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Budget Impact Analysis of Medical Care for Chronic Renal Disease Patients in Need of Renal Replacement Therapy Via Peritoneal Dialysis and Hemodialysis in the Russian Health Care Environment
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VA L U E I N H E A LT H 1 9 ( 2 0 1 6 ) A 1 - A 3 1 8
associated with kidney graft loss in patients who used maintenance immunosuppressive regimens containing cyclosporine or tacrolimus in SUS, in ten years. Methods: We analyzed a nationwide cohort of kidney transplant recipients from January 2000 to December 2010 developed through deterministic-probabilistic linkage of SUS administrative databases: Hospital Information System (SIH/SUS); Subsystem for High Complexity Procedures (SIA/SUS) and the Mortality Information System (SIM). To be included, patients must have used either cyclosporine or tacrolimus. Graft loss was defined as death or dialysis for more than three months. We used Cox proportional hazards model to evaluate the factors associated with progression to graft loss. Results: In total, 13,489 patients were included; 5,803 used cyclosporine, and 7,686 received tacrolimus. Most patients were male with a median age of 41 years. A higher risk of graft loss was associated with the use of tacrolimus (HR= 1.162; 95% CI, 1.051–1.285), deceased donor transplantation (1.630; 1.468–1.612), male gender (1.151; 1.043–1.271), an additional year of age (1.012; 1.008–1.016), a median dialysis period greater than 47 months (1.337; 1.205–1.485), and a diagnosis of diabetes as the primary cause of chronic kidney disease (1.361; 1.119–1.657). Conclusions: Among other factors, the use of tacrolimus was associated with worse graft survival. The choice of drug therapy is one of the few factors that influence survival amenable to direct action by health professionals. Therefore, the results of this study are important and should be disseminated aiming to better outcomes for kidney transplant patients and the sustainability of SUS. PUK7 Anemia: The Troublemaker Child of Chronic Kidney Disease Salman M1, Hussain K1, Khan AH2, Adnan AS3, Shehzadi N1, Syed Sulaiman SA2 1University of the Punjab, Lahore, Pakistan, 2Universiti Sains Malaysia, Pulau Pinang, Malaysia, 3Hospital Universiti Sains Malaysia, Kelantan, Malaysia
Objectives: This study aimed to investigate the prevalence and severity of anemia in pre-dialysis patients. Methods: A retrospective study was conducted on 615 adult pre-dialysis patients receiving treatment at Chronic Kidney Disease (CKD) Resource Center, Hospital Universiti Sains Malaysia from Jan, 2009-Dec, 2013. Results: The mean age of patients was 64.1 ± 12.0 years, with a preponderance of male subjects and Malay race. The most common etiology of CKD was diabetes followed by hypertension. The prevalence of anemia was 75.8% and the severity of anemia was mild in 47.7%, moderate in 32.2% and severe in 20.0% of the patients. The prevalence of anemia increased significantly by declining renal function (p < 0.001). Moreover, the prevalence of anemia was significantly higher in females than male CKD patients. Majority of the patients had normochromic-normocytic anemia followed by hypochromic-microcytic anemia. Oral iron supplements were prescribed to 38.0% of the patients and none of the patients was given erythropoietin stimulating agents and intravenous iron preparations. Conclusions: Our results suggest that the prevalence of anemia is higher in pre-dialysis patients and is found to be correlated with renal function; prevalence increases with declined renal function. An earlier identification as well as appropriate treatment of anemia may not only have a good impact on quality of life but also reduce hospitalizations of these patients due to cardiovascular events.
URINARY/KIDNEY DISORDERS – Cost Studies PUK8 Budget Impact Analysis of Medical Care for Chronic Renal Disease Patients in Need of Renal Replacement Therapy Via Peritoneal Dialysis and Hemodialysis in the Russian Health Care Environment Yagudina R, Kulikov A, Abdrashitova G, Serpik VG I.M. Sechenov First Moscow State Medical University, Moscow, Russia
Objectives: To conduct budget impact analysis of medical care for chronic renal disease patients in need of renal replacement therapy via peritoneal dialysis and hemodialysis in the Russian healthcare environment. Methods: We used the pharmacoeconomic analysis method – budget impact analysis and analysis of the direct and indirect costs. Direct costs included the costs of patient preparation to renal replacement therapy (RRT) and the costs of the conduct of RRT, also the costs of treatment infectious complications of RRT (sepsis, peritonit) and complications chronic renal disease (anemia, cardiovascular disease, secondary hyperparathyroidism). Indirect costs included the lump sum disability benefits, disability annuities (subject to the degree of disability) and loss of the gross domestic product because of the disablement of patients of economically active age. Results: We have carried out two scenarios: current scenario when the PD and HD population corresponds to the RRT actual practice and taken from reports of the Russian Dialysis Society (PD= 8,5%, HD= 91,5%), and predictive scenario with the one-to-one PD to HD treatment ratio (PD= 50%, HD= 50%). As a result, the total cost of treating the entire population of patients with chronic renal disease for one year at the current scenario, amounted to 480 766 632 $, while the value of the predictive scenario was 456 499 779 $ (1 $ = 76 RUB.) Conclusions: The results of budget impact analysis showed that the use of PD in the treatment of chronic renal disease can to allow save healthcare budget. PUK9 Cost of Illness Analysis of Nocturia in Germany, Sweden, and the United Kingdom Weidlich D1, Andersson FL2, Guest J1 1Catalyst Health Economics Consultants, Northwood, UK, 2Ferring Pharmaceuticals A/S, Copenhagen, Denmark
Objectives: To estimate the prevalence-based cost of illness imposed by nocturia (≥ 2 nocturnal voids per night) in Germany, Sweden and the UK in an average year. Methods: Information obtained from a review of published literature and
clinician interviews was used to construct an algorithm depicting the management of nocturia for Germany, Sweden and the UK. This enabled an estimation of (1) annual levels of healthcare resource use, (2) annual cost of healthcare resource use and (3) indirect societal cost arising from presenteeism and absenteeism attributable to nocturia in the individual countries. Results: In an average year there are an estimated 12.5, 1.2 and 8.6 million patients, aged 20 years and above, suffering from nocturia in Germany, Sweden and the UK respectively. In an average year, these patients were estimated to have 13.8, 1.4 and 10.0 million visits to a family practitioner or specialist in Germany, Sweden and the UK, respectively. Additionally, there were approximately 91,000, 9,000 and 63,000 hospital admissions attributable to nocturia in Germany, Sweden and the UK respectively and a further 216,000, 19,000 and 130,000 subjects in Germany, Sweden and the UK, respectively were estimated to incur a fracture resulting from their nocturia. The direct annual cost of healthcare resource use attributable to managing nocturia was estimated to be approximately Eur 2.32 billion in Germany, SEK 5.11 billion in Sweden and GBP 1.35 billion in the UK. The indirect societal cost arising from presenteeism and absenteeism was estimated to be approximately Eur 20.76 billion in Germany, SEK 19.65 billion in Sweden and GBP 4.32 billion in the UK. Conclusions: Nocturia appears to impose a substantial socioeconomic burden in all three countries. Clinical and economic benefits could accrue from an increased awareness of the impact that nocturia imposes on both patients, health services and society as a whole.
PUK10 Characterizing Health Care Utilization, Direct Costs, and Comorbidities Associated with Interstitial Cystitis: A Retrospective Claims Analysis Tung A1, Hepp Z2, Devine B1 1University of Washington, Seattle, WA, USA, 2Allergan, plc, Irvine, CA, USA
Objectives: Interstitial Cystitis (IC) is a debilitating condition that affects up to five percent of the United States (US) population (Clemens, 2015). The condition is characterized by bladder pain, urinary urgency and frequency, and in some patients, bladder lesions called Hunner’s Lesions (HL). Patients with HL experience a clinical course distinct from patients without HL. Prior research describing the burden of IC is outdated and lacks HL-level detail. This study aims to characterize healthcare utilization, direct costs, and comorbidities associated with IC, as well as elucidate differences between IC with and without HL. Methods: A retrospective analysis was conducted using healthcare claims from the Truven MarketScan® Research Databases. Adults with incident IC diagnosis between 2009 and 2014 were identified and matched to controls on age, gender, and geographic region. Healthcare utilization, direct costs, and comorbidities during the first 12 months after diagnosis were compared between the two cohorts, as well as between IC subgroups with and without HL. Results: IC patients (n= 24,836) were predominantly (92%) female, with a mean age of 49.0 years. IC patients utilized significantly more healthcare resources across all categories compared to non-IC patients. On average, total healthcare costs were more than twice as high among patients with IC compared to non-IC patients ($14,824 vs $6,984; p< 0.001), with outpatient costs contributing the most to this difference ($9,160 vs $3,878; p< 0.001). IC patients were significantly more likely than non-IC patients to develop comorbidities, with anxiety being the most common (11% vs 4%; p< 0.001). Among IC patients, the HL subgroup (n= 292) utilized significantly more healthcare resources across all categories and incurred significantly higher total healthcare costs compared to the non-HL subgroup ($21,371 vs $14,746; p< 0.001). Conclusions: Our findings suggest that IC is associated with significant healthcare utilization, costs, and comorbidities, which are further amplified in those with HL.
PUK11 Cost Effectiveness of Onabotulinumtoxina Versus Ptns and Sns for the Treatment of Overactive Bladder from the US Payer Perspective Hepp Z1, Yehoshua A1, Gultyaev D2, Lister J2 1Allergan, plc, Irvine, CA, USA, 2LA-SER Analytica, Lorrach, Germany
Objectives: Patients with overactive bladder (OAB) who have failed an oral therapy have a number of treatment options including onabotulinumtoxinA (onabotA) injection, percutaneous tibial nerve stimulation (PTNS), or implantable sacral neurostimulation (SNS) device. This analysis estimates the cost-effectiveness of onabotA 100U compared to PTNS and SNS from the US payer perspective. Methods: A Markov health state transition model was developed with 3-month cycles and health states based on daily urinary incontinence episodes (UIE). Patients were treated with either onabotA, PTNS, or SNS. Those who discontinued therapy transitioned to best supportive care. Individual patient level data from phase 3 and longterm extension studies informed efficacy and safety data for onabotA. Published literature informed safety and efficacy for PTNS and SNS. Resource utilization and unit cost data were obtained from published sources and expert opinion. Outcomes were expressed in 2014 USD ($) per Quality Adjusted Life Years (QALYs, measured by I-QOL mapped to EurQoL-5D). A 10-year time horizon and discount rate of 3.0% was applied. Parameter uncertainty was investigated using deterministic and probabilistic sensitivity analyses (PSA). Results: For the base case, total costs over 10 years were $13,030 for onabotA, $12,239 for PTNS, and $37,735 for SNS; total QALYs gained were 7.179, 7.106, and 7.130, respectively, yielding an incremental cost effective ratio (ICER) of $10,848 for onabotA vs PTNS; onabotA was dominant against SNS. PSAs demonstrated that onabotA had an 8% or 66% probability of being dominant and 70% or 68% likelihood of being below $100,000 cost-effectiveness threshold compared to PTNS and SNS, respectively. Conclusions: This analysis shows that OnabotA is a cost-effective therapy for OAB compared with PTNS and SNS. On grounds of its cost effectiveness, onabotA should be considered a treatment of choice among patients who have failed ≥ 1 anticholinergic.
VA L U E I N H E A LT H 1 9 ( 2 0 1 6 ) A 1 - A 3 1 8
associated with kidney graft loss in patients who used maintenance immunosuppressive regimens containing cyclosporine or tacrolimus in SUS, in ten years. Methods: We analyzed a nationwide cohort of kidney transplant recipients from January 2000 to December 2010 developed through deterministic-probabilistic linkage of SUS administrative databases: Hospital Information System (SIH/SUS); Subsystem for High Complexity Procedures (SIA/SUS) and the Mortality Information System (SIM). To be included, patients must have used either cyclosporine or tacrolimus. Graft loss was defined as death or dialysis for more than three months. We used Cox proportional hazards model to evaluate the factors associated with progression to graft loss. Results: In total, 13,489 patients were included; 5,803 used cyclosporine, and 7,686 received tacrolimus. Most patients were male with a median age of 41 years. A higher risk of graft loss was associated with the use of tacrolimus (HR= 1.162; 95% CI, 1.051–1.285), deceased donor transplantation (1.630; 1.468–1.612), male gender (1.151; 1.043–1.271), an additional year of age (1.012; 1.008–1.016), a median dialysis period greater than 47 months (1.337; 1.205–1.485), and a diagnosis of diabetes as the primary cause of chronic kidney disease (1.361; 1.119–1.657). Conclusions: Among other factors, the use of tacrolimus was associated with worse graft survival. The choice of drug therapy is one of the few factors that influence survival amenable to direct action by health professionals. Therefore, the results of this study are important and should be disseminated aiming to better outcomes for kidney transplant patients and the sustainability of SUS. PUK7 Anemia: The Troublemaker Child of Chronic Kidney Disease Salman M1, Hussain K1, Khan AH2, Adnan AS3, Shehzadi N1, Syed Sulaiman SA2 1University of the Punjab, Lahore, Pakistan, 2Universiti Sains Malaysia, Pulau Pinang, Malaysia, 3Hospital Universiti Sains Malaysia, Kelantan, Malaysia
Objectives: This study aimed to investigate the prevalence and severity of anemia in pre-dialysis patients. Methods: A retrospective study was conducted on 615 adult pre-dialysis patients receiving treatment at Chronic Kidney Disease (CKD) Resource Center, Hospital Universiti Sains Malaysia from Jan, 2009-Dec, 2013. Results: The mean age of patients was 64.1 ± 12.0 years, with a preponderance of male subjects and Malay race. The most common etiology of CKD was diabetes followed by hypertension. The prevalence of anemia was 75.8% and the severity of anemia was mild in 47.7%, moderate in 32.2% and severe in 20.0% of the patients. The prevalence of anemia increased significantly by declining renal function (p < 0.001). Moreover, the prevalence of anemia was significantly higher in females than male CKD patients. Majority of the patients had normochromic-normocytic anemia followed by hypochromic-microcytic anemia. Oral iron supplements were prescribed to 38.0% of the patients and none of the patients was given erythropoietin stimulating agents and intravenous iron preparations. Conclusions: Our results suggest that the prevalence of anemia is higher in pre-dialysis patients and is found to be correlated with renal function; prevalence increases with declined renal function. An earlier identification as well as appropriate treatment of anemia may not only have a good impact on quality of life but also reduce hospitalizations of these patients due to cardiovascular events.
URINARY/KIDNEY DISORDERS – Cost Studies PUK8 Budget Impact Analysis of Medical Care for Chronic Renal Disease Patients in Need of Renal Replacement Therapy Via Peritoneal Dialysis and Hemodialysis in the Russian Health Care Environment Yagudina R, Kulikov A, Abdrashitova G, Serpik VG I.M. Sechenov First Moscow State Medical University, Moscow, Russia
Objectives: To conduct budget impact analysis of medical care for chronic renal disease patients in need of renal replacement therapy via peritoneal dialysis and hemodialysis in the Russian healthcare environment. Methods: We used the pharmacoeconomic analysis method – budget impact analysis and analysis of the direct and indirect costs. Direct costs included the costs of patient preparation to renal replacement therapy (RRT) and the costs of the conduct of RRT, also the costs of treatment infectious complications of RRT (sepsis, peritonit) and complications chronic renal disease (anemia, cardiovascular disease, secondary hyperparathyroidism). Indirect costs included the lump sum disability benefits, disability annuities (subject to the degree of disability) and loss of the gross domestic product because of the disablement of patients of economically active age. Results: We have carried out two scenarios: current scenario when the PD and HD population corresponds to the RRT actual practice and taken from reports of the Russian Dialysis Society (PD= 8,5%, HD= 91,5%), and predictive scenario with the one-to-one PD to HD treatment ratio (PD= 50%, HD= 50%). As a result, the total cost of treating the entire population of patients with chronic renal disease for one year at the current scenario, amounted to 480 766 632 $, while the value of the predictive scenario was 456 499 779 $ (1 $ = 76 RUB.) Conclusions: The results of budget impact analysis showed that the use of PD in the treatment of chronic renal disease can to allow save healthcare budget. PUK9 Cost of Illness Analysis of Nocturia in Germany, Sweden, and the United Kingdom Weidlich D1, Andersson FL2, Guest J1 1Catalyst Health Economics Consultants, Northwood, UK, 2Ferring Pharmaceuticals A/S, Copenhagen, Denmark
Objectives: To estimate the prevalence-based cost of illness imposed by nocturia (≥ 2 nocturnal voids per night) in Germany, Sweden and the UK in an average year. Methods: Information obtained from a review of published literature and
clinician interviews was used to construct an algorithm depicting the management of nocturia for Germany, Sweden and the UK. This enabled an estimation of (1) annual levels of healthcare resource use, (2) annual cost of healthcare resource use and (3) indirect societal cost arising from presenteeism and absenteeism attributable to nocturia in the individual countries. Results: In an average year there are an estimated 12.5, 1.2 and 8.6 million patients, aged 20 years and above, suffering from nocturia in Germany, Sweden and the UK respectively. In an average year, these patients were estimated to have 13.8, 1.4 and 10.0 million visits to a family practitioner or specialist in Germany, Sweden and the UK, respectively. Additionally, there were approximately 91,000, 9,000 and 63,000 hospital admissions attributable to nocturia in Germany, Sweden and the UK respectively and a further 216,000, 19,000 and 130,000 subjects in Germany, Sweden and the UK, respectively were estimated to incur a fracture resulting from their nocturia. The direct annual cost of healthcare resource use attributable to managing nocturia was estimated to be approximately Eur 2.32 billion in Germany, SEK 5.11 billion in Sweden and GBP 1.35 billion in the UK. The indirect societal cost arising from presenteeism and absenteeism was estimated to be approximately Eur 20.76 billion in Germany, SEK 19.65 billion in Sweden and GBP 4.32 billion in the UK. Conclusions: Nocturia appears to impose a substantial socioeconomic burden in all three countries. Clinical and economic benefits could accrue from an increased awareness of the impact that nocturia imposes on both patients, health services and society as a whole.
PUK10 Characterizing Health Care Utilization, Direct Costs, and Comorbidities Associated with Interstitial Cystitis: A Retrospective Claims Analysis Tung A1, Hepp Z2, Devine B1 1University of Washington, Seattle, WA, USA, 2Allergan, plc, Irvine, CA, USA
Objectives: Interstitial Cystitis (IC) is a debilitating condition that affects up to five percent of the United States (US) population (Clemens, 2015). The condition is characterized by bladder pain, urinary urgency and frequency, and in some patients, bladder lesions called Hunner’s Lesions (HL). Patients with HL experience a clinical course distinct from patients without HL. Prior research describing the burden of IC is outdated and lacks HL-level detail. This study aims to characterize healthcare utilization, direct costs, and comorbidities associated with IC, as well as elucidate differences between IC with and without HL. Methods: A retrospective analysis was conducted using healthcare claims from the Truven MarketScan® Research Databases. Adults with incident IC diagnosis between 2009 and 2014 were identified and matched to controls on age, gender, and geographic region. Healthcare utilization, direct costs, and comorbidities during the first 12 months after diagnosis were compared between the two cohorts, as well as between IC subgroups with and without HL. Results: IC patients (n= 24,836) were predominantly (92%) female, with a mean age of 49.0 years. IC patients utilized significantly more healthcare resources across all categories compared to non-IC patients. On average, total healthcare costs were more than twice as high among patients with IC compared to non-IC patients ($14,824 vs $6,984; p< 0.001), with outpatient costs contributing the most to this difference ($9,160 vs $3,878; p< 0.001). IC patients were significantly more likely than non-IC patients to develop comorbidities, with anxiety being the most common (11% vs 4%; p< 0.001). Among IC patients, the HL subgroup (n= 292) utilized significantly more healthcare resources across all categories and incurred significantly higher total healthcare costs compared to the non-HL subgroup ($21,371 vs $14,746; p< 0.001). Conclusions: Our findings suggest that IC is associated with significant healthcare utilization, costs, and comorbidities, which are further amplified in those with HL.
PUK11 Cost Effectiveness of Onabotulinumtoxina Versus Ptns and Sns for the Treatment of Overactive Bladder from the US Payer Perspective Hepp Z1, Yehoshua A1, Gultyaev D2, Lister J2 1Allergan, plc, Irvine, CA, USA, 2LA-SER Analytica, Lorrach, Germany
Objectives: Patients with overactive bladder (OAB) who have failed an oral therapy have a number of treatment options including onabotulinumtoxinA (onabotA) injection, percutaneous tibial nerve stimulation (PTNS), or implantable sacral neurostimulation (SNS) device. This analysis estimates the cost-effectiveness of onabotA 100U compared to PTNS and SNS from the US payer perspective. Methods: A Markov health state transition model was developed with 3-month cycles and health states based on daily urinary incontinence episodes (UIE). Patients were treated with either onabotA, PTNS, or SNS. Those who discontinued therapy transitioned to best supportive care. Individual patient level data from phase 3 and longterm extension studies informed efficacy and safety data for onabotA. Published literature informed safety and efficacy for PTNS and SNS. Resource utilization and unit cost data were obtained from published sources and expert opinion. Outcomes were expressed in 2014 USD ($) per Quality Adjusted Life Years (QALYs, measured by I-QOL mapped to EurQoL-5D). A 10-year time horizon and discount rate of 3.0% was applied. Parameter uncertainty was investigated using deterministic and probabilistic sensitivity analyses (PSA). Results: For the base case, total costs over 10 years were $13,030 for onabotA, $12,239 for PTNS, and $37,735 for SNS; total QALYs gained were 7.179, 7.106, and 7.130, respectively, yielding an incremental cost effective ratio (ICER) of $10,848 for onabotA vs PTNS; onabotA was dominant against SNS. PSAs demonstrated that onabotA had an 8% or 66% probability of being dominant and 70% or 68% likelihood of being below $100,000 cost-effectiveness threshold compared to PTNS and SNS, respectively. Conclusions: This analysis shows that OnabotA is a cost-effective therapy for OAB compared with PTNS and SNS. On grounds of its cost effectiveness, onabotA should be considered a treatment of choice among patients who have failed ≥ 1 anticholinergic.