- Email: [email protected]
Select Resource Utilization During Advanced Renal Cell Carcinoma Treatment: Comparison Of Targeted Drug Classes
A2
VA L U E I N H E A LT H 1 9 ( 2 0 1 6 ) A 1 - A 3 1 8
CO2 Bayesian Network Meta-Analysis To Assess Comparative Effectiveness of Beta-Blockers In Patients With Heart Failure And Reduced Ejection Fraction
studies are warranted to determine if results are generalizable to overall resource utilization and costs associated with first line treatment options.
Aggarwal S 1, Kumar S 2, Topaloglu H 1 Health Strategies, Chevy Chase, MD, USA, 2Institute for Global Policy Research, Washington, DC, USA
CARDIOVASCULAR OUTCOMES STUDIES
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1NOVEL
Objectives: Several randomized trials have shown that blockade of beta adrenergic receptors leads to symptomatic improvement, reduced hospitalization and enhanced survival in many patients with heart failure (HF) and reduced ejection fraction. The objective of this study was to compare beta blockers for their efficacy in reducing mortality. Methods: A systematic literature search for randomized clinical trials for use of beta blockers in HF was undertaken for the databases Pubmed, Embase, Biosis, Google Scholar and Cochrane. Data was collected for the study type, methods, country and key findings. Extracted study data included study design, patient charatcertristcis and primary outcomes. A bayesian random effects network meta-analysis (NMA) model was developed in WinBUGS14. Results: We identified 830 references and found 21 randomized trials in 23,122 patients with 3,871 events. The treatments included in our study were Enalapril (E), Metoprolol (M), Atenolol (A), Bisoprolol (Bi), Bucindolol (Bu), Carvedilol (C), Metoprolol (M), Nebivolol (N) and placebo (P). All beta-blockers versus placebo were effective in reducing mortailty in HF and reduced ejection fraction patients. Carvedilol ranked the highest with a Surface Under the Cumulative RAnking curve (SUCRA) score of 0.8672, Atenolol was second with score of 0.7035. SUCRA scores for other drugs were: Bisoprolol 0.6897, Metoprolol 0.6139, Nebivolol 0.3704, Bucindolol 0.3519, Enalapriol 0.2635 and Placebo 0.1399. The odds ratios for Carvedilol and Atenolol versus placebo were 0.56 (0.43 – 0.71) and 0.54 (0.15 – 1.87), respectively. Conclusions: Network meta-analysis shows that Carvedilol ranks highest among beta-blockers for reduction in mortality in patients with heart failure and reduced ejection fraction. CO3 Comparative Effectiveness of Panitumumab Versus Cetuximab In Patients With Chemo-Refractory Wild-Type Kras Metastatic Colorectal Cancer Xu Y , Hay J W , Barzi A University of Southern California, Los Angeles, CA, USA .
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Objectives: In the recent head-to-head ASPECCT trial, P and C showed similar effectiveness, though their administration and toxicity are different. This study aims to evaluate the comparative effectiveness of P and C as monotherapy in chemo-refractory mCRC with WT KRAS from a U.S. societal perspective. Methods: A Markov model with three states: stable disease, progressive disease and death was developed. Transition probabilities between states were calculated from the ASPECCT trial report. Costs of drug and administration were based on the Veteran Affairs Federal Supply Schedule and Medicare reimbursement rates for a base case of a 61-year-old male. We used data from literature for toxicities cost and utilities. All costs are 2015 US dollars. The model was constructed using a 1-month cycle length and 3-year time horizon, discounted at an annual rate of 3%. The model used quality-adjusted life-year (QALY) to measure the health outcomes for each treatment option. Results: P produced 9.8 months life-expectancy gain and 0.56 QALYs at the cost of $74,827 per patient. C produced a 9.2 months survival gain and 0.53 QALYs for $79,916 per patient. The incremental net monetary benefit (NMB) of P is $10,168 when compared to C under a societal willingness-to-pay threshold of $150,000 per QALY. The model showed robustness to the one-way sensitivity analysis and various alternative scenarios, and was found to be most sensitive to the cost of C (when cost of C drops from $1,038 to $782 per 100mL vial the NMB would be even). Conclusions: Our results indicate that P can lower the cost of care from societal perspective in chemo-refractory setting. This finding provides a strong argument to use P in lieu of C in these patients. CO4 Select Resource Utilization During Advanced Renal Cell Carcinoma Treatment: Comparison Of Targeted Drug Classes Feinberg B A 1, Garofalo D F 1, Drenning J 2 Health, Dublin, OH, USA, 2Cardinal Health, Dallas, TX, USA .
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1Cardinal
Objectives: Conducting comparative effectiveness research among multiple classes of treatments may inform optimal treatment based on real-world effectiveness. We conducted a retrospective analysis comparing selected resource utilization (emergency room visits and hospitalizations) among six leading treatment options in renal cell carcinoma stratified by drug class and line of therapy. Methods: Using claims data (MORE2 Registry), patients with renal cell carcinoma (ICD9 189.0) who completed a first line treatment (switched to second line regimen or had at least 90 days of no treatment claims) during the study period (July 2014 to June 2015). Line of therapy (LOT) was assigned based on patient’s available treatment history. Analysis was stratified by drug class (mammalian target of rapamycin [MTOR] vs. tyrosine kinase inhibitors [TKI]) and by LOT. Independent samples t-test was performed to compare first line mean treatment duration. Chi-square analysis was performed to compare the frequency of emergency room visit and hospitalization during the first line of therapy. Results: 435 patients met study criteria. Median duration of first line treatment was as follows: TKI: 3.1 mo (n= 360); MTOR: 2.9 mo (n= 75). There was no statistically significant difference in mean duration of first line therapy (p= 0.666). The percent of first line patients with an ER visit during the line of therapy was as follows: TKI: 26% (n= 94); MTOR: 39% (n= 29), a statistically significant difference (p= 0.028). there was no statistically signficant difference in the percent of patients that had hospitalization during their first line treatment; TKI: 15% (n= 54); MTOR: 19% (n= 19%) (p= 0.426). Conclusions: In this study there was a statistically significant difference between leading RCC drug classes in the percent of patients that had an ER visit during their first line treatment. Further
CV1 Comparative Cost And Resource Utilization In Hospitalized Patients Treated With Unfractionated Heparin MonITORED By Anti-XA or APTT Craver C W 1, Belk K 2, Verma K 3 1MedAssets, Inc., Huntersville, NC, USA, 2MedAssets, Mooresville, NC, USA, 3Instrumentation Laboratory, Bedford, MA, USA .
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Objectives: The study aim was to compare cost and resource utilization between patients receiving unfractionated heparin (UFH) monitored with Antifactor Xa (Anti-Xa) and those monitored with activated partial thromboplastin (aPTT). Methods: A retrospective cohort study was conducted on patients diagnosed with acute coronary syndrome (ACS, N= 14,822), ischemic stroke (STK, N= 1,568) or (VTE, N= 4,414) in the MedAssets data from January 2009 to December 2013. Anti-Xa and aPTT cohorts were identified from hospital billing detail records. Propensity score techniques were used to match Anti-Xa cases to aPTT controls. Overall inpatient cost was the primary measure of utilization. Multivariate regression models were used to determine differences in utilization between groups. Results: In the matched sample the average patient age was 66.7 (ACS), 68.0 (STK) and 63.1 (VTE) years. Percent female was 37.2% (ACS), 49.4% (STK), and 52.2% (VTE). The average Charlson index was 3.8 (ACS), 4.7 (STK), and 2.7 (VTE). In post-match unadjusted comparisons the Anti-Xa cohort had significantly lower median cost in each subpopulation (ACS $17,161.96 vs. $21,143.68, p< .0001; STK $17,386.94 vs. $20,841.29, p< .0001; VTE $7,922.62 vs. $8,730.31, p = 0.0022). After controlling for patient age and gender, diagnostic risks (e.g. anemia, renal insufficiency, trauma) and invasive procedures (e.g. cardiac catheterization, hemodialysis, coronary artery bypass graft, red blood cell transfusions), Anti-Xa patients were predicted to have lower hospital costs (ACS RR= 0.83, p= 0.0048; STK RR= 0.9034, p= 0.0007; VTE RR: 0.96, p= 0.0442). Transfusions were the most impactful driver of cost (ACS RR= 1.94, p= 0.0062; STK RR= 1.54, p< 0.0001; VTE RR= 1.56, p< 0.0001). Post hoc analysis indicated Anti-Xa patients were less likely have a transfusion (ACS OR= 0.16, CI= 0.14-0.18; STK OR= 0.41, CI= 0.29-0.57; VTE OR= 0.35, CI= 0.260.48). Conclusions: UFH patients monitored by Anti-Xa have lower hospitalization costs compared to aTTP patients. These differences may be driven by lower transfusion rates in the Anti-Xa sample. CV2 Effectiveness And Safety Of Reduced Dose Non-Vitamin K Antagonist Oral Anticoagulants In Patients Without Severe Renal Impairment Yao X , Shah N D , Sangaralingham L R , Gersh B J Noseworthy PA, Mayo Clinic, Rochester, MN, USA .
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Objectives: The introduction of non-vitamin K antagonist oral anticoagulants (NOACs) has been a major advance for stroke prevention in atrial fibrillation. Because NOACs have significant renal clearance, dose reduction is needed in patients with severe kidney disease. However, some physicians may prescribe reduced-dose NOACs to patients with relatively good renal function due to the concerns over the bleeding risk. We sought to investigate the use and clinical outcomes of reduced-dose NOACs in patients without severe renal impairment. Methods: We performed a retrospective cohort analysis using a large U.S. commercial insurance database, OptumLabs Data Warehouse. We defined a renal indication for dose reduction as: dabigatran users with GFR < 30 mL/min/1.73 m2, rivaroxaban users with GFR < 50 mL/min/1.73 m2, and apixaban users with creatinine ≥ 1.5 mg/dL. Patients receiving reduced- and regular-dose NOACs were matched on socio-demographic characteristics, comorbidities, prior warfarin use and the use of concomitant P-gp and CYP3A4 inhibitors. Cox proportional hazard regression was used to compare the risk of stroke and major bleeding between patients received reduced- and regular-dose NOACs. Results: We identified 12,593 patients with nonvalvular atrial fibrillation who received NOACs but did not have any renal indication for dose adjustment. 12.4% received a reduced dose (dabigatran: 8.2%; rivaroxaban: 14.9%; apixaban: 15.4%). Older patients, females, and patients with higher stroke and bleeding risk at baseline were more likely to receive a reduced dose. In patients receiving dabigatran and apixaban, a reduced dose was associated with an increased risk of stroke (Hazard ratio [HR] 2.64 [1.01-6.89]), but little change in the risk of major bleeding (HR: 1.22 [0.67-2.23]). In patients receiving rivaroxaban, no relationship was observed between doses and the risk of stroke or major bleeding. Conclusions: Reducing dabigatran and apixaban doses in patients without severe renal impairment may be related to reduced effectiveness without any improvement in safety. CV3 How Lipid-Lowering Therapy Impacts Lipid Abnormalities Among ACS Patients In Hong Kong Hospital—A Retrospective Study Lee V W 1, Wang Y 1, Nichol M B 2, Qu L L 1, Cheng T C 1, Yan B P 1 1The Chinese University of Hong Kong, Shatin, Hong Kong, 2University of Southern California, Los Angeles, CA, USA .
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Objectives: To estimate the prevalence of statin therapy in high-risk patients new to Acute Coronary Syndrome (ACS) events, and establish the extent to which these lipid abnormalities were addressed by one-year statin therapy in Hong Kong clinical practice. Methods: The study was a retrospective analysis, conducted using the electronic database from a Hong Kong tertiary referral hospital. Patients (n= 186) who were hospitalized for ACS events during Sep 2009Mar 2010 were identified. Two periods were studied as follows: a pretreatment period, defined as the 6 months before the index hospitalization, and an average follow-up period of 12 months after the index hospitalization. Results: Before
VA L U E I N H E A LT H 1 9 ( 2 0 1 6 ) A 1 - A 3 1 8
CO2 Bayesian Network Meta-Analysis To Assess Comparative Effectiveness of Beta-Blockers In Patients With Heart Failure And Reduced Ejection Fraction
studies are warranted to determine if results are generalizable to overall resource utilization and costs associated with first line treatment options.
Aggarwal S 1, Kumar S 2, Topaloglu H 1 Health Strategies, Chevy Chase, MD, USA, 2Institute for Global Policy Research, Washington, DC, USA
CARDIOVASCULAR OUTCOMES STUDIES
.
.
.
1NOVEL
Objectives: Several randomized trials have shown that blockade of beta adrenergic receptors leads to symptomatic improvement, reduced hospitalization and enhanced survival in many patients with heart failure (HF) and reduced ejection fraction. The objective of this study was to compare beta blockers for their efficacy in reducing mortality. Methods: A systematic literature search for randomized clinical trials for use of beta blockers in HF was undertaken for the databases Pubmed, Embase, Biosis, Google Scholar and Cochrane. Data was collected for the study type, methods, country and key findings. Extracted study data included study design, patient charatcertristcis and primary outcomes. A bayesian random effects network meta-analysis (NMA) model was developed in WinBUGS14. Results: We identified 830 references and found 21 randomized trials in 23,122 patients with 3,871 events. The treatments included in our study were Enalapril (E), Metoprolol (M), Atenolol (A), Bisoprolol (Bi), Bucindolol (Bu), Carvedilol (C), Metoprolol (M), Nebivolol (N) and placebo (P). All beta-blockers versus placebo were effective in reducing mortailty in HF and reduced ejection fraction patients. Carvedilol ranked the highest with a Surface Under the Cumulative RAnking curve (SUCRA) score of 0.8672, Atenolol was second with score of 0.7035. SUCRA scores for other drugs were: Bisoprolol 0.6897, Metoprolol 0.6139, Nebivolol 0.3704, Bucindolol 0.3519, Enalapriol 0.2635 and Placebo 0.1399. The odds ratios for Carvedilol and Atenolol versus placebo were 0.56 (0.43 – 0.71) and 0.54 (0.15 – 1.87), respectively. Conclusions: Network meta-analysis shows that Carvedilol ranks highest among beta-blockers for reduction in mortality in patients with heart failure and reduced ejection fraction. CO3 Comparative Effectiveness of Panitumumab Versus Cetuximab In Patients With Chemo-Refractory Wild-Type Kras Metastatic Colorectal Cancer Xu Y , Hay J W , Barzi A University of Southern California, Los Angeles, CA, USA .
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.
.
Objectives: In the recent head-to-head ASPECCT trial, P and C showed similar effectiveness, though their administration and toxicity are different. This study aims to evaluate the comparative effectiveness of P and C as monotherapy in chemo-refractory mCRC with WT KRAS from a U.S. societal perspective. Methods: A Markov model with three states: stable disease, progressive disease and death was developed. Transition probabilities between states were calculated from the ASPECCT trial report. Costs of drug and administration were based on the Veteran Affairs Federal Supply Schedule and Medicare reimbursement rates for a base case of a 61-year-old male. We used data from literature for toxicities cost and utilities. All costs are 2015 US dollars. The model was constructed using a 1-month cycle length and 3-year time horizon, discounted at an annual rate of 3%. The model used quality-adjusted life-year (QALY) to measure the health outcomes for each treatment option. Results: P produced 9.8 months life-expectancy gain and 0.56 QALYs at the cost of $74,827 per patient. C produced a 9.2 months survival gain and 0.53 QALYs for $79,916 per patient. The incremental net monetary benefit (NMB) of P is $10,168 when compared to C under a societal willingness-to-pay threshold of $150,000 per QALY. The model showed robustness to the one-way sensitivity analysis and various alternative scenarios, and was found to be most sensitive to the cost of C (when cost of C drops from $1,038 to $782 per 100mL vial the NMB would be even). Conclusions: Our results indicate that P can lower the cost of care from societal perspective in chemo-refractory setting. This finding provides a strong argument to use P in lieu of C in these patients. CO4 Select Resource Utilization During Advanced Renal Cell Carcinoma Treatment: Comparison Of Targeted Drug Classes Feinberg B A 1, Garofalo D F 1, Drenning J 2 Health, Dublin, OH, USA, 2Cardinal Health, Dallas, TX, USA .
.
.
.
.
1Cardinal
Objectives: Conducting comparative effectiveness research among multiple classes of treatments may inform optimal treatment based on real-world effectiveness. We conducted a retrospective analysis comparing selected resource utilization (emergency room visits and hospitalizations) among six leading treatment options in renal cell carcinoma stratified by drug class and line of therapy. Methods: Using claims data (MORE2 Registry), patients with renal cell carcinoma (ICD9 189.0) who completed a first line treatment (switched to second line regimen or had at least 90 days of no treatment claims) during the study period (July 2014 to June 2015). Line of therapy (LOT) was assigned based on patient’s available treatment history. Analysis was stratified by drug class (mammalian target of rapamycin [MTOR] vs. tyrosine kinase inhibitors [TKI]) and by LOT. Independent samples t-test was performed to compare first line mean treatment duration. Chi-square analysis was performed to compare the frequency of emergency room visit and hospitalization during the first line of therapy. Results: 435 patients met study criteria. Median duration of first line treatment was as follows: TKI: 3.1 mo (n= 360); MTOR: 2.9 mo (n= 75). There was no statistically significant difference in mean duration of first line therapy (p= 0.666). The percent of first line patients with an ER visit during the line of therapy was as follows: TKI: 26% (n= 94); MTOR: 39% (n= 29), a statistically significant difference (p= 0.028). there was no statistically signficant difference in the percent of patients that had hospitalization during their first line treatment; TKI: 15% (n= 54); MTOR: 19% (n= 19%) (p= 0.426). Conclusions: In this study there was a statistically significant difference between leading RCC drug classes in the percent of patients that had an ER visit during their first line treatment. Further
CV1 Comparative Cost And Resource Utilization In Hospitalized Patients Treated With Unfractionated Heparin MonITORED By Anti-XA or APTT Craver C W 1, Belk K 2, Verma K 3 1MedAssets, Inc., Huntersville, NC, USA, 2MedAssets, Mooresville, NC, USA, 3Instrumentation Laboratory, Bedford, MA, USA .
.
.
.
Objectives: The study aim was to compare cost and resource utilization between patients receiving unfractionated heparin (UFH) monitored with Antifactor Xa (Anti-Xa) and those monitored with activated partial thromboplastin (aPTT). Methods: A retrospective cohort study was conducted on patients diagnosed with acute coronary syndrome (ACS, N= 14,822), ischemic stroke (STK, N= 1,568) or (VTE, N= 4,414) in the MedAssets data from January 2009 to December 2013. Anti-Xa and aPTT cohorts were identified from hospital billing detail records. Propensity score techniques were used to match Anti-Xa cases to aPTT controls. Overall inpatient cost was the primary measure of utilization. Multivariate regression models were used to determine differences in utilization between groups. Results: In the matched sample the average patient age was 66.7 (ACS), 68.0 (STK) and 63.1 (VTE) years. Percent female was 37.2% (ACS), 49.4% (STK), and 52.2% (VTE). The average Charlson index was 3.8 (ACS), 4.7 (STK), and 2.7 (VTE). In post-match unadjusted comparisons the Anti-Xa cohort had significantly lower median cost in each subpopulation (ACS $17,161.96 vs. $21,143.68, p< .0001; STK $17,386.94 vs. $20,841.29, p< .0001; VTE $7,922.62 vs. $8,730.31, p = 0.0022). After controlling for patient age and gender, diagnostic risks (e.g. anemia, renal insufficiency, trauma) and invasive procedures (e.g. cardiac catheterization, hemodialysis, coronary artery bypass graft, red blood cell transfusions), Anti-Xa patients were predicted to have lower hospital costs (ACS RR= 0.83, p= 0.0048; STK RR= 0.9034, p= 0.0007; VTE RR: 0.96, p= 0.0442). Transfusions were the most impactful driver of cost (ACS RR= 1.94, p= 0.0062; STK RR= 1.54, p< 0.0001; VTE RR= 1.56, p< 0.0001). Post hoc analysis indicated Anti-Xa patients were less likely have a transfusion (ACS OR= 0.16, CI= 0.14-0.18; STK OR= 0.41, CI= 0.29-0.57; VTE OR= 0.35, CI= 0.260.48). Conclusions: UFH patients monitored by Anti-Xa have lower hospitalization costs compared to aTTP patients. These differences may be driven by lower transfusion rates in the Anti-Xa sample. CV2 Effectiveness And Safety Of Reduced Dose Non-Vitamin K Antagonist Oral Anticoagulants In Patients Without Severe Renal Impairment Yao X , Shah N D , Sangaralingham L R , Gersh B J Noseworthy PA, Mayo Clinic, Rochester, MN, USA .
.
.
.
.
.
.
Objectives: The introduction of non-vitamin K antagonist oral anticoagulants (NOACs) has been a major advance for stroke prevention in atrial fibrillation. Because NOACs have significant renal clearance, dose reduction is needed in patients with severe kidney disease. However, some physicians may prescribe reduced-dose NOACs to patients with relatively good renal function due to the concerns over the bleeding risk. We sought to investigate the use and clinical outcomes of reduced-dose NOACs in patients without severe renal impairment. Methods: We performed a retrospective cohort analysis using a large U.S. commercial insurance database, OptumLabs Data Warehouse. We defined a renal indication for dose reduction as: dabigatran users with GFR < 30 mL/min/1.73 m2, rivaroxaban users with GFR < 50 mL/min/1.73 m2, and apixaban users with creatinine ≥ 1.5 mg/dL. Patients receiving reduced- and regular-dose NOACs were matched on socio-demographic characteristics, comorbidities, prior warfarin use and the use of concomitant P-gp and CYP3A4 inhibitors. Cox proportional hazard regression was used to compare the risk of stroke and major bleeding between patients received reduced- and regular-dose NOACs. Results: We identified 12,593 patients with nonvalvular atrial fibrillation who received NOACs but did not have any renal indication for dose adjustment. 12.4% received a reduced dose (dabigatran: 8.2%; rivaroxaban: 14.9%; apixaban: 15.4%). Older patients, females, and patients with higher stroke and bleeding risk at baseline were more likely to receive a reduced dose. In patients receiving dabigatran and apixaban, a reduced dose was associated with an increased risk of stroke (Hazard ratio [HR] 2.64 [1.01-6.89]), but little change in the risk of major bleeding (HR: 1.22 [0.67-2.23]). In patients receiving rivaroxaban, no relationship was observed between doses and the risk of stroke or major bleeding. Conclusions: Reducing dabigatran and apixaban doses in patients without severe renal impairment may be related to reduced effectiveness without any improvement in safety. CV3 How Lipid-Lowering Therapy Impacts Lipid Abnormalities Among ACS Patients In Hong Kong Hospital—A Retrospective Study Lee V W 1, Wang Y 1, Nichol M B 2, Qu L L 1, Cheng T C 1, Yan B P 1 1The Chinese University of Hong Kong, Shatin, Hong Kong, 2University of Southern California, Los Angeles, CA, USA .
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Objectives: To estimate the prevalence of statin therapy in high-risk patients new to Acute Coronary Syndrome (ACS) events, and establish the extent to which these lipid abnormalities were addressed by one-year statin therapy in Hong Kong clinical practice. Methods: The study was a retrospective analysis, conducted using the electronic database from a Hong Kong tertiary referral hospital. Patients (n= 186) who were hospitalized for ACS events during Sep 2009Mar 2010 were identified. Two periods were studied as follows: a pretreatment period, defined as the 6 months before the index hospitalization, and an average follow-up period of 12 months after the index hospitalization. Results: Before