- Email: [email protected]
ECONOMIC IMPLICATIONS OF BUDESONIDE MMX® ADVANTAGE IN ULCERATIVE COLITIS TREATMENT OVER SYSTEMIC STEROIDS: BUDESONIDE MMX® DECREASES ULCERATIVE COLITIS TREATMENT COSTS
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procedures and $16-$22 for laparoscopies. The anesthesia cost (minute) ranged from $7-$10 and the cost for hospital stay (day) ranged from $477-$591 regardless of procedure type. In European countries, the cost of operating rooms (minute) ranged from $15-$24 for open procedures and $15-$29 for laparoscopy. The cost for hospital stay (day) ranged from $234-$604. In Asia and Australia, the cost of operating rooms (minute) ranged from $4-$12 for open procedures and $4-$13 for laparoscopies. The cost for hospital stay (day) ranged from $159-$406. Conclusions: Asian-Pacific countries have reported lower direct hospital costs. Cost calculations for common surgical procedures like colectomy are challenging due to different costing methodologies and categories. A standardized costing methodology guideline is warranted and may shed light on the future considerations of reimbursement strategy. PGI10 COSTS AND OUTCOMES OF TREATING HCV PATIENTS IN KAZAKHSTAN HEALTH CARE SYSTEM Almadiyeva A 1, Ibrayev S 1, Kostyuk A 2 Medical University, Astana, Kazakhstan, 2KazAHTA, Astana, Kazakhstan .
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Objectives: Viral hepatitis is a major public health problem affecting millions of people worldwide. Long-term consequences are the development of liver cirrhosis and hepatocellular carcinoma. The aim of the study was to assess outcomes and costs of treating patients with HCV in clinical practice in Kazakhstan. Methods: We carried out a prospective noninterventional study. Information on treatment outcomes and resource utilization was provided from physicians throughout Kazakhstan. The EQ-5D Health Survey was administered for evaluation healthrelated quality of life. Consecutive unselected Kazakh patients with HCV completed the EQ-5D questionnaire before, during and after treatment with pegylated interferon and ribavirin before, during and after combination therapy. Data of 3708 monoinfected HCV-patients treated between 2011 and 2014 were analysed. Therapy consisted of peginterferon/ribavirin. Mean age of patients was 44.1 years, 59.8% were male and estimated duration of infection was 10.4 years. Predominantly genotype 1 (67.7%) or 3 (22.3%) infections were observed. Results: Sustained viral response (SVR)-rates in most frequently observed genotypes were 49.2% in GT-1 and 61.9% in GT-3 treatment-naive patients (Relapser: GT-1: 35.3% and GT-3: 57.3%; Nonresponder: GT-1: 25.0% and GT-3: 33.3%). Average treatment costs were lowest in treatment-naive patients (€ 19 762) and higher in patients who failed previous treatments (relapsers: € 25 233; nonresponders: € 20 158). Average costs per SVR in treatment-naive patients were € 46 447 for GT-1 and € 23 182 for GT-3. Treatment was associated with a decrease in quality of life; post-treatment quality of life was higher in patients achieving SVR. Conclusions: Our study on real-life treatment outcomes and costs can serve as a reference for a comparison with other treatments. There is high need for short-term and long-term cost-effectiveness analysis in real-life settings as newly introduced treatment strategies with direct acting antivirals result in high SVR-rates but are more costly. PGI11 ULCERATIVE COLITIS TREATMENT PATTERNS AND COST OF CARE Null K D 1, Xu Y 1, Pasquale M K 1, Su C 2, Marren A 2, Harnett J 3, Mardekian J 3, Manuchehri A 4, Healey P 5 1Comprehensive Health Insights, Humana, Louisville, KY, USA, 2Pfizer Inc., Collegeville, PA, USA, 3Pfizer Inc., New York, NY, USA, 4Pfizer Inc., Tadworth, UK, 5Pfizer Inc., Groton, CT, USA .
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Objectives: To examine treatment patterns, dosing, and cost of the tumor necrosis factor inhibitors (TNFi), adalimumab (ADA) and infliximab (IFX), among US Humana Commercial and Medicare members diagnosed with ulcerative colitis (UC). Methods: This retrospective cohort study identified the first pharmacy prescription or medical claim for ADA or IFX (July 1, 2007-December 31, 2013) in fully-insured members with continuous enrollment for ≥ 6 months pre- and ≥ 12 months post-index, with at least one UC diagnosis claim 6-months pre- and postindex. Members were excluded if they received a biologic for UC during 6-months pre-index, or two diagnoses ≥ 30 days apart of ankylosing spondylitis, Crohn’s disease, plaque psoriasis, or rheumatoid arthritis during 6-months pre- or postindex. TNFi discontinuation was defined as a therapy gap ≥ 56 days for ADA and ≥ 112 days for IFX. TNFi therapy switch was defined as initiation of non-index TNFi therapy. Results: The study population comprised 295 UC patients: mean age 50.9, 51% female, and 62% located in the Southern US. 50 (17%) patients received ADA treatment and 245 (83%) received IFX, at index. Treatment discontinuation was observed in 26 (52%) ADA and 111 (45%) IFX patients during the 12-months postindex, with respective mean times to discontinuation of 19 and 22 weeks. 12 (46%) ADA and 76 (68%) IFX patients did not restart or switch to another TNFi therapy. Similar rates of therapy switching were observed between ADA- and IFX-treated patients, with respective mean times to switch of 18 and 30 weeks. At 12-months post-index, mean TNFi medication cost represented $25,193 out of $41,618 mean total UC-related healthcare cost. Conclusions: Approximately half of ADA and IFX patients discontinued therapy, with approximately half of ADA and the majority of IFX patients not restarting or switching therapies. Further investigation of patient treatment patterns and outcomes following TNFi therapy discontinuation is required. PGI12 COST BURDEN OF INAPPROPRIATE PROTON-PUMP INHIBITOR USE AMONG GASTROESOPHAGEAL REFLUX DISEASE PATIENTS Rane P 1, Guha S 2, Garey K 1, Chen H 1, Johnson M L 1, Aparasu R 1 1University of Houston, Houston, TX, USA, 2University of Texas Health Science Center, Houston, TX, USA .
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Objectives: Proton Pump Inhibitors (PPIs) are widely used in the US and are often used for extended periods despite treatment guidelines recommending PPIs for short term use. The study examined the total healthcare costs for short term and long term PPI users among patients with Gastroesophageal reflux disease (GERD). Methods: A retrospective longitudinal analysis was conducted involving the 2003-2004 Truven MarketScan database. The study focused on adults aged ≥ 18
years of age who were diagnosed with GERD and initiated PPI treatment from July 2003 to September 2004. The persistence of PPI was defined as number of days to discontinuation of index PPI treatment without a gap of 30 or more days. Persistent PPI use for ≤ 8 weeks was classified as short term user and for > 8 weeks was classified as a long term PPI user. Descriptive statistics were performed to characterize the study population. Generalized linear models were used to analyze the cost difference and bootstrapping analysis was conducted to compute the 95% Confidence Interval (CI) as per percentile method. A statistical significance level of 0.05 was used in the study. SAS 9.3 software was used for statistical analysis. Results: The study population consisted of 75,503 patients with a GERD indication and incident PPI use. Majority of the patients were females (58.2%) and mean age of the cohort was 47.8 years. On an average, long term PPI users had higher all cause total costs [$53,196 (95% CI: $1,942 - $140,441)] as compared to short term PPI users. The difference in total costs was mainly attributed to prescription costs and medical costs. Conclusions: For efficacy, safety and cost considerations, PPIs should be used for the recommended duration among GERD patients to avoid unnecessary healthcare burden. PGI13 HEALTH CARE RESOURCE UTILIZATION AND MEDICAL CARE COST OF INGUINAL HERNIA REPAIR IN CHINA Ma Y 1, Wu J 2, Zhang Y 2, Jia Y 3 1Beijing University of Chinese Medicine, Beijing, China, 2Beijing Brainpower Pharma Consulting Co. Ltd, Beijing, China, 3Johnson & Johnson Medical Device, Shanghai, China .
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Objectives: To evaluate the healthcare resource utilization and direct costs of inguinal hernia repair by real world data. Methods: This retrospective study based on the Chinese Basic Medical Insurance system in 2013. Target patients diagnosed with inguinal hernia and underwent inguinal hernia repair surgery were selected. Information of patient demographic characters, city tier, hospital tier, type of operation and cost were collected for the analysis. Descriptive statistics were used to describe patient demographic characters, healthcare resource utilization and direct medical cost. Direct medical cost include diagnostic tests, anesthesia, surgery, medical devices, drug and administration cost. Generalized linear regression model (GLM) was used to identify influence factors on the direct cost. Results: Total 6,482 patients (74% adult; 86% male; mean age 44±27, 95% CI 1-82) were included. Mean (±SD) cost amounted to 8,121(±4,555; 95% CI 2,314-18,498) RMB, with 77.6% for operation related cost, 22.4% for drug. Factors significantly impacting inpatient cost were age, type of hernia (unilateral vs. bilateral), hospital tier, type of operation (open-mesh vs. laparoscopic), mesh using, type of insurance, gender (GLM, p< 0.05). There were considerable differences of costs in these dimensions: age (adults 9,563 RMB vs. children 4,924 RMB), type of hernia (bilateral 10,284 RMB vs. unilateral 7,875 RMB), hospital tier (tier III 9,050 RMB, tier II 6,755 RMB and tier I 4,777 RMB), types of inpatient wards (Intra day ward 5,977 RMB vs. hospitalized ward 8,265RMB). Conclusions: The observed hospital cost for inguinal hernia repair was varied: a number of factors especially age, type of hernia and hospital tier had significant influence on inpatient cost. These influencing factors should be considered in policy making. Treatment in intra day ward showed more advantage than inpatient ward. PGI14 TREATMENT OF CHRONIC HEPATITIS C VIRUS GENOTYPE 1 INFECTION: COMPARISON OF HEALTH-ECONOMIC OUTCOMES FOR NAÏVE PATIENTS Vitezic D 1, Mance D 2, Mance D 3, Vitezic M 4, Mrsic Pelcic J 5 1University of Rijeka, School of Medicine and University Hospital Centre Rijeka, Rijeka, Croatia, 2University of Rijeka, Rijeka, Croatia, 3University of Rijeka, Faculty of Economics, Rijeka, Croatia, 4University Orthopaedic Clinic Lovran and University of Rijeka Medical School, Lovran, Croatia, 5University of Rijeka Medical School, Rijeka, Croatia .
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Objectives: During the past couple of years very effective direct acting antiviral (DAA) therapies for treating hepatitis C virus (HCV) infection appeared on the market. Beside high efficacy, these therapies are also designated by high prices in comparison to the therapy with pegylated interferon (pegIFN). The objective of presented work was to compare the cost-effectiveness of the therapies for HCV genotype 1 (GT1) naïve patients currently available on Croatian market. Methods: Costs of therapies were calculated according to publicly available medication pricing list and information found in Summary of Product Characteristics (SmPC) documents. The main health-economic outcome was defined as cost per cure i.e. therapy cost per achieved sustained viral response (SVR). Final parameters were estimated by Monte Carlo simulations. ANOVA and Tukey post-hoc test were used to test differences between mean therapies’ costs per SVR. Results: Currently on the Croatian market, there are five different treatments of HCV GT1 naïve patients. Those therapies are therapies with pegIFN that have SVR rates 30-55% as well as DAAs therapies with SVR range 60-100 % for naïve HCV GT1 patients. There is statistically significant difference (p < 0.001) among average treatment costs per SVR of the therapies and those are as low as € 14,800 for pegIFN and for new therapies reach € 79,600 in case of patients without cirrhosis. For cirrhotic patients prices are in range from € 23,400 for pegIFN, up to € 91,500 for DAA therapies. Conclusions: Due to the low costs per achieved SVR we can expect that in future there will still remain certain portion of naïve HCV GT1 patients who will receive pegIFN therapy. “Pay per cure” policy in which pharmaceutical company is not being paid for the drugs in cases in which patient does not achieve SVR, seems to be good solution for health providers and appropriate answer to high prices of the new therapies. PGI15 ECONOMIC IMPLICATIONS OF BUDESONIDE MMX® ADVANTAGE IN ULCERATIVE COLITIS TREATMENT OVER SYSTEMIC STEROIDS: BUDESONIDE MMX® DECREASES ULCERATIVE COLITIS TREATMENT COSTS Bierut A 1, Jesionowski M 1, Pruszko C 2, Jachimowicz M 2, Kowalczyk M 2, Książek P 2 Pharmaceuticals Poland, Warsaw, Poland, 2MAHTA Ltd., Warsaw, Poland .
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Objectives: The main objective is to assess the economic implications of replacing standard oral corticosteroid treatment with budesonide MMX® for induction of remission in mild-to-moderate ulcerative colitis (UC). Steroid-associated adverse events (AEs) provoke high treatment costs and generate significant expenditures for the public payer. Budesonide MMX® was found to have favorable safety profile due to lower bioavailability than systemic steroids. According to these findings budesonide MMX allows for even 7-fold reduction in the risk of adverse events. Therefore, its potential to decrease AE related treatment cost requires further investigation. Methods: Electronic databases (Medline, Embase and The Cochrane Library) were systematically searched for clinical trials to compare budesonide MMX® versus other steroids and to assess long-term side effects of steroid use. The economic burden of steroid-related side effects including prevention and treatment costs was evaluated in an economic model. The risk of side effects was fitted proportionally to the cumulative dose of steroids. The costs of adverse events corresponded to the use of all resources being determined by Polish clinical practice as well as Polish and international guidelines for the treatment of all specific AEs. Results: Costs of nine most frequent and cost-intensive serious steroid-related side effects like osteoporosis, glaucoma, cataract, hypertension, type 2 diabetes, myopathy, neuropathy, depression and vein thrombosis were estimated. The cumulative projected 20-year treatment cost of all selected side effects was 2 310 € vs 425 € per patient treated with standard oral corticosteroids and with budesonide MMX®, respectively. The results were robust under sensitivity testing. Conclusions: Treatment of steroid-related side effects constitutes significant long-term cost of medical care. Budesonide MMX® could allow for substantial cost reduction. The favorable safety profile outcomes has delivered strong evidence of budesonide MMX® being costeffective compared with standard steroid therapy for induction of remission in mild-to-moderate UC. PGI16 COST EFFECTIVENESS OF EVEROLIMUS IN COMBINATION WITH REDUCED TACROLIMUS FOR LIVER TRANSPLANT RECIPIENTS Park T 1, Griggs S 1, Horwedel T 2, Hagopian J 2, Bowman L 3 Louis College of Pharmacy, St Louis, MO, USA, 2Barnes-Jewish Hospital, St Louis, MO, USA, 3Tampa General Hospital, Tampa, FL, USA .
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Objectives: Recent trials demonstrate that everolimus (EVR) in combination with reduced tacrolimus (rTAC) significantly improves renal function compared to tacrolimus (TAC) alone in liver transplant recipients. This study aims to conduct a cost-effectiveness analysis of EVR + rTAC for liver transplant recipients. Methods: A Markov model was developed to estimate the costs and quality-adjusted life years (QALYs) for liver transplant recipients who receive EVR + rTAC compared to those who receive TAC alone. We adopted the perspective of the US health care system, including direct costs only. A lifetime horizon was chosen. We derived parameter estimates from clinical studies and published sources. Deterministic and probabilistic sensitivity analyses were conducted to account for uncertainties of key model parameters. Results: Compared to the combination therapy (EVR + rTAC), monotherapy (TAC) resulted in lower lifetime accumulated costs ($390,900 and $874,400) and higher accumulated effectiveness (11.71 QALYs and 11.60 QALYs, respectively). Sensitivity analyses suggested that the main drivers of our model included the probability of dialysis after end stage renal disease and rates of transitions between different chronic kidney disease stages. Varying these parameters yielded an incremental cost-effectiveness ratio (ICER) ranging from $176,200 to $2,687,600 per QALY gained indicating TAC was still considered cost-effective given a willingness-to-pay threshold conventionally accepted. Conclusions: The combination therapy (EVR + rTAC) is not likely to be cost-effective for liver transplant recipients primarily because of substantial cost differences between EVR and TAC. Future research is warranted to investigate the cost-effectiveness of the combination therapy after generic EVR becomes available. PGI17 THE COST EFFECTIVENESS OF NOVEL HEPATITS C THERAPIES: A REVIEW Bickerstaff C Florida A&M University, Tallahassee, FL, USA .
Objectives: In the United States over 3 million individuals are infected with the Hepatitis C Virus (HCV) and 75% to 85% of them have or will develop Chronic Hepatitis C (CHC) which can lead to serious consequences such as liver cirrhosis, cancer, and death. Prior to 2013 the treatment of CHC was Pegylated Interferon + Ribavirin with or without a protease inhibitor such a Boceprevir/Telaprevir. These treatments had a cure rate or rate of sustained virologic response (SVR) of 66% to 80%. Since the close of 2013 several new direct acting agents (DAAs) for the treatment of CHC have been approved by the FDA. These new CHC treatments have cure rates of 80% to 100%; however, their price tags have been a point of great contention and debate with costs ranging from $63,000 to $168,000 per treatment course. The purpose of this review is to identify and analyze the body of cost-effectiveness evidence for new CHC therapies approved by the FDA. Methods: Using electronic databases Pub Med, Ovid Medline, and the University of York Centre for Reviews and Dissemination (CRD) Databases-NHS Economic Evaluation Database as well as a combination of the search terms “costs and cost analysis” OR costs OR cost effective* AND Hepatitis C, studies evaluating the cost-effectiveness of novel CHC treatments were reviewed. Results: The results of this review indicated that while various new DAAs for HCV treatment are cost-effective, cost-effectiveness is highly dependent upon factors including, but not limited to, HCV genotype, liver fibrosis progression, patient treatment history, HIV co-infection, treatment comparators, and willingness to pay thresholds. Conclusions: Informed decision making amongst patients, clinical practitioners, and payers alike requires a robust body of cost-effectiveness literature. Further research which utilizes comprehensive patient characteristics and novel DAA treatment comparators as well as the historical standard of care is necessary in order to facilitate thorough comparison of available treatment alternatives.
PGI18 PHARMACOECONOMIC ASSESSMENT OF QUADROTHERAPY WITH ORIGINAL BISMUTH SUBCITRATE DRUG VERSUS QUADROTHERAPY WITH GENERIC DRUG IN PATIENTS WITH PEPTIC ULCER ASSOCIATED WITH HELICOBACTER PYLORI IN UKRAINE Iakovlieva L , Gerasymova O , Mishchenko O , Bezditko N , Tkachova O , Kyrychenko O , Matyashova N National University of Pharmacy, Kharkiv, Ukraine .
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Objectives: Quadrotherapy including drugs of colloidal bismuth (bismuth preparation, a proton pump and two antibiotics) is replacement for standard triple antihelicobacter therapy (AHT) and contributes to a significant decrease in H. pylori resistance to antibiotics. Adding bismuth subcitrate preparation increases considerably AHT cost, which in turn reduces the economic availability of treatment to the patient. This is especially important for Ukrainian patients since they are main payers. Given this, the use of generic cheaper bismuth subcitrate drug has an actual task. The aim - pharmacoeconomic grounding the benefits of using of quadrotherapy with bismuth subcitrate generic drug (QTGB) versus quadrotherapy with bismuth subcitrate original drug (QTOB). Methods: Cost-effectiveness analysis of the two schemes QTOB and QTGB according to clinical research: G. D. Fadyeyenko, E. V. Kolesnikov. Place bismuth subcitrate in the treatment of patients with peptic ulcer disease, associated with Helicobacter pylori (Modern gastroenterology, 2015, №1 (81), p.37-43), was carried out. Onevariate sensitivity analysis of the results to changes in price of drugs was carried out. On 21.11.14 the currency ratio of UAH to € was 20.04:1. Results: Quadrotherapy with generic drug of bismuth subcitrate has a lower cost of treatment 19.84 € vs. 29.06 € and is less effective among the investigated schemes (90% of patients with H. pylori eradication vs. 96.7%, p < 0,05) and more cost effective (CER = 22.04 € per 1 patient with H. pylori eradication vs. 30.05 € ). The costs of an additional unit of effectiveness in the transition to a more effective QTOB are 119.55 € . Conclusions: In the context of the Ukrainian pharmaceutical market realities QTGB in patients with peptic ulser, associated with H. pylori, is more cost effective compared to QTOB, but less clinically effective. The sensitivity analysis showed, that the 36.3% decrease in the price of the original drug of bismuth subcitrate quadrotherapy with it would be dominant. PGI19 CONVERSION FROM LAPAROSCOPIC TO OPEN SURGICAL APPROACH IN LEFTHEMICOLECTOMY AND SIGMOIDECTOMY: RISK FACTORS AND IMPACT ON RESOURCE UTILIZATION Etter K 1, Yoo A 1, Roy S 2, Kalsekar I 1 & Johnson Co., New Brunswick, NJ, USA, 2Johnson and Johnson Global Surgery, Somerville, NJ, USA .
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Objectives: Explore factors associated with conversion from laparoscopic to open approach in left-sided colon resections and analyze differences in hospital cost, length of stay(LOS), and operating room time(ORT) for Lap-Conversion, OpenPlanned and Lap-Successful approaches. Methods: The Premier Perspective® Database containing billing data from ~600 hospitals in the U.S. was analyzed. All patients undergoing left-hemicolectomy or sigmoidectomy from 2009-2014 were identified. Lap-Conversion was identified by ICD9-code(V64.41) or when a laparoscopic and open procedure code occurred simultaneously. Lap-Conversion incidence was calculated for all procedures with evidence of a laparoscopic approach (Lap-Attempted). Resource utilization parameters of ORT, LOS, and hospital cost (2014 US-Dollars) were analyzed. For Lap-Attempted procedures, patient, provider, and procedure factors associated with conversion were explored in a multivariable model. Similar models were used on all procedures to evaluate the effect of surgical approach on LOS, ORT, and cost. All statistical analyses accounted for clustering within hospitals; p-values < 0.05 were considered significant. Results: A total of 80,078 patients undergoing left-hemicolectomy(18,279) or sigmoidectomy(61,799) were identified. There were 34,795 Lap-Attempted procedures and the incidence of Lap-Conversion was 16.86%(95%CI[15.90,17.82]). Adjusted mean LOS(SE) for Lap-Conversion was 9.1(0.1) days compared to 6.8(0.1) and 9.2(0.1) for Lap-Successful and Open-Planned, respectively. Adjusted mean cost(SE) followed a similar trend: $24,317($397) for Lap-Conversion, $20,603($284) and $24,317($323) for Lap-Successful and Open-Planned. Adjusted mean ORT(SE) for Lap-Conversion was 244(5.2) minutes compared to 218(4.1) and 194(3.3) for Lap-Successful and Open-Planned. Risk factors associated with Lap-Conversion included: left-hemicolectomy OR= 1.44(95%CI[1.30,1.60]), diverticulitis OR= 1.16(95%CI[1.052,1.28]) and inflammatory bowel disease (IBD) OR= 1.39(95%CI[1.06,1.83]). Robotic-assistance OR= 0.42(95%CI[0.33,0.55]) and elective procedures OR= 0.54(95%CI[0.49,0.60)] were associated with decreased risk. Conclusions: Lap-Conversion resulted in the disappearance of LOS and cost benefits of the laparoscopic approach. Lap-Conversion had longer ORT, but similar LOS and cost compared to Open-Planned approaches. Lap-Conversion and Open-Planned were associated with similar significant increases in LOS and costs compared to Lap-Successful.
GASTROINTESTINAL DISORDERS – Patient-Reported Outcomes & Patient Preference Studies PGI20 SOFOSBUVIR MEMBER COST-SHARING AND UTILIZATION OF SOFOSBUVIR AMONG THE COMMERCIALLY INSURED Karmarkar T 1, Starner C 2, Gleason P 2, Tiberg K 2, Alexander G C 1 Hopkins Bloomberg School of Public Health, Baltimore, MD, USA, 2Prime Therapeutics, Eagan, MN, USA .
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Objectives: New treatments for Hepatitis C offer higher rates of cure with fewer side effects, yet cost approximately $28,000 a month. We aim to examine associations between member cost sharing and initial medication adherence (IMA). Methods: We identified the members’ earliest sofosbuvir claim, between 1/1/2014 and 9/30/2015 and followed their sofosbuvir claims through 3/31/2015 in
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procedures and $16-$22 for laparoscopies. The anesthesia cost (minute) ranged from $7-$10 and the cost for hospital stay (day) ranged from $477-$591 regardless of procedure type. In European countries, the cost of operating rooms (minute) ranged from $15-$24 for open procedures and $15-$29 for laparoscopy. The cost for hospital stay (day) ranged from $234-$604. In Asia and Australia, the cost of operating rooms (minute) ranged from $4-$12 for open procedures and $4-$13 for laparoscopies. The cost for hospital stay (day) ranged from $159-$406. Conclusions: Asian-Pacific countries have reported lower direct hospital costs. Cost calculations for common surgical procedures like colectomy are challenging due to different costing methodologies and categories. A standardized costing methodology guideline is warranted and may shed light on the future considerations of reimbursement strategy. PGI10 COSTS AND OUTCOMES OF TREATING HCV PATIENTS IN KAZAKHSTAN HEALTH CARE SYSTEM Almadiyeva A 1, Ibrayev S 1, Kostyuk A 2 Medical University, Astana, Kazakhstan, 2KazAHTA, Astana, Kazakhstan .
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Objectives: Viral hepatitis is a major public health problem affecting millions of people worldwide. Long-term consequences are the development of liver cirrhosis and hepatocellular carcinoma. The aim of the study was to assess outcomes and costs of treating patients with HCV in clinical practice in Kazakhstan. Methods: We carried out a prospective noninterventional study. Information on treatment outcomes and resource utilization was provided from physicians throughout Kazakhstan. The EQ-5D Health Survey was administered for evaluation healthrelated quality of life. Consecutive unselected Kazakh patients with HCV completed the EQ-5D questionnaire before, during and after treatment with pegylated interferon and ribavirin before, during and after combination therapy. Data of 3708 monoinfected HCV-patients treated between 2011 and 2014 were analysed. Therapy consisted of peginterferon/ribavirin. Mean age of patients was 44.1 years, 59.8% were male and estimated duration of infection was 10.4 years. Predominantly genotype 1 (67.7%) or 3 (22.3%) infections were observed. Results: Sustained viral response (SVR)-rates in most frequently observed genotypes were 49.2% in GT-1 and 61.9% in GT-3 treatment-naive patients (Relapser: GT-1: 35.3% and GT-3: 57.3%; Nonresponder: GT-1: 25.0% and GT-3: 33.3%). Average treatment costs were lowest in treatment-naive patients (€ 19 762) and higher in patients who failed previous treatments (relapsers: € 25 233; nonresponders: € 20 158). Average costs per SVR in treatment-naive patients were € 46 447 for GT-1 and € 23 182 for GT-3. Treatment was associated with a decrease in quality of life; post-treatment quality of life was higher in patients achieving SVR. Conclusions: Our study on real-life treatment outcomes and costs can serve as a reference for a comparison with other treatments. There is high need for short-term and long-term cost-effectiveness analysis in real-life settings as newly introduced treatment strategies with direct acting antivirals result in high SVR-rates but are more costly. PGI11 ULCERATIVE COLITIS TREATMENT PATTERNS AND COST OF CARE Null K D 1, Xu Y 1, Pasquale M K 1, Su C 2, Marren A 2, Harnett J 3, Mardekian J 3, Manuchehri A 4, Healey P 5 1Comprehensive Health Insights, Humana, Louisville, KY, USA, 2Pfizer Inc., Collegeville, PA, USA, 3Pfizer Inc., New York, NY, USA, 4Pfizer Inc., Tadworth, UK, 5Pfizer Inc., Groton, CT, USA .
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Objectives: To examine treatment patterns, dosing, and cost of the tumor necrosis factor inhibitors (TNFi), adalimumab (ADA) and infliximab (IFX), among US Humana Commercial and Medicare members diagnosed with ulcerative colitis (UC). Methods: This retrospective cohort study identified the first pharmacy prescription or medical claim for ADA or IFX (July 1, 2007-December 31, 2013) in fully-insured members with continuous enrollment for ≥ 6 months pre- and ≥ 12 months post-index, with at least one UC diagnosis claim 6-months pre- and postindex. Members were excluded if they received a biologic for UC during 6-months pre-index, or two diagnoses ≥ 30 days apart of ankylosing spondylitis, Crohn’s disease, plaque psoriasis, or rheumatoid arthritis during 6-months pre- or postindex. TNFi discontinuation was defined as a therapy gap ≥ 56 days for ADA and ≥ 112 days for IFX. TNFi therapy switch was defined as initiation of non-index TNFi therapy. Results: The study population comprised 295 UC patients: mean age 50.9, 51% female, and 62% located in the Southern US. 50 (17%) patients received ADA treatment and 245 (83%) received IFX, at index. Treatment discontinuation was observed in 26 (52%) ADA and 111 (45%) IFX patients during the 12-months postindex, with respective mean times to discontinuation of 19 and 22 weeks. 12 (46%) ADA and 76 (68%) IFX patients did not restart or switch to another TNFi therapy. Similar rates of therapy switching were observed between ADA- and IFX-treated patients, with respective mean times to switch of 18 and 30 weeks. At 12-months post-index, mean TNFi medication cost represented $25,193 out of $41,618 mean total UC-related healthcare cost. Conclusions: Approximately half of ADA and IFX patients discontinued therapy, with approximately half of ADA and the majority of IFX patients not restarting or switching therapies. Further investigation of patient treatment patterns and outcomes following TNFi therapy discontinuation is required. PGI12 COST BURDEN OF INAPPROPRIATE PROTON-PUMP INHIBITOR USE AMONG GASTROESOPHAGEAL REFLUX DISEASE PATIENTS Rane P 1, Guha S 2, Garey K 1, Chen H 1, Johnson M L 1, Aparasu R 1 1University of Houston, Houston, TX, USA, 2University of Texas Health Science Center, Houston, TX, USA .
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Objectives: Proton Pump Inhibitors (PPIs) are widely used in the US and are often used for extended periods despite treatment guidelines recommending PPIs for short term use. The study examined the total healthcare costs for short term and long term PPI users among patients with Gastroesophageal reflux disease (GERD). Methods: A retrospective longitudinal analysis was conducted involving the 2003-2004 Truven MarketScan database. The study focused on adults aged ≥ 18
years of age who were diagnosed with GERD and initiated PPI treatment from July 2003 to September 2004. The persistence of PPI was defined as number of days to discontinuation of index PPI treatment without a gap of 30 or more days. Persistent PPI use for ≤ 8 weeks was classified as short term user and for > 8 weeks was classified as a long term PPI user. Descriptive statistics were performed to characterize the study population. Generalized linear models were used to analyze the cost difference and bootstrapping analysis was conducted to compute the 95% Confidence Interval (CI) as per percentile method. A statistical significance level of 0.05 was used in the study. SAS 9.3 software was used for statistical analysis. Results: The study population consisted of 75,503 patients with a GERD indication and incident PPI use. Majority of the patients were females (58.2%) and mean age of the cohort was 47.8 years. On an average, long term PPI users had higher all cause total costs [$53,196 (95% CI: $1,942 - $140,441)] as compared to short term PPI users. The difference in total costs was mainly attributed to prescription costs and medical costs. Conclusions: For efficacy, safety and cost considerations, PPIs should be used for the recommended duration among GERD patients to avoid unnecessary healthcare burden. PGI13 HEALTH CARE RESOURCE UTILIZATION AND MEDICAL CARE COST OF INGUINAL HERNIA REPAIR IN CHINA Ma Y 1, Wu J 2, Zhang Y 2, Jia Y 3 1Beijing University of Chinese Medicine, Beijing, China, 2Beijing Brainpower Pharma Consulting Co. Ltd, Beijing, China, 3Johnson & Johnson Medical Device, Shanghai, China .
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Objectives: To evaluate the healthcare resource utilization and direct costs of inguinal hernia repair by real world data. Methods: This retrospective study based on the Chinese Basic Medical Insurance system in 2013. Target patients diagnosed with inguinal hernia and underwent inguinal hernia repair surgery were selected. Information of patient demographic characters, city tier, hospital tier, type of operation and cost were collected for the analysis. Descriptive statistics were used to describe patient demographic characters, healthcare resource utilization and direct medical cost. Direct medical cost include diagnostic tests, anesthesia, surgery, medical devices, drug and administration cost. Generalized linear regression model (GLM) was used to identify influence factors on the direct cost. Results: Total 6,482 patients (74% adult; 86% male; mean age 44±27, 95% CI 1-82) were included. Mean (±SD) cost amounted to 8,121(±4,555; 95% CI 2,314-18,498) RMB, with 77.6% for operation related cost, 22.4% for drug. Factors significantly impacting inpatient cost were age, type of hernia (unilateral vs. bilateral), hospital tier, type of operation (open-mesh vs. laparoscopic), mesh using, type of insurance, gender (GLM, p< 0.05). There were considerable differences of costs in these dimensions: age (adults 9,563 RMB vs. children 4,924 RMB), type of hernia (bilateral 10,284 RMB vs. unilateral 7,875 RMB), hospital tier (tier III 9,050 RMB, tier II 6,755 RMB and tier I 4,777 RMB), types of inpatient wards (Intra day ward 5,977 RMB vs. hospitalized ward 8,265RMB). Conclusions: The observed hospital cost for inguinal hernia repair was varied: a number of factors especially age, type of hernia and hospital tier had significant influence on inpatient cost. These influencing factors should be considered in policy making. Treatment in intra day ward showed more advantage than inpatient ward. PGI14 TREATMENT OF CHRONIC HEPATITIS C VIRUS GENOTYPE 1 INFECTION: COMPARISON OF HEALTH-ECONOMIC OUTCOMES FOR NAÏVE PATIENTS Vitezic D 1, Mance D 2, Mance D 3, Vitezic M 4, Mrsic Pelcic J 5 1University of Rijeka, School of Medicine and University Hospital Centre Rijeka, Rijeka, Croatia, 2University of Rijeka, Rijeka, Croatia, 3University of Rijeka, Faculty of Economics, Rijeka, Croatia, 4University Orthopaedic Clinic Lovran and University of Rijeka Medical School, Lovran, Croatia, 5University of Rijeka Medical School, Rijeka, Croatia .
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Objectives: During the past couple of years very effective direct acting antiviral (DAA) therapies for treating hepatitis C virus (HCV) infection appeared on the market. Beside high efficacy, these therapies are also designated by high prices in comparison to the therapy with pegylated interferon (pegIFN). The objective of presented work was to compare the cost-effectiveness of the therapies for HCV genotype 1 (GT1) naïve patients currently available on Croatian market. Methods: Costs of therapies were calculated according to publicly available medication pricing list and information found in Summary of Product Characteristics (SmPC) documents. The main health-economic outcome was defined as cost per cure i.e. therapy cost per achieved sustained viral response (SVR). Final parameters were estimated by Monte Carlo simulations. ANOVA and Tukey post-hoc test were used to test differences between mean therapies’ costs per SVR. Results: Currently on the Croatian market, there are five different treatments of HCV GT1 naïve patients. Those therapies are therapies with pegIFN that have SVR rates 30-55% as well as DAAs therapies with SVR range 60-100 % for naïve HCV GT1 patients. There is statistically significant difference (p < 0.001) among average treatment costs per SVR of the therapies and those are as low as € 14,800 for pegIFN and for new therapies reach € 79,600 in case of patients without cirrhosis. For cirrhotic patients prices are in range from € 23,400 for pegIFN, up to € 91,500 for DAA therapies. Conclusions: Due to the low costs per achieved SVR we can expect that in future there will still remain certain portion of naïve HCV GT1 patients who will receive pegIFN therapy. “Pay per cure” policy in which pharmaceutical company is not being paid for the drugs in cases in which patient does not achieve SVR, seems to be good solution for health providers and appropriate answer to high prices of the new therapies. PGI15 ECONOMIC IMPLICATIONS OF BUDESONIDE MMX® ADVANTAGE IN ULCERATIVE COLITIS TREATMENT OVER SYSTEMIC STEROIDS: BUDESONIDE MMX® DECREASES ULCERATIVE COLITIS TREATMENT COSTS Bierut A 1, Jesionowski M 1, Pruszko C 2, Jachimowicz M 2, Kowalczyk M 2, Książek P 2 Pharmaceuticals Poland, Warsaw, Poland, 2MAHTA Ltd., Warsaw, Poland .
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Objectives: The main objective is to assess the economic implications of replacing standard oral corticosteroid treatment with budesonide MMX® for induction of remission in mild-to-moderate ulcerative colitis (UC). Steroid-associated adverse events (AEs) provoke high treatment costs and generate significant expenditures for the public payer. Budesonide MMX® was found to have favorable safety profile due to lower bioavailability than systemic steroids. According to these findings budesonide MMX allows for even 7-fold reduction in the risk of adverse events. Therefore, its potential to decrease AE related treatment cost requires further investigation. Methods: Electronic databases (Medline, Embase and The Cochrane Library) were systematically searched for clinical trials to compare budesonide MMX® versus other steroids and to assess long-term side effects of steroid use. The economic burden of steroid-related side effects including prevention and treatment costs was evaluated in an economic model. The risk of side effects was fitted proportionally to the cumulative dose of steroids. The costs of adverse events corresponded to the use of all resources being determined by Polish clinical practice as well as Polish and international guidelines for the treatment of all specific AEs. Results: Costs of nine most frequent and cost-intensive serious steroid-related side effects like osteoporosis, glaucoma, cataract, hypertension, type 2 diabetes, myopathy, neuropathy, depression and vein thrombosis were estimated. The cumulative projected 20-year treatment cost of all selected side effects was 2 310 € vs 425 € per patient treated with standard oral corticosteroids and with budesonide MMX®, respectively. The results were robust under sensitivity testing. Conclusions: Treatment of steroid-related side effects constitutes significant long-term cost of medical care. Budesonide MMX® could allow for substantial cost reduction. The favorable safety profile outcomes has delivered strong evidence of budesonide MMX® being costeffective compared with standard steroid therapy for induction of remission in mild-to-moderate UC. PGI16 COST EFFECTIVENESS OF EVEROLIMUS IN COMBINATION WITH REDUCED TACROLIMUS FOR LIVER TRANSPLANT RECIPIENTS Park T 1, Griggs S 1, Horwedel T 2, Hagopian J 2, Bowman L 3 Louis College of Pharmacy, St Louis, MO, USA, 2Barnes-Jewish Hospital, St Louis, MO, USA, 3Tampa General Hospital, Tampa, FL, USA .
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Objectives: Recent trials demonstrate that everolimus (EVR) in combination with reduced tacrolimus (rTAC) significantly improves renal function compared to tacrolimus (TAC) alone in liver transplant recipients. This study aims to conduct a cost-effectiveness analysis of EVR + rTAC for liver transplant recipients. Methods: A Markov model was developed to estimate the costs and quality-adjusted life years (QALYs) for liver transplant recipients who receive EVR + rTAC compared to those who receive TAC alone. We adopted the perspective of the US health care system, including direct costs only. A lifetime horizon was chosen. We derived parameter estimates from clinical studies and published sources. Deterministic and probabilistic sensitivity analyses were conducted to account for uncertainties of key model parameters. Results: Compared to the combination therapy (EVR + rTAC), monotherapy (TAC) resulted in lower lifetime accumulated costs ($390,900 and $874,400) and higher accumulated effectiveness (11.71 QALYs and 11.60 QALYs, respectively). Sensitivity analyses suggested that the main drivers of our model included the probability of dialysis after end stage renal disease and rates of transitions between different chronic kidney disease stages. Varying these parameters yielded an incremental cost-effectiveness ratio (ICER) ranging from $176,200 to $2,687,600 per QALY gained indicating TAC was still considered cost-effective given a willingness-to-pay threshold conventionally accepted. Conclusions: The combination therapy (EVR + rTAC) is not likely to be cost-effective for liver transplant recipients primarily because of substantial cost differences between EVR and TAC. Future research is warranted to investigate the cost-effectiveness of the combination therapy after generic EVR becomes available. PGI17 THE COST EFFECTIVENESS OF NOVEL HEPATITS C THERAPIES: A REVIEW Bickerstaff C Florida A&M University, Tallahassee, FL, USA .
Objectives: In the United States over 3 million individuals are infected with the Hepatitis C Virus (HCV) and 75% to 85% of them have or will develop Chronic Hepatitis C (CHC) which can lead to serious consequences such as liver cirrhosis, cancer, and death. Prior to 2013 the treatment of CHC was Pegylated Interferon + Ribavirin with or without a protease inhibitor such a Boceprevir/Telaprevir. These treatments had a cure rate or rate of sustained virologic response (SVR) of 66% to 80%. Since the close of 2013 several new direct acting agents (DAAs) for the treatment of CHC have been approved by the FDA. These new CHC treatments have cure rates of 80% to 100%; however, their price tags have been a point of great contention and debate with costs ranging from $63,000 to $168,000 per treatment course. The purpose of this review is to identify and analyze the body of cost-effectiveness evidence for new CHC therapies approved by the FDA. Methods: Using electronic databases Pub Med, Ovid Medline, and the University of York Centre for Reviews and Dissemination (CRD) Databases-NHS Economic Evaluation Database as well as a combination of the search terms “costs and cost analysis” OR costs OR cost effective* AND Hepatitis C, studies evaluating the cost-effectiveness of novel CHC treatments were reviewed. Results: The results of this review indicated that while various new DAAs for HCV treatment are cost-effective, cost-effectiveness is highly dependent upon factors including, but not limited to, HCV genotype, liver fibrosis progression, patient treatment history, HIV co-infection, treatment comparators, and willingness to pay thresholds. Conclusions: Informed decision making amongst patients, clinical practitioners, and payers alike requires a robust body of cost-effectiveness literature. Further research which utilizes comprehensive patient characteristics and novel DAA treatment comparators as well as the historical standard of care is necessary in order to facilitate thorough comparison of available treatment alternatives.
PGI18 PHARMACOECONOMIC ASSESSMENT OF QUADROTHERAPY WITH ORIGINAL BISMUTH SUBCITRATE DRUG VERSUS QUADROTHERAPY WITH GENERIC DRUG IN PATIENTS WITH PEPTIC ULCER ASSOCIATED WITH HELICOBACTER PYLORI IN UKRAINE Iakovlieva L , Gerasymova O , Mishchenko O , Bezditko N , Tkachova O , Kyrychenko O , Matyashova N National University of Pharmacy, Kharkiv, Ukraine .
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Objectives: Quadrotherapy including drugs of colloidal bismuth (bismuth preparation, a proton pump and two antibiotics) is replacement for standard triple antihelicobacter therapy (AHT) and contributes to a significant decrease in H. pylori resistance to antibiotics. Adding bismuth subcitrate preparation increases considerably AHT cost, which in turn reduces the economic availability of treatment to the patient. This is especially important for Ukrainian patients since they are main payers. Given this, the use of generic cheaper bismuth subcitrate drug has an actual task. The aim - pharmacoeconomic grounding the benefits of using of quadrotherapy with bismuth subcitrate generic drug (QTGB) versus quadrotherapy with bismuth subcitrate original drug (QTOB). Methods: Cost-effectiveness analysis of the two schemes QTOB and QTGB according to clinical research: G. D. Fadyeyenko, E. V. Kolesnikov. Place bismuth subcitrate in the treatment of patients with peptic ulcer disease, associated with Helicobacter pylori (Modern gastroenterology, 2015, №1 (81), p.37-43), was carried out. Onevariate sensitivity analysis of the results to changes in price of drugs was carried out. On 21.11.14 the currency ratio of UAH to € was 20.04:1. Results: Quadrotherapy with generic drug of bismuth subcitrate has a lower cost of treatment 19.84 € vs. 29.06 € and is less effective among the investigated schemes (90% of patients with H. pylori eradication vs. 96.7%, p < 0,05) and more cost effective (CER = 22.04 € per 1 patient with H. pylori eradication vs. 30.05 € ). The costs of an additional unit of effectiveness in the transition to a more effective QTOB are 119.55 € . Conclusions: In the context of the Ukrainian pharmaceutical market realities QTGB in patients with peptic ulser, associated with H. pylori, is more cost effective compared to QTOB, but less clinically effective. The sensitivity analysis showed, that the 36.3% decrease in the price of the original drug of bismuth subcitrate quadrotherapy with it would be dominant. PGI19 CONVERSION FROM LAPAROSCOPIC TO OPEN SURGICAL APPROACH IN LEFTHEMICOLECTOMY AND SIGMOIDECTOMY: RISK FACTORS AND IMPACT ON RESOURCE UTILIZATION Etter K 1, Yoo A 1, Roy S 2, Kalsekar I 1 & Johnson Co., New Brunswick, NJ, USA, 2Johnson and Johnson Global Surgery, Somerville, NJ, USA .
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Objectives: Explore factors associated with conversion from laparoscopic to open approach in left-sided colon resections and analyze differences in hospital cost, length of stay(LOS), and operating room time(ORT) for Lap-Conversion, OpenPlanned and Lap-Successful approaches. Methods: The Premier Perspective® Database containing billing data from ~600 hospitals in the U.S. was analyzed. All patients undergoing left-hemicolectomy or sigmoidectomy from 2009-2014 were identified. Lap-Conversion was identified by ICD9-code(V64.41) or when a laparoscopic and open procedure code occurred simultaneously. Lap-Conversion incidence was calculated for all procedures with evidence of a laparoscopic approach (Lap-Attempted). Resource utilization parameters of ORT, LOS, and hospital cost (2014 US-Dollars) were analyzed. For Lap-Attempted procedures, patient, provider, and procedure factors associated with conversion were explored in a multivariable model. Similar models were used on all procedures to evaluate the effect of surgical approach on LOS, ORT, and cost. All statistical analyses accounted for clustering within hospitals; p-values < 0.05 were considered significant. Results: A total of 80,078 patients undergoing left-hemicolectomy(18,279) or sigmoidectomy(61,799) were identified. There were 34,795 Lap-Attempted procedures and the incidence of Lap-Conversion was 16.86%(95%CI[15.90,17.82]). Adjusted mean LOS(SE) for Lap-Conversion was 9.1(0.1) days compared to 6.8(0.1) and 9.2(0.1) for Lap-Successful and Open-Planned, respectively. Adjusted mean cost(SE) followed a similar trend: $24,317($397) for Lap-Conversion, $20,603($284) and $24,317($323) for Lap-Successful and Open-Planned. Adjusted mean ORT(SE) for Lap-Conversion was 244(5.2) minutes compared to 218(4.1) and 194(3.3) for Lap-Successful and Open-Planned. Risk factors associated with Lap-Conversion included: left-hemicolectomy OR= 1.44(95%CI[1.30,1.60]), diverticulitis OR= 1.16(95%CI[1.052,1.28]) and inflammatory bowel disease (IBD) OR= 1.39(95%CI[1.06,1.83]). Robotic-assistance OR= 0.42(95%CI[0.33,0.55]) and elective procedures OR= 0.54(95%CI[0.49,0.60)] were associated with decreased risk. Conclusions: Lap-Conversion resulted in the disappearance of LOS and cost benefits of the laparoscopic approach. Lap-Conversion had longer ORT, but similar LOS and cost compared to Open-Planned approaches. Lap-Conversion and Open-Planned were associated with similar significant increases in LOS and costs compared to Lap-Successful.
GASTROINTESTINAL DISORDERS – Patient-Reported Outcomes & Patient Preference Studies PGI20 SOFOSBUVIR MEMBER COST-SHARING AND UTILIZATION OF SOFOSBUVIR AMONG THE COMMERCIALLY INSURED Karmarkar T 1, Starner C 2, Gleason P 2, Tiberg K 2, Alexander G C 1 Hopkins Bloomberg School of Public Health, Baltimore, MD, USA, 2Prime Therapeutics, Eagan, MN, USA .
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Objectives: New treatments for Hepatitis C offer higher rates of cure with fewer side effects, yet cost approximately $28,000 a month. We aim to examine associations between member cost sharing and initial medication adherence (IMA). Methods: We identified the members’ earliest sofosbuvir claim, between 1/1/2014 and 9/30/2015 and followed their sofosbuvir claims through 3/31/2015 in