Committee Decision Research Articles

Degarelix for Treating Advanced Hormone-Dependent Prostate Cancer: An Evidence Review Group Perspective of a NICE Single Technology Appraisal.

As part of its Single Technology Appraisal Process, the National Institute for Health and Care Excellence (NICE) invited the manufacturer of degarelix (Ferring Pharmaceuticals) to submit evidence for the clinical and cost effectiveness of degarelix for the treatment of advanced hormone-dependent prostate cancer. The School of Health and Related Research Technology Appraisal Group at the University of Sheffield was commissioned to act as the independent Evidence Review Group (ERG). The ERG produced a critical review of the evidence contained within the company's submission to NICE. The evidence, which included a randomised controlled trial (RCT) of degarelix versus leuprorelin, found that degarelix was non-inferior to leuprorelin for reduction of testosterone levels and that degarelix achieved a more rapid suppression of prostate-specific antigen levels and subsequently decreased incidences of testosterone flare associated with luteinising hormone releasing-hormone (LHRH) agonists. However, protection against testosterone flare for the comparators in the clinical trials was not employed in line with UK clinical practice. Further claims surrounding overall survival, cardiovascular adverse events and clinical equivalence of the comparator drugs from six RCTs of degarelix should be regarded with caution because of flaws and inconsistencies in the pooling of trial data to draw conclusions. The cost-effectiveness evidence included a de novo economic model. Based on the ERG's preferred base case, the deterministic incremental cost-effectiveness analysis (ICER) for degarelix versus 3-monthly triptorelin was £14,798 per quality-adjusted life-year (QALY) gained. Additional scenario analyses undertaken by the ERG resulted in ICERs for degarelix versus 3-monthly triptorelin ranging from £17,067 to £35,589 per QALY gained. Subgroup analyses undertaken using the Appraisal Committee's preferred assumptions suggested that degarelix was not cost effective for the subgroup with metastatic disease but could be cost effective for the subgroup with spinal metastases. The company submitted further evidence to NICE following an initial negative Appraisal Committee decision. Further analyses from the Decision Support Unit found that that, whilst some evidence indicated that degarelix could be cost effective for a small subgroup of people with spinal cord compression (SCC), data on the potential size of this subgroup and the rate of SCC were insufficient to estimate an ICER based on the evidence submitted by the company and a separately commissioned systematic review. NICE recommended degarelix as an option for treating advanced hormone-dependent prostate cancer in people with spinal metastases, only if the commissioner can achieve at least the same discounted drug cost as that available to the UK NHS in June 2016.

Building International Investment Law: The First 50 Years of ICSID

The International Centre for the Settlement of Investment Disputes (ICSID) is celebrating the fiftieth anniversary of the ICSID Convention. 2 To commemorate this milestone, ICSID has, among other things, published Building International Investment Law: The First 50 Years of ICSID . 3 Professors, arbitrators and practitioners from around the world analyse the history of ICSID and the development of international investment law through some of the leading cases that have marked the practice of investment arbitration, address ongoing challenges and offer suggestions for future improvements. The first part of the book contains six chapters dedicated to the analysis of ‘general principles’ in investment arbitration, in general, and in ICSID arbitration, in particular. Michael Reisman and Judge Mahnoush Arsanjani offer an analysis of the history of Article 42 of the ICSID Convention, which governs the law applicable to a dispute. 4 They take us through the decisions of the first ad hoc committees ( Klöckner v Cameroon and Amco Asia v Indonesia , both brought pursuant to an arbitration clause in a contract) 5 and their interpretations of Article 42 at a time when ICSID consent under bilateral investment treaties (BITs) was not the norm, and they contrast such interpretations with one of the first annulment committee decisions under a BIT, Wena v Egypt . 6 The authors conclude that from the legislative history of Article 42 it is clear that ‘some role [has been] reserved for domestic law’, 7 and they lament that the two contradictory approaches undertaken by the ad hoc committees do not allow any defaulting operation for domestic law but revert to the application of international law.

Indicator selection with committee decision of filter methods for stock market price trend in ISE

Prediction of the stock market price direction is a challenging and important task of the financial time series. This study presents the prediction of the next day stock price direction by the optimal subset indicators selected with ensemble feature selection approach. The main focus is to obtain the final best feature subset which also yields good prediction of the next day price trend by removing irrelevant and redundant indicators from the dataset. For this purpose, filter methods are combined, support vector machines (SVM) has been carried out and finally voting scheme is applied. In order to conduct these processes, a real dataset obtained from Istanbul Stock Exchange (ISE) is used with technical and macroeconomic indicators. The result of this study shows that the prediction of the next day direction with reduced dataset has an improvement over the prediction of it with full dataset.

A Comparative Review of Waivers Granted in Pediatric Drug Development by FDA and EMA from 2007-2013.

The European Union and the United States have different legal frameworks in place for pediatric drug development, which can potentially lead to different pediatric research requirements for the pharmaceutical industry. This manuscript compares pediatric clinical trial waivers granted by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). This is a retrospective review comparing EMA's Paediatric Committee (PDCO) decisions with FDA's Pediatric Review Committee (PeRC) recommendations for all product-specific pediatric full waiver applications submitted to EMA from January 2007 through December 2013. Using baseline data from EMA, we matched product-specific waivers with their FDA equivalents during the study period. For single active substance products, PDCO and PeRC adopted similar opinions in 42 of 49 indications (86%). For fixed-dose combinations, PDCO and PeRC adopted similar opinions in 24 of 31 indications (77%). Despite the different legal frameworks, criteria, and processes of determination, the waiver decisions of the 2 agencies were similar in the majority of cases.

From ‘Standard-Takers’ to ‘Standard-Makers’: Developing Countries and Least-Developed Countries’ Perspectives in the Harmonization of Technical Regulations Through Internation

The Agreement on Technical Barriers to Trade (hereinafter ‘TBT Agreement’) pursues the harmonization of technical regulations – one of the most commonly used measures affecting trade – through the use of international standards. International standards are developed by international standardizing bodies outside the World Trade Organization. Developing countries and least-developed countries (LDCs), however, encounter several obstacles impeding their effective participation in international standard setting, and, as a result, tend to determine ex post, based on their trade flows, which international standards to follow. Therefore, they are often referred to as ‘standard-takers’ instead of ‘standard-makers’. This article argues that a detailed look at the text of the TBT Agreement and the TBT Committee Decision makes clear that concrete steps to remove these obstacles and to engage developing countries and LDCs in international standard setting must become a prerequisite for promoting documents prepared by standardizing bodies to the status of an international standard within the meaning of the TBT Agreement.

Letters to the Editor: Menstrual problems in women with intellectual disability

The Editorial Executive Committee welcomes letters, which should be less than 250 words. Before a decision to publish is made, letters which refer to a published article may be sent to the author for a response. Any letter may be sent to an expert for comment. When letters are published, they are usually accompanied in the same issue by any responses or comments. The Committee screens out discourteous, inaccurate or libellous statements. The letters are sub-edited before publication. Authors are required to declare any conflicts of interest. The Committee's decision on publication is final.

Can an ethics officer role reduce delays in research ethics approval? A mixed-method evaluation of an improvement project

ObjectiveFrustration continues to be directed at delays in gaining approvals for undertaking health research in the UK. We aimed to evaluate the impact of an ethics officer intervention on rates...

Voting in Central Banks: Theory versus Stylized Facts

Abstract The paper examines the ability of several alternative group decision-making models to generate proposing, voting and decision patterns matching those observed in the Bank of England’s Monetary Policy Committee and the US Federal Reserve’s Federal Open Market Committee. A decision-making procedure, common to all the models, is to vote between adoption of the chairman’s proposal and retention of the status-quo policy, with heterogeneous votes generated by private information of the models’ monetary policy committee members. The members can additionally express reservations regarding the final committee decision. The three alternative models differ in the degree of informational influence between the chairman and the remaining members. We find that a “supermajoritarian” model, in which the chairman proposes a policy she knows would be accepted by a supermajority of the committee members, combined with allowance for reservations, closely replicates real-world decision-making patterns. The model predicts no rejections of chairman’s proposals, low but non-trivial dissent, even during meetings where the chairman proposes no change in policy, and predictive power of the voting record of the whole committee regarding future monetary policy changes.

PMD68 - HEALTH PLAN COVERAGE FOR MEDICAL DEVICES AND THE USE OF ELECTRONIC MEDICAL RECORD SYSTEMS

Medical devices are used to treat different conditions, are reviewed by the FDA, and potentially paid for by insurers/payors. For some payors medical devices payments are mandated through specific benefit. To manage their plans/practices, many organizations use Electronic Medical Record systems [EMRs]. To understand the review and coverage of medical devices; and the adoption/funding of EMRs. Managed care (MC) medical+pharmacy directors [MDs+PDs] completed an online-interactive survey of: advisor+plan information; medical device coverage/reviews; and EMR adoption/use. Respondents were mostly MDs (54.6%) and worked for health plans (83.6%). The plans were local=39.6%, National=35.4%, and regional=25.0%; Plans could cover multiple member-types: commercial=91.3%, Medicaid=89.1%, Medicare MA-PDP=91.3% and Medicare PDP-only=76.1%. The majority were involved with medical device reviews (66% versus 86% for pharmaceutical reviews). AMCP-dossiers for medical devices were not required by 76.6% of plans and only 4.4% used AMCP-dossiers in their reviews. In their reviews medical devices were compared with: standards of care (63.8%), other medical devices only (23.4%) or pharmaceuticals (12.8%). Respondent involvement in medical device reviews were: all cases=66%, based on a cost-threshold=10.6%, under the medical plan due to Medicare regulations=4.3% and not-involved=19.1%. EMRs were used for billing (30.2% of plans); ePrescribing (27.9%); and lab tests (21.4%). Among the plans that require EMRs: 31.6% previously acquired; EMRs were provided at no cost (31.6%) and 5.3% at a cost; 21.0% didn’t specify funding; and other sources funded (10.6%). ACA funding had already been received (27.9% of plans) and 2.3% planned to receive funding through the ACA; 69.8% didn’t know. The environment for P&T Committee decision making in managed care is undergoing a series of changes. Health plan medical and pharmacy directors, who commonly serve as P&T Committee members, have distinct opinions as to how to alter the process to adapt to these influences as they review medical devices and implement EMRs.

International Standards as Global Public Goods in the World Trading System

International standards have assumed special legal significance in the World Trade Organization (WTO) Agreement on Technical Barriers to Trade (‘TBT Agreement’). This article conceptualizes international standards as global public goods and argues for applying global administrative law principles to vet international standards before they are afforded quasi-legislative status in the WTO law. We traced how the WTO Appellate Body has changed its original hands-off approach in EC – Sardines in 2002 to a more intrusive approach in US – Tuna II in 2012.We submit that the WTO Appellate Body’s new approach to international standards marks a distinctive pathway for the development of global administrative law in producing global public goods. The compliance with global administrative law principles set out in the TBT Committee Decision in turn provides international standardizing bodies with additional legitimacy and accountability. However, contrary to popular opinion, we submit that adoption by consensus is not a necessary condition for a standard to be recognized as an international standard in the world trading system.

Money or friends: Social identity and deception in networks

Strategic communication occurs in virtually all committee decision environments. Theory suggests that small differences in monetary incentives between committee members can leave deception a strategically optimal decision (Crawford and Sobel, 1982; Galeotti et al., 2013). At the same time, in natural environments social incentives can also play an important role in determining the way people share or withhold truthful information. Unfortunately, little is known about how monetary and social incentives interact to determine truth-telling. We investigate this issue by first building a novel model and then testing its equilibrium predictions using laboratory data. In the absence of social identity, the model׳s predictions are supported: there is more truthful communication between those who share monetary incentives than those who do not. We find that the effect of identity is asymmetric: sharing the same identity does not promote truth-telling but holding different identities reduces truthfulness. Overall, as compared to environments lacking social identity, committees with both monetary and social incentives exhibit truthful communication substantially less frequently.

Forecast combination for discrete choice models: predicting FOMC monetary policy decisions

This paper provides a methodology for combining forecasts based on several discrete choice models. This is achieved primarily by combining one-step-ahead probability forecast associated with each model. The paper applies well-established scoring rules for qualitative response models in the context of forecast combination. Log-scores and quadratic-scores are both used to evaluate the forecasting accuracy of each model and to combine the probability forecasts. In addition to producing point forecasts, the effect of sampling variation is also assessed. This methodology is applied to forecast the US Federal Open Market Committee (FOMC) decisions in changing the federal funds target rate. Several of the economic fundamentals influencing the FOMC decisions are nonstationary over time and are modelled in a similar fashion to Hu and Phillips (2004a, JoE). The empirical results show that

Medical Technologies Evaluation Programme: A review of NICE progression decisions, 2010–2013

ObjectivesTo review the progression decisions for notifications considered at National Institute of Health and Care Excellence (NICE) Medical Technology Advisory Committee (MTAC) meetings during its first three years (2010–2013) to identify trends. MethodsThe list of medical devices discussed at committee, briefing notes, committee decisions, and non-progression letters, where applicable, were obtained from NICE. Each medical device presented to committee was classified using five different medical device categorisation systems. Trends in progression decision, scores against programme selection criteria over time, and reasons provided by committee to support the non-progression decision, were analysed. ResultsBetween January 2010 and March 2013 31 MTAC meetings were held. Of the 110 medical technologies considered, 45 were given a progression decision (23 selected for Medical Technologies Guidance development, 22 routed for guidance development in other NICE programmes), 64 did not progress to guidance development and 1 was excluded from analysis whilst awaiting final committee decision. The six programme categories and total scores were not sensitive or specific predictors of progression to guidance decision. No significant change in the proportion selected for progression over time was observed (P>0.05). No compelling evidence of an association between the type of medical device and progression decision was found. Fifteen distinct reasons for non-progression were identified; ‘lack of evidence’ being provided in the majority, 93.8%, of cases. ConclusionsDuring its first three years, MTAC׳s progression decisions for guidance development on medical technologies were not associated with device type and there is no evidence of changes over time.

The Role of Monetary Policy Announcements on Turkish Banks' Stock Returns

This paper investigates the impact of monetary policy committee decisions of the Central Bank of the Republic of Turkey on the stock returns of the deposit banks listed in Borsa Istanbul Banks Index (XBANK). The cumulative abnormal returns of the banks are calculated for 2008 and 2012. We report that the monetary policy announcements affect cumulative abnormal returns of the deposits banks both in 2008 and 2012. Since the announcement of the monetary policy decisions created abnormal returns, we conclude that the market does not have semi-strong form efficiency.

The Even–Odd Nature of Audit Committees and Corporate Earnings Quality

We apply voting theory to the context of audit committees and examine how the even–odd nature of audit committees is related to earnings quality. We hypothesize that an audit committee with an odd number of directors can improve the committee’s voting efficiency by better aggregating directors’ information and thus enhance the quality of committee decisions, as compared with an audit committee with an even number of directors. Supporting this implication, we find that an odd audit committee is associated with lower likelihood of financial restatements than an even audit committee, and that this relation is stronger when the committee members have more heterogeneous opinions, hold less equity ownership, are in a smaller audit committee, and face a more entrenched management.

Committee Decisions under Majority Rule Revisited

AbstractSpatial committee decision-making experiments provide ample evidence for the predictive power of the majority rule core if it is not empty. Furthermore, an empty core does not substantively reduce the stability of majority decision making. In this article, I put these two findings to a critical test using two preference configurations from Fiorina's and Plott's (1978) seminal committee experiments. In my experiment, committees with fixed individual preferences make multiple decisions over time. Contrary to the existing evidence, I find that results diverge from the core in the course of the experiment. In line with previous research, an empty core has no noticeable behavioral effects.

MATHEMATICAL MODEL OF REIMBURSEMENT DECISION MAKING IN RUSSIA. RESULTS OF VIM LIST FOR 2016

Background: In 2014 we firstly analyzed the formalized system (points and expert opinions) of drug inclusion and exclusion into the reimbursement lists in Russian Federation. The liner mathematical model of decision making was developed and adopted. Aim. Update the existing model using the results of reimbursement procedures acting from 2106. Material and methods. The linear models developed and adopted in 2014 were used. In 2015 we included data on 141 drug dossiers. We analyzed the decision of the expert body, chief Ministry of Health expert and the final committee decision. Results. 43 new drugs were included into the reimbursement lists acting from 2016. The model of expert body decision had an error 7,09% (12,4% in 2014). The model of chief Ministry of Health expert decision had an error – 7% (10% in 2014). The above mentioned experts became more experienced in the formalized procedure of decision making. The model of final decision had an error about 42% (35% in 2014). Conclusion. Linear models are working tools for modelling reimbursement system decisions. At the mean time the existing system of decision making needs more formalization.

Смыслы несобственных задач классификации и оптимизации

In this article we study the interpretation of the formalized Committee decisions and conflicting objectives recognition and also reliability of such solutions. Inconsistently corresponding logic is built. Also a necessary and sufficient condition for the building committees for the separation of hard-separable, but still disjoint finite sets is provided. The design close to the concept of the Committee, their interpretation and application are described. Special attention is paid to the use of the Committee structures in the area of optimization problems. It is noted that the applicability of these structures in solving applied problems is based not only on solving specific problems, but also confirmed by a rigorous mathematical justification, which is given in this article as theorems. Also it is concluded that in non-native tasks or there are no solutions, or violated the relation of duality.

The NPC Standing Committee Decision on Strengthening the Network Information Protection

The NPC Standing Committee Decision on Strengthening the Network Information Protection

The Even-Odd Nature of Audit Committees and Corporate Earnings Quality

We apply voting theory to the context of audit committees and examine how the even-odd nature of audit committees is related to earnings quality. We hypothesize that an audit committee with an odd number of directors can improve the committee’s voting efficiency by better aggregating directors’ information and thus enhance the quality of committee decisions, as compared to an audit committee with an even number of directors. Supporting this implication, we find that an odd audit committee is associated with lower likelihood of financial restatements than an even audit committee and that this relation is stronger when the committee members have more heterogeneous opinions, hold less equity ownership, are in a smaller audit committee, and face an more entrenched management.