Conference Theme: Towards an HTA Ecosystem: From Local Needs to Global Opportunities
Poster Presentations
PP020 Decision-Making Beyond Evidence Alone – Topic Prioritization For Health Technology Assessment
- Hong Ju, Kwong Ng, Elaine Teo, Daphne Khoo
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- Published online by Cambridge University Press:
- 12 January 2018, pp. 77-78
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INTRODUCTION:
The number of health technologies needing evaluation far outweighs available resources, and most Health Technology Assessment (HTA) agencies use criteria-based frameworks for topic prioritization (1,2). Despite variability, most frameworks include clinical, economic and budget impact. Some limitations of current frameworks lack mentioning of any explicit political/ethical deliberation and an evaluation on the potential impact of the HTAs (1).
METHODS:During a topic prioritization for HTA, Left Ventricular Assist Device (LVAD) as destination therapy for adults with end-stage heart failure was submitted. The prioritization criteria used were largely in line with those described above. We also included criteria on ethical/equity consideration and the potential impact of an HTA on decision making. A literature search was conducted to gather clinical and economic evidence on LVAD for the target population, supplemented by local data on potential need for and budget impact of providing a LVAD service.
RESULTS:LVAD was scored high on clinical, economic and budget impact with a moderately high need, which would generally subject it to an HTA in order to inform a policy decision. However LVAD was also considered as a technology with a high impact on ethical and political grounds, given that it is a technology offering survival and quality-of-life benefits for a small group of patients for whom effective treatment is otherwise lacking. Through deliberation, the prioritization panel concluded that the impact of an HTA would be low, as a policy decision on whether a LVAD program should be funded would go beyond evidence. Therefore an HTA was not recommended for LVAD.
CONCLUSIONS:To inform decision making, an evaluation on the potential impact of the HTA itself taking into account of the ethical/political consideration of funding a technology is of equal importance as the evidence alone. Subsequently, limited HTA resources can be reserved for technologies where an HTA can truly make a difference.
PP021 Peer Review Innovations For Grant Applications: Efficient And Effective?
- Geoff Frampton, Jonathan Shepherd, Karen Pickett, Jeremy Wyatt
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- Published online by Cambridge University Press:
- 12 January 2018, pp. 78-79
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INTRODUCTION:
Peer review of grant applications is employed routinely by health research funding bodies to determine which research proposals should be funded. Peer review faces a number of criticisms, however, especially that it is time consuming, financially expensive, and may not select the best proposals. Various modifications to peer review have been examined in research studies but these have not been systematically reviewed to guide Health Technology Assessment (HTA) funding agencies.
METHODS:We developed a systematic map based on a logic model to summarize the characteristics of empirical studies that have investigated peer review of health research grant applications. Consultation with stakeholders from a major health research funder (the United Kingdom National Institute for Health Research, NIHR) helped to identify topic areas within the map of particular interest. Innovations that could improve the efficiency and/or effectiveness of peer review were agreed as being a priority for more detailed analysis. Studies of these innovations were identified using pre-specified eligibility criteria and were subjected to a full systematic review.
RESULTS:The systematic map includes eighty-one studies, most published since 2005, indicating an increasing area of investigation. Studies were mostly observational and retrospective in design, and a large proportion have been conducted in the United States, with many conducted by the National Institutes of Health. An example of an innovation is video training to improve reviewer reliability. Although research councils in the United Kingdom have conducted several relevant studies, these have mainly examined existing practices rather than testing peer review innovations. Full results of the systematic review will be provided in the presentation, and we will assess which innovations could improve the efficiency and/or effectiveness of peer review for selecting health research proposals.
CONCLUSIONS:Despite considerable interest in, and criticism of, peer review for helping to select health research proposals, there have been few detailed systematic examinations of the primary research evidence in this area. Our evidence synthesis provides the most up-to-date overview of evidence in this important developing area, with recommendations for health research funders in their decision making.
PP022 New Models Are Needed To Optimize The Management Of New Medicines
- Brian Godman, Eduardo Diogene, Jurij Fürst, Kristina Garuoliene, Augusto Guerra, Roberta Joppi, Rickard Malmström, Wija Oortwijn, Gisbert Selke, Angela Timoney, Björn Wettermark
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- Published online by Cambridge University Press:
- 12 January 2018, pp. 79-80
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INTRODUCTION:
Countries are struggling to fund new premium priced medicines with ever increasing prices. In addition, there are substantial savings as medicines lose their patents. This requires coordinated approaches. Models are being developed centering on three pillars: pre-launch including horizon scanning; peri-launch including pricing and reimbursement (P & R)/ risk sharing; and post-launch including assessing effectiveness (1,2). This will continue to enable access to safe, effective and affordable medicines.
METHODS:Desk research of regulatory and other relevant policy documents as well as a thorough and extensive literature search in peer-reviewed databases were conducted.
RESULTS:Models to optimize the use of new medicines are being developed. These center on three pillars: pre-launch activities including horizon scanning with a specific focus on unmet needs, drugs expected place in therapy, drugs preliminary budget impact and forecasting (including medicines likely to lose their patents); peri-launch activities including P & R assessment and assessments of risk sharing arrangements; and post-launch activities include assessing the effectiveness and safety of new medicines in routine clinical care (1,2). Pre-launch activities to agree the number of potential patients for new cancer medicines resulted in hospitals staying within budget (3); and health authorities that had instigated activities pre-launch saw limited excess bleeding with dabigatran (3). Risk-sharing arrangements have increased access to new medicines; however, concerns with their confidential nature and administrative burden (2,3). Qualitative and/or quantitative approaches are also being developed to better value (new) medicines. There is also growing use of patient level data post launch, for example, studies highlighted concerns with dabigatran prescribing in Spain and anti-obesity medicines in Sweden. Long-term follow-up studies have shown greater effectiveness of ciclosporin versus tacrolimus for transplants despite the rhetoric.
CONCLUSIONS:Stakeholders in the healthcare field are working together and developing methods to increase funding for new valued medicines whilst restricting their use where there are concerns to optimize resource use. This will (need to) continue to enable access to safe, (cost-) effective and affordable medicines.
PP023 Applying Oncology Patient Registries As A Health Technology Assessment Tool
- Alexander Kostyuk, Alexandr Kostyuk, Amangali Akanov
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- 12 January 2018, p. 80
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INTRODUCTION:
The limited healthcare resources have to be invested efficiently; Health Technology Assessment (HTA) is applied ever more often in many health care systems for “rational decision-making”. The oncology patient registries (OPR) track the eligibility of patients and the complete flow of treatments, guaranteeing appropriateness in use of pharmaceutical products, according to approved indications.
METHODS:Normative legal acts and other regulatory documents in the field of oncology medical and pharmaceutical activity, include content and maintenance oncology registries. The system, process and information analysis, direct observation, comparative analysis, logical modelling, sociological methods (surveys and expert opinions) are applied.
RESULTS:A temporary coverage/funding of oncology drugs often requires additional collection of data on safety, effectiveness, cost-effectiveness, and the appropriate use of the drug. Many of the oncology drugs show little or marginal effectiveness at time of approval and reimbursement agencies demand further data before deciding whether to cover the new drug. Pragmatic clinical trials, patient access schemes and standard data requirements on patient relevant outcomes in OPR are some of the approaches to generate further evidence and to fill the gap between knowledge on efficacy at time of approval and demanded knowledge on effectiveness for coverage decisions. For each monitored drug, patients eligible for treatment are registered in the specific therapeutic indication dynamic monitoring database to collect epidemiologic and clinical data, including data on the safety profile, and ex-post information missing at first evaluation stage.
CONCLUSIONS:OPR provide a detailed view of the morbidity, mortality and resource utilization associated with an oncologies diseases entity. This data is of prime importance in coming to decisions on coverage of a drug or treatment. The collation of information is also quick and efficient owing to better methods of data management. OPR of Kazakhstan are equipped with sophisticated data processing software and technologies.
PP024 Changes In Reporting Characteristics Of Systematic Reviews For The United Kingdom
- Eva Kaltenthaler, Christopher Carroll
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- Published online by Cambridge University Press:
- 12 January 2018, pp. 80-81
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INTRODUCTION:
A recent publication reported that increasing numbers of systematic reviews are being published and, although standards have improved, many are still poorly conducted and reported, especially non-Cochrane systematic reviews (1). The aim of this study was to assess the quality of the conduct and reporting of systematic reviews undertaken for the United Kingdom (UK) Health Technology Assessment (HTA) programme and published in the International Journal of Technology Assessment in Health Care (2) and compare those undertaken in 2004 and 2014.
METHODS:A comparative sample of all systematic reviews published in 2004 and 2014 in the UK HTA monograph series was identified by a structured search of MEDLINE in August 2016. After piloting of the form, two reviewers each extracted relevant data. These data were tabulated and summarized.
RESULTS:The search identified twenty-three systematic reviews from 2004 and thirty from 2014. By 2014, compared with 2004, a smaller proportion of treatment (53 percent versus 70 percent) and pharmaceutical (20 percent versus 57 percent) reviews were being published. In 2014, there were much higher percentages of review registrations (70 percent versus 0 percent) and available protocols (90 percent versus 17 percent); increased explicit inclusion of unpublished literature (65 percent versus 39 percent); less frequent use of local checklists (32 percent versus 61 percent) for critical appraisal; more complete reporting of study flow for inclusion (97 percent versus 57 percent) and exclusion (91 percent and 65 percent) of studies; and there were more reviews reporting limitations affecting the review itself (73 percent versus 49 percent). The process had clearly become more reflective and rigorous. However, some previous weaknesses persisted, including the general absence of any assessment of publication bias and the failure to report overall numbers of patients in the review.
CONCLUSIONS:Marked improvements can be seen in the conduct and reporting of systematic reviews published by the UK HTA programme as a result of the publication and general acceptance of the PRISMA statement (3) and the increased application of a smaller number of relevant standards.
PP025 Thrombopoietin Receptor Agonist For Treatment Of Adults With Chronic Immune Thrombocytopenic Purpura
- Huang Grace Li Ying, Gau Churn-Shiouh
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- Published online by Cambridge University Press:
- 12 January 2018, pp. 81-82
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INTRODUCTION:
This study aims to report the clinical effectiveness and cost-effectiveness of Thrombopoietin (TPO) receptor agonist for the treatment of adults with spontaneous Immune Thrombocytopenic Purpura (ITP) in Taiwan.
METHODS:In the clinical effectiveness evaluation section, particularly for the TPO receptor agonist, we searched PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials to identify all randomized trials in chronic ITP. In the economic evaluation section, we performed a long-term cost-effectiveness analysis using a Markov model to evaluate the value of TPO receptor agonist to achieve durable platelet response for chronic ITP patients.
RESULTS:Our findings revealed that the National Health Insurance (NHI) in Taiwan covers TPO receptor agonists romiplostim and eltrombopag, which have also been recommended by the Pharmaceutical Benefits Advisory Committee (PBAC) of Australia and the National Institute for Health and Care Excellence (NICE) in the United Kingdom. In addition, a systematic review and meta-analysis combining six trials were included to assess the current evidence on the role of TPO receptor agonist in chronic ITP. The primary outcome of randomized controlled trials (RCTs) showed an improving trend in significant bleeding events; however there was not any significant difference between the TPO receptor agonists group and the control group (placebo). The gain in life years and quality-adjusted life-years (QALYs) from introducing long-term use of TPO receptor agonists over current clinical practice were 1.52 years and 1.44 QALYs, respectively. Most of the sensitivity analysis results show that the ICER values were greater than 3GDP per capita in Taiwan.
CONCLUSIONS:Compared to placebo, and despite a significantly increased platelet response, there was no evidence to demonstrate that TPO receptor agonists did improve significant bleeding events in chronic ITP. The effect on overall survival awaits further analysis. Although long-term studies are lacking, current data demonstrated that adverse effects of TPO receptor agonists were similar to that of placebo.
PP028 Hyperhidrosis Quality Of Life Measures: Review And Patient Perspective
- Julie Jones-Diette, Ros Wade, Kath Wright, Alexis Llewellyn, Stephen Rice, Eoin Moloney, Julija Stoniute, Alison Layton, Nick Levell, Gerard Stansby, Dawn Craig, Nerys Woolacott
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- Published online by Cambridge University Press:
- 12 January 2018, pp. 82-83
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INTRODUCTION:
Primary hyperhidrosis has no discernible cause and is characterised by uncontrollable excessive and unpredictable sweating, which occurs at rest, regardless of temperature. The symptoms of hyperhidrosis can significantly affect quality of life, and can lead to social embarrassment, loneliness, anxiety and depression.
The aim of this literature review was to identify the tools used to measure quality of life in studies of hyperhidrosis. Patient advisors provided insight and their perspective.
METHODS:Studies were identified through searches undertaken in January 2016. The search strategies combined topic terms for hyperhidrosis with a recognised search filter for “quality of life”. All studies that reported measuring quality of life or described a quality of life measure/tool in the context of primary hyperhidrosis were included. The information on the tools and their use in hyperhidrosis was summarized in a narrative synthesis. Patient advisors contributed to the interpretation of the findings.
RESULTS:The review included 184 studies and many studies used multiple tools. Twenty-two individual tools were identified. The review identified disease specific, dermatology specific, and general health/utility tools. The most commonly identified tools were the Dermatology Life Quality Index (DLQI), the Hyperhidrosis Disease Severity Scale (HDSS), and the Hyperhidrosis Quality of Life Questionnaire (HQLQ). The Hyperhidrosis Quality of Life index (HidroQoL©) is recently designed and validated, and therefore was used only in its validation study.
When asked about these four quality of life tools patient advisors agreed that the HidroQoL© tool covered disease-specific quality of life dimensions relevant to them most comprehensively and was easy to complete. The DLQI was considered to be too general and too focussed on the skin. The HDSS was considered to be too basic and not sufficiently discriminating.
CONCLUSIONS:Future studies of the effectiveness of interventions for hyperhidrosis on health-related quality of life may benefit from including the HidroQoL© tool.
PP029 Hospitalizations And Costs In Bipolar Disorder Patients Initiating Long-acting Injectable Antipsychotics
- Mallik Greene, Tingjian Yan, Eunice Chang, Ann Hartry, Michael Broder
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- Published online by Cambridge University Press:
- 12 January 2018, p. 83
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INTRODUCTION:
Existing studies have not investigated the effectiveness of one long-acting injectable antipsychotic (LAI) versus another in preventing hospitalizations among patients with bipolar disorder (BD). This study was conducted to compare all-cause inpatient healthcare utilization and associated costs among BD patients who initiated LAIs.
METHODS:This retrospective cohort analysis used the Truven Health Analytics MarketScan® Commercial and Medicaid claims database. Bipolar patients >18 years with at least one claim for one of the following LAIs were identified between 1 January 2013 and 30 June 2014 (identification period): aripiprazole, haloperidol, paliperidone, and risperidone. The first day of initiating an LAI was considered the index date. Logistic regression and generalized linear regression models were conducted to estimate risk of inpatient hospitalization and associated costs during the 1-year follow up.
RESULTS:A total of 1,540 BD patients initiated an LAI: 14.5 percent aripiprazole, 16.3 percent risperidone, 21.0 percent haloperidol, and 48.1 percent paliperidone. With the aripiprazole cohort as the reference group, the odds of having any inpatient hospitalizations were significantly higher in haloperidol [Odds Ratio, OR (95 percent Confidence Interval, CI): 1.49 (1.01 - 2.19)] and risperidone [1.78 (1.19 - 2.66)] cohorts. The paliperidone cohort also had a higher risk of having a hospitalization than aripiprazole, but the difference was not statistically significant (p>.05). Among LAI initiators having any inpatient hospitalizations, the adjusted mean all-cause inpatient costs were lowest in the aripiprazole cohort (USD26,002), followed by risperidone (USD27,937), haloperidol (USD30,411), and paliperidone (USD33,240). However, the cost difference was not statistically significant.
CONCLUSIONS:Our study findings highlight the value of aripiprazole in reducing all-cause inpatient hospitalizations and associated costs among patients with BD during the 1-year follow-up. It is worthwhile to note that bipolar diagnoses were identified from healthcare claims coded for reimbursement purposes, thus misclassification was possible. Future studies are warranted to understand the impact of LAI use in a longer period of time.
PP030 Socioeconomics Of Cardiac Rehabilitation: A Meta-Analysis
- Yin Ge, Tomoyuki Takura, Ebata Nozomi
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- Published online by Cambridge University Press:
- 12 January 2018, pp. 83-84
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INTRODUCTION:
The Guidelines for Rehabilitation in Patients with Cardiovascular Disease recommends convalescent cardiac rehabilitation (CR) as the standard treatment for patients with ST elevation myocardial infarction (STEMI) (class I, evidence level B) (1). However, health economic evaluation of cardiac rehabilitation (CR) is limited.
METHODS:This systematic review, meta-analysis study elucidated the cost-effectiveness of CR in the short term. The target population in this study included convalescent and comprehensive CR patients with coronary artery disease (CAD), most with myocardial infarction (MI). We used mortality, life years (LY, expected life years), medical costs, and cost-effectiveness as the evaluation parameters in this analysis. We set medical costs in the analysis associated with testing, diagnosis, and treatment during the observation period related to CR. For cost-effectiveness analysis, we analyzed medical cost per LY. We examined the differences in effects for two comparisons (CR versus Usual Care, UC) using the Risk Ratio (RR) and Standardized Mean Difference (SMD). We assumed the standard deviation (SD) of cost effectiveness in this study by applying the error propagation.
RESULTS:We reviewed fifty-nine studies and identified three that matched our selection criteria. The studies had the following characteristics: two randomized clinical trials and one systematic review/meta-analysis; a control that does not include exercise in patients with CAD; an observation period longer than 1 year; adapting medical costs, LY, cost/LY, and mortality as the evaluation index. In total, 129,272 patients were included. Meta-analysis results revealed that the CR arm significantly improved LY (SMD: -.78, 95 percent Confidence Interval (CI): -1.37, -.19) compared with UC. Similar to LY, the CR arm significantly improved the mortality (SMD: .57, 95 percent CI: .22, 1.47) compared with UC arm. Since medical costs showed a high tendency (SMD:.02, 95 percent CI: -.08, .13), cost/LY demonstrated no improvement (SMD: .00; 95 percent CI: -.17, .18). Substantial statistical heterogeneity was observed between the studies with respect to LY and cost/LY.
CONCLUSIONS:While sufficient evidence to conclude health economic efficiency is not available at present, these results suggest that CR is not potentially cost-effective in the short term.
PP031 iStent® For Open Angle Glaucoma: Standard Or Emerging Care?
- Genevieve Asselin, Renee Drolet, Andrew Toren, Martin Coulombe, Marc Rhainds
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- Published online by Cambridge University Press:
- 12 January 2018, pp. 84-85
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INTRODUCTION:
Increased intraocular pressure (IOP) in open angle glaucoma (OAG) may lead to optic nerve damage due to progressive obstruction of aqueous humor drainage. Among surgery options, trabecular micro-bypass stent (iStent®) was recently introduced. This Health Technology Assessment (HTA) aimed to assess the effectiveness and safety of iStent®, combined or not with cataract surgery, in patients with mild-to-moderate OAG.
METHODS:A systematic review (SR) was performed from 2000 to August 2016. Studies reporting data at three months or more on IOP and hypotensive medication use following iStent® implant were eligible. Governmental databases on safety issues were reviewed. The project involved an interdisciplinary group of experts.
RESULTS:Two HTA reports, one SR, four randomized controlled trials (RCTs) and nine observational studies (OSs) were included. Compared to cataract surgery alone, implantation of iStent®combined with cataract surgery was associated with a decrease in IOP at 12 months in RCTs (-1.37 mmHg; 95 percent Confidence Interval, CI: - 2.76 to .03 mmHg, p = .055). Results from RCTs and OSs on the effect of iStent® combined or not with cataract surgery suggest also a 12-month positive effect on IOP (mean reduction: 1.5 to 9.5 mmHg) and on mean number of medications (reduction: .3 to 2.0) compared to baseline. Scattered results were found on the proportion of patients who no longer use glaucoma medications. Small sample size, short duration of follow-up, and potential conflicts of interest were among studies limitations. The most common adverse events reported were posterior capsular opacification, decrease in visual acuity, and stent obstruction or malposition.
CONCLUSIONS:Appraisal of the effectiveness and safety suggests that iStent® implantation combined to cataract surgery in mild-to-moderate OAG is an emerging practice. Uncertainties related to clinical benefits, safety and care organization need to be clarified before an introduction as a standard of medical practice.
PP032 Holistic Patient Access Processes Of Medical Devices In South Korea
- Sang-Soo Lee, Moo Yeol Lee, Veronica Kim, Kyungja Lee, Young-Kwan Kwon
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- Published online by Cambridge University Press:
- 12 January 2018, pp. 85-86
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INTRODUCTION:
Historically, patient access processes of new and innovative medical devices including in-vitro diagnostics are made in the sequence of regulatory approval, new Health Technology Assessment (nHTA) approval, reimbursement coverage and coding finally reaching the pricing approval stage in South Korea. Although the individual patient access process has its own distinct objective and perspective, there are still opportunities for the authorities or agencies in charge to streamline their processes by working together to promote earlier patient access of new and innovative medical devices to patients without impacting their own decision making.
METHODS:This research examined and analyzed the current policies about: patient access processes with a holistic viewpoint, industry-wide survey about patient access practices; case studies of two innovative medical devices for patient access in South Korea and also proposed new or alternative programs which can contribute to patient access harmonization efforts with a holistic approach.
RESULTS:Historically, health authorities play defensive strategies by delaying the adoption of new and innovative medical devices and implementing certain periods (that is, 2 to 5 years) for a patient's out-of-pocket payment scheme. It is well illustrated with the statistic that only twenty-nine percent of new and innovative medical technologies which have successfully gone through the nHTA process were determined for reimbursement coverage in the past 7 years.
The survey by the medical device industry to determine the patient access lead-time of innovative medical devices with a holistic perspective indicated significantly delayed patient access even considerabley exceeding the legally required decision-making lead time. The in-depth case studies with two innovative devices indicated the disadvantageous patient access processes to the innovator in terms of both final approval timing and the price level.
CONCLUSIONS:The concurrent review process for reimbursement coverage decision making for medical procedures, medical devices and reimbursement coverage payment guidelines committed within the Health Insurance Review and Assessment Service shall be created. New programs to deal with uncertainty in reimbursement coverage decision making shall be considered such as coverage with evidence development, performance-based risk-sharing arrangement, multi-criteria decision analysis and economic evaluation.
PP033 Patient And Public Involvement In Health Technology Assessment: The Brazilian Experience
- Tacila Mega, Aline Silva, Clarice Petramale, Roberta Rabelo
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- Published online by Cambridge University Press:
- 12 January 2018, p. 86
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INTRODUCTION:
The National Committee for Health Technology Incorporation (CONITEC) (1) was created in 2011, when the participation of civil society in the Health Technology Assessment (HTA) process was formalized in Brazil. According to legislation, patient and public involvement (PPI) in HTA occurs through: public consultations (PC); representation of SUS (Brazilian Public Health System) users in the plenary of CONITEC and by public hearings in relevant cases. Due the incipient culture of social participation in Brazil, strategies involving better communication, direct participation and popular education were developed to broaden and qualify this participation.
METHODS:• Case study about PPI strategies developed in 5 years of CONITEC
• Analysis of documents and official records from the Brazilian Ministry of Health.
RESULTS:Since its creation, the innovations of CONITEC regarding PPI were: creation of specific PC form to reproduce or represent the perspectives of patients and caregivers; summarized versions of technical reports written in a simplified language to improve users involvement; surveys prior to elaborating clinical guidelines, a bi-weekly educational program transmitted by streaming, and the recent launch of an HTA Users Guide and a mobile app.
After the implementation of these strategies (which started in 2014), there was an increase of annual contributions, from 2,584 in 2014 to 13,619 in 2015. Most participants were patients, family members or caregivers. Surveys concerning clinical guidelines received about 3,000 contributions. There were thirty-seven published society reports until December 2016. The publication of the HTA Users Guide and other related actions increased the number of accesses to the CONITEC website and its subsection for social participation. The educational program had more than 800 online accesses in five months.
CONCLUSIONS:These actions allowed expanding and qualifying PPI beyond what is legally defined, and it is possible to predict an increasingly favorable scenario regarding the patient and public participation in HTA in Brazil.
PP037 Quality Criteria And Good Practices In The Health Technology Assessment Spanish Network
- Sergio Márquez-Peláez, Carmen Navarro-Palenzuela, Teresa Molina-Lopez, María del Mar Castellano-Zurera, José Luis Castro-Campos
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- Published online by Cambridge University Press:
- 12 January 2018, pp. 86-87
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INTRODUCTION:
The Spanish Network of Agencies for Health Technology Assessment (REDETS) is a group of eight agencies, units and services, depending on National and Regional Governments that coordinate their work within a common methodological framework, guided by the principles of mutual recognition and cooperation. In this work, guided by the necessity of implementing a Quality Management System, we present the process to achieve this objective.
METHODS:As an initial step, a review was carried out based on a structured search strategy in the main electronic databases Medline and EMBASE, and a manual search in websites of national and international agencies (March 2016) in order to collate previous knowledge and experiences. Through the information included in this review, a proposal to create a quality, self-evaluating tool is necessary.
RESULTS:In total, 800 references were found and finally 6 studies were included in the review (1-3). All had a similar structure. Some lists of good practices, classified in dimensions related to different quality aspects in Health Technology Assessment (HTA) organizations, were found. Also some information about questions for evaluating quality standards was indicated. Taking all this information, a proposal of sixty-six standard titles was put forward. These standards were then grouped into twelve quality criteria structured in four dimensions: I Responsibility, II Clients and Stakeholders, III Production Process and IV Resources.
CONCLUSIONS:Based on the systematic review, we developed a proposal for a self-evaluating tool and this is the baseline for a common Quality Management System for the Spanish Network of HTA Agencies. The quality management process will require the development of a handbook by each member of REDETS that will be based on agreed quality standards.
PP038 EQ-5D-3L Electronic Version Development For The Brazilian Population
- Sandro Miguel, Ângela Bagattini, Suzi Camey, Carisi Polanczyk, Luciane Cruz
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- Published online by Cambridge University Press:
- 12 January 2018, pp. 87-88
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INTRODUCTION:
Quality of Life (QoL) is considered to be an important outcome which is widely used in Health Technology Assessment (HTA). In economic evaluations QoL is represented by quality-adjusted life years (QALYs) - adding utility scores to the years of life lived in a determined health status (1). The EuroQol - 5 dimensions (EQ-5D) is a QoL questionnaire that generates utility scores and provides a simple and generic measure of health (2). Electronic QoL instruments have been reported equivalent to paper-based methods, however no studies have assessed agreement between EQ-5D application methods in Brazil (3). Thus, our study aimed to evaluate the measurement equivalence between the original (paper) and adapted (tablet) versions of the EQ-5D-3L Brazilian questionnaire.
METHODS:A cross-sectional study was conducted on 509 adult individuals selected at random in economically different regions of two major Brazilian cities. EQ-5D-3L and Visual Analogue Scale, paper and tablet versions, were applied. Subjects were randomized to two groups; one group assigned for test-retest assessment using only electronic media (tablet-tablet), and a crossover group - half of which answered the tablet version before the paper questionnaire (tablet-paper), and the other half which answered the tablet version after the paper questionnaire (paper-tablet). There was a washout period of a minimum of 24 hours and maximum of 7 days between applications. The Intraclass Correlation Coefficient (ICC) and kappa coefficient were used to determine the agreement between methods. The level of significance was set at .05 for all analyses.
RESULTS:Females predominated in all groups, and the mean age ranged from 41 to 44 years. In the crossover group the obtained ICC values were: .76 (CI .58–.89) for EQ-5D scores and .77 (CI .68–.84) for Visual Analogue Scale (VAS) scores in the tablet-paper subjects; .83 (CI .75–.89) for EQ-5D scores and .75 (CI .67–.85) for VAS scores in the paper-tablet subjects. In the test-retest group, the ICC values were .85 (CI .73–.91) for EQ-5D scores, .79 (CI .66–.87) for VAS scores. Kappa values were higher than .69 in test-retest group. Internal consistency was similar between methods.
CONCLUSIONS:Paper and tablet versions of the EQ-5D were equivalent. Test-retest and crossover agreement was high and the acceptability of the methods was similar.
PP039 Health Utility Values In Renal Cell Carcinoma: A Systematic Review
- Johanna Lister, Sanja Stanisic, Monika Neumann, Jerome Dinet, Sylvie Gabriel
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- Published online by Cambridge University Press:
- 12 January 2018, pp. 88-89
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INTRODUCTION:
Advanced or metastatic renal cell-carcinoma (RCC) is associated with poor health outcomes; in particular in those whose disease progressed after first line treatment. A literature review was conducted to elucidate evidence on health-related utility associated with advanced and metastatic RCC.
METHODS:A systematic literature search from 2006 onwards (date of search: July 2016) was conducted for studies evaluating health-related quality of life (QoL) and utility outcomes. Searches included Medline, Embase, National Health Service (NHS) Economic Evaluation Database and HTA Database and were supplemented by free internet search for key European Health Technology Assessment reports. Publications were limited to 2006 onwards as previous research (1) revealed no prior relevant evidence.
RESULTS:The search yielded 4,178 records. The selection process revealed seventy-eight relevant publications. Generic EuroQol (EQ)-5D scale was most commonly used. Health-state utilities were assessed for specific treatments and at different time points. Mean reported value for patients after failure of one prior systemic therapy ranged from .79 - .62. For patients without progression (on and off-treatment) reported utility values were in range from .80 – .63. Utility in stable patients with adverse events ranged from .71 - .47. For patients with progressive diseases, utility was reported from .71 - .36. Utility for interventions due to skeletal-related events in patients with bone metastasis was reported to range between .46 and .15.
CONCLUSIONS:Identified evidence confirms advanced or metastatic RCC leads to significant detriment to patients health-related utility. Further research efforts are warranted to assess health-state utility beyond clinical trial assessment.
PP040 Hospitalization Costs In Schizophrenia: Long-acting Injectable Antipsychotics Versus Oral Antipsychotic Use
- Mallik Greene, Eunice Chang, Ann Hartry, Michael Broder
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- Published online by Cambridge University Press:
- 12 January 2018, p. 89
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INTRODUCTION:
Existing findings on effectiveness of long-acting injectable antipsychotics (LAIs) versus oral antipsychotics in preventing hospitalizations are inconclusive. This study was conducted to compare hospitalization costs between Medicaid patients diagnosed with schizophrenia who initiated a LAI and those who changed from one oral antipsychotic to another.
METHODS:This retrospective cohort analysis used the Truven Health Analytics MarketScan® Medicaid claims database to study patients ≥18 years with schizophrenia. The two cohorts were: “LAI”, defined as initiating LAI (no prior LAI therapy) between 1 January 2013 and 30 June 2014; and “oral”, defined as changing from one oral antipsychotic to another during the same period. The first day of LAI or the new oral antipsychotic was the index date. A linear regression model was conducted to estimate hospitalization costs.
RESULTS:The final sample included 2,861 (36.7 percent) LAI and 4,926 (63.3 percent) oral users. Compared to oral users, LAI patients were younger (mean (Standard Deviation, SD): 39.9 (13.2) versus 42.7 (13.1); p<.001) and had a lower mean Charlson Comorbidity Index score (mean (SD): 1.1 (1.9) versus 1.7 (2.3); p<.001). Of the 877 LAI initiators and 1,688 oral users who were hospitalized during the 1-year post-index follow-up period, the unadjusted mean hospitalization costs for LAI and oral users were USD32,626 and USD36,048, respectively. After adjusting for patient demographic and clinical characteristics, baseline medication use, and baseline ED or hospitalizations, the adjusted average hospitalization costs were USD1,170 lower in LAI initiators than oral users. None of the unadjusted or adjusted differences were statistically significant.
CONCLUSIONS:This real-world study suggests that among hospitalized patients, hospitalization costs are lower in LAI initiators than in oral antipsychotic users, although the difference is not statistically significant. Our study is limited as our results are reflective of a multi-state Medicaid population. Future studies are warranted to confirm the results in non-Medicaid patient populations.
PP041 Universal Coverage Through Innovative Telediagnosis Technology
- Pedro Galvan, Miguel Velazquez, Ronald Rivas, Antonio Barrios, Enrique Hilario, Gualberto Benitez
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- Published online by Cambridge University Press:
- 12 January 2018, pp. 89-90
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INTRODUCTION:
Through technological innovations based information and communication technologies (ICT), advantageous telediagnostic systems can be developed to improve the health care of remote populations (1). In the context of universal coverage and the efficient use of available resources, there is a favorable opportunity to develop telemedicine towards an integrated ecosystem to improve health care in remote locations without access to specialists. This study, performed by the Telemedicine Unit (MoH) in collaboration with the Biomedical Engineering Dept (IICS-UNA) and the Basque Country University (UPV/EHU) evaluated a telediagnostic system implemented in 2014 in public health. The results of a cost utility analysis for this telediagnosis project in remote, regional and district hospitals in Paraguay are presented.
METHODS:This is a prospective study, where the results of using telediagnosis implemented in remote hospitals over three years 2014–16 were evaulated. For these purposes, a utility analysis was carried out by comparing the cost of performing telediagnosis versus performing it “face to face” in a diagnosis center in the capital city.
RESULTS:During the study 182,406 remote diagnoses were performed in the fifty-four remote hospitals using the telediagnosis tool. Of the total, 37.3 percent (68,085) corresponded to tomography (CT), 62.0 percent (113,059) to electrocardiography (ECG), 0.68 percent (1,243) to electroencephalography (EEG) and 0.01 percent (19) to ultrasound studies. The average cost of a tele-tomography, tele-ECG and tele-ultrasound was USD2.6, and USD8.6 for tele-EEG, respectively. The cost reduction through the telediagnosis was 26.4 times for tomography, 4.5 times for ECG, 8.0 times for EEG and 8.3 times for ultrasound. The cost utility analysis performed demonstrates an economic benefit of USD12.9 million to the citizens of the fifty-four communities included in this project.
CONCLUSIONS:Despite the potential benefit of the telediagnosis (2) to facilitate the universal coverage, and optimize the use of scarce human and health financial resources shown in this study, other important aspects such as acceptance of the technology, patient satisfaction and a widespread use-assessment should be analyzed (3) before a large diffusion.
PP042 Rapid Health Technology Assessment - No Flare Reaction With Synolis V-A In Knee Osteoarthritis
- Keng Ho Pwee
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- Published online by Cambridge University Press:
- 12 January 2018, pp. 90-91
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INTRODUCTION:
The Changi General Hospital (CGH) carries out viscosupplementation for patients with knee osteoarthritis through intra-articular hyaluronic acid injections, using Synvisc or Synvisc-One (containing hylan G-F 20). Some patients on Synvisc are susceptible to flare or pseudoseptic reaction on repeated therapy. It was proposed to procure Synolis V-A intra-articular injection as an alternative for these patients.
METHODS:A rapid health technology assessment was carried out on the following PICO elements: Population - Patients with knee osteoarthritis, Intervention - Synolis V-A, Comparator - Synvisc, Outcomes - Risk of flare reaction/pseudoseptic arthritis.
Based on a preliminary scan of the literature, a simple search was conducted for all publications on Synolis V-A, and for reviews on the risk of flare/pseudoseptic reaction with Synvisc.
RESULTS:No publications reporting on flare/pseudoseptic reactions with Synolis V-A were found. There are limited case series of patients treated with Synolis V-A, with most evidence coming from a prospective post-marketing surveillance case series, which showed reduced pain and functional impairment at 6 months. Adverse reactions were rare. CGH's own small trial of Synolis V-A did not show any flare reactions.
In contrast, flare/pseudoseptic reactions with Synvisc are an established phenomenon. A systematic review of randomized controlled trials documented one flare reaction among 381 patients (0.26 percent) in Synvisc compared to none in patients receiving other hyaluronan products. Small case series of patients on Synvisc showed incidences of flare reaction of 21 percent (in repeat treatment) to 27 percent. CGH's own experience is that flare occurs in 4.7 percent of patients on Synvisc.
CONCLUSIONS:It is reasonable for the hospital to stock an alternative for patients who show repeated flare reactions to Synvisc. The limited evidence base is not a barrier to using Synolis V-A as an alternative, given the local experience.
PP044 Adherence To Enzyme Replacement Therapy In Gaucher Disease
- Amanda Quevedo, Alicia Dornelles, Livia Paskulin, Taciane Alegra, Barbara Krug, Filippo Vairo, Rafael Picon, Ida Shwartz, Paulo Picon
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- Published online by Cambridge University Press:
- 12 January 2018, pp. 91-92
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INTRODUCTION:
Gaucher disease (GD) is a genetic autosomic disorder for which treatment has been funded by the Brazilian government since the 1990s. In our state most patients are treated with enzyme replacement therapy (ERT) and followed by our Reference Center under the recommendation of the Ministry of Health Brazilian guidelines. There is a lack in the literature about adherence of patients to treatment. The objective was to describe adherence to the treatment in a cohort of all GD patients in the southern state of Brazil.
METHODS:This was a cohort study of all GD patients treated with velaglucerase α, taliglucerase α and imiglucerase from January 2010 to January 2015. Adherence was measured as recommended by the Brazilian guidelines as to perform more than 50 percent of the anticipated infusions per year.
RESULTS:Our study included thirty-seven patients of both genders. Doses of ERT varied from 15 to 45IU/kg for type 1 patients and from 30 to 60 IU/kg for type 3 patients. A mean of 83 percent of anticipated infusions were performed and from all patients only one did not adhere to the treatment during the 5 years of our study. The majority of the patients performed at least 50 percent of all anticipated infusions.
CONCLUSIONS:We noted a very high rate of adherence to treatment with a very few adverse effects. Our data might be showing that the very high rate of adherence in these chronic disease patients may be attributed to the value of treatment by patients and their family, and also due to the existence of a multidisciplinary team at the reference center. These data might be useful for public health policy making in other countries.
PP046 Screening In Women Vaccinated Against Human Papillomavirus: Governing Innovation
- Paolo Giorgi Rossi, Francesca Carozzi, Antonio Federici, Guglielmo Ronco, Marco Zappa, Silvia Franceschi
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- Published online by Cambridge University Press:
- 12 January 2018, p. 92
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INTRODUCTION:
In Italy, the cohorts of women who were offered Human papillomavirus (HPV) vaccination in 2007/08 will reach the age for cervical cancer (CC) screening from 2017. According to the National Prevention Plan 2014–18, HPV-based screening must be implemented for women ≥30 years old, following the Italian Health Technology Assessment (HTA) report recommendations (1). The simultaneous shift from cytology-based screening to HPV test-based screening gives the opportunity for unprecedented reorganisation of CC prevention.
METHODS:The National Screening Monitoring Centre and the Italian Group for Cervical Screening, following a commitment by the Italian the Ministry of Health (MoH), identified the consensus conference as the most suitable method for addressing this topic. The objective was defining the best screening methods in girls vaccinated against HPV and the knowledge needs for defining evidence-based screening strategies. During the consensus celebration (24 November 2015) a jury made recommendations about questions and proposals formulated by a panel of experts representative of Italian scientific societies involved in CC prevention and based on systematic reviews (2).
RESULTS:The jury considered changing the screening protocols for girls vaccinated in their 12th year as appropriate. Tailored screening protocols based on vaccination status could be replaced by “one size fits all” protocols only when a herd immunity effect has been reached. Vaccinated women should start screening at age 30, instead of 25, with the HPV test. Furthermore, there is a strong rationale for applying longer intervals for re-screening HPV negative women than the currently recommended 5 years, but research is needed to determine the optimal screening time points. For non-vaccinated women and for women vaccinated in their 15th year or later, the current protocol should be kept.
CONCLUSIONS:As further action, in 2016 the Ministry of Health funded a Health Technology Assessment program of the new screening protocol proposed by the consensus conference and a cohort study for determining a safe interval in vaccinated women.