Assessing the Quality of Economic Evaluations of FDA Novel Drug Approvals

2016 ◽  
Vol 50 (12) ◽  
pp. 1028-1040
Author(s):  
Alex L. Woersching ◽  
Matthew E. Borrego ◽  
Dennis W. Raisch
Keyword(s):  
Economic Evaluation ◽  
Cost Effectiveness ◽  
Study Design ◽  
Cost Minimization ◽  
Cost Utility ◽  
Economic Evaluations ◽  
Study Quality ◽  
Novel Drugs ◽  
Quality Aspects

Objective: To systematically review and assess the quality of the novel drugs’ economic evaluation literature in print during the drugs’ early commercial availability following US regulatory approval. Data Sources: MEDLINE and the United Kingdom National Health Service Economic Evaluation Database were searched from 1946 through December 2011 for economic evaluations of the 50 novel drugs approved by the FDA in 2008 and 2009. Study Selection and Data Extraction: The inclusion criteria were English-language, peer-reviewed, original economic evaluations (cost-utility, cost-effectiveness, cost-minimization, and cost-benefit analyses). We extracted and analyzed data from 36 articles considering 19 of the 50 drugs. Two reviewers assessed each publication’s quality using the Quality of Health Economic Studies (QHES) instrument and summarized study quality on a 100-point scale. Data Synthesis: Study quality had a mean of 70.0 ± 16.2 QHES points. The only study characteristics associated with QHES score (with P < 0.05) were having used modeling or advanced statistics, 75.1 versus 61.9 without; using quality-adjusted life years as an outcome, 75.9 versus 64.7 without; and cost-utility versus cost-minimization analysis, 75.9 versus 58.7. Studies most often satisfied quality aspects about stating study design choices and least often satisfied aspects about justifying design choices. Conclusion: The reviewed literature considered a minority of the 2008-2009 novel drugs and had mixed study quality. Cost-effectiveness stakeholders might benefit from efforts to improve the quality and quantity of literature examining novel drugs. Editors and reviewers may support quality improvement by stringently imposing economic evaluation guidelines about justifying study design choices.

scholarly journals Systematic Review and Quality Evaluation of Pharmacoeconomic Studies on Traditional Chinese Medicines

2021 ◽  
Vol 9 ◽  
Author(s):  
Nan Yang ◽  
Huihui Zhang ◽  
Taoyi Deng ◽  
Jeff Jianfei Guo ◽  
Ming Hu
Keyword(s):  
Sample Size ◽  
Study Design ◽  
Design Research ◽  
Cost Minimization ◽  
Pharmacoeconomic Evaluation ◽  
Cost Utility ◽  
Quality Score ◽  
Future Research ◽  
Economic Evaluations

Objectives: This study was aimed to find and appraise the available published pharmacoeconomic research on Traditional Chinese Medicine (TCM), to identify related issues and make suggestions for improvement in future research.Methods: After developing a search strategy and establishing inclusion and exclusion criteria, pharmacoeconomic studies on TCM were sourced from seven Chinese and English databases from inception to April 2020. Basic information about the studies and key pharmacoeconomic items of each study were extracted. The quality of each study was evaluated by using the British Medical Journal economic submissions checklist for authors and peer reviewers, focusing on factors such as study design, research time horizon, sample size, perspective, and evaluation methods.Results: A total of 431 published pharmacoeconomic articles with 434 studies on topics including cost-effectiveness, cost-benefit, cost-minimization, cost-utility, or combination analyses were identified and included in this review. Of these, 424 were published in Chinese and 7 in English. These studies conducted economic evaluations of 264 Chinese patent medicines and 70 types of TCM prescriptions for 143 diseases, including those of the central nervous, cardiovascular, respiratory, gynecologyical, and other systems. The studied TCMs included blood-activating agents (such as Xuesaitong tablet, Fufant Danshen tablet, and Danhong Injection), blood circulation promoting agents (such as Shuxuetong injection, Rupixiao tablet, and Fufang Danshen injection), and other therapeutic agents. The overall quality score of the studies was 0.62 (range 0.38 to 0.85). The mean quality score of studies in English was 0.72, which was higher than that of studies in Chinese with 0.62.Conclusions: The quality of pharmacoeconomic studies on TCM was relatively, generally low. Major concerns included study design, inappropriate pharmacoeconomic evaluation, insufficient sample size, or non-scientific assessment. Enhanced methodological training and cooperation, the development of a targeted pharmacoeconomic evaluation guideline, and proposal of a reasonable health outcome index are warranted to improve quality of future studies.

Economic evaluations of videoconference and telephone consultations in primary care: A systematic review

2021 ◽  
pp. 1357633X2110433
Author(s):  
Keshia R De Guzman ◽  
Centaine L Snoswell ◽  
Liam J Caffery ◽  
Anthony C Smith
Keyword(s):  
Primary Care ◽  
Economic Evaluation ◽  
Cost Effectiveness ◽  
Cost Minimization ◽  
Health Economic Evaluation ◽  
Reporting Quality ◽  
Cost Effective ◽  
Cost Utility ◽  
Economic Evaluations ◽  
Published Evidence

Introduction Telehealth services using videoconference and telephone modalities have been increasing exponentially in primary care since the coronavirus pandemic. The challenge now is ensuring that these services remain sustainable. This review investigates the cost-effectiveness of videoconference and telephone consultations in primary care settings, by summarizing the available published evidence. Methods A systematic search of PubMed, Embase, Scopus, and CINAHL databases was used to identify articles published from January 2000 to July 2020, using keyword synonyms for telehealth, primary care, and economic evaluation. Databases were searched, and title, abstract, and full-text reviews were conducted. Article reporting quality was assessed using the Consolidated Health Economic Evaluation Reporting Standards checklist. Results Twenty articles were selected for inclusion, with 12 describing telephone triage services, seven describing telehealth substitution services, and one describing another telehealth service in primary care. These services were delivered by nurses, doctors, and allied health clinicians. Of the 20 included studies, 11 used cost analyses, five used cost-minimization analyses, and four used one or more methods, including either a cost–consequence analysis, a cost–utility analysis, or a cost-effectiveness analysis. Conclusions Telephone and videoconference consultations in primary care were cost-effective to the health system when deemed clinically appropriate, clinician when time was used efficiently, and when overall demand on health services was reduced. The societal benefits of telehealth consultations should be considered an important part of telehealth planning and should influence funding reform decisions for telehealth services in primary care.

scholarly journals Cost-effectiveness of treatment optimisation with biomarkers for immunotherapy in solid tumours: a systematic review protocol

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e048141
Author(s):  
Sara Mucherino ◽  
Valentina Lorenzoni ◽  
Valentina Orlando ◽  
Isotta Triulzi ◽  
Marzia Del Re ◽  
...  
Keyword(s):  
Systematic Review ◽  
Cost Effectiveness ◽  
Immune Checkpoint ◽  
Cost Utility ◽  
Solid Tumours ◽  
Economic Evaluations ◽  
Monetary Benefit ◽  
The Cost ◽  
Net Monetary Benefit

IntroductionThe combination of biomarkers and drugs is the subject of growing interest both from regulators, physicians and companies. This study protocol of a systematic review is aimed to describe available literature evidences about the cost-effectiveness, cost-utility or net-monetary benefit of the use of biomarkers in solid tumour as tools for customising immunotherapy to identify what further research needs.Methods and analysisA systematic review of the literature will be carried out according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement guidelines. PubMed and Embase will be queried from June 2010 to June 2021. The PICOS model will be applied: target population (P) will be patients with solid tumours treated with immune checkpoint inhibitors (ICIs); the interventions (I) will be test of the immune checkpoint predictive biomarkers; the comparator (C) will be any other targeted or non-targeted therapy; outcomes (O) evaluated will be health economic and clinical implications assessed in terms of incremental cost-effectiveness ratio, net health benefit, net monetary benefit, life years gained, quality of life, etc; study (S) considered will be economic evaluations reporting cost-effectiveness analysis, cost-utility analysis, net-monetary benefit. The quality of the evidence will be graded according to Grading of Recommendations Assessment, Development and Evaluation.Ethics and disseminationThis systematic review will assess the cost-effectiveness implications of using biomarkers in the immunotherapy with ICIs, which may help to understand whether this approach is widespread in real clinical practice. This research is exempt from ethics approval because the work is carried out on published documents. We will disseminate this protocol in a related peer-reviewed journal.PROSPERO registration numberCRD42020201549.

scholarly journals Economic Evaluations in the Canadian Mental Health System I: Theory behind Economic Evaluation*

1989 ◽  
Vol 34 (7) ◽  
pp. 633-636 ◽  
Author(s):  
Bruce J. Fried ◽  
Catherine Worthington ◽  
Raisa B. Deber
Keyword(s):  
Mental Health ◽  
Economic Evaluation ◽  
Health Program ◽  
Cost Benefit Analysis ◽  
Cost Benefit ◽  
Cost Utility ◽  
Economic Evaluations ◽  
Utility Analysis ◽  
Mental Health Programs

Economic evaluation is becoming an increasingly important part of the evaluation of health and mental health services. Current models for conducting economic evaluation, including cost-effectiveness analysis, cost-benefit analysis, and cost-utility analysis, have great potential for improving the quality of decision-making and for making mental health programs more effective and efficient. This paper presents the basic economic theory underlying the various forms of economic evaluation and provides general guidelines for developing and conducting an economic analysis of a health program.

Quality of economic evaluations of ventricular assist devices: A systematic review

2020 ◽  
Vol 36 (4) ◽  
pp. 380-387
Author(s):  
Sarah Fontenay ◽  
Lionel Catarino ◽  
Soumeya Snoussi ◽  
Hélène van den Brink ◽  
Judith Pineau ◽  
...  
Keyword(s):  
Systematic Review ◽  
Health Economic ◽  
Economic Evaluation ◽  
Cost Effectiveness ◽  
Health Economic Evaluation ◽  
Ventricular Assist Devices ◽  
Economic Evaluations ◽  
Level Of Evidence ◽  
Ventricular Assist

ObjectiveBecause of a lack of suitable heart donors, alternatives to transplantation are required. These alternatives can have high costs. The aim of this study was to perform a systematic review of cost-effectiveness studies of ventricular assist devices (VADs) and to assess the level of evidence of relevant studies. The purpose was not to present economic findings.MethodsA systematic review was performed using four electronic databases to identify health economic evaluation studies dealing with VADs. The methodological quality and reporting quality of the studies was assessed using three different tools, the Drummond, Cooper, and CHEERS (Consolidated Health Economic Evaluation Reporting Standards) checklists.ResultsOf the 1,258 publications identified, thirteen articles were included in this review. Twelve studies were cost–utility analyses and one was a cost-effectiveness analysis. According to the Cooper hierarchy scale, the quality of the data used was heterogeneous. The level of evidence used for clinical effect sizes, safety data, and baseline clinical data was of poor quality. In contrast, cost data were of high quality in most studies. Quality of reporting varied between studies, with an average score of 17.4 (range 15–19) according to the CHEERS checklist.ConclusionThe current study shows that the quality of clinical data used in economic evaluations of VADs is rather poor in general. This is a concern that deserves greater attention in the process of health technology assessment of medical devices.

scholarly journals Economic Evaluation of Palliative Care Interventions: A Review of the Evolution of Methods From 2011 to 2019

2021 ◽  
pp. 104990912110111
Author(s):  
Anna Parackal ◽  
Karishini Ramamoorthi ◽  
Jean-Eric Tarride
Keyword(s):  
Palliative Care ◽  
Cost Effectiveness ◽  
Literature Review ◽  
Cost Utility ◽  
Previous Literature ◽  
Therapeutic Interventions ◽  
Economic Evaluations ◽  
Qualitative Synthesis ◽  
Life Years

Background: End-of-life care is a driver of increasing healthcare costs; however, palliative care interventions may significantly reduce these costs. Economic evaluations that measure the incremental cost per quality adjusted life years (QALY) are warranted to inform cost-effectiveness of the intervention relative to a comparator and permit evaluation of investment against other therapeutic interventions. Evidence from the literature up to 2011 indicates a scarcity of cost-utility studies in palliative care research. Aim: This literature review evaluates economic studies published between 2011 and 2019 to determine whether the methods of economic evaluations have evolved since 2011. Design and Data Sources: A literature search was completed using CENTRAL, OVID MEDLINE, EMBASE and other sources for publications between 2011 and 2019. Study characteristics, methodology and key findings of publications that met the inclusion criteria were reviewed. Quality of studies were assessed using indicators developed by authors of the previous literature review. Results: 46 papers were included for qualitative synthesis. Among them only 6 studies conducted formal cost-effectiveness evaluations-of these 5 measured QALYs and 1 employed probabilistic analyses. In addition, with the exception of 1 costing analysis, all other economic evaluations undertook a healthcare payer perspective. Quality of evidence were comparable to the previous literature review published in 2011. Conclusion: Despite the small increase in the number of cost-utility studies, the methods of palliative care economic evaluations have not evolved significantly since 2011. More probabilistic cost-utility analyses of palliative care interventions from a societal perspective are necessary to truly evaluate the value for money.

scholarly journals Economic evaluation of HIV testing options for low-prevalence high-income countries: a systematic review

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Olanrewaju Medu ◽  
Adegboyega Lawal ◽  
Doug Coyle ◽  
Kevin Pottie
Keyword(s):  
Systematic Review ◽  
Economic Evaluation ◽  
Cost Effectiveness ◽  
Hiv Testing ◽  
High Income ◽  
Economic Evaluations ◽  
Rapid Hiv Testing ◽  
The Cost ◽  
Low Prevalence

Abstract Introduction This study reviewed the economic evidence of rapid HIV testing versus conventional HIV testing in low-prevalence high-income countries; evaluated the methodological quality of existing economic evaluations of HIV testing studies; and made recommendations on future economic evaluation directions of HIV testing approaches. Methods A systematic search of selected databases for relevant English language studies published between Jan 1, 2001, and Jan 30, 2019, was conducted. The methodological design quality was assessed using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) and the Drummond tool. We reported the systematic review according to the PRISMA guidelines. Results Five economic evaluations met the eligibility criteria but varied in comparators, evaluation type, perspective, and design. The methodologic quality of the included studies ranged from medium to high. We found evidence to support the cost-effectiveness of rapid HIV testing approaches in low-prevalence high-income countries. Rapid HIV testing was associated with cost per adjusted life year (QALY), ranging from $42,768 to $90,498. Additionally, regardless of HIV prevalence, rapid HIV testing approaches were the most cost-effective option. Conclusions There is evidence for the cost-effectiveness of rapid HIV testing, including the use of saliva-based testing compared to usual care or hospital-based serum testing. Further studies are needed to draw evidence on the relative cost-effectiveness of the distinct options and contexts of rapid HIV testing.

scholarly journals A Systematic Review of Economic Analyses Studying Rituximab in R-CHOP Therapy in Patients with Non-Hodgkin Lymphoma

2009 ◽  
Vol 2 (1) ◽  
pp. 1-9 ◽  
Author(s):  
Jenna L. Yoder ◽  
Khalid M. Kamal
Keyword(s):  
Cost Effectiveness ◽  
Hodgkin Lymphoma ◽  
Cost Utility ◽  
Economic Evaluations ◽  
Non Hodgkin Lymphoma ◽  
Life Years ◽  
The Cost ◽  
Economic Studies ◽  
Chop Therapy

Objectives: To explore the use of pharmacoeconomic principles through examination of economic evaluations pertaining to the combination of the monoclonal antibody rituximab with conventional CHOP (cyclophosphamide/doxorubicin/ vincristine/ prednisone) or CHOP-like chemotherapy regimens in patients with non-Hodgkin lymphoma. Methods: A literature search was conducted using Evidence-Based Medical Reviews (EBMR), International Pharmaceutical Abstracts (IPA), and Medline databases to identify all economic studies relating to rituximab in combination with CHOP or CHOP-like regimens. The systematic evaluation also utilized the Quality of Health Economic Studies instrument to assess the quality of each study that was included in the final review. Results: Initially, eight studies were retrieved which included the use of rituximab in non-Hodgkin lymphoma treatment. Of these, four studies were excluded as rituximab was used as a stand-alone treatment option. The remaining four studies involved conventional CHOP therapy versus the combination with rituximab (R-CHOP) in patients with non-Hodgkin lymphoma. One study employed a cost-effectiveness analysis while the remaining three studies used a cost-utility analysis and reported the outcomes in terms of quality-adjusted life years (QALYs). Conclusions: The cost-effectiveness evaluation illustrated the dominance of R-CHOP over CHOP-alone in terms of both lower costs and increased life years gained. The cost-utility of R-CHOP in terms of costs/QALYs were below the accepted threshold of 50,000 in international monetary units. Through examination of evaluation principles employed, it is found that valid results are highly dependent on the input data, assumptions, and sensitivity analyses. Clinical decisionmakers must take into account specific inclusions of costs relevant to their own practice setting.

scholarly journals Economic Evaluation of Severe Anaemia: Review-Based Recommendations and a Conceptual Framework

2020 ◽  
Keyword(s):  
Economic Evaluation ◽  
Cost Effectiveness ◽  
Blood Cell ◽  
Conceptual Framework ◽  
Red Blood Cell ◽  
Budget Impact ◽  
Cost Utility ◽  
Economic Evaluations ◽  
Economic Analyses ◽  
Impact Models

Objective: Novel anaemia treatments have greatly improved patient outcomes in the last decade and have also undergone economic evaluations in various settings using heterogenous model structures, costs, and inputs. The objectives were to review published economic evaluation studies in major red blood cell disorders, identify limitations in the applied methodology, provide a set of recommendations, and produce a conceptual framework for future economic research in this disease area. Methods: A targeted search was conducted for economic literature evaluating treatments in major red blood cell disorders related to anaemia. Disorders included autoimmune haemolytic anaemia, β-thalassaemia, chemotherapy-induced anaemia, anaemia in chronic kidney disease, and severe aplastic anaemia. Budget impact models and cost-effectiveness and cost-utility analyses were considered. Modelling assumptions regarding the model structure, time horizon, perspective, and type of costs were reviewed and recommendations and a conceptual framework for future economic analyses were created. Results: A total of four budget impact models, nine cost-utility analyses, and four cost-effectiveness analyses were investigated. A major limitation was that the included costs varied significantly across studies. Costs which were rarely included, and generally should be considered, were related to adverse events, mortality, and productivity. Additionally, relationships between levels of serum ferritin, hepatic or total body iron, and haemoglobin with long-term complications and mortality were rarely included. Conclusion: Published economic analyses evaluating treatments for major red blood cell disorders frequently exclude vital costs. A set of recommendations and a conceptual framework will aid researchers in applying a more comprehensive approach for economic evaluations in major red blood cell disorders.

Economic evaluations of leukemia: A review of the literature

2007 ◽  
Vol 23 (1) ◽  
pp. 43-53 ◽  
Author(s):  
Frida Kasteng ◽  
Patrik Sobocki ◽  
Christer Svedman ◽  
Jonas Lundkvist
Keyword(s):  
Health Economic ◽  
Cost Effectiveness ◽  
Myeloid Leukemia ◽  
Cost Minimization ◽  
Treatment Strategies ◽  
Indirect Costs ◽  
Lymphocytic Leukemia ◽  
Economic Evaluations ◽  
New Treatment

Objectives:Leukemia, together with lymphoma and multiple myeloma, are hematological malignancies, malignancies of the blood-forming organs. There are four major types of leukemia: acute lymphocytic leukemia (ALL), acute myeloid leukemia (AML), chronic myeloid leukemia (CML), and chronic lymphocytic leukemia (CLL). There is a growing amount of literature of the health economic aspects of leukemia. However, no comprehensive review is yet performed on the health economic evidence for the disease. Hence, our aim was to review and analyze the existing literature on economic evaluations of the different types of leukemia.Methods:A systematic literature search used electronic databases to identify published cost analyses and economic evaluations of leukemia treatments. After reviewing all identified studies, sixty studies were considered relevant for the purpose of the review.Results:The identified studies were published after 1990, with a few exceptions. Many of the identified economic evaluations in leukemia, particularly for ALL and AML, may be defined as cost-minimization analyses, where only the costs of different treatment strategies are compared. In CML, a new treatment, imatinib, was introduced in 2001 and several cost-effectiveness analyses have since then been conducted comparing imatinib with previous first line treatments.Conclusions:This review indicates that there is a shortage of cost-effectiveness information in leukemia. The introduction of new therapies will stress the need for new economic evaluations in this group of diseases. More information about the total costs, that is, including indirect costs, and quality of life effects would be valuable in future evaluations in leukemia.

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