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VA L U E I N H E A LT H 2 0 ( 2 0 1 7 ) A 3 9 9 – A 8 1 1
1Pfizer Inc., New York, NY, USA, 2Adelphi Values Ltd, Bollington, UK, 3Pfizer Inc., Collegeville, PA, USA, 4Pfizer Inc., Pearl River, NY, USA
Objectives: Group B streptococcus (GBS) rectovaginal carriage during late pregnancy and birth is associated with neonatal GBS disease which is life threatening and survivors may have long lasting sequelae. GBS screening of pregnant women and subsequent intrapartum antibiotic prophylaxis (IAP) has proved effective at reducing GBS early onset disease (EOD) in areas where it is universally applied. Despite the recommendation of these preventative measures, the incidence of neonatal GBS, particularly late-onset disease (LOD), is increasing. We therefore conducted a literature review to assess the adherence of European countries to GBS screening and IAP. Methods: A literature review was conducted in Medline, Embase, PsycINFO, EconLIT, and EBM Reviews (2006–2016), using key search terms for GBS treatment, management and associated burden. Results: Adherence to screening guidelines is high in France (89–96%) and low in Germany (23%). Assessment of whether the mothers of GBS positive infants had been screened during pregnancy revealed that in France and Italy 9% and 20% were unscreened. In the UK, IAP is provided on a risk factor basis yet mothers without risk factors accounted for 33% of GBS-positive neonates. Many women in these countries are eligible for IAP but do not receive IAP (range 11% [Germany] to 36% [Italy]). Nonadherence to screening guidelines may be due to increased costs when screening is not reimbursed, and non-adherence to treatment guidelines due to failure to document GBS-positive status, caesarean births and antibiotic resistance. Neonatal GBS is associated with a high economic and social burden, with management of LOD neonates costing over three times as much as healthy neonates. Conclusions: Maternal GBS screening and IAP remains inadequate across Europe in both nonadherence to guidelines and treatment, which is concerning given the costs associated with management. An alternative strategy, such as vaccination, could reduce GBS incidence and associated costs. PIN109 Deciding On Universal Rotavirus Vaccination In The Netherlands Again Dvortsin E1, Zeevat F1, Novak A2, Postma MJ3 of Groningen / Asc Academics, Groningen, The Netherlands, 2Anovak Services, Apeldoorn, The Netherlands, 3University of Groningen, Groningen, The Netherlands
1University
Objectives: Since 2006 vaccines against rotavirus-induced gastroenteritis are available in Europe. Many European countries offer these vaccines to their infant population. In the Netherlands, the implementation of rotavirus (RV) vaccination is still under discussion due to various reasons and is currently under consideration in the Chamber for Vaccines Assessments “BeoordelingsKamer Vaccins” (BKV). The BKV combines the assessments of both the Dutch Health Council and Care Institute. For the BKV, cost-effectiveness presents one aspect of consideration. This study aimed to provide a cost-effectiveness analysis of the pentavalent vaccine based on the newest incidence data, which seemed lower than assumed. Methods: An age-structured, discrete time-event, deterministic cohort model has been developed to evaluate the cost-effectiveness of adding RotaTeq® to the Dutch National Immunization Program. Model inputs were based on a previously published and generally accepted model of rotavirus vaccination. We also analyzed a vaccination strategy for high-risk children. Results: Similar to the first assessment in 2008, universal vaccination of rotavirus again seems cost-effective from the societal perspective, resulting in an incremental cost effectiveness ratio of € 18,672 per QALY. Vaccinating a birth cohort of 170,510 infants results in reductions of 30,891 rotavirus episodes, of which 21,434 are mild, 5,785 moderate and 3,671 severe. A total of 4 lives are saved. In addition, targeted vaccination was deemed dominant over the no vaccination strategy. The inclusion of at least moderate herd immunity effects seems justified as relevant reductions in disease in non-vaccinated populations have been observed in several countries were rotavirus vaccination has been introduced. Conclusions: We conclude that universal and targeted vaccination are both effective and cost-effective strategied for reducing rotavirus incidence in the Netherlands within the context of a national program. PIN110 Difficulties In Vaccine Introduction In A Large-Area Country: Meningococcal Vaccination In Russia Namazova-Baranova L1, Chemakina D1, Bock H2, Vishneva E1, Selimzianova L1 1FSAI “National Scientific and Practical Center of Children’s Health” of the Ministry of Health of the Russian Federation, Moscow, Russia, Moscow, Russia, 2GRID Consultancy Services Singapore Pte Ltd, Singapore, Singapore
Objectives: Country experts’ opinions have a huge impact on the identification of the strategy of the health economics analysis, which is crucial before the introduction of any intervention. The determination of a unique strategy seems to be very challenging in a large area country where the epidemiology differs a lot and the disease does not have a huge burden but leads to the severe sequelae. The objective of the study is to determine the importance of the introduction of the vaccination against meningococcal infection into the National Immunization Program (NIP) in Russia. Methods: 18 regional vaccination experts from 14 Russian areas were interviewed. The on-line survey created in google forms was used to obtain information. The experts were asked about the importance of the vaccination against meningococcal infection in their region by ranking it from 1 (not needed) to 5 (most needed), the type of the vaccine to be used and the optimal age group for introduction. Results: The opinions of 18 experts on the importance of the meningococcal vaccination were diverse and distributed between not needed (3 experts) to most needed (2 experts). More than a half of experts (55.6%) opted for the introduction of two vaccines (conjugated-ACWY, recombinant MenB vaccine) simultaneously. Although the majority believes in 10-13 years of age (55.6%) as the most suitable time period for immunization, others consider that the vaccination should be implemented for younger or older children first. Conclusions: There is no unanimous opinion on the universal strategy of meningococcal vaccination implementation into the Russian NIP. A few regions with high demand should be selected for a pilot
project where health economics analysis should be conducted and further the vaccine introduced prior to the national implementation. PIN111 Hepatoprotective Effect Of Herbal Remedy With Anti-Tuberculosis Treatment Satayeva L G , Sagantayeva S Kh , Garankina R U L Kazakchstan National medical university, Almaty, Kazakhstan .
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S.D. Asfendiyarov Kazakh National Medical University, Almaty, Republic of Kazakhstan Introduction: Tuberculosis is one of the leading causes of death among infectious diseases in developing and undeveloped countries. According to the WHO Western Pacific Region fact sheet on tuberculosis. Hepatotoxicity, a common adverse effect of anti-tuberculosis drugs, varies from asymptomatic elevation of liver enzymes to fulminant hepatic failure. Methods: The study protocol was approved by the Ethics Committee on Human Rights related research. Results: From the total of 55 patients, there were no significant differences in the distribution of the demographic characteristics. Antituberculosis drug-induced hepatotoxicity (ATDH) was seen in 17 (18.8%) out of 90 patients. Average age of the ATDH case was 35.65 ± 10.8 (CL 95% 18-81) sex ratio was 22.5% in men, 16% in women. During pre and post-treatment liver biochemical analyzes criteria such as AST, ALT, total bilirubin, and protein were not statistical significant between groups which are treated with Silymarin. However, in control group had a statistically significant difference total bilirubin and protein between pre and post-treatment liver biochemical analyzes criteria such as AST, ALT. Anti-tuberculosis drugs are used in combination, except in latent tuberculosis or chemoprophylaxis. The rate of hepatotoxicity is much higher in developing countries like India (8%–30%) compared to that in advanced countries. Therefore, we selected patients who have tuberculosis to study the hepatotoxic effect of antituberculosis drugs and hepatoprotective action of Silymarin. The serum ALT, AST of the control group (group I) and the Silymarin group (group II, III) show significant difference when compared with baseline values. This showed that Silymarin has significant desired actions. Conclusions Silymarin reduced the incidence of antiTB-DILI. The benefit of Silymarin may be explained from superoxide dismutase restoration. Larger clinical trials are required to confirm the result of our small study. References: 1. WHO.Global tuberculos report 2014 PIN112 Value Of Treating All Liver Fibrosis Stages To Reach Elimination Of Diagnosed Chronic Hepatitis C: A Modelling Approach In France Tanguy Melac A1, Asselah T2, Ethgen O3, Sanchez Y4, Roudot-Thoraval F5, Jeanblanc G6 of Epidemiology, Biostatistics and Clinical Research, Bichat-Claude-Bernard Hospital, Paris Diderot University, Paris, France, 2Beaujon hospital, Clichy, France, 3SERFAN innovation, Namur, Belgium, 4AbbVie, North Chicago, IL, USA, 5Henri Mondor hospital, Créteil, France, 6AbbVie Inc., Rungis, France 1AP-HP, Department
Objectives: With the increased efficacy and tolerability of all-oral direct-acting antivirals (DAAs) against hepatitis C virus (HCV) infection, there is a growing will to treat all patients. Our objective is to determine the optimal and budget-feasible treatment path towards diagnosed HCV elimination in France. Methods: Using a sequential multi-cohort model, the diagnosed HCV population in France, 68% of the 150,000 prevalent cases, was projected over a 20-year horizon from the payer perspective. Treatment effectiveness was based on clinical trial data of secondgeneration pangenotypic DAAs. Treatment course was assumed to cost 30,000€ . A declining treatment budget was considered from 600M€ in 2017 to 500M€ in 2018 and 400M€ beyond. Two treatment scenarios were compared: the recently adopted policy in France of generalized treatment which treats proportionally all fibrosis stages, and a top-down strategy which treats the most serious fibrosis stages first and the less serious stages last according to the budget constraint. Results: Our modelbased analysis demonstrates that the elimination of diagnosed HCV is budgetfeasible and could be reached in 2024 with the current universal treatment policy: 103,927 treated patients, 776 liver transplant, 4,445 liver-related deaths and 787,895 QALYs for a global budget of 3,7B€ over the 20 years. However, it is dominated by the top-down strategy, resulting in 4,661 less patients treated, 1,718 more liver-related deaths, 18,935 QALY lost, and 434M€ more healthcare spending. The undiagnosed population in 2024 is still of 45,964 patients. Conclusions: Widespread access to DAAs is an important milestone to reach WHO elimination goal in 2030 but the more severe patients still need to be prioritized from public health and efficiency perspectives. Full elimination of HCV requires increased investments for screening and treatment, and greater awareness and urgency to treat. PIN113 Evaluation Of Measles Vaccination Coverage In Austria Miksch F1, Popper N2, Bicher M3, Haar K4, Paulke-Korinek M4 1dwh GmbH, Vienna, Austria, 2dwh GmbH, simulation services / Technical University, Institute for Analysis and Scientific Computing, Vienna, Austria, 3Technical University, Institute for Analysis and Scientific Computing, Vienna, Austria, 4Austrian Federal Ministry of Health and Women’s Affairs, Wien, Austria
Objectives: Monitoring the measles vaccination coverage is important towards the WHO goal to eradicate measles until 2020. In Austria, small outbreaks still occur occasionally. The aim is a coverage of 95% with two doses for all adults and children of age 2 and above. Methods: As a basis, we used an agent-based model of the Austrian population that simulates from 1998 until 2015, where each person is represented by an agent. The model includes ageing, births, deaths, emigration, and immigration, and is based on data from Statistics Austria and Eurostat. Vaccination data from different sources since the introduction of the national immunization program in 1998 were combined: the administered vaccinations including the age of children, the delivered doses without age-specific information, and sales data from the private market. The resulting vaccination numbers were distributed among the model population according to the recommended immunization scheme in each year. The initial coverage of age groups born before 1998 is estimated based on the 1998 vaccination data. Results: The model showed reliable results for children
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born 1997 and later. In 2015, more than 95% of 6 year olds are vaccinated once. However, 2-5 years olds only have a coverage of 92%. The coverage for two doses was 85% and 82% respectively. Additionally, it turns out that a third of young adults born before 1997 are missing a second dose. Conclusions: The model is able to give insights into the situation on measles coverage in Austria and to inform decision makers about the most important issues. Coverage for small children can be presented in a high quality while coverage for teenagers and young adults underlie a greater uncertainty due to immigrants with unknown vaccination status and vaccinations of persons with an undocumented age. PIN114 Inter-State Variability Of Adult Vaccination Coverage In The United States: Can We Explain It? Kurosky S1, Trantham L1, La EM1, Aris E2, Hogea CS3 1RTI Health Solutions, Research Triangle Park, NC, USA, 2GlaxoSmithKline, Wavre, Belgium, 3GSK, Philadelphia, PA, USA
Objectives: Despite routine recommendations, adult uptake of influenza, pneumococcal, pertussis, and zoster vaccines in the United States is low. To inform development of evidence-based vaccination interventions, this study sought to evaluate inter-state variability and better understand local factors influencing adult vaccination coverage. Methods: Logistic regression models were employed to estimate state-level adult vaccination coverage adjusted for individual-level characteristics using Behavioral Risk Factor Surveillance System data. States were ranked according to the sum of each state’s calculated z-score for each vaccine’s model-adjusted coverage, providing a composite metric across all four vaccines. Further considering the states ranked at the extremes, we then conducted a targeted review of state immunization websites and published literature to describe facilitators/barriers and interventions targeting adult vaccination, using the Social Ecological Model as a guiding theoretical framework to categorize interventions by level of influence on vaccination. Results: Based on calculated z-scores, New Jersey, Florida, Illinois, Mississippi, and New York were ranked as low coverage states, while Minnesota, Washington, Colorado, Vermont, and New Mexico were ranked as high coverage states. All interventions reported on state immunization websites were implemented at the institutional or policy level, with immunization information systems most frequently reported (n= 10 states). Only a subset of states reported quality improvement programs (n= 6) and standing order interventions (n= 4). Other common interventions were school immunization laws and state-purchased vaccines. All interventions from the literature (n= 12 interventions) targeted improving vaccination at the institutional, interpersonal, or intrapersonal level. Data on state-specific vaccination facilitators/barriers were not identified. Conclusions: There is substantial inter-state variability in adult vaccination coverage in the United States. Existing data provide very limited insight on local facilitators/barriers or interventions impacting adult vaccination. Further efforts to bridge this information gap are critical towards developing targeted interventions to increase coverage. Collection of qualitative data from local stakeholders may provide further insights. PIN115 A Survey On The Society’s Awareness Level On Aids In Turkey Malhan S1, Oksuz E1, Numanoglu Tekin R2 1Baskent University, Ankara, Turkey, 2Baskent University, Health Care Management, Ankara, Turkey
Objectives: The survey aims to measure the society’s awareness level on AIDS in Turkey. Methods: Data were collected through a questionnaire on AIDS carried out with face-to-face interview method. A short and clear questionnaire was prepared and it was aimed to reach more people in the society. A total of 21,377 people were reached and information on the society’s awareness level on AIDS was collected. Results: The mean age was 32.9 and 51.8% of the participators were female and 47.4% were male. 63.3% of respondents stated that they have a lot of information; 22.7% stated that they have little information and 14.1% stated that they have no information about HIV. 74.3% of respondents stated that HIV is transmitted through blood; 10,2% stated that it is transmitted through handshake; 33,8% stated that it is transmitted through kissing; 77,5% stated that it is transmitted through unprotected sex. 25% said that AIDS patients can continue their normal lives after taking the necessary treatment; 32.6% said that they cannot continue their normal life and 42.4% said that they do not know much about it. 53.4% of respondents stated that HIV testing can only be done in hospitals; 39.9% stated that it can be done in primary health care institutions and 6.7% stated that it can be done in all health care institutions. 49.7% of the respondents stated that their identity should be kept secret and that it is not right to submit their identity to the hospital when they have an HIV test. Conclusions: Although the prevalence of AIDS in Turkey is low compared to other countries, it shows an increasing trend according to the estimations made. However, since the disease is not accepted by the society in terms of culture and religion, the transfer of information on the disease has always been limited. PIN116 Mapping Of Skin And Soft Tissue Infections Worldwide: An Approach From Literature Review Lizano-Díez I, Garrido E, Zsolt I, Espinosa C Ferrer, Barcelona, Spain
Objectives: The aim of this study was to conduct a global mapping of skin and soft tissue infections (SSTIs), to describe its clinical classification (bacterial, viral, parasitic, dermatomycoses and other infestations), as well as the geographical area of occurrence and climate (tropical, subtropical, desert, cold, temperate and others). Methods: A systematic literature search was conducted (18/05/2017) through the PubMed database to identify the available evidence on SSTIs related to climate and humidity conditions. Five search strategies were designed taking into consideration terms located by MeSH vocabulary. Two additional filters were applied to search results (1. abstract availability; 2. title + abstract screening, in order to identify
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reports of SSTIs). The identified studies were evaluated by two independent reviewers to assess their inclusion in this project. Results: All search strategies resulted in 1,122 references after duplicates removal. Subsequent filtration excluded 447 of them, resulting in 675 references for analysis. Global results showed that almost 20% of evidence was specific for Central America, Caribbean and Latin America areas (Brazil and Colombia accounted about 60%), followed by Africa (13%; highlighting Nigeria, Cameroon and Ethiopia). More than 50% of publications were focused on reporting a wide casuistry of parasitic SSTIs, followed by dermatomycoses (18%) and bacterial infections (16%). Parasitic SSTIs recorded were related to leishmaniasis in 60% of cases, dermatomycoses showed high variability of cases and bacterial SSTIs were mostly related to staphylococci and streptococci, accounting for 48% of references (i.e. abscess, furunculosis, cellulitis and impetigo/pyoderma). Studies located in tropical and subtropical climates exceeded 40% of total, followed by temperate (18%) and desert (15%). Maps with global and specific results for SSTIs and climates will be disclosed. Conclusions: The greatest burden of disease occurrs in tropical and subtropical climates (mostly in Central America, Caribbean, Latin America and Africa areas), which are resource-limited settings with endemic populations of SSTIs. PIN117 Processes And Requirements For Health Economic Assessment Of Antibiotics For Hta Purposes: Time For A Paradigm Shift? Gaultney J1, Yesufu-Udechuku A2, Bending MW3 1Mapi Group, Houten, The Netherlands, 2Mapi Group, London, UK, 3Mapi, London, UK
Objectives: Regulatory incentives for development of antibiotics have increased the number approved by EMA allowing them to come to market based on adapted evidence requirements, challenging the generation of evidence required for health technology assessment (HTA) reimbursement decision making purposes and impeding patient access to effective treatments. We aimed to assess the potential mis-alignment between regulatory approval requirements and HTA requirements for antibiotics in Europe. Methods: A targeted review was conducted to identify the appraisal processes and health economic assessment requirements as well as incentive schemes for antibiotics (NICE, SMC, AWMSG, TLV and HAS). To understand the relationship between EMA approvals and HTA body appraisals, a search via the EMA website was performed to identify all antibiotics that were approved since 2013 followed by a search via the HTA body website to identify those that were eventually appraised. Finally, a review of the HTA appraisal challenges with the health economic assessment was performed. Results: All but NICE appraise innovative antibiotics. Of those, only HAS instituted adapted appraisal criteria for antibiotics. Since 2013, a total of 8 antibiotics were approved by EMA. The SMC appraised all antibiotics on this list (n= 8), followed by HAS (n= 5), AWMSG (n= 4) and TLV (n= 3). The appraisals cited the following challenges with the health economic assessment: difficulty in establishing added therapeutic effectiveness due to non-inferiority design, small sample size and uncertainty around treatment effects, short treatment duration hindering lifetime horizon, and choice of comparators. None incorporated the impact of treatment on resistance and spill-over effects. Conclusions: HTA processes in Europe need to be adapted for innovative antibiotics to support the regulatory incentives for their development and to accelerate patient access. As a start, traditional requirements for health economic assessment methodology, which does not capture the public health value of antibiotics, should be adapted specifically for antibiotics. PIN118 Are We Prep-Ared For Differences Between Nice And SMC Decision Making? Hendrich J, Boodhna T WG Access, London, UK
Objectives: Recently, emtricitabine/tenofovir disoproxil for pre-exposure prophylaxis (PrEP) of HIV has been approved by NHS Scotland after appraisal by the SMC. However, following an evidence review by NICE it has been decided that further study is required before emtricitabine/tenofovir disoproxil can be approved for use in England. A case study was performed to evaluate this recent disparity between NHS England and NHS Scotland. Methods: A comparative evaluation was performed to assess differences in decision making between each agency regarding emtricitabine/tenofovir disoproxil. The methods and findings of Evidence Summary ESNM78 from NICE and the SMC technology appraisal (No. 1225/17) were compared qualitatively. The NICE evidence summary did not offer formal guidance or include economic analysis. Results: NICE evaluated data from four clinical trials of emtricitabine/tenofovir disoproxil, compared with the SMC which focused on two of the studies. Both bodies considered the drug combination to be clinically effective, with NICE reporting a reduced relative risk (of acquiring HIV infection) between 44% and 86% compared with placebo or no prophylaxis. The SMC performed an economic analysis, which estimated an annual cost of £4,316 per patient (£4.27m overall annual cost). However, the NICE evidence summary did not consider it possible to provide estimated usage based on the available data, citing prioritisation and eligibility criteria as factors influencing uptake. Conclusions: This decision makes Scotland the first country in the UK to adopt emtricitabine/tenofovir disoproxil for PrEP of HIV, while further research is considered necessary in England. This research is necessary to ascertain variables such as: uptake, adherence, sexual behaviour, and drug resistance. Differing epidemiology may explain the difference in approach. The example of emtricitabine/tenofovir disoproxil for PrEP of HIV hints at SMC divergence from simply following NICE recommendations and evidence requirements, indicating a growing influence of the SMC as a self-contained centre for technology appraisal. PIN119 The Early Bird Catches The Worm: Measuring The Potential Value Of Mesenchymal Stem Cells Therapy For Septic Shock Using The Early Health Economic Evaluation Thavorn K1, Van Katwyk S1, Krahn M2, Coyle D3, McIntyre L1