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The Economic Burden of Coeliac Disease in North America and Europe: A Systematic Review
A636
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
response, hence to reduce the risk of post-hepatectomy complications and mortality. Evidences also indicated the Ulinastatin’s ability of shortening the length of stay (LOS) after hepatectomy, illustrating potential economic value to be assessed. This study aimed to analyse the cost-effectiveness of Ulinastatin versus standard care for hepatectomy patients. Methods: A discrete event simulation model was constructed from the payers’ perspective. The time-to-events were simulated using an exponential distribution, with the exception of LOS using a log-normal distribution. The complication and death costs were acquired through a KOL consultation. Other cost, efficacy and utility data were sourced from literature. All costs were inflation-adjusted to 2016. The quality-adjusted life-year (QALY) was calculated with area under curve technique. The model has run through with numerous sample sizes to determine the number of simulated entities needed to generate a stable result. One-way sensitivity analysis and probabilistic sensitivity analysis were conducted. Results: The total cost for per patient who has received Ulinastatin is $1197.09, while the total QALY gained for 1 year after the surgery is 0.8895. Oppositely, for entity who has not been administrated, the total cost and total QALY gained are $1342.10, and 0.8884, respectively. Consequently, the use of Ulinastatin for patients undergoing a hepatectomy provides minor extra QALY gain (0.0011), and some cost saving ($145.01) during the hospitalisation. According to one-way sensitivity analysis, the most influencing parameter is the average daily inpatient expense. In probabilistic sensitivity analysis, using Ulinastatin had a 99.6% probability of being cost-effective versus not using it at a $23,745.91/QALY threshold (i.e. three times of Chinese national gross domestic product in 2016). Conclusions: Administrating Ulinastatin is a dominatingly cost-effective intervention for patients undergoing hepatectomy. PGI26 The Economic Burden of Coeliac Disease in North America and Europe: A Systematic Review Boulanger T1, Taylor A2, Leffler D3, Mearns ES1, Gerber M4 Health Analytics, an IBM Company, Cambridge, MA, USA, 2Tadeka Development Centre Europe Ltd, London, UK, 3Takeda Pharmaceuticals International, Cambridge, MA, USA, 4Takeda Pharmeuticals International, Cambridge, MA, USA 1Truven
Objectives: The prevalence of coeliac disease (CD) has rapidly increased over recent decades. Its economic burden can be substantial, but remains poorly understood. This systematic review assessed the economic burden of CD in North America and Europe. Methods: Medline, Embase, EconLit, and Cochrane Library were systematically searched to identify English-language literature published during the last 10 years assessing costs, cost-effectiveness, and health resource utilization for CD. Results: Thirty-three studies met inclusion criteria. Most (20) were from Europe, and most (18) reported or modeled costs of screening and diagnosis. Cost per positive CD diagnosis of screening patients already undergoing esophagogastroduodenoscopy (EGD) for other indications, such as anaemia or irritable bowel syndrome, ranged from $1,300 in Canada to more than € 44,000 in the Netherlands. In these populations, screening was cost-effective with strategies combining diagnostic modalities, including serology then biopsy, versus no screening. Direct annual excess costs to a US payer per diagnosed CD patient totaled $6,000 ($US 2013) more than for a person without CD, chiefly due to outpatient care, with higher costs among patients with poor disease control. Hospitalizations, emergency visits, and medication use were more common in patients with CD versus controls. After initiating a gluten-free diet (GFD), patients visited primary care providers less often, but used more medications. Gluten-free (GF) foods cost 240-518% more than gluten-containing equivalents. Three Scandinavian studies on absenteeism found fewer days missed from school and work following GFD initiation. Conclusions: Most economic studies of CD assess screening and diagnosis costs, especially in Europe. Methods of screening generally are considered cost-effective when they combine diagnostic modalities in symptomatic patients. Most costs to a payer of managing CD derive from outpatient care, especially for patients with poorly controlled disease. Patients on a GFD lose fewer days from work and school but pay high costs for GF foods. PGI27 Cost Utility Analysis of Infliixmab and Adalimumab Compared with Conventional Therapy in Patients with Crohn Disease in the Islamic Republic of Iran
Cost Effectiveness Ratios (ICERs) was -48,469 USD per QALY gained. Conclusions: Study results showed that due to difference between Infliximab and Adalimumab medications` prices, Adalimumab is the dominant alternative in Islamic Republic of Iran, considering its threshold which is about 3,700 USD. Hence it is recommended that Adalimumab to be administered as the first choice of biologic therapy which is controversial to current approach of /most Iranian gastroenterologists. PGI28 Healthcare Resource Utilization in Patients with Moderate to Severe Crohn’s Disease: A Brazilian Real World Study Decimoni TC1, Sztajnbok S1, Feitosa MR2, Parra RS2 Pharmaceuticals Brazil, São Paulo, Brazil, 2Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto – USP, Ribeirão Preto, Brazil
1Takeda
Objectives: Describe the use of health resources related to the management of moderate to severe Crohn’s disease (CD) in Brazil. Methods: This was a retrospective analysis that collected data from patient medical records in multiple Brazilian centres in 2017. Healthcare resource utilization data related to the management of patients (≥ 18 years old) diagnosed with moderate to severe CD at least 6 months before the inclusion day were presented using descriptive statistics. Results: A total of 264 patients with moderate to severe CD were included in this analysis. The mean age of the patients was 42.9±12.96 years and 54.2% were female. The mean weight and body mass index were 69kg ±14.52 and 25.1 kg/m2 (15.2-44 kg/m2), respectively. The time since diagnosis of moderate to severe CD was on average 8.0±6.3 years. Surgeries were required in 25.4% of patients and the average number of surgeries per patient was 1.6±0.9. The majority (20.4%) of surgeries were anal procedures (fistulectomy). The number of mean hospitalizations was 1.7±0.89 times for CD patients with a mean duration of 0.4 months. The mean medical appointments per patient was 12.1±6.81 during the period and more than 90% corresponded to an IBD specialist visit. The number of imaging and laboratory tests performed was on average 21.8±18.1 per patient. Hemogram was the most frequent test performed (40.8%), followed by C-reactive protein (31.2%). Biological therapy was the most common type of therapy (36.5%), followed by immunosuppressants (36.1%). Regarding biological treatment, 20.3% of dose changes were due to poor effectiveness. Conclusions: Moderate to severe CD was associated with substantial healthcare resource utilization in Brazil. PGI29 Health Economic Evaluations in Inflammatory Bowel Disease in Brazil: A Systematic Review Decimoni TC1, Sztajnbok S1, Moraes AC2 1Takeda Pharmaceuticals Brazil, São Paulo, Brazil, 2Hospital Copa D´Or, Rio de Janeiro, Brazil
Objectives: The objective of this study was to systematically review health economic evaluations (HEE) in Inflammatory Bowel Disease (IBD) in Brazil. Methods: Electronic databases (MEDLINE, LILACS, SciELO, NHS EED, HTA) and the Brazilian Journal of Health Economics were searched with no restriction of population, language and period. Editorials, letters, commentaries, opinion papers and reviews were excluded. Two researchers examined titles, abstracts and full articles for criteria eligibility and carried out data extraction independently. A qualitative narrative synthesis was performed. Results: Abstracts and titles were screened (n= 260) and seven studies were included, two conference abstracts and five articles. Five complete HEE (three cost-minimization analyses, one cost-effectiveness analysis, one cost-utility analysis), one cost analysis and one budget impact analysis were included. The target population in all analysis was adults. Two studies compared mesalazine drugs (MMX vs conventional; Mesalazine once vs twice a day) in ulcerative colitis and five assessed the biologic treatment in Crohns Disease (two adalimumab vs infliximab and three certolizumab vs adalimumab vs infliximab). In the biologic treatments comparisons, three studies evaluated just the drug acquisition costs and two conducted additional analysis based on specialist opinions and international literature. The resource use for public and private systems was obtained from the Official Brazilian Administrative Database (DATASUS) and expert opinion, respectively. Costs were obtained from official sources (DATASUS and CMED). The cost-utility analysis used international utility data. Conclusions: IBD is a chronic disease with substantial financial and quality of life impact but currently there is a lack of studies evaluating the economic and societal burden of the disease in Brazil.
Zaboli P1, Nikfar S1, Kebriaeezadeh A2, Malekzadeh R3, Akbari Sari A4, Sima A3, Abdollahi M2, Mirzaei S3, Sharafkhah M3, Rohani E2 1Department of Pharmacoeconomics and Pharmaceutical Management, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran (Islamic Republic of), 2Tehran University of Medical Sciences, Tehran, Iran (Islamic Republic of), 3Digestive Disease Research Institute, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran, Tehran, Iran (Islamic Republic of), 4School of Public Health, Tehran University of Medical Sciences, Tehran, Iran
1Takeda
Objectives: In spite of expensive medication costs of Crohn Disease treatment, an economic evaluation has not been done locally in Islamic Republic of Iran yet, in order to assess this medications cost effectiveness. Therefore, prescribers can`t judge the cost-effective alternative. This study aims to implement a cost utility analysis for two most biologic medications used in severe non Fistulizing Crohn Disease from a societal perspective in Islamic Republic of Iran. Methods: This study target population was adults’ patients with Non Fistulizing Sever Crohn Disease who did not reply to first line therapy. 109 patients were enrolled to study from Shariati Public Hospital and Masoud Clinic which both are referral centers. Study arms included Infliximab and Adalimumab as comparators. Model structure was based on disease natural history and clinicians` consultations. All direct medical and non-medical costs were entered to model. Indirect costs were calculated through Human Capital approach. Patients’ utilities were extracted by EQ5D questionnaire through face to face interview. Mortality rates were derived from Iran National Statistics Database. Transition probabilities were extracted by a systematic review from published Randomized Clinical Trials. A markov model designed with 2 month length cycles and 5 year time horizon in Excel 2013 software. Probabilistic sensitivity analysis was done by Treeage 2011 software. Results: Calculated Incremental
Objectives: Describe the use of health resources related to the management of moderate to severe ulcerative colitis (UC) in Brazil. Methods: This was a retrospective analysis that collected data from patient medical records in multiple Brazilian centres in 2017. Healthcare resource utilization data related to the management of patients (≥ 18 years old) diagnosed with moderate to severe UC at least 6 months before the inclusion day were presented using descriptive statistics. Results: A total of 143 patients with moderate to severe UC were included in this analysis. The mean age was 45.9±13.83 years and 56.6% were female. The mean weight and body mass index were 70.1±14.33 kg and 25.7±4.63 kg/m2, respectively. The time since diagnosis of moderate to severe UC was on average 6.1±4.85 years. Surgeries were required in 2.8% of patients and the average number of surgeries per patient was 1.8±0.5. Total colectomy and closure of enterostomy (any segment) corresponded (each one) to 28.6% of surgeries. The mean number of hospitalizations was 1.5±0.92 times for UC; the mean duration was 0.7 months. The mean number of medical appointments per patient was 10.8±6.56 during the period and 92.5% corresponded to an IBD specialist visit. The average number of imaging and laboratory tests was 17.8±14.02. Hemogram was the most frequent test performed (38.8%), followed by
PGI30 Healthcare Resource Utilization in Patients with Moderate to Severe Ulcerative Colitis: A Brazilian Real World Study Decimoni TC1, Sztajnbok S1, Feitosa MR2, Parra RS2 Pharmaceuticals Brazil, São Paulo, Brazil, 2Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto – USP, Ribeirão Preto, Brazil
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
response, hence to reduce the risk of post-hepatectomy complications and mortality. Evidences also indicated the Ulinastatin’s ability of shortening the length of stay (LOS) after hepatectomy, illustrating potential economic value to be assessed. This study aimed to analyse the cost-effectiveness of Ulinastatin versus standard care for hepatectomy patients. Methods: A discrete event simulation model was constructed from the payers’ perspective. The time-to-events were simulated using an exponential distribution, with the exception of LOS using a log-normal distribution. The complication and death costs were acquired through a KOL consultation. Other cost, efficacy and utility data were sourced from literature. All costs were inflation-adjusted to 2016. The quality-adjusted life-year (QALY) was calculated with area under curve technique. The model has run through with numerous sample sizes to determine the number of simulated entities needed to generate a stable result. One-way sensitivity analysis and probabilistic sensitivity analysis were conducted. Results: The total cost for per patient who has received Ulinastatin is $1197.09, while the total QALY gained for 1 year after the surgery is 0.8895. Oppositely, for entity who has not been administrated, the total cost and total QALY gained are $1342.10, and 0.8884, respectively. Consequently, the use of Ulinastatin for patients undergoing a hepatectomy provides minor extra QALY gain (0.0011), and some cost saving ($145.01) during the hospitalisation. According to one-way sensitivity analysis, the most influencing parameter is the average daily inpatient expense. In probabilistic sensitivity analysis, using Ulinastatin had a 99.6% probability of being cost-effective versus not using it at a $23,745.91/QALY threshold (i.e. three times of Chinese national gross domestic product in 2016). Conclusions: Administrating Ulinastatin is a dominatingly cost-effective intervention for patients undergoing hepatectomy. PGI26 The Economic Burden of Coeliac Disease in North America and Europe: A Systematic Review Boulanger T1, Taylor A2, Leffler D3, Mearns ES1, Gerber M4 Health Analytics, an IBM Company, Cambridge, MA, USA, 2Tadeka Development Centre Europe Ltd, London, UK, 3Takeda Pharmaceuticals International, Cambridge, MA, USA, 4Takeda Pharmeuticals International, Cambridge, MA, USA 1Truven
Objectives: The prevalence of coeliac disease (CD) has rapidly increased over recent decades. Its economic burden can be substantial, but remains poorly understood. This systematic review assessed the economic burden of CD in North America and Europe. Methods: Medline, Embase, EconLit, and Cochrane Library were systematically searched to identify English-language literature published during the last 10 years assessing costs, cost-effectiveness, and health resource utilization for CD. Results: Thirty-three studies met inclusion criteria. Most (20) were from Europe, and most (18) reported or modeled costs of screening and diagnosis. Cost per positive CD diagnosis of screening patients already undergoing esophagogastroduodenoscopy (EGD) for other indications, such as anaemia or irritable bowel syndrome, ranged from $1,300 in Canada to more than € 44,000 in the Netherlands. In these populations, screening was cost-effective with strategies combining diagnostic modalities, including serology then biopsy, versus no screening. Direct annual excess costs to a US payer per diagnosed CD patient totaled $6,000 ($US 2013) more than for a person without CD, chiefly due to outpatient care, with higher costs among patients with poor disease control. Hospitalizations, emergency visits, and medication use were more common in patients with CD versus controls. After initiating a gluten-free diet (GFD), patients visited primary care providers less often, but used more medications. Gluten-free (GF) foods cost 240-518% more than gluten-containing equivalents. Three Scandinavian studies on absenteeism found fewer days missed from school and work following GFD initiation. Conclusions: Most economic studies of CD assess screening and diagnosis costs, especially in Europe. Methods of screening generally are considered cost-effective when they combine diagnostic modalities in symptomatic patients. Most costs to a payer of managing CD derive from outpatient care, especially for patients with poorly controlled disease. Patients on a GFD lose fewer days from work and school but pay high costs for GF foods. PGI27 Cost Utility Analysis of Infliixmab and Adalimumab Compared with Conventional Therapy in Patients with Crohn Disease in the Islamic Republic of Iran
Cost Effectiveness Ratios (ICERs) was -48,469 USD per QALY gained. Conclusions: Study results showed that due to difference between Infliximab and Adalimumab medications` prices, Adalimumab is the dominant alternative in Islamic Republic of Iran, considering its threshold which is about 3,700 USD. Hence it is recommended that Adalimumab to be administered as the first choice of biologic therapy which is controversial to current approach of /most Iranian gastroenterologists. PGI28 Healthcare Resource Utilization in Patients with Moderate to Severe Crohn’s Disease: A Brazilian Real World Study Decimoni TC1, Sztajnbok S1, Feitosa MR2, Parra RS2 Pharmaceuticals Brazil, São Paulo, Brazil, 2Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto – USP, Ribeirão Preto, Brazil
1Takeda
Objectives: Describe the use of health resources related to the management of moderate to severe Crohn’s disease (CD) in Brazil. Methods: This was a retrospective analysis that collected data from patient medical records in multiple Brazilian centres in 2017. Healthcare resource utilization data related to the management of patients (≥ 18 years old) diagnosed with moderate to severe CD at least 6 months before the inclusion day were presented using descriptive statistics. Results: A total of 264 patients with moderate to severe CD were included in this analysis. The mean age of the patients was 42.9±12.96 years and 54.2% were female. The mean weight and body mass index were 69kg ±14.52 and 25.1 kg/m2 (15.2-44 kg/m2), respectively. The time since diagnosis of moderate to severe CD was on average 8.0±6.3 years. Surgeries were required in 25.4% of patients and the average number of surgeries per patient was 1.6±0.9. The majority (20.4%) of surgeries were anal procedures (fistulectomy). The number of mean hospitalizations was 1.7±0.89 times for CD patients with a mean duration of 0.4 months. The mean medical appointments per patient was 12.1±6.81 during the period and more than 90% corresponded to an IBD specialist visit. The number of imaging and laboratory tests performed was on average 21.8±18.1 per patient. Hemogram was the most frequent test performed (40.8%), followed by C-reactive protein (31.2%). Biological therapy was the most common type of therapy (36.5%), followed by immunosuppressants (36.1%). Regarding biological treatment, 20.3% of dose changes were due to poor effectiveness. Conclusions: Moderate to severe CD was associated with substantial healthcare resource utilization in Brazil. PGI29 Health Economic Evaluations in Inflammatory Bowel Disease in Brazil: A Systematic Review Decimoni TC1, Sztajnbok S1, Moraes AC2 1Takeda Pharmaceuticals Brazil, São Paulo, Brazil, 2Hospital Copa D´Or, Rio de Janeiro, Brazil
Objectives: The objective of this study was to systematically review health economic evaluations (HEE) in Inflammatory Bowel Disease (IBD) in Brazil. Methods: Electronic databases (MEDLINE, LILACS, SciELO, NHS EED, HTA) and the Brazilian Journal of Health Economics were searched with no restriction of population, language and period. Editorials, letters, commentaries, opinion papers and reviews were excluded. Two researchers examined titles, abstracts and full articles for criteria eligibility and carried out data extraction independently. A qualitative narrative synthesis was performed. Results: Abstracts and titles were screened (n= 260) and seven studies were included, two conference abstracts and five articles. Five complete HEE (three cost-minimization analyses, one cost-effectiveness analysis, one cost-utility analysis), one cost analysis and one budget impact analysis were included. The target population in all analysis was adults. Two studies compared mesalazine drugs (MMX vs conventional; Mesalazine once vs twice a day) in ulcerative colitis and five assessed the biologic treatment in Crohns Disease (two adalimumab vs infliximab and three certolizumab vs adalimumab vs infliximab). In the biologic treatments comparisons, three studies evaluated just the drug acquisition costs and two conducted additional analysis based on specialist opinions and international literature. The resource use for public and private systems was obtained from the Official Brazilian Administrative Database (DATASUS) and expert opinion, respectively. Costs were obtained from official sources (DATASUS and CMED). The cost-utility analysis used international utility data. Conclusions: IBD is a chronic disease with substantial financial and quality of life impact but currently there is a lack of studies evaluating the economic and societal burden of the disease in Brazil.
Zaboli P1, Nikfar S1, Kebriaeezadeh A2, Malekzadeh R3, Akbari Sari A4, Sima A3, Abdollahi M2, Mirzaei S3, Sharafkhah M3, Rohani E2 1Department of Pharmacoeconomics and Pharmaceutical Management, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran (Islamic Republic of), 2Tehran University of Medical Sciences, Tehran, Iran (Islamic Republic of), 3Digestive Disease Research Institute, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran, Tehran, Iran (Islamic Republic of), 4School of Public Health, Tehran University of Medical Sciences, Tehran, Iran
1Takeda
Objectives: In spite of expensive medication costs of Crohn Disease treatment, an economic evaluation has not been done locally in Islamic Republic of Iran yet, in order to assess this medications cost effectiveness. Therefore, prescribers can`t judge the cost-effective alternative. This study aims to implement a cost utility analysis for two most biologic medications used in severe non Fistulizing Crohn Disease from a societal perspective in Islamic Republic of Iran. Methods: This study target population was adults’ patients with Non Fistulizing Sever Crohn Disease who did not reply to first line therapy. 109 patients were enrolled to study from Shariati Public Hospital and Masoud Clinic which both are referral centers. Study arms included Infliximab and Adalimumab as comparators. Model structure was based on disease natural history and clinicians` consultations. All direct medical and non-medical costs were entered to model. Indirect costs were calculated through Human Capital approach. Patients’ utilities were extracted by EQ5D questionnaire through face to face interview. Mortality rates were derived from Iran National Statistics Database. Transition probabilities were extracted by a systematic review from published Randomized Clinical Trials. A markov model designed with 2 month length cycles and 5 year time horizon in Excel 2013 software. Probabilistic sensitivity analysis was done by Treeage 2011 software. Results: Calculated Incremental
Objectives: Describe the use of health resources related to the management of moderate to severe ulcerative colitis (UC) in Brazil. Methods: This was a retrospective analysis that collected data from patient medical records in multiple Brazilian centres in 2017. Healthcare resource utilization data related to the management of patients (≥ 18 years old) diagnosed with moderate to severe UC at least 6 months before the inclusion day were presented using descriptive statistics. Results: A total of 143 patients with moderate to severe UC were included in this analysis. The mean age was 45.9±13.83 years and 56.6% were female. The mean weight and body mass index were 70.1±14.33 kg and 25.7±4.63 kg/m2, respectively. The time since diagnosis of moderate to severe UC was on average 6.1±4.85 years. Surgeries were required in 2.8% of patients and the average number of surgeries per patient was 1.8±0.5. Total colectomy and closure of enterostomy (any segment) corresponded (each one) to 28.6% of surgeries. The mean number of hospitalizations was 1.5±0.92 times for UC; the mean duration was 0.7 months. The mean number of medical appointments per patient was 10.8±6.56 during the period and 92.5% corresponded to an IBD specialist visit. The average number of imaging and laboratory tests was 17.8±14.02. Hemogram was the most frequent test performed (38.8%), followed by
PGI30 Healthcare Resource Utilization in Patients with Moderate to Severe Ulcerative Colitis: A Brazilian Real World Study Decimoni TC1, Sztajnbok S1, Feitosa MR2, Parra RS2 Pharmaceuticals Brazil, São Paulo, Brazil, 2Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto – USP, Ribeirão Preto, Brazil