- Email: [email protected]
The Public Health Impact Of A New Herpes Zoster Vaccine To The German Population
A400
VA L U E I N H E A LT H 1 9 ( 2 0 1 6 ) A 3 4 7 – A 7 6 6
Medical evaluation Chair ESC Dijon, Dijon, France
For several decades now clinical and observational studies of wounds and wound healing have been governed by a virtually standard format. This includes an enrolment visit and follow-up visits with an investigating physician during which information is recorded about the changing state of the wound, the nursing care given, and any secondary effects arising from it. This traditional format has numerous limitations that affect the quality of studies and are potential obstacles to identifying the effect of the dressings or other medical devices under study. The use of Information Communication Technology and especially Smartphone applications can overhaul this traditional framework of study by introducing closer follow-up of the wound healing process, systematized image capture with few constraints, and even the more active involvement of those must concerned – the patients themselves. The main difficulty to solve is not the development of a Case Record Form on a smartphone being able to manage data, pictures and analogic scale but guaranty the medical secrecy and the protection of medical personal data in accordance to French law and European directive on data protection. We develop a system of cryptography allowing the involvement of medical practitioner, caregivers and patients themselves in the data records using asymmetric algorithms which have been validate in the framework of a national wound observatory by the French health and data protection authorities. This data collection system is applicable to many other domain and a next authorization has been given for cardiovascular prevention observatory. The security organisation and the algorithms used will be presented in the paper. This system will be also used in daily care to improve the follow up of patients presenting wound and to increase their quality of care while reducing their cost, in particular by reducing delays for a skill medical advices and transport fees.
Disease- Specific Studies
INDIVIDUAL’S HEALTH – Clinical Outcomes Studies PIH1 Association Between Exposure To Anticholinergic And Sedative Drugs And Healthcare Costs In Elderly Patients With Cognitive Complaint Gervais F1, Dauphinot V2, Krolak-Salmon P2, Mouchoux C3 1Hôpital Edouard Herriot, Hospices Civils de Lyon, Lyon, France, 2Clinical and Research Memory Centre of Lyon, Villeurbanne, France, 3Clinical Research Centre (CRC) - VCF (Aging – Brain Frailty), Villeurbanne, France
Objectives: Drug-related problems (DRP) are associated with a high clinical and economic burden on elderly patients, care-givers and the healthcare systems. A high exposure to anticholinergic and sedative drugs, measured by the Drug Burden Index (DBI), has been shown to negatively affect the cognitive performance and the functional status of older adults and to increase the risk of falls. Increasing DBI has been associated with greater number of general practitioner visits, hospital stays and length of hospital stay. This study aims to explore the economic impact on healthcare costs of reducing the DBI Methods: A cross-sectional study was conducted. A cohort of patients with cognitive complaint was retrieved in the French health insurance databases between January 2013 and June 2014. For each patient, the DBI was calculated according to daily dose and the defined daily dose (World Health Organization) every 6 months. Mean costs including inpatient and outpatient care, office-based practitioner, pharmacy, transport services and daily allowances were extracted. Relationships between the DBI and costs, controlling for corresponding baseline cognitive function (MMSE), comorbidities, disease status and etiology, healthcare utilisation and sociodemographic characteristics (age, gender), were assessed using analysis of covariance and multiple linear regression analysis. Results: 1060 patients were included in the study. Patients exposed to anticholinergic and sedative drugs are significantly associated with higher healthcare use (inpatient and outpatient cares, office-based visits, polypharmacy and transport services). A one unit decrease (e.g., discontinuing both furosemide 40mg and zopiclone 7.5mg) in DBI was associated with a significant division in total costs by 1.65 (p< 0.01). Conclusions: DBI is an evidence-based tool that can contribute clinically and economically relevant information in the process of detecting at risk patients. Interventional and cost-utility studies are required to assess the clinical and economic impact of a strategy based on DBI to daily optimise inappropriate prescribing in older people.
the cost / effectiveness (Keff) was 155 000/60 = 2 583. 3 group:The effectiveness of this treatment was 80%. Delivery period was 39,9 ± 0,4 (39-40) week gestation and interval between the pessaries removing and the birth was 10,7 ± 0,5 (9-12) days. The cost per patient was 21,000 kzt., 10 patients - 210000 kzt. Index the cost / effectiveness (Keff) was 210 000/80 = 2 625. Conclusions: According to the clinical outcomes, the combined method of predicting preterm births is more effectiveness (80% of cases contributes to prolongation of pregnancy to 39-40 weeks). However, from the perspective of pharmacoeconomics the introduction of the pessaries + progesterone is more rational than cerclage + progesterone. PIH4 Effect Of A Multifactorial, Interdisciplinary Intervention On Falls And Fall Rate Of The Older People In The Community Lee SH1, Kim HS2 University, Incheon, South Korea, 2Chonbuk National University, Jeonju, Jeolabuk-do, South Korea
1Gachon
Objectives: Falls are a common problem and cause considerable morbidity in older people. The overall effect of various programs for preventing falls including exercise or multifactorial programs in in the community remains controversial. The aim of this study was to determine the effect of several prevention programs on fall rates, number of fallers and fall-related injuries in the community. Methods: We searched Medline, EMBASE, CINAHL, Cochrane, Korea med systematically to Mar 2016 for randomised controlled trials to reduce falls among older people residing in in the community. The outcomes were fall rates, number of falls, fallers. Results: The computerized search strategy found 828 potential articles, thirty of which met the inclusion criteria. Fourty four trials were eligible. Meta analysis found that multifactorial interventions significantly reduced fall rates (RR = 0.83, 95% CI = 0.74-0.92), while exercise tended to reduce fall rates but did not achieve a significant reduction (RR= 0.94, 95% CI = 0.76 – 1.17). Conclusions: The study show that a multifactorial intervention to reduce the risk of falling among elderly people living in the community. However, the exercise was not significant to prevent falls. It needs more explorations considering the components and intensities of exercise programs. PIH5 The Public Health Perspective Of An Investigational Herpes Zoster Vaccine In The United Kingdom (Uk) van Oorschot DA1, Hunjan M2, Varghese L3, Canavan C2, Curran D1 1GSK Vaccines, Wavre, Belgium, 2GSK UK, Uxbridge, UK, 3GlaxoSmithKline Vaccines, Singapore, Singapore
Objectives: Herpes Zoster (HZ) presents a considerable public health burden in the United Kingdom (UK), affecting more than 7.91 patients per 100,000 person/years. A new HZ subunit candidate vaccine (HZ/su) has been developed, which in clinical studies demonstrated high efficacy against HZ and its complications. The aim of this study is to assess the public health impact of introducing this new vaccine to the UK population aged ≥ 65 years old. Methods: Projected population demographics by age group were obtained from the UK Office of National Statistics. HZ incidence and the proportion of HZ patients who subsequently develop post-herpetic neuralgia (PHN) were derived from a study by van Hoek et al. (2009; DOI:10.1016/j. vaccine.2008.12.024). Vaccine efficacy data were based on the results of the ZOE50 study, Lal et al. (2015; DOI:10.1056/NEJMoa1501184), with exponential waning modeled set at 2% and 4%. First dose coverage was assumed at 72.8%, similar to the influenza vaccine coverage in the 2014-2015 season in UK. For the second dose, we assumed 100% compliance. The analysis was performed using a multi-cohort static Markov model developed in MS Excel that uses an annual cycle length (GSK study identifier: HO-16-17272). The impact of HZ/su vaccination is compared to no vaccination over a lifetime horizon. Results: The UK cohort contained 11,610,117 people aged ≥ 65 years old. Without vaccination there were approximately 1.5 million HZ cases and 434,000 PHN cases. By vaccinating 72.8% of this cohort, this prevented between 759,000 – 901,000 HZ cases and 200,000 – 245,000 PHN cases, depending on the waning rate assumed. Conclusions: Introduction of the HZ/su vaccine in the age group ≥ 65 years of age could potentially reduce the burden of disease related to HZ substantially in the UK population. PIH6 The Public Health Impact Of A New Herpes Zoster Vaccine To The German Population van Oorschot DA1, Anastassopoulou A2, Schlegel K2, Varghese L3, von Krempelhuber A2, Curran D1 Germany, München, Germany, 3GlaxoSmithKline Vaccines, Singapore, Singapore
1GSK Vaccines, Wavre, Belgium, 2GSK
PIH3 Determination Of Clinical And Cost-Effectiveness Of Various Methods Of Predicting Preterm Birth In Women With High Risk Tuletova A, Dochshanova A Astana Medical University, Astana, Kazakhstan
Objectives: To determine the clinical and cost-effectiveness of various methods of predicting preterm birth in groups with high risk Methods: The study included a prospective analysis of the outcomes of pregnancy and childbirth, 30 women with short cervix (< 25 mm) from 16 to 20 gestation weeks. Depending on the method of treatment divided three groups: Group 1 - 10 patients with cerclage and vaginal micronized progesterone (VMP) 400mg; Group 2 - 10 patients only with VMP 400 mg; Group 3 - 10 patients with obstetric pessaries and VMP 400mg. According to the clinical outcomes was conducted pharmacoeconomic analysis Results: 1 group: The effectiveness was 80%. Delivery period was 39,1 ± 0,2 week gestation, the time from the cerclage removed untill delivery was 9,3 ± 0,5 (7-10) days. The cost per patient was 40,500 kzt., 10 patients - 405000 kzt. Index the cost / effectiveness was 405 000/80 = 5 063. 2 group: The hormonotherapy efficiency was 60%. Delivery period was 37,2 ± 0,5 week gestatoin, the time from the last medicaments untill delivery was 5,5 ± 0,3 (5-7) days. The cost per patient was 15,500 kzt., 10 patients -155000 kzt. Index
Objectives: The aim of this study was to assess public health impact of introducing a new Herpes Zoster (HZ) subunit candidate vaccine (HZ/su), which in clinical studies demonstrated high efficacy against HZ and its complications, in the German populations aged ≥ 50 and ≥ 60 years. Methods: Demographic data were obtained from the German federal statistical office (DeStatis). HZ incidence as well as the proportion of HZ subjects who subsequently developed post-herpetic neuralgia (PHN) was derived from Hillebrand et al. (2014; DOI:0.1016/j.jinf.2014.08.018). Agespecific vaccine efficacy data are based on the results of the phase III efficacy study, published by Lal et al. (2015; DOI:10.1056/NEJMoa1501184), while assuming annual waning rate of the vaccine efficacy of 2% and 4%. The scenarios were explored for the populations aged ≥ 50 years old and ≥ 60 years. Coverage of the first dose was assumed to be comparable to the influenza vaccine coverage in these age groups in Germany, with 25% and 36.7% respectively. Compliance of the second dose is assumed to be 100%. A multi-cohort static Markov model that uses an annual cycle length was developed in MS Excel to model the progression of HZ after vaccination (GSK study identifier: HO-16-17270). The cohorts were assessed over their lifetime and the outcomes were compared against no vaccination. Results: Vaccinating 25% of the 34,932,000 adults ≥ 50 years old with the HZ/su vaccine could potentially prevent between 853,000 – 1 million HZ cases and between 153,000 – 199,000 PHN
VA L U E I N H E A LT H 1 9 ( 2 0 1 6 ) A 3 4 7 – A 7 6 6
cases, depending on the waning rate assumed. Similarly, when vaccinating 36.7% of the 22,219,000 adults ≥ 60 years old the vaccine could potentially prevent between 747,000 – 903,000 HZ cases and 145,000 – 177,000 PHN cases. Conclusions: The HZ/ su vaccine could potentially reduce the HZ-related burden of disease significantly in both age cohorts in Germany. PIH7 The Prevalence Of Sexual Dysfunctions Among Hungarian Men Palancsa M1, Damásdi M1, Gitta S1, Tardi P2, Járomi M1, Ács P1, Boncz I1, Hock M1 of Pécs, Pécs, Hungary, 2Train-Health Nonprofit Ltd., Harkány, Hungary
1University
Objectives: Premature ejaculation (PE) and erectile dysfunction (ED) are the most common sexual dysfunctions among men. The perineal muscles surrounding the penis are responsible for the control and maintenance of erection and ejaculation and have a tendency of losing strength. Although pelvic-floor muscles (PFM) are striated muscles which are trainable according to adequate principles, PFMexercises are relatively unknown to men. In the research, we aimed to discover the occurrence of sexual dysfunctions among Hungarian men and observe the relations between sexual habits and the possible dysfunctions that may relate to PFM malfunction. Methods: Questionnaires were spread via the internet (n= 114). The survey consisted of questions regarding sexual habits and culture, satisfaction with sexual life, the understanding of PFM functions and a 5-item “Premature Ejaculation Diagnostic Tool” (PEDT) questionnaire to identify the possibility and degree of PE. Subjective estimations were asked about the frequency and duration of masturbation, and about Intravaginal Ejaculatory Latency Time (IELT) that marks the time from vaginal penetration to intravaginal ejaculation. Results: Prevalence of PE according to the sample is 37.3-38.1% (PEDT). Correlation was found among the followings: duration of masturbation-IELT (p< 0.05; r= 0.2978); IELT-ejaculatorycontrol (p< 0.01; r= 0.500); IELT-PEDT (r= -0.420); sexual satisfaction and ejaculatorycontrol (r= 0.354); PEDT-sexual satisfaction (r= -0.271); PEDT-ejaculatory-control (r= -0.493). Conclusions: Scientific literature estimates the prevalence of PE between 20-30% but presumably, this number is higher. According to questionnaires, the duration of masturbation has an effect on the length of sexual intercourse (IELT) but also shows connection with the ability to prolong ejaculation. However, IELT showed no significant connection with the satisfaction of sexual life. The results also show a lack of awareness of PFM and its function. PIH8 Iron Deficiency Anemia In Pregnant Women In France: A Prospective Cohort Study Clavel T1, Zkik A2, Berdeaux G3, Auges M4, Sanchez C3, Harvey T5 1Thierry Clavel Consulting, REVEL, France, 2Pierre Fabre, Boulogne Billancourt, France, 3Pierre Fabre Medicament, Boulogne-Billancourt, France, 4Pierre Fabre, boulogne billancourt, France, 5Maternité GH Diaconesses Croix St Simon, Paris, France
Objectives: Anemia and iron deficiency are common during pregnancy and expose mothers to several risks. Regarding the foetus, presumed risks include unfavourable obstetric outcomes. The objective of the study was to explore the prevalence of anemia among pregnant women and clinical symptoms associated. Methods: A prospective cohort study was conducted in 84 centers in France between March 2013 and June 2014. Randomly selected investigators (gynecologists, obstetricians, midwives registered in the CEGEDIM®database) were asked to include the first 5 pregnant women they assessed as having a risk of iron deficiency. Data collected consisted in age, gestation week, laboratory values (e.g. Hb), type of medication and lifestyle or dietary advice given/received, questionnaires completed by patients covered signs and symptoms of anemia and SF12. Results: 363 women were included in the analysis. The majority (68.2%) were aged 25–35 years, and most (80.5%) were in the first (33%) or second (48%) trimester. Anemia was confirmed in 32.8% cases by Hb dosage; the prevalence of anemia increased with increasing duration of pregnancy, from 24.6% among women who were in the first trimester, to 32.1% in the second trimester, and 56.9% in the third trimester. Factors identified as being independently associated with anemia were third trimester of pregnancy (OR= 3.05 versus first trimester, P = 0.0022) and paleness (OR= 1.20 per unit increase, P = 0.0001). Women with anemia commonly had tiredness and hair fragility, and a trend towards reduced QoL (physical activity). Most women received medication, generally ferrous sulfate/folic acid. Conclusions: Anemia due to iron deficiency is a highly prevalent morbidity in pregnant women. Due attention should be paid at symptoms associated with anemia during the last trimester.
INDIVIDUAL’S HEALTH – Cost Studies
A401
of which were hysterectomies. Before the launch of UPA in France, number of surgeries increased by 380 each year. The introduction of UPA was correlated with a trend reversal, showing a decrease in the number of surgeries of 1,236 each year from mid-2013. UPA did not have an impact on the type of surgery, neither on the surgical approach. The savings associated with the use of UPA pre-operatively (cost of treatment and avoided surgeries included) were estimated at 2M€ in 2013 and will reach 9M€ in 2016, that was considered as a plateau for the following years. The cumulated budgetary impact from 2016 to 2019 is estimated at -37M€ . Conclusions: Thanks to avoided surgeries, the use of UPA as pre-operative treatment is associated with financial savings, which cover largely the treatment costs. PIH10 Budget-Impact Analysis (Bia) Of The Introduction Of 52mg Levonorgestrel-Releasing Intrauterine System (Lng-Ius) As A Contraceptive Method Option In The Brazilian Public Healthcare System (Sus) To Avoid Unintended Pregnancy (Up) In 15 To 19 Year-Old Adolescents Ramos NB, Honda A, Sakagute M, Nakada C, Tobaruella F Bayer Healthcare, São Paulo, Brazil
Objectives: Unintended pregnancy represents a significant economic burden to the health system with an estimated medical cost for SUS of BRL4.1 billion annually. Adolescent women have a high risk of UP, mainly due to the compliance required by most of the available contraceptive methods. Therefore, as LNG-IUS effectiveness doesn’t rely on user adherence, our objective is to evaluate the budget impact of the incorporation of LNG-IUS in SUS. Methods: BIA was developed with a 5-year time horizon. The number of 15 to 19-year old adolescents was obtained from the Brazilian Census data (IBGE), from which 67.2% would be sexually active according to the Ministry of Health and were considered as users of contraceptive methods. Initial market share of each method was estimated from UNESCO survey. It was assumed that LNG-IUS garnered 0.7% of the contraceptive market in the first year reaching 5% in the 5th year, taking most of its share from short-acting methods. The analysis considered the cost of each method, its medical resources and also the endpoint (UP cost). Prices of contraceptive methods were obtained from public sources: LNG-IUS 52mg (maximum government selling price) and current methods in SUS from public disclosures (Health Prices Database and the Official Gazette). Costs expressed in 2016 prices, exchange rate 1.00USD= 3.70BRL. Results: The expected number of women using LNG-IUS is 279.110 after 5 years. BIA showed overall savings of BRL12.7 million in 5 years, driven mainly by decreased UP-related expenditures and long-term savings in contraceptive costs. First-year acquisition cost of the device lead to increased costs in the first 2 years of incorporation. Conclusions: LNG-IUS is a highly effective contraceptive method that has the potential to yield savings for avoiding UP in 15 to 19-year old adolescents in the Brazilian Public Health care system. PIH11 Availability And Costs Of Pediatric Formulations In India : A Case Study Tayal H1, Roy V2 1Maulana Azad Medical college, Delhi, India, 2Maulana Azad Medical College, University of Delhi, New Delhi, India
Objectives: To assess the availability of pediatric formulations in private and public sector in india. Comparison of costs of key medicines in private and public sector. Methods: In this study, to assess the availability of medicines in the private sector , a commercial source of drug information(drug compendium) was used. In public sector, availability was assessed using National list of essential medicines and Delhi essential medicine list and their comparison with the WHO essential medicine list for children was done. To assess the cost of medicines in the private sector, prices of key 30 tracer medicines was recorded from the Drug Compendium. For the public sector prices , the Hospital rate contract of the year 2015 was used. Acomparison was made between the both. Results: Only 250 medicines were available in pediatric formulations which was less than those mentioned in the WHO essential medicines list for children. Maximum shortage was seen the cardiovascular system category . In the essential medicines list the number of pediatric medicines in National list of essential medicines and Delhi essential medicine list was very less in comparison to those recommended in the WHO essential medicines list for children.Palliative category of drugs was totally neglected in Delhi and National list of essential medicines. The prices of medicines in the private sector were higher in comparison to the public sector prices by a wide margin.(332%) Conclusions: The study results show that there is a need for formulation of policy in India for improving the availability and costs of medicines in children.
PIH9 Budget Impact Of Ulipristal Acetate 5mg In Pre-Operative Treatment Of Uterine Fibroids: An Analysis Based On Public Data On Hospital Stays In France
PIH12 Economic Evaluation Of Rfsh And Hp-Hmg For Infertility Treatment In Brazil
Trancart M1, Lehmann M2, Lafuma A1 1Cemka-Eval, Bourg La Reine, France, 2Gedeon Richter - PregLem S.A., Geneva, Switzerland
1Merck, São
Objectives: To estimate the budget impact of ulipristal acetate 5mg (UPA) in the preoperative treatment of uterine fibroids (UF) within a 3-year time horizon in France, by analyzing a national hospital database. Methods: The “Programme de Médicalisation des Systèmes d’Information” (PMSI) database is a comprehensive and exhaustive database on hospital stays in acute care facilities in France. These hospitalizations are mostly overnight stays, but also include day care stays for ambulatory procedures like surgery. Surgeries for uterine fibroids (hysterectomies and myomectomies) were identified between 2006 and 2014. Number of avoided surgeries through the use of UPA was estimated by comparing trends before and after the commercialization of the product in France (August 2013). Number of patients treated with UPA was recalculated from the number of units sold between 2013 and mid-2016, based on GERS data. For the subsequent years, data were extrapolated and trends were supposed to stabilize from the end of 2016. Results: In 2012, 34,480 surgeries for UF were performed, 46%
Souza PV1, Simões AC2, Zanini FE1, Sato CC1 Paulo, Brazil, 2Merck, Rio de Janeiro, Brazil
Objectives: To compare outcomes and treatment costs between a recombinant follicle-stimulating hormone (rFSH) and a highly purified human menopausal gonadotrophin (hp-HMG) in assisted reproduction in Brazil. Methods: A cost per outcome model was developed to simulate one in vitro fertilization (IVF) cycle with up to four embryo tranfers - one fresh and up to three frozen. The clinical and economical impact of comparators were assessed. Outcomes were derived from a pooled results analysis of clinical trials. Drug acquisition costs were derived from official drug list price in Brazil. Results: Treatment with rFSH uses approximately 2,007 IU while 2,600 IU are needed when hp-HMG is chosen. Drug acquisition costs for ovarian stimulation is R$ 4,623 and R$ 3,738 for rFSH and hp-HMG, respectively. rFSH yields 2 more oocytes than hp-HMG (11 vs. 9) and 1,6 more embryos (5,6 vs. 4) in average. Cumulative clinical pregnancy rate and cumulative live birth rate for rFSH are 31% and 24% higher than hp-HMG, respectively. Overall, cost per oocyte is equal for both drugs (R$ 400); cost per embryo is R$ 832 and R$ 935 for rFSH and
VA L U E I N H E A LT H 1 9 ( 2 0 1 6 ) A 3 4 7 – A 7 6 6
Medical evaluation Chair ESC Dijon, Dijon, France
For several decades now clinical and observational studies of wounds and wound healing have been governed by a virtually standard format. This includes an enrolment visit and follow-up visits with an investigating physician during which information is recorded about the changing state of the wound, the nursing care given, and any secondary effects arising from it. This traditional format has numerous limitations that affect the quality of studies and are potential obstacles to identifying the effect of the dressings or other medical devices under study. The use of Information Communication Technology and especially Smartphone applications can overhaul this traditional framework of study by introducing closer follow-up of the wound healing process, systematized image capture with few constraints, and even the more active involvement of those must concerned – the patients themselves. The main difficulty to solve is not the development of a Case Record Form on a smartphone being able to manage data, pictures and analogic scale but guaranty the medical secrecy and the protection of medical personal data in accordance to French law and European directive on data protection. We develop a system of cryptography allowing the involvement of medical practitioner, caregivers and patients themselves in the data records using asymmetric algorithms which have been validate in the framework of a national wound observatory by the French health and data protection authorities. This data collection system is applicable to many other domain and a next authorization has been given for cardiovascular prevention observatory. The security organisation and the algorithms used will be presented in the paper. This system will be also used in daily care to improve the follow up of patients presenting wound and to increase their quality of care while reducing their cost, in particular by reducing delays for a skill medical advices and transport fees.
Disease- Specific Studies
INDIVIDUAL’S HEALTH – Clinical Outcomes Studies PIH1 Association Between Exposure To Anticholinergic And Sedative Drugs And Healthcare Costs In Elderly Patients With Cognitive Complaint Gervais F1, Dauphinot V2, Krolak-Salmon P2, Mouchoux C3 1Hôpital Edouard Herriot, Hospices Civils de Lyon, Lyon, France, 2Clinical and Research Memory Centre of Lyon, Villeurbanne, France, 3Clinical Research Centre (CRC) - VCF (Aging – Brain Frailty), Villeurbanne, France
Objectives: Drug-related problems (DRP) are associated with a high clinical and economic burden on elderly patients, care-givers and the healthcare systems. A high exposure to anticholinergic and sedative drugs, measured by the Drug Burden Index (DBI), has been shown to negatively affect the cognitive performance and the functional status of older adults and to increase the risk of falls. Increasing DBI has been associated with greater number of general practitioner visits, hospital stays and length of hospital stay. This study aims to explore the economic impact on healthcare costs of reducing the DBI Methods: A cross-sectional study was conducted. A cohort of patients with cognitive complaint was retrieved in the French health insurance databases between January 2013 and June 2014. For each patient, the DBI was calculated according to daily dose and the defined daily dose (World Health Organization) every 6 months. Mean costs including inpatient and outpatient care, office-based practitioner, pharmacy, transport services and daily allowances were extracted. Relationships between the DBI and costs, controlling for corresponding baseline cognitive function (MMSE), comorbidities, disease status and etiology, healthcare utilisation and sociodemographic characteristics (age, gender), were assessed using analysis of covariance and multiple linear regression analysis. Results: 1060 patients were included in the study. Patients exposed to anticholinergic and sedative drugs are significantly associated with higher healthcare use (inpatient and outpatient cares, office-based visits, polypharmacy and transport services). A one unit decrease (e.g., discontinuing both furosemide 40mg and zopiclone 7.5mg) in DBI was associated with a significant division in total costs by 1.65 (p< 0.01). Conclusions: DBI is an evidence-based tool that can contribute clinically and economically relevant information in the process of detecting at risk patients. Interventional and cost-utility studies are required to assess the clinical and economic impact of a strategy based on DBI to daily optimise inappropriate prescribing in older people.
the cost / effectiveness (Keff) was 155 000/60 = 2 583. 3 group:The effectiveness of this treatment was 80%. Delivery period was 39,9 ± 0,4 (39-40) week gestation and interval between the pessaries removing and the birth was 10,7 ± 0,5 (9-12) days. The cost per patient was 21,000 kzt., 10 patients - 210000 kzt. Index the cost / effectiveness (Keff) was 210 000/80 = 2 625. Conclusions: According to the clinical outcomes, the combined method of predicting preterm births is more effectiveness (80% of cases contributes to prolongation of pregnancy to 39-40 weeks). However, from the perspective of pharmacoeconomics the introduction of the pessaries + progesterone is more rational than cerclage + progesterone. PIH4 Effect Of A Multifactorial, Interdisciplinary Intervention On Falls And Fall Rate Of The Older People In The Community Lee SH1, Kim HS2 University, Incheon, South Korea, 2Chonbuk National University, Jeonju, Jeolabuk-do, South Korea
1Gachon
Objectives: Falls are a common problem and cause considerable morbidity in older people. The overall effect of various programs for preventing falls including exercise or multifactorial programs in in the community remains controversial. The aim of this study was to determine the effect of several prevention programs on fall rates, number of fallers and fall-related injuries in the community. Methods: We searched Medline, EMBASE, CINAHL, Cochrane, Korea med systematically to Mar 2016 for randomised controlled trials to reduce falls among older people residing in in the community. The outcomes were fall rates, number of falls, fallers. Results: The computerized search strategy found 828 potential articles, thirty of which met the inclusion criteria. Fourty four trials were eligible. Meta analysis found that multifactorial interventions significantly reduced fall rates (RR = 0.83, 95% CI = 0.74-0.92), while exercise tended to reduce fall rates but did not achieve a significant reduction (RR= 0.94, 95% CI = 0.76 – 1.17). Conclusions: The study show that a multifactorial intervention to reduce the risk of falling among elderly people living in the community. However, the exercise was not significant to prevent falls. It needs more explorations considering the components and intensities of exercise programs. PIH5 The Public Health Perspective Of An Investigational Herpes Zoster Vaccine In The United Kingdom (Uk) van Oorschot DA1, Hunjan M2, Varghese L3, Canavan C2, Curran D1 1GSK Vaccines, Wavre, Belgium, 2GSK UK, Uxbridge, UK, 3GlaxoSmithKline Vaccines, Singapore, Singapore
Objectives: Herpes Zoster (HZ) presents a considerable public health burden in the United Kingdom (UK), affecting more than 7.91 patients per 100,000 person/years. A new HZ subunit candidate vaccine (HZ/su) has been developed, which in clinical studies demonstrated high efficacy against HZ and its complications. The aim of this study is to assess the public health impact of introducing this new vaccine to the UK population aged ≥ 65 years old. Methods: Projected population demographics by age group were obtained from the UK Office of National Statistics. HZ incidence and the proportion of HZ patients who subsequently develop post-herpetic neuralgia (PHN) were derived from a study by van Hoek et al. (2009; DOI:10.1016/j. vaccine.2008.12.024). Vaccine efficacy data were based on the results of the ZOE50 study, Lal et al. (2015; DOI:10.1056/NEJMoa1501184), with exponential waning modeled set at 2% and 4%. First dose coverage was assumed at 72.8%, similar to the influenza vaccine coverage in the 2014-2015 season in UK. For the second dose, we assumed 100% compliance. The analysis was performed using a multi-cohort static Markov model developed in MS Excel that uses an annual cycle length (GSK study identifier: HO-16-17272). The impact of HZ/su vaccination is compared to no vaccination over a lifetime horizon. Results: The UK cohort contained 11,610,117 people aged ≥ 65 years old. Without vaccination there were approximately 1.5 million HZ cases and 434,000 PHN cases. By vaccinating 72.8% of this cohort, this prevented between 759,000 – 901,000 HZ cases and 200,000 – 245,000 PHN cases, depending on the waning rate assumed. Conclusions: Introduction of the HZ/su vaccine in the age group ≥ 65 years of age could potentially reduce the burden of disease related to HZ substantially in the UK population. PIH6 The Public Health Impact Of A New Herpes Zoster Vaccine To The German Population van Oorschot DA1, Anastassopoulou A2, Schlegel K2, Varghese L3, von Krempelhuber A2, Curran D1 Germany, München, Germany, 3GlaxoSmithKline Vaccines, Singapore, Singapore
1GSK Vaccines, Wavre, Belgium, 2GSK
PIH3 Determination Of Clinical And Cost-Effectiveness Of Various Methods Of Predicting Preterm Birth In Women With High Risk Tuletova A, Dochshanova A Astana Medical University, Astana, Kazakhstan
Objectives: To determine the clinical and cost-effectiveness of various methods of predicting preterm birth in groups with high risk Methods: The study included a prospective analysis of the outcomes of pregnancy and childbirth, 30 women with short cervix (< 25 mm) from 16 to 20 gestation weeks. Depending on the method of treatment divided three groups: Group 1 - 10 patients with cerclage and vaginal micronized progesterone (VMP) 400mg; Group 2 - 10 patients only with VMP 400 mg; Group 3 - 10 patients with obstetric pessaries and VMP 400mg. According to the clinical outcomes was conducted pharmacoeconomic analysis Results: 1 group: The effectiveness was 80%. Delivery period was 39,1 ± 0,2 week gestation, the time from the cerclage removed untill delivery was 9,3 ± 0,5 (7-10) days. The cost per patient was 40,500 kzt., 10 patients - 405000 kzt. Index the cost / effectiveness was 405 000/80 = 5 063. 2 group: The hormonotherapy efficiency was 60%. Delivery period was 37,2 ± 0,5 week gestatoin, the time from the last medicaments untill delivery was 5,5 ± 0,3 (5-7) days. The cost per patient was 15,500 kzt., 10 patients -155000 kzt. Index
Objectives: The aim of this study was to assess public health impact of introducing a new Herpes Zoster (HZ) subunit candidate vaccine (HZ/su), which in clinical studies demonstrated high efficacy against HZ and its complications, in the German populations aged ≥ 50 and ≥ 60 years. Methods: Demographic data were obtained from the German federal statistical office (DeStatis). HZ incidence as well as the proportion of HZ subjects who subsequently developed post-herpetic neuralgia (PHN) was derived from Hillebrand et al. (2014; DOI:0.1016/j.jinf.2014.08.018). Agespecific vaccine efficacy data are based on the results of the phase III efficacy study, published by Lal et al. (2015; DOI:10.1056/NEJMoa1501184), while assuming annual waning rate of the vaccine efficacy of 2% and 4%. The scenarios were explored for the populations aged ≥ 50 years old and ≥ 60 years. Coverage of the first dose was assumed to be comparable to the influenza vaccine coverage in these age groups in Germany, with 25% and 36.7% respectively. Compliance of the second dose is assumed to be 100%. A multi-cohort static Markov model that uses an annual cycle length was developed in MS Excel to model the progression of HZ after vaccination (GSK study identifier: HO-16-17270). The cohorts were assessed over their lifetime and the outcomes were compared against no vaccination. Results: Vaccinating 25% of the 34,932,000 adults ≥ 50 years old with the HZ/su vaccine could potentially prevent between 853,000 – 1 million HZ cases and between 153,000 – 199,000 PHN
VA L U E I N H E A LT H 1 9 ( 2 0 1 6 ) A 3 4 7 – A 7 6 6
cases, depending on the waning rate assumed. Similarly, when vaccinating 36.7% of the 22,219,000 adults ≥ 60 years old the vaccine could potentially prevent between 747,000 – 903,000 HZ cases and 145,000 – 177,000 PHN cases. Conclusions: The HZ/ su vaccine could potentially reduce the HZ-related burden of disease significantly in both age cohorts in Germany. PIH7 The Prevalence Of Sexual Dysfunctions Among Hungarian Men Palancsa M1, Damásdi M1, Gitta S1, Tardi P2, Járomi M1, Ács P1, Boncz I1, Hock M1 of Pécs, Pécs, Hungary, 2Train-Health Nonprofit Ltd., Harkány, Hungary
1University
Objectives: Premature ejaculation (PE) and erectile dysfunction (ED) are the most common sexual dysfunctions among men. The perineal muscles surrounding the penis are responsible for the control and maintenance of erection and ejaculation and have a tendency of losing strength. Although pelvic-floor muscles (PFM) are striated muscles which are trainable according to adequate principles, PFMexercises are relatively unknown to men. In the research, we aimed to discover the occurrence of sexual dysfunctions among Hungarian men and observe the relations between sexual habits and the possible dysfunctions that may relate to PFM malfunction. Methods: Questionnaires were spread via the internet (n= 114). The survey consisted of questions regarding sexual habits and culture, satisfaction with sexual life, the understanding of PFM functions and a 5-item “Premature Ejaculation Diagnostic Tool” (PEDT) questionnaire to identify the possibility and degree of PE. Subjective estimations were asked about the frequency and duration of masturbation, and about Intravaginal Ejaculatory Latency Time (IELT) that marks the time from vaginal penetration to intravaginal ejaculation. Results: Prevalence of PE according to the sample is 37.3-38.1% (PEDT). Correlation was found among the followings: duration of masturbation-IELT (p< 0.05; r= 0.2978); IELT-ejaculatorycontrol (p< 0.01; r= 0.500); IELT-PEDT (r= -0.420); sexual satisfaction and ejaculatorycontrol (r= 0.354); PEDT-sexual satisfaction (r= -0.271); PEDT-ejaculatory-control (r= -0.493). Conclusions: Scientific literature estimates the prevalence of PE between 20-30% but presumably, this number is higher. According to questionnaires, the duration of masturbation has an effect on the length of sexual intercourse (IELT) but also shows connection with the ability to prolong ejaculation. However, IELT showed no significant connection with the satisfaction of sexual life. The results also show a lack of awareness of PFM and its function. PIH8 Iron Deficiency Anemia In Pregnant Women In France: A Prospective Cohort Study Clavel T1, Zkik A2, Berdeaux G3, Auges M4, Sanchez C3, Harvey T5 1Thierry Clavel Consulting, REVEL, France, 2Pierre Fabre, Boulogne Billancourt, France, 3Pierre Fabre Medicament, Boulogne-Billancourt, France, 4Pierre Fabre, boulogne billancourt, France, 5Maternité GH Diaconesses Croix St Simon, Paris, France
Objectives: Anemia and iron deficiency are common during pregnancy and expose mothers to several risks. Regarding the foetus, presumed risks include unfavourable obstetric outcomes. The objective of the study was to explore the prevalence of anemia among pregnant women and clinical symptoms associated. Methods: A prospective cohort study was conducted in 84 centers in France between March 2013 and June 2014. Randomly selected investigators (gynecologists, obstetricians, midwives registered in the CEGEDIM®database) were asked to include the first 5 pregnant women they assessed as having a risk of iron deficiency. Data collected consisted in age, gestation week, laboratory values (e.g. Hb), type of medication and lifestyle or dietary advice given/received, questionnaires completed by patients covered signs and symptoms of anemia and SF12. Results: 363 women were included in the analysis. The majority (68.2%) were aged 25–35 years, and most (80.5%) were in the first (33%) or second (48%) trimester. Anemia was confirmed in 32.8% cases by Hb dosage; the prevalence of anemia increased with increasing duration of pregnancy, from 24.6% among women who were in the first trimester, to 32.1% in the second trimester, and 56.9% in the third trimester. Factors identified as being independently associated with anemia were third trimester of pregnancy (OR= 3.05 versus first trimester, P = 0.0022) and paleness (OR= 1.20 per unit increase, P = 0.0001). Women with anemia commonly had tiredness and hair fragility, and a trend towards reduced QoL (physical activity). Most women received medication, generally ferrous sulfate/folic acid. Conclusions: Anemia due to iron deficiency is a highly prevalent morbidity in pregnant women. Due attention should be paid at symptoms associated with anemia during the last trimester.
INDIVIDUAL’S HEALTH – Cost Studies
A401
of which were hysterectomies. Before the launch of UPA in France, number of surgeries increased by 380 each year. The introduction of UPA was correlated with a trend reversal, showing a decrease in the number of surgeries of 1,236 each year from mid-2013. UPA did not have an impact on the type of surgery, neither on the surgical approach. The savings associated with the use of UPA pre-operatively (cost of treatment and avoided surgeries included) were estimated at 2M€ in 2013 and will reach 9M€ in 2016, that was considered as a plateau for the following years. The cumulated budgetary impact from 2016 to 2019 is estimated at -37M€ . Conclusions: Thanks to avoided surgeries, the use of UPA as pre-operative treatment is associated with financial savings, which cover largely the treatment costs. PIH10 Budget-Impact Analysis (Bia) Of The Introduction Of 52mg Levonorgestrel-Releasing Intrauterine System (Lng-Ius) As A Contraceptive Method Option In The Brazilian Public Healthcare System (Sus) To Avoid Unintended Pregnancy (Up) In 15 To 19 Year-Old Adolescents Ramos NB, Honda A, Sakagute M, Nakada C, Tobaruella F Bayer Healthcare, São Paulo, Brazil
Objectives: Unintended pregnancy represents a significant economic burden to the health system with an estimated medical cost for SUS of BRL4.1 billion annually. Adolescent women have a high risk of UP, mainly due to the compliance required by most of the available contraceptive methods. Therefore, as LNG-IUS effectiveness doesn’t rely on user adherence, our objective is to evaluate the budget impact of the incorporation of LNG-IUS in SUS. Methods: BIA was developed with a 5-year time horizon. The number of 15 to 19-year old adolescents was obtained from the Brazilian Census data (IBGE), from which 67.2% would be sexually active according to the Ministry of Health and were considered as users of contraceptive methods. Initial market share of each method was estimated from UNESCO survey. It was assumed that LNG-IUS garnered 0.7% of the contraceptive market in the first year reaching 5% in the 5th year, taking most of its share from short-acting methods. The analysis considered the cost of each method, its medical resources and also the endpoint (UP cost). Prices of contraceptive methods were obtained from public sources: LNG-IUS 52mg (maximum government selling price) and current methods in SUS from public disclosures (Health Prices Database and the Official Gazette). Costs expressed in 2016 prices, exchange rate 1.00USD= 3.70BRL. Results: The expected number of women using LNG-IUS is 279.110 after 5 years. BIA showed overall savings of BRL12.7 million in 5 years, driven mainly by decreased UP-related expenditures and long-term savings in contraceptive costs. First-year acquisition cost of the device lead to increased costs in the first 2 years of incorporation. Conclusions: LNG-IUS is a highly effective contraceptive method that has the potential to yield savings for avoiding UP in 15 to 19-year old adolescents in the Brazilian Public Health care system. PIH11 Availability And Costs Of Pediatric Formulations In India : A Case Study Tayal H1, Roy V2 1Maulana Azad Medical college, Delhi, India, 2Maulana Azad Medical College, University of Delhi, New Delhi, India
Objectives: To assess the availability of pediatric formulations in private and public sector in india. Comparison of costs of key medicines in private and public sector. Methods: In this study, to assess the availability of medicines in the private sector , a commercial source of drug information(drug compendium) was used. In public sector, availability was assessed using National list of essential medicines and Delhi essential medicine list and their comparison with the WHO essential medicine list for children was done. To assess the cost of medicines in the private sector, prices of key 30 tracer medicines was recorded from the Drug Compendium. For the public sector prices , the Hospital rate contract of the year 2015 was used. Acomparison was made between the both. Results: Only 250 medicines were available in pediatric formulations which was less than those mentioned in the WHO essential medicines list for children. Maximum shortage was seen the cardiovascular system category . In the essential medicines list the number of pediatric medicines in National list of essential medicines and Delhi essential medicine list was very less in comparison to those recommended in the WHO essential medicines list for children.Palliative category of drugs was totally neglected in Delhi and National list of essential medicines. The prices of medicines in the private sector were higher in comparison to the public sector prices by a wide margin.(332%) Conclusions: The study results show that there is a need for formulation of policy in India for improving the availability and costs of medicines in children.
PIH9 Budget Impact Of Ulipristal Acetate 5mg In Pre-Operative Treatment Of Uterine Fibroids: An Analysis Based On Public Data On Hospital Stays In France
PIH12 Economic Evaluation Of Rfsh And Hp-Hmg For Infertility Treatment In Brazil
Trancart M1, Lehmann M2, Lafuma A1 1Cemka-Eval, Bourg La Reine, France, 2Gedeon Richter - PregLem S.A., Geneva, Switzerland
1Merck, São
Objectives: To estimate the budget impact of ulipristal acetate 5mg (UPA) in the preoperative treatment of uterine fibroids (UF) within a 3-year time horizon in France, by analyzing a national hospital database. Methods: The “Programme de Médicalisation des Systèmes d’Information” (PMSI) database is a comprehensive and exhaustive database on hospital stays in acute care facilities in France. These hospitalizations are mostly overnight stays, but also include day care stays for ambulatory procedures like surgery. Surgeries for uterine fibroids (hysterectomies and myomectomies) were identified between 2006 and 2014. Number of avoided surgeries through the use of UPA was estimated by comparing trends before and after the commercialization of the product in France (August 2013). Number of patients treated with UPA was recalculated from the number of units sold between 2013 and mid-2016, based on GERS data. For the subsequent years, data were extrapolated and trends were supposed to stabilize from the end of 2016. Results: In 2012, 34,480 surgeries for UF were performed, 46%
Souza PV1, Simões AC2, Zanini FE1, Sato CC1 Paulo, Brazil, 2Merck, Rio de Janeiro, Brazil
Objectives: To compare outcomes and treatment costs between a recombinant follicle-stimulating hormone (rFSH) and a highly purified human menopausal gonadotrophin (hp-HMG) in assisted reproduction in Brazil. Methods: A cost per outcome model was developed to simulate one in vitro fertilization (IVF) cycle with up to four embryo tranfers - one fresh and up to three frozen. The clinical and economical impact of comparators were assessed. Outcomes were derived from a pooled results analysis of clinical trials. Drug acquisition costs were derived from official drug list price in Brazil. Results: Treatment with rFSH uses approximately 2,007 IU while 2,600 IU are needed when hp-HMG is chosen. Drug acquisition costs for ovarian stimulation is R$ 4,623 and R$ 3,738 for rFSH and hp-HMG, respectively. rFSH yields 2 more oocytes than hp-HMG (11 vs. 9) and 1,6 more embryos (5,6 vs. 4) in average. Cumulative clinical pregnancy rate and cumulative live birth rate for rFSH are 31% and 24% higher than hp-HMG, respectively. Overall, cost per oocyte is equal for both drugs (R$ 400); cost per embryo is R$ 832 and R$ 935 for rFSH and