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Analysis of Real-World Database: Endometriosis Treatment Practice in Ukraine
A176
VA L U E I N H E A LT H 1 9 ( 2 0 1 6 ) A 1 - A 3 1 8
across countries. A standardized costing methodology guideline is warranted and may shed light on the future considerations of reimbursement strategy. PIH22 Real-Life Evidence in the Treatment of Gynecological Diseases in Ukraine: Use in Decision Making Piniazhko O1, Zaliska O1, Pyrohova V1, Malachynska M2, Veresnyuk N2, Van Doeveren N3 Halytsky Lviv National Medical University, Lviv, Ukraine, 2Danylo Halytsky Lviv National Medical University, Lviv Regional Reproductive Health Centre, Lviv, Ukraine, 3Lviv Regional Clinical Hospital, Lviv, Ukraine
1Danylo
Objectives: Increasingly, effectiveness data obtained from real-life settings are required to make reimbursement decisions through coverage with evidence development schemes in line with current WHO recommendations. Due to the reforming process in Ukraine health care system there is a high need to match international requirements to HTA, pricing and reimbursement practice. The study aims to review, examine prescribing practice, estimate costs of treatment for the inflammatory gynecological disorders, which rank the first place among gynecologic diseases in reproductive age women. Methods: We used electronic database registry of patients in the Lviv Regional Reproductive Health Centre in 2015. We analyzed 80 e-medical records of women diagnosed with inflammatory gynecological disorders and calculated average costs of medicine treatment per patient. We used the weighted average prices from Morion company database (Ukraine) on 01.12.2015 (1 USD = 23,3 UAH). Results: The costs for out-patient care were estimated from the patients’ perspective while all the payments for the prescribed medicines were out-of-pocket. In 75% of patients were diagnosed inflammatory gynecological disorders – bacterial vaginosis, salpingitis, cervicitis. The treatment schemes included antibiotics, antiprotozoal, antifungal, antiseptic and comb drugs, probiotics for an average 10 days period: jozamycin, doxycycline, natamycin, ampicillin, ceftriaxone, clarithromycin, clindamicin+clotrymazol, ciprofloxacin+ornidazole, ofloxacin+ornidazole, secnidazole, fluconazole, fenticonazole, metronidazole, miramistine. The average cost of treatment is $30. 25% of women had associated diagnosis with endometriosis or uterine fibroids. In this case treatment schemes differed by adding hormonal, herbal medicines. Conclusions: On the example of gynecological treatment we outlined how real-world evidence across different therapeutic areas provides a dataset to inform health care decisions, rational reimbursement policies for state payers, private insurers and helps to develop local and national drug formularies. A usability of solutions to handle big data and analytical methods to deal with the non-randomised nature of this data are needed to be secured by IT-providers for health care systems. PIH23 Cost Study of Ovarian Stimulation for Art in Ukraine Piniazhko O1, Horbachevska K1, Zaliska O1, Ferenc M2 Halytsky Lviv National Medical University, Lviv, Ukraine, 2Danylo Halytsky Lviv National Medical University, Lviv Regional Reproductive Health Center, Lviv, Ukraine
1Danylo
Objectives: Ovarian stimulation has become a key component of assisted reproductive technologies (ART) and in vitro fertilization (IVF) aims to achieve cost-effective, patient-friendly regimens which optimize the balance between outcomes and risks. The use of ART in Ukraine is approved by the Decree of MOH No.787 dated 09.09.2013. Our aim was to analyze the average cost of gonadotropin treatment use in short stimulation protocol for one cycle of ovarian stimulation from patients’ perspective, based on the real-life practice in the specialized reproductive center in Ukraine. Methods: The average direct costs of gonadotropins per cycle were calculated from individual data, multiplying the cost of a single IU by the weighted means of IU used per cycle. We used the weighted average prices from Morion company database (Ukraine) on 01.12.2015 (1 USD = 23,3 UAH). Results: The short protocol is evaluated in 90% of all cases. We have been revealed the use of humanderived follicle-stimulating hormones (HP-hFSH) and recombinant FSH (rFSH) in the physicians’ prescribing practice. Clinical efficacy of HP-hFSH versus recombinant rFSH in IVF cycles has long been compared, but no clear evidence of the superiority of preparation over the other has been found. It has been calculated that the average cost for HP-hFSH and rFSH in short stimulation protocol ranged from $650 to $1082,7 per one cycle for woman. Conclusions: The cost of one cycle of ovarian stimulation with HP-hFSH (urofollitropin, menotrophin) is on 23,4% lower versus rFSH – follitropin beta and on 40% lower versus rFSH follitropin alfa. In Ukraine due to the unstable economic situation and out-of-pocket expenditures for medicines, the use of HP-hFSH in the ovarian stimulation protocols is economically beneficial. PIH24 Analysis of Real-World Database: Endometriosis Treatment Practice in Ukraine Piniazhko O1, Zaliska O1, Pyrohova V1, Malachynska M2, Veresnyuk N2, Vernikovskyy I3 Halytsky Lviv National Medical University, Lviv, Ukraine, 2Danylo Halytsky Lviv National Medical University, Lviv Regional Reproductive Health Centre, Lviv, Ukraine, 3Lviv Regional Reproductive Health Centre, Lviv, Ukraine
1Danylo
Objectives: Interest in real-life data is high yet its use in decision-making is still limited due to a number of challenges within data collection and analysis to interpretation. Our aim was to gather, capture and analyze real-life data in the context of using patient level data on the example of treatment of the most common gynecological diseases. Methods: We used electronic database registry of patients in the Lviv Regional Reproductive Health Centre in 2015. We analyzed 150 e-medical records of women and found out 30 cases diagnosed with endometriosis and adenomyosis. We calculated average costs of medicine treatment course per patient for 3 months duration. We used the weighted average prices from Morion company database (Ukraine) on 01.12.2015 (1 USD = 23,3 UAH). Results: All costs for out-patient care were from the patients’ perspective while all the payments for the prescribed medicines were out-of-pocket. Among the prescribed medicines were hormonal and symptomatic treatment schemes (while in 46% of cases endometriosis was associated with inflammatory gynecological disorders such as salpingitis,
cervicitis, bacterial vaginosis) according to the current official clinical protocols for the ambulatory gynecological care in Ukraine (Decree of the MOH No.417 dd 15.07.2011). Hormonal drugs were prescribed in 20% cases: norethisterone (Table 5 mg) – $16,5, medroxyprogesterone (susp. for injection 150 mg/ml) – $21,8, levonorgestrel releasing intrauterine system (LNG-IUS) – $87, dienogest (Table 2 mg) – $111, 7. The average cost of herbal medicines along with the recommendation of long-term monitoring was $26,7 in 30% of patients. Other patients were treated symptomatically with antibiotics, antiprotozoal medicines for an average 10 days (jozamycin, clindamicin+clotrymazol, ciprofloxacin+ornidazole, doxycycline). Conclusions: Accessibility and usability of patients’electronic databases provides a dataset for healthcare system stakeholders to make rational and evidence-based decisions about whether a particular treatment should be approved or reimbursed on the local and national level. PIH25 Carbetocin In Prevention of Uterine Atony Following Delivery by Cesarean Section in Population Who Experienced Postpartum Hemorrhage: Costs in Polish Settings Pacocha K1, Pieniazek I1, Sobkowski M2, Celewicz Z3, Kalinka J4, Szymanowski K2, Serafin M5, Szpak K3, Grzymala-Figura A3, Walczak J1, Bierut A6, Izbicki W6 1Arcana Institute Ltd, Krakow, Poland, 2Gynecological and Obstetrics Clinical Hospital of Poznan Medical Science University, Poznan, Poland, 3Department of Perinatology, Obstetrics and Gynecology, Pomeranian Medical University in Szczecin, Police, Poland, 4Department of Perinatology, Medical University of Lodz, Lodz, Poland, 5M. Pirogowa Regional Specialized Hospital in Lodz, Lodz, Poland, 6Ferring Pharmaceuticals Poland, Warsaw, Poland
Objectives: The aim of the study was to estimate costs and consequences of carbetocin use in prevention of uterine atony following delivery by Cesarean section in comparison to standard methods (oxytocin) in Poland. Methods: A retrospective study based on patient medical records was conducted in three reference medical centres in Poland (Lodz, Poznan, Police). Costs and resource use data were gathered via electronic questionnaire for patients with/without risk of postpartum hemorrhage (PPH). This paper focuses on subpopulations who experienced PPH to evaluate whether carbetocin use instead of oxytocin may bring savings for the hospital. Results: 132 out of 275 medical records concerned patients who experienced severe or other than severe PPH (4 subpopulations of patients depending on risk status and PPH severity). Since the characteristics of patients in chosen centres were consistent, pooling and averaging the data was methodologically justified. In each subpopulation costs incurred by the hospital were lower for carbetocin arm versus oxytocin. The highest difference was observed in patients who experienced severe PPH. Using carbetocin instead of oxytocin, the hospital could save 652 USD and 1,523 USD respectively for patients without/with the risk of PPH. In 3 out of 4 subpopulations, costs of delivery and PPH management were underestimated by the National Health Fund (NHF), what resulted in the higher deficit in the hospital’s budget. The mean underestimation of severe PPH unit cost by NHF amounts 1453 USD. Although the hospital could generate savings from carbetocin use, costs were not covered by NHF. Nevertheless, losses for the hospital were lower with carbetocin use. Conclusions: Prophylaxis of PPH following Caesarean delivery using carbetocin is relevant from both patients and hospital perspective. In the first case it helps to avoid traumatic and life threatening situation. In the second case, it is especially important because of limited hospitals’ budget. PIH27 The Cost Effectiveness of Oral Nutrition Supplementation for Malnourished Older Hospital Patients Zhong Y1, Cohen JT2, Goates S3, Luo M3, Nelson J3, Neumann PJ1 for the Evaluation of Value and Risk in Health, Institute for Clinical Research and Health Policy Studies,Tufts Medical Center, Boston, MA, USA, 2Center for the Evaluation of Value and Risk in Health,Tufts Medical Center, Boston, MA, USA, 3Abbott Nutrition, Columbus, OH, USA 1Center
Objectives: Malnutrition, which is associated with increased medical complications in older hospitalized patients, can be addressed by providing nutritional supplements. This study evaluates the cost-effectiveness of a specialized oral nutritional supplement (ONS) in malnourished older hospitalized patients. Methods: We conducted an economic evaluation alongside a multicenter, randomized, controlled clinical trial (NOURISH Study). The target population was malnourished older hospitalized patients. We used 90-day (base case) and lifetime (sensitivity analysis) time horizons. The study compared a nutrient-dense ONS, containing high protein and β -hydroxy-β -methylbutyrate to placebo. Outcomes included health care costs, measured as the product of resource use and per unit cost; quality-adjusted life years (QALYs) (90-day time horizon); life-years (LYs) saved (lifetime time horizon); and the incremental cost-effectiveness ratio (ICER). Results: In the base case analysis, 90-day treatment group costs averaged $22,506 per person, compared to $22,133 for the control group. Treatment group patients gained 0.011 more QALYs than control group subjects, reflecting the treatment group’s significantly greater probability of survival through 90 days follow-up, as reported by the clinical trial. Hence, the 90-day follow-up period ICER was $33,818/QALY. Assuming a lifetime time horizon, estimated treatment group life expectancy exceeded control group life expectancy by 0.71 years. Hence, the lifetime ICER was $524/LY. Conclusions: Our findings suggest that the investigative ONS cost-effectively extends the lives of malnourished hospitalized patients. The follow-up period for the trial was relatively short. Some of the patients were lost to follow-up, thus reducing collection of health care utilization data during the clinical trial. PIH28 Cost-Effectiveness and Cost-Utility Analysis Comparing Uterine Artery Embolization and Surgical Methods for the Treatment of Symptomatic Uterine Leiomyomas Fonseca M1, Machado M2, Castro R1, Girao M1 University of São Paulo, São Paulo, Brazil, 2University of Toronto, Toronto, ON, Canada
1Federal
VA L U E I N H E A LT H 1 9 ( 2 0 1 6 ) A 1 - A 3 1 8
across countries. A standardized costing methodology guideline is warranted and may shed light on the future considerations of reimbursement strategy. PIH22 Real-Life Evidence in the Treatment of Gynecological Diseases in Ukraine: Use in Decision Making Piniazhko O1, Zaliska O1, Pyrohova V1, Malachynska M2, Veresnyuk N2, Van Doeveren N3 Halytsky Lviv National Medical University, Lviv, Ukraine, 2Danylo Halytsky Lviv National Medical University, Lviv Regional Reproductive Health Centre, Lviv, Ukraine, 3Lviv Regional Clinical Hospital, Lviv, Ukraine
1Danylo
Objectives: Increasingly, effectiveness data obtained from real-life settings are required to make reimbursement decisions through coverage with evidence development schemes in line with current WHO recommendations. Due to the reforming process in Ukraine health care system there is a high need to match international requirements to HTA, pricing and reimbursement practice. The study aims to review, examine prescribing practice, estimate costs of treatment for the inflammatory gynecological disorders, which rank the first place among gynecologic diseases in reproductive age women. Methods: We used electronic database registry of patients in the Lviv Regional Reproductive Health Centre in 2015. We analyzed 80 e-medical records of women diagnosed with inflammatory gynecological disorders and calculated average costs of medicine treatment per patient. We used the weighted average prices from Morion company database (Ukraine) on 01.12.2015 (1 USD = 23,3 UAH). Results: The costs for out-patient care were estimated from the patients’ perspective while all the payments for the prescribed medicines were out-of-pocket. In 75% of patients were diagnosed inflammatory gynecological disorders – bacterial vaginosis, salpingitis, cervicitis. The treatment schemes included antibiotics, antiprotozoal, antifungal, antiseptic and comb drugs, probiotics for an average 10 days period: jozamycin, doxycycline, natamycin, ampicillin, ceftriaxone, clarithromycin, clindamicin+clotrymazol, ciprofloxacin+ornidazole, ofloxacin+ornidazole, secnidazole, fluconazole, fenticonazole, metronidazole, miramistine. The average cost of treatment is $30. 25% of women had associated diagnosis with endometriosis or uterine fibroids. In this case treatment schemes differed by adding hormonal, herbal medicines. Conclusions: On the example of gynecological treatment we outlined how real-world evidence across different therapeutic areas provides a dataset to inform health care decisions, rational reimbursement policies for state payers, private insurers and helps to develop local and national drug formularies. A usability of solutions to handle big data and analytical methods to deal with the non-randomised nature of this data are needed to be secured by IT-providers for health care systems. PIH23 Cost Study of Ovarian Stimulation for Art in Ukraine Piniazhko O1, Horbachevska K1, Zaliska O1, Ferenc M2 Halytsky Lviv National Medical University, Lviv, Ukraine, 2Danylo Halytsky Lviv National Medical University, Lviv Regional Reproductive Health Center, Lviv, Ukraine
1Danylo
Objectives: Ovarian stimulation has become a key component of assisted reproductive technologies (ART) and in vitro fertilization (IVF) aims to achieve cost-effective, patient-friendly regimens which optimize the balance between outcomes and risks. The use of ART in Ukraine is approved by the Decree of MOH No.787 dated 09.09.2013. Our aim was to analyze the average cost of gonadotropin treatment use in short stimulation protocol for one cycle of ovarian stimulation from patients’ perspective, based on the real-life practice in the specialized reproductive center in Ukraine. Methods: The average direct costs of gonadotropins per cycle were calculated from individual data, multiplying the cost of a single IU by the weighted means of IU used per cycle. We used the weighted average prices from Morion company database (Ukraine) on 01.12.2015 (1 USD = 23,3 UAH). Results: The short protocol is evaluated in 90% of all cases. We have been revealed the use of humanderived follicle-stimulating hormones (HP-hFSH) and recombinant FSH (rFSH) in the physicians’ prescribing practice. Clinical efficacy of HP-hFSH versus recombinant rFSH in IVF cycles has long been compared, but no clear evidence of the superiority of preparation over the other has been found. It has been calculated that the average cost for HP-hFSH and rFSH in short stimulation protocol ranged from $650 to $1082,7 per one cycle for woman. Conclusions: The cost of one cycle of ovarian stimulation with HP-hFSH (urofollitropin, menotrophin) is on 23,4% lower versus rFSH – follitropin beta and on 40% lower versus rFSH follitropin alfa. In Ukraine due to the unstable economic situation and out-of-pocket expenditures for medicines, the use of HP-hFSH in the ovarian stimulation protocols is economically beneficial. PIH24 Analysis of Real-World Database: Endometriosis Treatment Practice in Ukraine Piniazhko O1, Zaliska O1, Pyrohova V1, Malachynska M2, Veresnyuk N2, Vernikovskyy I3 Halytsky Lviv National Medical University, Lviv, Ukraine, 2Danylo Halytsky Lviv National Medical University, Lviv Regional Reproductive Health Centre, Lviv, Ukraine, 3Lviv Regional Reproductive Health Centre, Lviv, Ukraine
1Danylo
Objectives: Interest in real-life data is high yet its use in decision-making is still limited due to a number of challenges within data collection and analysis to interpretation. Our aim was to gather, capture and analyze real-life data in the context of using patient level data on the example of treatment of the most common gynecological diseases. Methods: We used electronic database registry of patients in the Lviv Regional Reproductive Health Centre in 2015. We analyzed 150 e-medical records of women and found out 30 cases diagnosed with endometriosis and adenomyosis. We calculated average costs of medicine treatment course per patient for 3 months duration. We used the weighted average prices from Morion company database (Ukraine) on 01.12.2015 (1 USD = 23,3 UAH). Results: All costs for out-patient care were from the patients’ perspective while all the payments for the prescribed medicines were out-of-pocket. Among the prescribed medicines were hormonal and symptomatic treatment schemes (while in 46% of cases endometriosis was associated with inflammatory gynecological disorders such as salpingitis,
cervicitis, bacterial vaginosis) according to the current official clinical protocols for the ambulatory gynecological care in Ukraine (Decree of the MOH No.417 dd 15.07.2011). Hormonal drugs were prescribed in 20% cases: norethisterone (Table 5 mg) – $16,5, medroxyprogesterone (susp. for injection 150 mg/ml) – $21,8, levonorgestrel releasing intrauterine system (LNG-IUS) – $87, dienogest (Table 2 mg) – $111, 7. The average cost of herbal medicines along with the recommendation of long-term monitoring was $26,7 in 30% of patients. Other patients were treated symptomatically with antibiotics, antiprotozoal medicines for an average 10 days (jozamycin, clindamicin+clotrymazol, ciprofloxacin+ornidazole, doxycycline). Conclusions: Accessibility and usability of patients’electronic databases provides a dataset for healthcare system stakeholders to make rational and evidence-based decisions about whether a particular treatment should be approved or reimbursed on the local and national level. PIH25 Carbetocin In Prevention of Uterine Atony Following Delivery by Cesarean Section in Population Who Experienced Postpartum Hemorrhage: Costs in Polish Settings Pacocha K1, Pieniazek I1, Sobkowski M2, Celewicz Z3, Kalinka J4, Szymanowski K2, Serafin M5, Szpak K3, Grzymala-Figura A3, Walczak J1, Bierut A6, Izbicki W6 1Arcana Institute Ltd, Krakow, Poland, 2Gynecological and Obstetrics Clinical Hospital of Poznan Medical Science University, Poznan, Poland, 3Department of Perinatology, Obstetrics and Gynecology, Pomeranian Medical University in Szczecin, Police, Poland, 4Department of Perinatology, Medical University of Lodz, Lodz, Poland, 5M. Pirogowa Regional Specialized Hospital in Lodz, Lodz, Poland, 6Ferring Pharmaceuticals Poland, Warsaw, Poland
Objectives: The aim of the study was to estimate costs and consequences of carbetocin use in prevention of uterine atony following delivery by Cesarean section in comparison to standard methods (oxytocin) in Poland. Methods: A retrospective study based on patient medical records was conducted in three reference medical centres in Poland (Lodz, Poznan, Police). Costs and resource use data were gathered via electronic questionnaire for patients with/without risk of postpartum hemorrhage (PPH). This paper focuses on subpopulations who experienced PPH to evaluate whether carbetocin use instead of oxytocin may bring savings for the hospital. Results: 132 out of 275 medical records concerned patients who experienced severe or other than severe PPH (4 subpopulations of patients depending on risk status and PPH severity). Since the characteristics of patients in chosen centres were consistent, pooling and averaging the data was methodologically justified. In each subpopulation costs incurred by the hospital were lower for carbetocin arm versus oxytocin. The highest difference was observed in patients who experienced severe PPH. Using carbetocin instead of oxytocin, the hospital could save 652 USD and 1,523 USD respectively for patients without/with the risk of PPH. In 3 out of 4 subpopulations, costs of delivery and PPH management were underestimated by the National Health Fund (NHF), what resulted in the higher deficit in the hospital’s budget. The mean underestimation of severe PPH unit cost by NHF amounts 1453 USD. Although the hospital could generate savings from carbetocin use, costs were not covered by NHF. Nevertheless, losses for the hospital were lower with carbetocin use. Conclusions: Prophylaxis of PPH following Caesarean delivery using carbetocin is relevant from both patients and hospital perspective. In the first case it helps to avoid traumatic and life threatening situation. In the second case, it is especially important because of limited hospitals’ budget. PIH27 The Cost Effectiveness of Oral Nutrition Supplementation for Malnourished Older Hospital Patients Zhong Y1, Cohen JT2, Goates S3, Luo M3, Nelson J3, Neumann PJ1 for the Evaluation of Value and Risk in Health, Institute for Clinical Research and Health Policy Studies,Tufts Medical Center, Boston, MA, USA, 2Center for the Evaluation of Value and Risk in Health,Tufts Medical Center, Boston, MA, USA, 3Abbott Nutrition, Columbus, OH, USA 1Center
Objectives: Malnutrition, which is associated with increased medical complications in older hospitalized patients, can be addressed by providing nutritional supplements. This study evaluates the cost-effectiveness of a specialized oral nutritional supplement (ONS) in malnourished older hospitalized patients. Methods: We conducted an economic evaluation alongside a multicenter, randomized, controlled clinical trial (NOURISH Study). The target population was malnourished older hospitalized patients. We used 90-day (base case) and lifetime (sensitivity analysis) time horizons. The study compared a nutrient-dense ONS, containing high protein and β -hydroxy-β -methylbutyrate to placebo. Outcomes included health care costs, measured as the product of resource use and per unit cost; quality-adjusted life years (QALYs) (90-day time horizon); life-years (LYs) saved (lifetime time horizon); and the incremental cost-effectiveness ratio (ICER). Results: In the base case analysis, 90-day treatment group costs averaged $22,506 per person, compared to $22,133 for the control group. Treatment group patients gained 0.011 more QALYs than control group subjects, reflecting the treatment group’s significantly greater probability of survival through 90 days follow-up, as reported by the clinical trial. Hence, the 90-day follow-up period ICER was $33,818/QALY. Assuming a lifetime time horizon, estimated treatment group life expectancy exceeded control group life expectancy by 0.71 years. Hence, the lifetime ICER was $524/LY. Conclusions: Our findings suggest that the investigative ONS cost-effectively extends the lives of malnourished hospitalized patients. The follow-up period for the trial was relatively short. Some of the patients were lost to follow-up, thus reducing collection of health care utilization data during the clinical trial. PIH28 Cost-Effectiveness and Cost-Utility Analysis Comparing Uterine Artery Embolization and Surgical Methods for the Treatment of Symptomatic Uterine Leiomyomas Fonseca M1, Machado M2, Castro R1, Girao M1 University of São Paulo, São Paulo, Brazil, 2University of Toronto, Toronto, ON, Canada
1Federal