to be comparable to those of other accepted medical interventions. Interest in incorporating QOL parameters in formulary and public health decision making concerning the use of new agents for RA is increasing.
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Affiliation(s)
- Anthony S Russell
- Rheumatic Disease Unit, Heritage Medical Research Centre, University of Alberta, Edmonton, Alberta, Canada.
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Vasiliadis HM, Collet JP, Penrod JR, Ferraro P, Poirier C. A cost-effectiveness and cost-utility study of lung transplantation. J Heart Lung Transplant 2006; 24:1275-83. [PMID: 16143245 DOI: 10.1016/j.healun.2004.10.012] [Citation(s) in RCA: 31] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/09/2004] [Revised: 10/11/2004] [Accepted: 10/11/2004] [Indexed: 11/19/2022] Open
Abstract
BACKGROUND Life-threatening complications and expensive posttransplantation medical care raises the issue whether lung transplantation (L-Tx) is cost effective. We studied, from a health care system perspective, the cost effectiveness (C/E) and cost utility (C/U) of L-Tx in a Canadian setting. METHODS An incremental C/E and C/U analysis of L-Tx, compared with the waiting list (WL), was carried out on 124 patients accepted into the Quebec L-Tx WL (1997-2001). Survival was presented in mean life-years (LYs). Utility, assessed with the standard gamble, was used in computing the quality-adjusted life-years (QALY). Different person-time experiences were simulated. Costs (95% confidence interval), in US dollars, were discounted at 5%. RESULTS The mean LYs and QALYs gained were 0.57 (0.36-0.78) and 0.62 (0.36-0.78), respectively. The cost per patient without Tx was 1102 dollars (856 dollars-1348 dollars) per month. The L-Tx program induced a screening cost of 6208 dollars per patient. The cost of the L-Tx procedure (n = 91) was 31,815 dollars (25,301 dollars-44,816 dollars). The post-Tx cost per month in the first, second, third, and fourth year was 1809 dollars dollars (1187 dollars-2446 dollars), 1060 dollars (703 dollars-1478 dollars), 1128 dollars (519 dollars-1735 dollars), and 626 dollars (495 dollars-758 dollars), respectively. The projected C/E and C/U of the L-Tx program, assessed on the basis of pre- and post-Tx extrapolations, reached 40,048 dollars and 46,631 dollars, respectively. CONCLUSIONS L-Tx in this Canadian setting yielded a benefit in mean LYs and QALYs gained. Although the program is expensive, the C/E and C/U ratios for some patient groups prove to be an acceptable cost for the benefits observed.
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Abstract
This paper considers how health economists can assist nurse managers, using the concepts and tools of economic evaluation. We aim to clarify these and also explode some of the myths about economic evaluation and its role in health care decision-making. Economic evaluation techniques compare alternative courses of action in terms of their costs and consequences. There are four principal methods; cost-minimization, cost-effectiveness, cost-utility and cost-benefit analysis, all of which synthesize costs and outcomes, at different levels of outcome. Economic evaluation is an intrinsic part of national decision-making about the efficient provision of effective treatments and services, and increasingly, organizational matters. In the UK, such technology evaluation is disseminated in guidelines from the National Institute for Clinical Effectiveness (NICE), having a top-down impact on the nurse manager. But economic evaluation is increasingly relevant to the nurse manager at local level, through newer techniques such as Programme Budgeting Marginal Analysis (PBMA), which facilitates explicit, transparent decisions, from the bottom-up. Nurse managers need to weigh up competing demands on resources and decide in ways which maximize health gain. Economic evaluation can help here because it presents evidence to challenge or support existing allocations, and provides a systematic framework to analyse health care decisions. In the current context of competition for scarce resources, we suggest that nurse managers need to embrace these techniques, or be marginalized from the resource allocation process.
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Abstract
In multiple sclerosis, evaluation of quality of life is important because the patients are usually confronted with a decrease in physical, cognitive and social functioning. Apart from the personal suffering, the financial consequences for these patients and their family and the economic burden for society are enormous. Measurement of health related quality of life is important for the understanding of disease burden and the impact of specific MS treatments. Rising costs associated with new treatments and spending limits have prompted a search for gratter efficiency. Although health economics research can suggest ways to maximize health benefits within fixed budgets it is currently underused in MS. The purpose of this review of the literature is to explain some of the basic principles underlying both quality of life and economic evaluations, and analyse their contribution to understanding and managing patients with MS. Neurologists should not underestimate how dramatic their contributions can be to this maturing field that will influence the future of MS patients care.
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Affiliation(s)
- J Grimaud
- Laboratoire d'Analyse des Systèmes de Santé, Université Claude-Bernard, Bâtiment du Doyen Braconnier, 27-29 Boulevard du 11 Novembre 1918, 69622 Villeurbanne cedex.
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Prieto L, Sacristán JA. Problems and solutions in calculating quality-adjusted life years (QALYs). Health Qual Life Outcomes 2003. [PMID: 14687421 DOI: 10.1186/1477-7525-1-80.] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.0] [Reference Citation Analysis] [Abstract] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/10/2022] Open
Abstract
The quality-adjusted life-year (QALY) is a measure of the value of health outcomes. Since health is a function of length of life and quality of life, the QALY was developed as an attempt to combine the value of these attributes into a single index number. The QALY calculation is simple: the change in utility value induced by the treatment is multiplied by the duration of the treatment effect to provide the number of QALYs gained. QALYs can then be incorporated with medical costs to arrive at a final common denominator of cost/QALY. This parameter can be used to compare the cost-effectiveness of any treatment. Nevertheless, QALYs have been criticised on technical and ethical grounds. A salient problem relies on the numerical nature of its constituent parts. The appropriateness of the QALY arithmetical operation is compromised by the essence of the utility scale: while life-years are expressed in a ratio scale with a true zero, the utility is an interval scale where 0 is an arbitrary value for death. In order to be able to obtain coherent results, both scales would have to be expressed in the same units of measurement. The different nature of these two factors jeopardises the meaning and interpretation of QALYs. A simple general linear transformation of the utility scale suffices to demonstrate that the results of the multiplication are not invariant. Mathematically, the solution to these limitations happens through an alternative calculation of QALYs by means of operations with complex numbers rooted in the well known Pythagorean theorem. Through a series of examples, the new calculation arithmetic is introduced and discussed.
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Affiliation(s)
- Luis Prieto
- Health Outcomes Research Unit, Eli Lilly & Co, Spain, Av, de Industria 30, 28108 Alcobendas, Spain.
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Prieto L, Sacristán JA. Problems and solutions in calculating quality-adjusted life years (QALYs). Health Qual Life Outcomes 2003; 1:80. [PMID: 14687421 PMCID: PMC317370 DOI: 10.1186/1477-7525-1-80] [Citation(s) in RCA: 201] [Impact Index Per Article: 9.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/22/2003] [Accepted: 12/19/2003] [Indexed: 12/17/2022] Open
Abstract
The quality-adjusted life-year (QALY) is a measure of the value of health outcomes. Since health is a function of length of life and quality of life, the QALY was developed as an attempt to combine the value of these attributes into a single index number. The QALY calculation is simple: the change in utility value induced by the treatment is multiplied by the duration of the treatment effect to provide the number of QALYs gained. QALYs can then be incorporated with medical costs to arrive at a final common denominator of cost/QALY. This parameter can be used to compare the cost-effectiveness of any treatment. Nevertheless, QALYs have been criticised on technical and ethical grounds. A salient problem relies on the numerical nature of its constituent parts. The appropriateness of the QALY arithmetical operation is compromised by the essence of the utility scale: while life-years are expressed in a ratio scale with a true zero, the utility is an interval scale where 0 is an arbitrary value for death. In order to be able to obtain coherent results, both scales would have to be expressed in the same units of measurement. The different nature of these two factors jeopardises the meaning and interpretation of QALYs. A simple general linear transformation of the utility scale suffices to demonstrate that the results of the multiplication are not invariant. Mathematically, the solution to these limitations happens through an alternative calculation of QALYs by means of operations with complex numbers rooted in the well known Pythagorean theorem. Through a series of examples, the new calculation arithmetic is introduced and discussed.
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Affiliation(s)
- Luis Prieto
- Health Outcomes Research Unit. Eli Lilly & Co. Spain. Av. de la Industria 30, 28108 Alcobendas, Spain
| | - José A Sacristán
- Health Outcomes Research Unit. Eli Lilly & Co. Spain. Av. de la Industria 30, 28108 Alcobendas, Spain
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