- Email: [email protected]
EFFICACY AND SAFETY OF RITUXIMAB FOR SYSTEMIC LUPUS TREATMENT: SYSTEMATIC REVIEW
A256
VA L U E I N H E A LT H 1 9 ( 2 0 1 6 ) A 1 - A 3 1 8
95% CI: 6.76-72.90] and 6-15 claims [OR: 4.62, 95% CI: 1.43-14.99]), had higher education level (some college [OR: 2.25, 95% CI: 1.05-4.85] and college graduate [OR: 3.12, 95% CI: 1.34-7.28]), lived in metropolitan areas (OR: 2.30, 95% CI: 1.18-4.48), lived in Northeast (OR: 3.01, 95% CI: 1.41-6.45), were eligible for Medicare care because of age (OR: 6.99, 95% CI: 3.06-15.93), had fair or poor health (OR: 2.11, 95% CI: 1.18-3.76), and had low-income subsidy (OR: 2.53, 95% CI: 1.25-5.13). Conclusions: The society, healthcare providers, and patients should be aware of factors associated with ESA use under Medicare Part D. Appropriate actions should be taken to improve the utilization of ESAs under Medicare Part D to generate cost-savings in the society. PSY84 EFFECT OF A “PILL MILL” LAW ON OPIOID PRESCRIBING AND UTILIZATION: THE CASE OF TEXAS Lyapustina T 1, Rutkow .
L 2, Chang .
H 2, Daubresse .
M 3, Ramji A F 1, Faul .
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M 4, Stuart .
E A 2, .
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Alexander G C 2 1Johns Hopkins University, Baltimore, MD, USA, 2Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA, 3Johns Hopkins School of Public Health, Baltimore, MD, USA, 4Centers for Disease Control and Prevention, Atlanta, GA, USA .
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Objectives: States have attempted to reduce prescription opioid abuse through strengthening the regulation of pain management clinics; however, the effect of such measures remains unclear. We quantified the impact of Texas’s September 2010 “pill mill” law on opioid prescribing and utilization. Methods: We used the IMS Health LRx LifeLink database to examine anonymized, patient-level pharmacy claims for a closed cohort of individuals filling prescription opioids in Texas between September 2009 and August 2011. Our primary outcomes were derived at a monthly level and included: (1) average morphine equivalent dose (MED) per transaction; (2) aggregate opioid volume; (3) number of opioid prescriptions; and (4) quantity of opioid pills dispensed. We compared observed values with the counterfactual, which we estimated from pre-intervention levels and trends. Results: Texas’s pill mill law was associated with declines in average MED per transaction (-0.57 mg/month, 95% confidence interval [CI] -1.09, -0.057), monthly opioid volume (-9.99 kg/month, CI -12.86, -7.11), monthly number of opioid prescriptions (-12,200 prescriptions/month, CI -15,300, -9,150) and monthly quantity of opioid pills dispensed (-714,000 pills/month, CI -877,000, -550,000). These reductions reflected decreases of 8.1% to 24.3% across the outcomes at one year compared with the counterfactual, and they were concentrated among prescribers and patients with the highest opioid prescribing and utilization at baseline. Conclusions: Following the implementation of Texas’s 2010 pill mill law, there were clinically significant reductions in opioid dose, volume, prescriptions and pills dispensed within the state, which were limited to individuals with higher levels of baseline opioid prescribing and utilization. PSY86 THE ECONOMIC BURDEN OF THE BARIATRIC SURGICAL WAITING LINE Luque A , Junqueira Junior S M , Oliveira D Johnson & Johnson Medical Brazil, São Paulo, Brazil .
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Objectives: Over 3.5 million Brazilians are eligible to bariatric surgery and with limited access to public health care system, in 2014, 7025 patients was surgically treated in the public system, evidencing a huge access gap. The aim of the study was to analyze the economic burden of the waiting line for the bariatric surgery in the Brazilian Public Health Care system. Methods: A decision tree analysis comparing immediate surgery with 2 years delay in the waiting line was built on Treeage Pro 2014, effectiveness data was extracted from literature, direct and indirect costs was extracted from public perspective, and the model represented a time horizon of 2 years surgical delay. Only the impact of type II Diabetes progression or remission was considered in the comorbidities impact. Results: The model showed that for each 100 patients waiting 2 years in the waiting line, 12 to 20 patients will progress to type II diabetes with a 2 years clinical treatment costs varying from R$48.576 (USD 12.144) to R$80.960 (USD 20.240), 8 to 12 diabetes patient will delay full remission of type II diabetes for 2 years, which would avoid clinical treatment varying from R$32.384 (USD 8.096) to R$48.576 (USD 12.144), 1 to 2 patients will die waiting for the surgery and 7 to 14 patients will reduce the work capacity (Absenteeism or presenteeism), representing a social cost varying from R$336.000 (USD 84.000) to R$672.000 (USD 168.000). The total cost of the waiting line range from R$464.960 (USD 166.240) to R$ 897.536 (USD 224.384), this amount could be reinvest to funding over 100 surgeries in the public system. Conclusions: The cost of 2 years waiting line for bariatric surgery could leverage the surgical treatment improving the clinical outcomes and decreasing the economic burden of the obesity. PSY87 CONTRIBUTION TO THE CLINICAL SAFETY AND ECONOMIC IMPACT THROUGH DETECTION OF MEDICATION ERRORS PERFORMED BY CLINICAL PHARMACISTS IN PATIENTS WITH HEMATOLOGIC DIAGNOSTICS: EXPERIENCE IN AN ONCOLOGY HOSPITAL IN MEXICO Colín Gómez D P , Paredes García P , Hernández Martínez J F , Morales Perez M , Toledo Vigueras I , Guzmán S , Soto Molina H , Sánchez Ródriguez I , Health Solutions M Centro Oncológico Estatal, ISSEMyM, Toluca, Mexico .
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Objectives: To identify and evaluate medication errors in terms of clinical impact and costs avoided by the pharmaceutical intervention. Methods: The pharmaceutical monitoring in patients with hematologic diseases was performed since July 2014 to July 2015 to identify medication errors and classify them according to Otero et al. (2000). A descriptive analysis was performed including central and dispersion measures to detail their distribution and to estimate the incidence and prevalence. Each error was evaluated to identify whether it was related to the patient´s safety and /or had a clinical and economic consequence. The most common clinical consequence was determined based on scientific information of the drugs involved. The cost estimate for complications avoided was taken of Diagnosis Related Groups 2015 of Mexican Institute of Social Security expressed in US dollars. Results: A total of 345 events of medication errors were detected; the prevalence and incidence estimated were 12% and 25% respectively. In the sample 49 (58%) patients were men; the mean age was 48.7 ±16.18 years. Non-Hodgkin lymphoma had the most frequent errors, in total 115 (33%). The most common errors were detected during
the prescription with 137 (40%) events; the major cause was lapse/distracting in 161 (47%) errors. The most frequent error type was medication omission 143 (41%). All errors were categorized without damage. A total 316 pharmaceutical interventions were performed, preventing 47 clinical complications, this results in annual avoided cost of 97,247.92 USD, the cost saving amount per avoided complications were 2,069.10 USD and a saving per patient of 1,144.09 USD. Conclusions: Early detection of medication errors by pharmacists intervention improves the safety of pharmacotherapy, ensures the effectiveness and prevents issues to the patient, furthermore, reduces costs by optimizing resources, providing just the necessary therapy and avoiding complications which could increase direct medical cost. PSY88 EFFICACY AND SAFETY OF RITUXIMAB FOR SYSTEMIC LUPUS TREATMENT: SYSTEMATIC REVIEW Godói I P 1, Rodrigues L F 2, Lemos L L 3, Acurcio F A 3, Guerra Júnior A A 3 University of Minas Gerais; CCATES, Belo Horizonte, Brazil, 2Universidade Federal de Minas Gerais, Belo Horizonte, Brazil, 3CCATES, Federal University of Minas Gerais, Belo Horizonte, Brazil .
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1Federal
Objectives: Rituximab is monoclonal antibody that targets B-cells, acting as a powerful immunosuppressant agent. This study evaluated the efficacy and safety of rituximab for systemic lupus erythematosus (LES) treatment, an off-label use. Methods: Medline (via Pubmed), The Cochrane Library (via Bireme), Lilacs and the Centre for Reviews Dissemination (CRD) were searched randomized controlled trials (RCT) and for systematic reviews (SR) of clinical trials and/or observational studies comparing rituximab with placebo in the pharmacotherapy of adults with active systemic lupus erythematosus. The quality of evidence and strength of recommendation were assessed using the GRADE system. Results: Two SR with meta-analysis and three RCT were included, whose quality ranged from very low to moderate. One systematic review that included 19 observational studies and 2 RCT showed favorable results for rituximab when compared to placebo or in addition to glucocorticoid with respect to SLEDAI score and reduction in glucocorticoid dose. For BILAG score and renal function the results were not statistically significant. The other SR included three RCT and did not show favorable results for rituximab in addition to glucocorticoid+antimalaric+imunosupressant. One RCT showed a temporal benefit with rituximab use – patients exposed to it showed reduction in disease activity index four months earlier than patients who did not use it in addition to cyclophosphamide. The other two RCT showed good results for rituximab in addition to glucocorticoids+immunospresasant in serological outcomes. In all SRs and RCTs rituximab presented a satisfactory safety profile. Conclusions: Rituximab results for systemic lupus erythematosus treatment are modest and inconclusive. This is confirmed by the fact that the producer itself has not solicited rituximab licensing for LES in FDA or EMA. With data published until now, off-label use should be restricted and discouraged. LES patients remain awaiting for an effective new technology. PSY89 IDENTIFYING PRECEDENT DEVICE-RELIANT GENERIC EROSION DEFENSE STRATEGIES: AN ANALOG ASSESSMENT Black J , Proach J , Winters D Market Access Solutions LLC, Raritan, NJ, USA .
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Objectives: Pharmaceutical products facing imminent patent expiration historically have taken steps, such as an enhancement in formulation, to minimize the impact of generic competitors. We sought to understand and identify successful non-price-related strategies leveraged by manufacturers to mitigate sales erosion due to generic entry in the orphan disease space. Methods: A database of 240 orphan disease pharmaceutical therapies marketed from 1999–2009 were identified. An attribute based sequenced screening protocol was repeated, eliminating non-relevant products, providing a list of qualified analogs experiencing generic entry and delivery device innovation. To isolate and interpret the effect of mitigation strategies on sales erosion due to generic entry, products were analyzed assessing historical pricing, sales data, and market and product shaping activities ASP pricing data was obtained from CMS, while sales data was extracted from publicly available SEC reports. Results: Of the 240 orphan drugs, multiple screenings resulted in three therapies qualifying for analysis. An additional three non-orphan disease analogs were incorporated to further assess the function and impact of device innovation as a mitigating strategy. Multiple strategies were identified as successful in maintaining a majority market share over generic entry. The most impactful were: improved patient convenience, manifesting as less frequent dosing schedules; proactively transitioning patients to a new, less frequent dose ahead of generic entry, thereby inhibiting patient drop-off to a less convenient generic; and innovative delivery devices that improve provider and Payer management. Additional strategies utilized included advertising to encourage brand loyalty; patient support activities; and lobbying from thought leaders to influence the treatment paradigm. Conclusions: Less frequent dosing schedules provide strong incentives for patients’ preference, and have historically been successful in preventing or mitigating sales erosion due to generic entry within the orphan disease area. Manufacturers may consider the development of a longer acting formulation as a viable mitigation tactic. PSY90 MANAGEMENT AND PRICING RELATIONSHIPS IN NON-ONCOLOGY ORPHAN DRUGS IN THE UNITED STATES (2006-2016) Leibfried M J , Carroll E , Kelly S GfK, New York, NY, USA .
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Objectives: Orphan drug pricing has come under increased scrutiny in the last few years as product launches have increased overall category spend. However, stricter management has not necessarily been implemented by Managed Care Organizations (MCOs), particularly in disease areas with only one/two products. The objective of this research was to build on Leibfried MJ et.al (2014 ISPOR) to
VA L U E I N H E A LT H 1 9 ( 2 0 1 6 ) A 1 - A 3 1 8
95% CI: 6.76-72.90] and 6-15 claims [OR: 4.62, 95% CI: 1.43-14.99]), had higher education level (some college [OR: 2.25, 95% CI: 1.05-4.85] and college graduate [OR: 3.12, 95% CI: 1.34-7.28]), lived in metropolitan areas (OR: 2.30, 95% CI: 1.18-4.48), lived in Northeast (OR: 3.01, 95% CI: 1.41-6.45), were eligible for Medicare care because of age (OR: 6.99, 95% CI: 3.06-15.93), had fair or poor health (OR: 2.11, 95% CI: 1.18-3.76), and had low-income subsidy (OR: 2.53, 95% CI: 1.25-5.13). Conclusions: The society, healthcare providers, and patients should be aware of factors associated with ESA use under Medicare Part D. Appropriate actions should be taken to improve the utilization of ESAs under Medicare Part D to generate cost-savings in the society. PSY84 EFFECT OF A “PILL MILL” LAW ON OPIOID PRESCRIBING AND UTILIZATION: THE CASE OF TEXAS Lyapustina T 1, Rutkow .
L 2, Chang .
H 2, Daubresse .
M 3, Ramji A F 1, Faul .
.
.
M 4, Stuart .
E A 2, .
.
Alexander G C 2 1Johns Hopkins University, Baltimore, MD, USA, 2Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA, 3Johns Hopkins School of Public Health, Baltimore, MD, USA, 4Centers for Disease Control and Prevention, Atlanta, GA, USA .
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Objectives: States have attempted to reduce prescription opioid abuse through strengthening the regulation of pain management clinics; however, the effect of such measures remains unclear. We quantified the impact of Texas’s September 2010 “pill mill” law on opioid prescribing and utilization. Methods: We used the IMS Health LRx LifeLink database to examine anonymized, patient-level pharmacy claims for a closed cohort of individuals filling prescription opioids in Texas between September 2009 and August 2011. Our primary outcomes were derived at a monthly level and included: (1) average morphine equivalent dose (MED) per transaction; (2) aggregate opioid volume; (3) number of opioid prescriptions; and (4) quantity of opioid pills dispensed. We compared observed values with the counterfactual, which we estimated from pre-intervention levels and trends. Results: Texas’s pill mill law was associated with declines in average MED per transaction (-0.57 mg/month, 95% confidence interval [CI] -1.09, -0.057), monthly opioid volume (-9.99 kg/month, CI -12.86, -7.11), monthly number of opioid prescriptions (-12,200 prescriptions/month, CI -15,300, -9,150) and monthly quantity of opioid pills dispensed (-714,000 pills/month, CI -877,000, -550,000). These reductions reflected decreases of 8.1% to 24.3% across the outcomes at one year compared with the counterfactual, and they were concentrated among prescribers and patients with the highest opioid prescribing and utilization at baseline. Conclusions: Following the implementation of Texas’s 2010 pill mill law, there were clinically significant reductions in opioid dose, volume, prescriptions and pills dispensed within the state, which were limited to individuals with higher levels of baseline opioid prescribing and utilization. PSY86 THE ECONOMIC BURDEN OF THE BARIATRIC SURGICAL WAITING LINE Luque A , Junqueira Junior S M , Oliveira D Johnson & Johnson Medical Brazil, São Paulo, Brazil .
.
.
.
Objectives: Over 3.5 million Brazilians are eligible to bariatric surgery and with limited access to public health care system, in 2014, 7025 patients was surgically treated in the public system, evidencing a huge access gap. The aim of the study was to analyze the economic burden of the waiting line for the bariatric surgery in the Brazilian Public Health Care system. Methods: A decision tree analysis comparing immediate surgery with 2 years delay in the waiting line was built on Treeage Pro 2014, effectiveness data was extracted from literature, direct and indirect costs was extracted from public perspective, and the model represented a time horizon of 2 years surgical delay. Only the impact of type II Diabetes progression or remission was considered in the comorbidities impact. Results: The model showed that for each 100 patients waiting 2 years in the waiting line, 12 to 20 patients will progress to type II diabetes with a 2 years clinical treatment costs varying from R$48.576 (USD 12.144) to R$80.960 (USD 20.240), 8 to 12 diabetes patient will delay full remission of type II diabetes for 2 years, which would avoid clinical treatment varying from R$32.384 (USD 8.096) to R$48.576 (USD 12.144), 1 to 2 patients will die waiting for the surgery and 7 to 14 patients will reduce the work capacity (Absenteeism or presenteeism), representing a social cost varying from R$336.000 (USD 84.000) to R$672.000 (USD 168.000). The total cost of the waiting line range from R$464.960 (USD 166.240) to R$ 897.536 (USD 224.384), this amount could be reinvest to funding over 100 surgeries in the public system. Conclusions: The cost of 2 years waiting line for bariatric surgery could leverage the surgical treatment improving the clinical outcomes and decreasing the economic burden of the obesity. PSY87 CONTRIBUTION TO THE CLINICAL SAFETY AND ECONOMIC IMPACT THROUGH DETECTION OF MEDICATION ERRORS PERFORMED BY CLINICAL PHARMACISTS IN PATIENTS WITH HEMATOLOGIC DIAGNOSTICS: EXPERIENCE IN AN ONCOLOGY HOSPITAL IN MEXICO Colín Gómez D P , Paredes García P , Hernández Martínez J F , Morales Perez M , Toledo Vigueras I , Guzmán S , Soto Molina H , Sánchez Ródriguez I , Health Solutions M Centro Oncológico Estatal, ISSEMyM, Toluca, Mexico .
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Objectives: To identify and evaluate medication errors in terms of clinical impact and costs avoided by the pharmaceutical intervention. Methods: The pharmaceutical monitoring in patients with hematologic diseases was performed since July 2014 to July 2015 to identify medication errors and classify them according to Otero et al. (2000). A descriptive analysis was performed including central and dispersion measures to detail their distribution and to estimate the incidence and prevalence. Each error was evaluated to identify whether it was related to the patient´s safety and /or had a clinical and economic consequence. The most common clinical consequence was determined based on scientific information of the drugs involved. The cost estimate for complications avoided was taken of Diagnosis Related Groups 2015 of Mexican Institute of Social Security expressed in US dollars. Results: A total of 345 events of medication errors were detected; the prevalence and incidence estimated were 12% and 25% respectively. In the sample 49 (58%) patients were men; the mean age was 48.7 ±16.18 years. Non-Hodgkin lymphoma had the most frequent errors, in total 115 (33%). The most common errors were detected during
the prescription with 137 (40%) events; the major cause was lapse/distracting in 161 (47%) errors. The most frequent error type was medication omission 143 (41%). All errors were categorized without damage. A total 316 pharmaceutical interventions were performed, preventing 47 clinical complications, this results in annual avoided cost of 97,247.92 USD, the cost saving amount per avoided complications were 2,069.10 USD and a saving per patient of 1,144.09 USD. Conclusions: Early detection of medication errors by pharmacists intervention improves the safety of pharmacotherapy, ensures the effectiveness and prevents issues to the patient, furthermore, reduces costs by optimizing resources, providing just the necessary therapy and avoiding complications which could increase direct medical cost. PSY88 EFFICACY AND SAFETY OF RITUXIMAB FOR SYSTEMIC LUPUS TREATMENT: SYSTEMATIC REVIEW Godói I P 1, Rodrigues L F 2, Lemos L L 3, Acurcio F A 3, Guerra Júnior A A 3 University of Minas Gerais; CCATES, Belo Horizonte, Brazil, 2Universidade Federal de Minas Gerais, Belo Horizonte, Brazil, 3CCATES, Federal University of Minas Gerais, Belo Horizonte, Brazil .
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1Federal
Objectives: Rituximab is monoclonal antibody that targets B-cells, acting as a powerful immunosuppressant agent. This study evaluated the efficacy and safety of rituximab for systemic lupus erythematosus (LES) treatment, an off-label use. Methods: Medline (via Pubmed), The Cochrane Library (via Bireme), Lilacs and the Centre for Reviews Dissemination (CRD) were searched randomized controlled trials (RCT) and for systematic reviews (SR) of clinical trials and/or observational studies comparing rituximab with placebo in the pharmacotherapy of adults with active systemic lupus erythematosus. The quality of evidence and strength of recommendation were assessed using the GRADE system. Results: Two SR with meta-analysis and three RCT were included, whose quality ranged from very low to moderate. One systematic review that included 19 observational studies and 2 RCT showed favorable results for rituximab when compared to placebo or in addition to glucocorticoid with respect to SLEDAI score and reduction in glucocorticoid dose. For BILAG score and renal function the results were not statistically significant. The other SR included three RCT and did not show favorable results for rituximab in addition to glucocorticoid+antimalaric+imunosupressant. One RCT showed a temporal benefit with rituximab use – patients exposed to it showed reduction in disease activity index four months earlier than patients who did not use it in addition to cyclophosphamide. The other two RCT showed good results for rituximab in addition to glucocorticoids+immunospresasant in serological outcomes. In all SRs and RCTs rituximab presented a satisfactory safety profile. Conclusions: Rituximab results for systemic lupus erythematosus treatment are modest and inconclusive. This is confirmed by the fact that the producer itself has not solicited rituximab licensing for LES in FDA or EMA. With data published until now, off-label use should be restricted and discouraged. LES patients remain awaiting for an effective new technology. PSY89 IDENTIFYING PRECEDENT DEVICE-RELIANT GENERIC EROSION DEFENSE STRATEGIES: AN ANALOG ASSESSMENT Black J , Proach J , Winters D Market Access Solutions LLC, Raritan, NJ, USA .
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Objectives: Pharmaceutical products facing imminent patent expiration historically have taken steps, such as an enhancement in formulation, to minimize the impact of generic competitors. We sought to understand and identify successful non-price-related strategies leveraged by manufacturers to mitigate sales erosion due to generic entry in the orphan disease space. Methods: A database of 240 orphan disease pharmaceutical therapies marketed from 1999–2009 were identified. An attribute based sequenced screening protocol was repeated, eliminating non-relevant products, providing a list of qualified analogs experiencing generic entry and delivery device innovation. To isolate and interpret the effect of mitigation strategies on sales erosion due to generic entry, products were analyzed assessing historical pricing, sales data, and market and product shaping activities ASP pricing data was obtained from CMS, while sales data was extracted from publicly available SEC reports. Results: Of the 240 orphan drugs, multiple screenings resulted in three therapies qualifying for analysis. An additional three non-orphan disease analogs were incorporated to further assess the function and impact of device innovation as a mitigating strategy. Multiple strategies were identified as successful in maintaining a majority market share over generic entry. The most impactful were: improved patient convenience, manifesting as less frequent dosing schedules; proactively transitioning patients to a new, less frequent dose ahead of generic entry, thereby inhibiting patient drop-off to a less convenient generic; and innovative delivery devices that improve provider and Payer management. Additional strategies utilized included advertising to encourage brand loyalty; patient support activities; and lobbying from thought leaders to influence the treatment paradigm. Conclusions: Less frequent dosing schedules provide strong incentives for patients’ preference, and have historically been successful in preventing or mitigating sales erosion due to generic entry within the orphan disease area. Manufacturers may consider the development of a longer acting formulation as a viable mitigation tactic. PSY90 MANAGEMENT AND PRICING RELATIONSHIPS IN NON-ONCOLOGY ORPHAN DRUGS IN THE UNITED STATES (2006-2016) Leibfried M J , Carroll E , Kelly S GfK, New York, NY, USA .
.
.
.
Objectives: Orphan drug pricing has come under increased scrutiny in the last few years as product launches have increased overall category spend. However, stricter management has not necessarily been implemented by Managed Care Organizations (MCOs), particularly in disease areas with only one/two products. The objective of this research was to build on Leibfried MJ et.al (2014 ISPOR) to