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MODELING THE BUDGET IMPACT OF AVAILABILITY OF BIOSIMILARS OF INFLIXIMAB AND ADALIMUMAB FOR TREATMENT FOR RHEUMATOID ARTHRITIS USING PUBLISHED CLAIM-BASED ALGORITHM DATA IN THE UNITED STATES
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the study. Cox regression models were used to determine associations between sUA and AMI’s. Results: 54,421 patients with 311,568.7 person-years of follow-up were included in the study. The average age was 58.3 years and 70% were male. During follow-up 1387 AMI’s occurred. A nonlinear relationship existed between sUA and AMI (best described by a squared sUA function). The unadjusted rate of AMI increased from 3.9 per 1000 person-years at sUA between 5-6 mg/dL to 25.6 per 1000 person-years at sUA between 14-22 mg/dL. With the multivariable Cox model, using sUA of 6 mg/dL as the reference, the hazard ratio (HR) for a sUA of 7.0 mg/ dL was 1.042 (95% CI, 1.035-1.050) and for a sUA of 11.0 mg/dL was 1.312 (95% CI, 1.252-1.374). Conclusions: In this population, elevated sUA was associated with an increased risk of AMI. The relationship was nonlinear and remained significant after controlling for confounders. PMS19 Readmission Due to Infection Following Total Hip and Total Knee Procedures Shi L1, Wang Y1, Shao H1, Liu E2, Song C3, Schoonmaker M3 1Tulane University, New Orleans, LA, USA, 2Intuitive Surgical, Sunnyvale, CA, USA, 3CEPHEID, Sunnyvale, LA, USA
Objectives: Policymakers have expanded readmissions penalties to include elective arthroplasties, but little is known about the risk factors for readmissions following these procedures. We hypothesized that infections after total hip and total knee ((TH/TK) arthroplasty can lead to readmissions and drive up the costs. This study aims to evaluate the proportion of readmissions due to infections following TH/TK arthroplasties. Methods: Healthcare Cost and Utilization Project- State Inpatient Databases (HCUP-SID) were used for our study. Procedure code ‘8151’ and ‘8154’ were used to identify all inpatient discharges with total hip arthroplasty and total knee arthroplasty in Florida from 2009 to 2013, Massachusetts from 2010 to 2012, California from 2009 to 2011. Readmission was measured by CMS validated algorithm which included readmitting to any acute care hospital, for any reason, with the exception of certain planned readmissions, occurring within 30 days of the discharge date of the index hospitalization. Infections were identified by ICD-9-CM codes : 99859, 99666, 6826, 0389, 486, 4821, 00845, 5990, 48242, 04111, 04112,04119,0417, 99591, 99592. Descriptive analysis were performed. Results: In California, among patients discharged for TH/TK arthroplasty during 2009 to 2011, 4.29% were readmitted, and 33.02% of the readmissions were for infection. While in Florida during the period of 2009 to 2013, 4.7% were readmitted and 33.39% of the readmissions were for infection. In Massachusetts from 2010 to 2012, the readmission rate was 3.92%, and infection among readmission was 35.2%. Of those readmissions due to infection, MRSA and MSSA together are specifically account for 14.88% in California, 13.11% in Massachusetts and 13.38% in Florida. Conclusions: The rate of infection is similar across the state of California, Florida and Massachusetts, and it is a leading cause for readmission following THTK procedures. Programs to reduce the likelihood of MRSA or MSSA infection following THTK procedures would likely reduce readmissions due to infection. PMS20 Predictors of Early Mortality in Patients with Second Hip Fracture Juhász K1, Molics B2, Boncz I3, Sebestyén A1 Health Insurance Fund Administration, Pécs, Hungary, 2University of Pécs, Pécs, Hungary, 3University of Pécs, Pécs, Hungary
1National
Objectives: Patients with second hip fractures are at increased risk of death. The aim of the study was to identify the predictors for early mortality in elderly patients suffered from second hip fracture. Methods: Patients aged 60 years and over treated with primary femoral neck fractures in the year 2000 were and suffered from contralateral hip fractures between 01 January 2000 and 31 December 2008 were selected from the database of the Hungarian National Health Insurance Fund. Patients’ data including age, gender, comorbidities, location of second hip fracture, type of surgical intervention, and local complication after second hip fracture were studied. Predictors for 30-day mortality were evaluated by multivariate Cox proportional hazard model and logistic regression analysis. Results: 312 patients were met the criteria. The 30-day mortality rate was 8.3%. Cox regression identified pertrochanteric fracture (pertrochanteric fracture vs. femoral neck fracture, HR: 4.85, p= 0.001, CI: 1.89-12.44), and absence of surgery (absence of surgery vs. osteosynthesis, HR: 6.39, p= 0.034, CI: 1.15-35.46) as risk factor for early mortality. Logistic regression analysis also showed significantly higher risk of patients with pertrochanteric fracture (pertrochanteric fracture vs. femoral neck fracture, HR: 4.71, p= 0.002, CI: 1.75-12.68) and having no surgery after the second hip fracture (absence of surgery vs. osteosynthesis, HR: 7.67, p= 0.030, CI: 1.22-48.07). Conclusions: Pertrochanteric fracture and absence of surgery were associated with higher 30-day mortality in elderly patients. The higher risk of early mortality in patients with pertrochanteric fracture could be explained by better blood supply, and higher risk for hemorrhage of this region. Further analyses are needed to identify the exact role of the other risk factors in deaths after second hip fracture. Effective prevention strategies could reduce mortality after hip fracture. PMS21 The Persistence of Golimumab in Daily Clinical Practice for the Treatment of Rheumatoid Arthritis, Ankylosing Spondylitis, and Psoriatic Arthritis: Analysis of Prospectively Collected Data in the Slovenian National Online Registry of Patients Treated with Biologics Biorx Si, Rotar Z, Tomsic M University Medical Centre Ljubljana, Ljubljana, Slovenia
Objectives: To assess long-term persistence of golimumab in patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic spondyloarthritis (PsA) in daily clinical practice. Methods: We retrospectively analyzed prospectively collected data of all patients treated with golimumab during 2010–2015 from the mandatory Slovenian national BioRx.si registry. The Kaplan-Meier method was
used to estimate the persistence of treatment overall and comparatively between biologics naïve patients and switchers from other biologics. Results: Threehundred-one (103 RA, 122 AS, 76 PsA) patients were followed for 515 patient-years (median 1.24 (IQR 0.5–2.7) years). The proportions of females in RA/AS/PsA groups were 76%/37%/51%. Median ages at golimumab initiation and times from diagnosis to golimumab treatment in RA/AS/PsA groups were 59/49/44 and 6.8/4.8/8.0 years, respectively. Golimumab was the first biologic in 79%/67%/70% of patients with RA/AS/PsA. Amongst RA patients 73%/74% were RF/ACPA positive and 86% of AS patients HLA-B27 positive. The proportions of RA/PsA patients who were on concomitant conventional DMARDs (glucocorticoids) at baseline were 85% (36%)/72% (8%). At the initiation of golimumab mean PromisHAQ was 40/31/39 in RA/AS/PsA; mean DAS28 5.6/5.0 in RA/PsA; mean BASDAI 5.9 in AS group(s). Among patients with measured disease activity at 6 (12) months 47% (59%)/77% (64%) of RA/PsA patients achieved DAS28< 3.2 and 54% (54%) of AS patients achieved at least 2.0 reduction of BASDAI. The proportions of RA/AS/PsA patients discontinuing golimumab treatment overall were 42%/23%/37%. Reasons for discontinuation were ineffectiveness in 68%/89%/71% in RA/AS/PsA. The unadjusted persistence of golimumab treatment for RA/AS/PsA at 6, 12, 24 months was 97%, 82%, 65%/96%, 91%, 73%/97%, 83%, 57%, respectively and did not differ significantly between biologics-naïve patients and switchers. Conclusions: In Slovenia, the persistence of golimumab after 2 years of treatment was 65%/73%/57% in RA/AS/PsA groups. Switcher status seems not to affect the persistence of golimumab regardless of indication.
MUSCULAR-SKELETAL DISORDERS – Cost Studies PMS22 MODELING THE BUDGET IMPACT OF AVAILABILITY OF BIOSIMILARS OF INFLIXIMAB AND ADALIMUMAB FOR TREATMENT FOR RHEUMATOID ARTHRITIS USING PUBLISHED CLAIM-BASED ALGORITHM DATA IN THE UNITED STATES Shah A , Mwamburi M Market Access Solutions LLC, Raritan, NJ, USA .
.
Objectives: FDA is reviewing biosimilars as first-line treatment of moderateto-severe rheumatoid arthritis (RA) patients. We estimated the budget impact of availability of biosimilars of infliximab and adalimumab in the market by assessing the influence of differences in price, effectiveness, and market share between the original biologics and respective biosimilars. Methods: We simulated preand post-biosimilar scenarios to assess the impact of biosimilars on the cost per effectively treated patients with RA using a claims-based effectiveness algorithm. For pre-biosimilar scenario, we utilized data from a cohort of patients with RA aged 18-63 years in the IMS PharMetrics Plus database that assessed coverage of biologics including adalimumab, etanercept, golimumab, abatacept and infliximab. For the post-biosimilar basecase scenario, biosimilars of infliximab and adalimumab were included in the analysis for the same patient cohort assuming biosimilars’ market share and price discount at 30% and 25% respectively and no effectiveness deviation with respect to reference biologics. We estimated the impact on annual treatment costs and annual cost of treating a RA patient effectively. Effectiveness was defined based on adherence, medication switching, dose escalation, and treatment modifications in the algorithm. Results: The introduction of biosimilars resulted in an annual cost saving of $6.1 million per 10,000 insured patients. The annual treatment cost per effectively treated patient reduced by 3.5% from $60,660 (pre-biosimilar) to $58,520 (post-biosimilar) for the basecase. One-way sensitivity analyses revealed the budget impact to be affected more by changes in market share and in price discounts of biosimilars, but less so by deviations in effectiveness. Conclusions: Budget impact of biosimilars will likely be driven by factors influencing market share growth, the cumulative price discounts achievable, and the rates of acceptance and adaptation of biosimilars by prescribers and patients. Each of these represents unique challenges for the various stakeholders. PMS23 BUDGET IMPACT ANALYSIS OF THE INCLUSION OF TOFACITINIB AS AN ALTERNATIVE FOR RHEUMATOID ARTHRITIS TREATMENT AFTER CONVENTIONAL DMARDS FAILURE IN CHILE Gutierrez-Ardila M V Pfizer Chile S.A., Santiago, Chile .
.
Objectives: Rheumatoid Arthritis (RA) is a chronic inflammatory disease that can lead to functional disability of patients; the use of biologic therapies in Chile is limited by the cost. Tofacitinib is an oral JAK inhibitor for RA treatment. The aim of this work is to estimate the budget impact of the inclusion of tofacitinib for RA treatment as 1stline after conventional Disease Modifying Antirheumatic Drugs (DMARDs) failure in Chile. Methods: An economic model was used to model the population covered by the Ministerial pilot program for RA (n= 110 patients) as baseline scenario, the expansion of the pilot (n= 300) by year-1 and assumed that with High-Cost Medication Fund the number of patients from pilot would be doubled by year-2 (n= 600). Comparison were made among the four biological therapies approved in pilot (abatacept (125mg/week), adalimumab (40mg/ q2weeks), etanercept (50mg/week), tocilizumab (162mg/week)) to a scenario that included tofacitinib (5mg twice/day) as an alternative. Only direct costs related to drugs were considered, prices were obtained from public tenders, using the lowest price identified. Market share was calculated based on observed behavior in tenders. It was assumed a gradual increase in market share for tofacitinib, from 12% (year-1) to 17% (year-2). A discount rate of 3% was used. Results are expressed in 2015USD (US$1= CLP$700). Results: Average annual cost-per-patient is lowest with tofacitinib (US$7,154) and highest with tocilizumab (US$10,733). For the target population for year-1 (n= 300) expected cost is US$2,692,737 without tofacitinib and US$2,601,281 with tofacitinib (Savings= US$91,456). Increasing the use of tofacitinib
VA L U E I N H E A LT H 1 9 ( 2 0 1 6 ) A 1 - A 3 1 8
the study. Cox regression models were used to determine associations between sUA and AMI’s. Results: 54,421 patients with 311,568.7 person-years of follow-up were included in the study. The average age was 58.3 years and 70% were male. During follow-up 1387 AMI’s occurred. A nonlinear relationship existed between sUA and AMI (best described by a squared sUA function). The unadjusted rate of AMI increased from 3.9 per 1000 person-years at sUA between 5-6 mg/dL to 25.6 per 1000 person-years at sUA between 14-22 mg/dL. With the multivariable Cox model, using sUA of 6 mg/dL as the reference, the hazard ratio (HR) for a sUA of 7.0 mg/ dL was 1.042 (95% CI, 1.035-1.050) and for a sUA of 11.0 mg/dL was 1.312 (95% CI, 1.252-1.374). Conclusions: In this population, elevated sUA was associated with an increased risk of AMI. The relationship was nonlinear and remained significant after controlling for confounders. PMS19 Readmission Due to Infection Following Total Hip and Total Knee Procedures Shi L1, Wang Y1, Shao H1, Liu E2, Song C3, Schoonmaker M3 1Tulane University, New Orleans, LA, USA, 2Intuitive Surgical, Sunnyvale, CA, USA, 3CEPHEID, Sunnyvale, LA, USA
Objectives: Policymakers have expanded readmissions penalties to include elective arthroplasties, but little is known about the risk factors for readmissions following these procedures. We hypothesized that infections after total hip and total knee ((TH/TK) arthroplasty can lead to readmissions and drive up the costs. This study aims to evaluate the proportion of readmissions due to infections following TH/TK arthroplasties. Methods: Healthcare Cost and Utilization Project- State Inpatient Databases (HCUP-SID) were used for our study. Procedure code ‘8151’ and ‘8154’ were used to identify all inpatient discharges with total hip arthroplasty and total knee arthroplasty in Florida from 2009 to 2013, Massachusetts from 2010 to 2012, California from 2009 to 2011. Readmission was measured by CMS validated algorithm which included readmitting to any acute care hospital, for any reason, with the exception of certain planned readmissions, occurring within 30 days of the discharge date of the index hospitalization. Infections were identified by ICD-9-CM codes : 99859, 99666, 6826, 0389, 486, 4821, 00845, 5990, 48242, 04111, 04112,04119,0417, 99591, 99592. Descriptive analysis were performed. Results: In California, among patients discharged for TH/TK arthroplasty during 2009 to 2011, 4.29% were readmitted, and 33.02% of the readmissions were for infection. While in Florida during the period of 2009 to 2013, 4.7% were readmitted and 33.39% of the readmissions were for infection. In Massachusetts from 2010 to 2012, the readmission rate was 3.92%, and infection among readmission was 35.2%. Of those readmissions due to infection, MRSA and MSSA together are specifically account for 14.88% in California, 13.11% in Massachusetts and 13.38% in Florida. Conclusions: The rate of infection is similar across the state of California, Florida and Massachusetts, and it is a leading cause for readmission following THTK procedures. Programs to reduce the likelihood of MRSA or MSSA infection following THTK procedures would likely reduce readmissions due to infection. PMS20 Predictors of Early Mortality in Patients with Second Hip Fracture Juhász K1, Molics B2, Boncz I3, Sebestyén A1 Health Insurance Fund Administration, Pécs, Hungary, 2University of Pécs, Pécs, Hungary, 3University of Pécs, Pécs, Hungary
1National
Objectives: Patients with second hip fractures are at increased risk of death. The aim of the study was to identify the predictors for early mortality in elderly patients suffered from second hip fracture. Methods: Patients aged 60 years and over treated with primary femoral neck fractures in the year 2000 were and suffered from contralateral hip fractures between 01 January 2000 and 31 December 2008 were selected from the database of the Hungarian National Health Insurance Fund. Patients’ data including age, gender, comorbidities, location of second hip fracture, type of surgical intervention, and local complication after second hip fracture were studied. Predictors for 30-day mortality were evaluated by multivariate Cox proportional hazard model and logistic regression analysis. Results: 312 patients were met the criteria. The 30-day mortality rate was 8.3%. Cox regression identified pertrochanteric fracture (pertrochanteric fracture vs. femoral neck fracture, HR: 4.85, p= 0.001, CI: 1.89-12.44), and absence of surgery (absence of surgery vs. osteosynthesis, HR: 6.39, p= 0.034, CI: 1.15-35.46) as risk factor for early mortality. Logistic regression analysis also showed significantly higher risk of patients with pertrochanteric fracture (pertrochanteric fracture vs. femoral neck fracture, HR: 4.71, p= 0.002, CI: 1.75-12.68) and having no surgery after the second hip fracture (absence of surgery vs. osteosynthesis, HR: 7.67, p= 0.030, CI: 1.22-48.07). Conclusions: Pertrochanteric fracture and absence of surgery were associated with higher 30-day mortality in elderly patients. The higher risk of early mortality in patients with pertrochanteric fracture could be explained by better blood supply, and higher risk for hemorrhage of this region. Further analyses are needed to identify the exact role of the other risk factors in deaths after second hip fracture. Effective prevention strategies could reduce mortality after hip fracture. PMS21 The Persistence of Golimumab in Daily Clinical Practice for the Treatment of Rheumatoid Arthritis, Ankylosing Spondylitis, and Psoriatic Arthritis: Analysis of Prospectively Collected Data in the Slovenian National Online Registry of Patients Treated with Biologics Biorx Si, Rotar Z, Tomsic M University Medical Centre Ljubljana, Ljubljana, Slovenia
Objectives: To assess long-term persistence of golimumab in patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic spondyloarthritis (PsA) in daily clinical practice. Methods: We retrospectively analyzed prospectively collected data of all patients treated with golimumab during 2010–2015 from the mandatory Slovenian national BioRx.si registry. The Kaplan-Meier method was
used to estimate the persistence of treatment overall and comparatively between biologics naïve patients and switchers from other biologics. Results: Threehundred-one (103 RA, 122 AS, 76 PsA) patients were followed for 515 patient-years (median 1.24 (IQR 0.5–2.7) years). The proportions of females in RA/AS/PsA groups were 76%/37%/51%. Median ages at golimumab initiation and times from diagnosis to golimumab treatment in RA/AS/PsA groups were 59/49/44 and 6.8/4.8/8.0 years, respectively. Golimumab was the first biologic in 79%/67%/70% of patients with RA/AS/PsA. Amongst RA patients 73%/74% were RF/ACPA positive and 86% of AS patients HLA-B27 positive. The proportions of RA/PsA patients who were on concomitant conventional DMARDs (glucocorticoids) at baseline were 85% (36%)/72% (8%). At the initiation of golimumab mean PromisHAQ was 40/31/39 in RA/AS/PsA; mean DAS28 5.6/5.0 in RA/PsA; mean BASDAI 5.9 in AS group(s). Among patients with measured disease activity at 6 (12) months 47% (59%)/77% (64%) of RA/PsA patients achieved DAS28< 3.2 and 54% (54%) of AS patients achieved at least 2.0 reduction of BASDAI. The proportions of RA/AS/PsA patients discontinuing golimumab treatment overall were 42%/23%/37%. Reasons for discontinuation were ineffectiveness in 68%/89%/71% in RA/AS/PsA. The unadjusted persistence of golimumab treatment for RA/AS/PsA at 6, 12, 24 months was 97%, 82%, 65%/96%, 91%, 73%/97%, 83%, 57%, respectively and did not differ significantly between biologics-naïve patients and switchers. Conclusions: In Slovenia, the persistence of golimumab after 2 years of treatment was 65%/73%/57% in RA/AS/PsA groups. Switcher status seems not to affect the persistence of golimumab regardless of indication.
MUSCULAR-SKELETAL DISORDERS – Cost Studies PMS22 MODELING THE BUDGET IMPACT OF AVAILABILITY OF BIOSIMILARS OF INFLIXIMAB AND ADALIMUMAB FOR TREATMENT FOR RHEUMATOID ARTHRITIS USING PUBLISHED CLAIM-BASED ALGORITHM DATA IN THE UNITED STATES Shah A , Mwamburi M Market Access Solutions LLC, Raritan, NJ, USA .
.
Objectives: FDA is reviewing biosimilars as first-line treatment of moderateto-severe rheumatoid arthritis (RA) patients. We estimated the budget impact of availability of biosimilars of infliximab and adalimumab in the market by assessing the influence of differences in price, effectiveness, and market share between the original biologics and respective biosimilars. Methods: We simulated preand post-biosimilar scenarios to assess the impact of biosimilars on the cost per effectively treated patients with RA using a claims-based effectiveness algorithm. For pre-biosimilar scenario, we utilized data from a cohort of patients with RA aged 18-63 years in the IMS PharMetrics Plus database that assessed coverage of biologics including adalimumab, etanercept, golimumab, abatacept and infliximab. For the post-biosimilar basecase scenario, biosimilars of infliximab and adalimumab were included in the analysis for the same patient cohort assuming biosimilars’ market share and price discount at 30% and 25% respectively and no effectiveness deviation with respect to reference biologics. We estimated the impact on annual treatment costs and annual cost of treating a RA patient effectively. Effectiveness was defined based on adherence, medication switching, dose escalation, and treatment modifications in the algorithm. Results: The introduction of biosimilars resulted in an annual cost saving of $6.1 million per 10,000 insured patients. The annual treatment cost per effectively treated patient reduced by 3.5% from $60,660 (pre-biosimilar) to $58,520 (post-biosimilar) for the basecase. One-way sensitivity analyses revealed the budget impact to be affected more by changes in market share and in price discounts of biosimilars, but less so by deviations in effectiveness. Conclusions: Budget impact of biosimilars will likely be driven by factors influencing market share growth, the cumulative price discounts achievable, and the rates of acceptance and adaptation of biosimilars by prescribers and patients. Each of these represents unique challenges for the various stakeholders. PMS23 BUDGET IMPACT ANALYSIS OF THE INCLUSION OF TOFACITINIB AS AN ALTERNATIVE FOR RHEUMATOID ARTHRITIS TREATMENT AFTER CONVENTIONAL DMARDS FAILURE IN CHILE Gutierrez-Ardila M V Pfizer Chile S.A., Santiago, Chile .
.
Objectives: Rheumatoid Arthritis (RA) is a chronic inflammatory disease that can lead to functional disability of patients; the use of biologic therapies in Chile is limited by the cost. Tofacitinib is an oral JAK inhibitor for RA treatment. The aim of this work is to estimate the budget impact of the inclusion of tofacitinib for RA treatment as 1stline after conventional Disease Modifying Antirheumatic Drugs (DMARDs) failure in Chile. Methods: An economic model was used to model the population covered by the Ministerial pilot program for RA (n= 110 patients) as baseline scenario, the expansion of the pilot (n= 300) by year-1 and assumed that with High-Cost Medication Fund the number of patients from pilot would be doubled by year-2 (n= 600). Comparison were made among the four biological therapies approved in pilot (abatacept (125mg/week), adalimumab (40mg/ q2weeks), etanercept (50mg/week), tocilizumab (162mg/week)) to a scenario that included tofacitinib (5mg twice/day) as an alternative. Only direct costs related to drugs were considered, prices were obtained from public tenders, using the lowest price identified. Market share was calculated based on observed behavior in tenders. It was assumed a gradual increase in market share for tofacitinib, from 12% (year-1) to 17% (year-2). A discount rate of 3% was used. Results are expressed in 2015USD (US$1= CLP$700). Results: Average annual cost-per-patient is lowest with tofacitinib (US$7,154) and highest with tocilizumab (US$10,733). For the target population for year-1 (n= 300) expected cost is US$2,692,737 without tofacitinib and US$2,601,281 with tofacitinib (Savings= US$91,456). Increasing the use of tofacitinib