- Email: [email protected]
Visual Outcome of Cataract Surgery At Gondar University Hospital Tertiary Eye Care and Training Center, North West Ethiopia
A942
VA L U E I N H E A LT H 2 0 ( 2 0 1 7 ) A 8 5 3 – A 9 4 3
SENSORY SYSTEMS DISORDERS – Clinical Outcomes Studies
pared to World Health Organization’s recommendations, and it has been recognized that there is significant progression of visual acuity in different consecutive weeks.
PSS1 An Updated Review Of The Health & Economic Burden Of Varicella In Latin America And The Caribbean M1, Parellada
CI2, Monsanto
H3, Mangat
G4, Kamra
S4, Weiss TJ5, Wolfson
LJ5
Cashat-Cruz Sharp & Dohme SRL de CV, Mexico City, Mexico, 2Merck Sharp & Dohme, Sao Paolo, Brazil, 3Merck Sharp & Dohme IA LLC, Carolina, PR, PR, 4PAREXEL International, Chandigarh, India, 5Merck & Co., Inc., Kenilworth, NJ, USA
1Merck
Objectives: To characterize the burden of varicella in Latin American and Carribean (LAC) countries. Methods: A systematic electronic search was conducted in Embase® and MEDLINE® from database inception through January 2016. Ministry of Health websites, PAHO and WHO databases were searched. Publications related to varicella epidemiology (incidence, seroprevalence, complications, mortality, vaccine recommendations utilization) and economic burden (healthcare resource use, direct/indirect costs) in English were reviewed for data extraction. Results: Universal varicella vaccination (UVV) programs exist in 12/35 countries in LAC covering 54% of the regional population, a fourfold increase from 2011. Argentina, Barbados, Bermuda, Brazil, Costa Rica, Ecuador, and Paraguay have one-dose programmes, and Bahamas, Colombia, Panama, Puerto Rico and Uruguay have twodose programmes. An additional 8 countries have targeted recommendations for vaccination of special risk groups. The review identified 23 epidemiologic studies covering 8 countries. The most commonly reported outcomes were seroprevalence (12), incidence (7), mortality (5), and complications (4). Annual reported pre-vaccine incidence rates ranged from 140-437 per 100,000 in Argentina, Colombia, Costa Rica, Mexico, and Venezuela. A seasonal pattern of infection was observed with incidence peaking during winter and spring. The highest number of cases were in children < 10 years. Seropositivity was present in > 80% of 10-14 year olds in Mexico and Bolivia and > 95% of > 20 year olds in Brazil and Argentina, implying underreporting of incidence. Two studies reported on cost-effectiveness of UVV, seven studies on varicella-related health-care resource utilization, and four on economic burden. Conclusions: Although significant data gaps exist, 9 LAC countries have introduced UVV between 2012-2016. With more than 50% of the region’s population living in countries with UVV, improved varicella surveillance is needed to evaluate the impact of the vaccination programmes, monitor for potential shifts in the age-distribution of cases and support evidence-based decision making around UVV in LAC.
PSS4 Efficacy and Safety of Topical Dapsone Gel 7.5% for Treatment of Acne Vulgaris by Fitzpatrick Skin Type Taylor SC1, Cook-Bolden FE2, McMichael A3, Downie JB4, Rodriguez DA5, Mariwalla K6, Alexis AF7, Callender VD8, Alvandi N9 1University of Pennsylvania, Philadelphia, PA, USA, 2Skin Specialty Dermatology, New York, NY, USA, 3Wake Forest Baptist Health, Winston-Salem, NC, USA, 4Image Dermatology, Montclair, NJ, USA, 5Dermatology Associates and Research, Coral Gables, FL, USA, 6Mariwalla Dermatology, Islip, NY, USA, 7Skin of Color Center, Mount Sinai St. Luke’s and Roosevelt Hospitals, Icahn School of Medicine at Mount Sinai, New York, NY, USA, 8Callender Dermatology and Cosmetic Center, Glenn Dale, MD, USA, 9Allergan plc, Irvine, CA, USA
Objectives: We evaluated safety and efficacy of dapsone gel 7.5% (DAP) in acne patients by Fitzpatrick skin type. Methods: Data were pooled from 2 identically designed, phase 3, multicenter, randomized, double-blind studies in patients ≥ 12 years of age with moderate acne. Patients applied DAP or vehicle (VEH) once daily for 12 weeks. Efficacy assessments included Global Acne Assessment Score (GAAS) and lesion counts. Patients self-evaluated acne impact using Acne Symptom and Impact Scale (ASIS). Adverse events (AEs) and dermal tolerability were assessed. Results: In total, 4327 patients (2216 type I–III, 2111 type IV–VI) were included. At week 12, mean GAAS change from baseline was significantly greater with DAP versus VEH in skin types I–III and IV–VI (both, P< 0.001). Additionally, 71.4% with types I–III and 76.6% with types IV–VI using DAP achieved ≥ 1-grade improvement in GAAS at week 12 versus 62.8% and 67.9% using VEH (P< 0.001). In types I–III and IV–VI, mean week 12 percent reductions were significantly greater for DAP versus VEH in inflammatory lesions (types I–III, P< 0.001; IV–VI, P= 0.002), comedones (types I–III, P< 0.001; IV–VI, P= 0.01), and total lesions (both, P< 0.001). For both skin type groups, inflammatory lesion improvements occurred first; similar improvement patterns occurred in GAAS, comedones, and ASIS domains. Local dermal tolerability and AE incidences were similar between skin type groups and between DAP and VEH. Conclusions: Once-daily DAP monotherapy was safe and effective in lighter and darker Fitzpatrick skin type patients with moderate acne.
SENSORY SYSTEMS DISORDERS – Cost Studies PSS2 Crosslinking to Corneal Keratoconus Oliveira DF1, Castro RS1, Okanobo A1, Psaltikidis EM1, Evangelista-Poderoso R2, Toma TS3 1Clinical Hospital of State University of Campinas, Campinas, Brazil, 2Faculty of Medical Sciences of State University of Campinas, Campinas, Brazil, 3São Paulo State Health Secretariat, São Paulo, Brazil
PSS6 The Cost-Effectiveness of Varicella Vaccination In Peru Blas M1, Gutierrez R2, Petrozzi V2, Monsanto H3, Best P2, Pillsbury M4, Weiss TJ4, Pavelyev A4, Wolfson LJ4 1Cayetano Heredia Peruvian University, Lima, Peru, 2Merck Sharp & Dohme Peru S.R.L, Lima, Peru, 3Merck Sharp & Dohme (IA) LLC, Carolina, PR, USA, 4Merck & Co., Inc., Kenilworth, NJ, USA
Objectives: Corneal crosslinking consists of minimally invasive therapeutic procedure aimed at avoiding the progression of keratoconus by strengthening the molecular bonds of the corneal stroma, preventing or delaying corneal transplant. The aim of the study is to assess the effectiveness of corneal crosslinking in keratoconus stabilization and the prevention of progressive worsening of visual acuity. Methods: The PICO tool was used: patients with keratoconus (P) submitted to corneal crosslinking (I) compared to standard procedure (C), with the outcomes being corneal topography measurements, visual acuity, corneal transplantation, complications and adverse events (O). The databases used were Pubmed, Embase, Bireme Evidence Portal, Lilacs and Cochrane Library, and health technologies assessment sites. The costs of crosslinking were obtained by direct costing system, including fixed cost and variable components directly related to the execution of the procedure. Results: 152 studies were identified and, after selection, two systematic reviews with meta-analysis, one systematic review, four randomized controlled trials, one nonrandomized controlled trial and five health technology assessments were included. Literature analysis demonstrated that corneal crosslinking is an effective procedure in the stabilization of keratoconus by avoiding the progression of corneal curvature measurements (moderate level of evidence to the GRADE, and outcome classified as important). Visual acuity was a critical outcome, which showed moderate level of evidence. No study identified the occurrence of serious complications. The crosslinking costs are low (US$ 95.36) and, based on the incidence of keratoconus in our population, the annual cost to provide this technology in Brazil would be US$ 232,078.33. Conclusions: The corneal crosslinking is a minimally invasive procedure, with low cost and low risk of complications. There is moderate level of evidence for its effectiveness in stabilizing keratoconus measures of the corneal curvature and visual acuity.
Objectives: Sentinel surveillance in Peru reports 29,132 outpatient (average 200914) and 9,124 hospitalized (2016) varicella cases, likely an underestimate of true burden. The objective of this study was to quantify the burden of varicella in Peru, and estimate potential impact and cost-effectiveness of universal varicella vaccination (UVV). Methods: A dynamic transmission model of varicella infection was calibrated to reported age-specific varicella incidence data, adjusted for underreporting and care-seeking patterns. Results from a recent chart review study provided data on unit costs and health-care resource utilization. Vaccination strategies based on the current Peruvian vaccination calendar and coverage were considered (A: 1st dose 12m/90% coverage; B: 1st dose 18m/60%; C: 1st dose 12m/90% + 2nd dose 18m/60%; D: 1st dose 12m/90% + 2nddose 4y/50%). Scenario analyses focused on varicella vaccine qualities (effectiveness, duration) and costs. Results: More than 500,000 varicella cases per year at a cost of over S/50M (Peruvian S/1= 0.31USD) were estimated, and all vaccination strategies were cost-saving (payer perspective). The most cost-effective strategy for a vaccine with long duration of protection was D, followed by C, A, and B, but for vaccines with shorter duration of protection C was preferred to D. Notably, two-dose strategies based on high-quality vaccines, even at higher prices, were more effective and cost-effective than strategies (one or two dose) using low-quality vaccines at lower prices. The least expensive strategy is A with a high-quality vaccine; this is estimated to prevent 3.4M cases and 557 deaths over ten years. Conclusions: Both one and two dose UVV are cost-effective/cost saving. Due to low coverage of other vaccines administered at potential time points for 2nddose (18m or 4y), the incremental value of this dose is dependent on ability to raise coverage at that visit. UVV in Peru has the potential to bring immediate and sustainable health gains.
PSS3 Visual Outcome of Cataract Surgery At Gondar University Hospital Tertiary Eye Care and Training Center, North West Ethiopia
SENSORY SYSTEMS DISORDERS – Health Care Use & Policy Studies
Seid MA University of Gondar, Gondar, Ethiopia
Objectives: To evaluate the postoperative level of visual acuity to provide a baseline information regarding visual outcome and design a standardized protocol to maximize it. Methods: A hospital-based cross-sectional study was conducted at the Gondar University Hospital Tertiary Eye Care and Training Center on 223 patients who underwent cataract surgery, selected using simple random technique from April to June 2015. Results: This study consisted of 218 patients or eyes that underwent cataract surgery. The median age of the participants was 65 years with an interquartile range of 20 years. Of 218 cataract-operated visually impaired eyes (< 6/60), 26.6% of them achieved good visual acuity (≥ 6/18), 28.9% of them had borderline acuity (< 6/18–6/60), and the remaining of 44.5% were remained as poor visual acuity (< 6/60). It has been observed that the postoperative visual acuity had an association with postoperative follow up time duration (P= 0.035). Conclusions: In this study, the visual outcome of cataract surgery was significantly low as com-
PSS7 Cataract Prevalence Estimation and Financial Requirements for Surgery Unmet Needs in Mexico: A Secondary Sources Analysis De leon M1, Sashka D2, Castañón I1, Ortiz A1, Gryzbowski E3, Kramis J3 1ALCON, CDMX, Mexico, 2ALCON a Novartis company, Distrito Federal, Mexico, 3Springer Health Care, México DF, Mexico
Objectives: There is a lack in information in Mexico regarding to cataract prevalence estimation, unmeet surgery needs and resource allocation to meet this need. The aim of this study is to present the expected financial requirements to treat cataract in Mexico from the analysis of public secondary sources. Methods: Through a literature review and a critical analysis cataract prevalence (CP) was extracted from three different sources and were standardized to 2015 Intercensal National Survey, using assumptions we assessed the cataract patient affiliation, number of surgeries (NS) and access to health institutions; subsequently, a multi-scenario comparison
VA L U E I N H E A LT H 2 0 ( 2 0 1 7 ) A 8 5 3 – A 9 4 3
SENSORY SYSTEMS DISORDERS – Clinical Outcomes Studies
pared to World Health Organization’s recommendations, and it has been recognized that there is significant progression of visual acuity in different consecutive weeks.
PSS1 An Updated Review Of The Health & Economic Burden Of Varicella In Latin America And The Caribbean M1, Parellada
CI2, Monsanto
H3, Mangat
G4, Kamra
S4, Weiss TJ5, Wolfson
LJ5
Cashat-Cruz Sharp & Dohme SRL de CV, Mexico City, Mexico, 2Merck Sharp & Dohme, Sao Paolo, Brazil, 3Merck Sharp & Dohme IA LLC, Carolina, PR, PR, 4PAREXEL International, Chandigarh, India, 5Merck & Co., Inc., Kenilworth, NJ, USA
1Merck
Objectives: To characterize the burden of varicella in Latin American and Carribean (LAC) countries. Methods: A systematic electronic search was conducted in Embase® and MEDLINE® from database inception through January 2016. Ministry of Health websites, PAHO and WHO databases were searched. Publications related to varicella epidemiology (incidence, seroprevalence, complications, mortality, vaccine recommendations utilization) and economic burden (healthcare resource use, direct/indirect costs) in English were reviewed for data extraction. Results: Universal varicella vaccination (UVV) programs exist in 12/35 countries in LAC covering 54% of the regional population, a fourfold increase from 2011. Argentina, Barbados, Bermuda, Brazil, Costa Rica, Ecuador, and Paraguay have one-dose programmes, and Bahamas, Colombia, Panama, Puerto Rico and Uruguay have twodose programmes. An additional 8 countries have targeted recommendations for vaccination of special risk groups. The review identified 23 epidemiologic studies covering 8 countries. The most commonly reported outcomes were seroprevalence (12), incidence (7), mortality (5), and complications (4). Annual reported pre-vaccine incidence rates ranged from 140-437 per 100,000 in Argentina, Colombia, Costa Rica, Mexico, and Venezuela. A seasonal pattern of infection was observed with incidence peaking during winter and spring. The highest number of cases were in children < 10 years. Seropositivity was present in > 80% of 10-14 year olds in Mexico and Bolivia and > 95% of > 20 year olds in Brazil and Argentina, implying underreporting of incidence. Two studies reported on cost-effectiveness of UVV, seven studies on varicella-related health-care resource utilization, and four on economic burden. Conclusions: Although significant data gaps exist, 9 LAC countries have introduced UVV between 2012-2016. With more than 50% of the region’s population living in countries with UVV, improved varicella surveillance is needed to evaluate the impact of the vaccination programmes, monitor for potential shifts in the age-distribution of cases and support evidence-based decision making around UVV in LAC.
PSS4 Efficacy and Safety of Topical Dapsone Gel 7.5% for Treatment of Acne Vulgaris by Fitzpatrick Skin Type Taylor SC1, Cook-Bolden FE2, McMichael A3, Downie JB4, Rodriguez DA5, Mariwalla K6, Alexis AF7, Callender VD8, Alvandi N9 1University of Pennsylvania, Philadelphia, PA, USA, 2Skin Specialty Dermatology, New York, NY, USA, 3Wake Forest Baptist Health, Winston-Salem, NC, USA, 4Image Dermatology, Montclair, NJ, USA, 5Dermatology Associates and Research, Coral Gables, FL, USA, 6Mariwalla Dermatology, Islip, NY, USA, 7Skin of Color Center, Mount Sinai St. Luke’s and Roosevelt Hospitals, Icahn School of Medicine at Mount Sinai, New York, NY, USA, 8Callender Dermatology and Cosmetic Center, Glenn Dale, MD, USA, 9Allergan plc, Irvine, CA, USA
Objectives: We evaluated safety and efficacy of dapsone gel 7.5% (DAP) in acne patients by Fitzpatrick skin type. Methods: Data were pooled from 2 identically designed, phase 3, multicenter, randomized, double-blind studies in patients ≥ 12 years of age with moderate acne. Patients applied DAP or vehicle (VEH) once daily for 12 weeks. Efficacy assessments included Global Acne Assessment Score (GAAS) and lesion counts. Patients self-evaluated acne impact using Acne Symptom and Impact Scale (ASIS). Adverse events (AEs) and dermal tolerability were assessed. Results: In total, 4327 patients (2216 type I–III, 2111 type IV–VI) were included. At week 12, mean GAAS change from baseline was significantly greater with DAP versus VEH in skin types I–III and IV–VI (both, P< 0.001). Additionally, 71.4% with types I–III and 76.6% with types IV–VI using DAP achieved ≥ 1-grade improvement in GAAS at week 12 versus 62.8% and 67.9% using VEH (P< 0.001). In types I–III and IV–VI, mean week 12 percent reductions were significantly greater for DAP versus VEH in inflammatory lesions (types I–III, P< 0.001; IV–VI, P= 0.002), comedones (types I–III, P< 0.001; IV–VI, P= 0.01), and total lesions (both, P< 0.001). For both skin type groups, inflammatory lesion improvements occurred first; similar improvement patterns occurred in GAAS, comedones, and ASIS domains. Local dermal tolerability and AE incidences were similar between skin type groups and between DAP and VEH. Conclusions: Once-daily DAP monotherapy was safe and effective in lighter and darker Fitzpatrick skin type patients with moderate acne.
SENSORY SYSTEMS DISORDERS – Cost Studies PSS2 Crosslinking to Corneal Keratoconus Oliveira DF1, Castro RS1, Okanobo A1, Psaltikidis EM1, Evangelista-Poderoso R2, Toma TS3 1Clinical Hospital of State University of Campinas, Campinas, Brazil, 2Faculty of Medical Sciences of State University of Campinas, Campinas, Brazil, 3São Paulo State Health Secretariat, São Paulo, Brazil
PSS6 The Cost-Effectiveness of Varicella Vaccination In Peru Blas M1, Gutierrez R2, Petrozzi V2, Monsanto H3, Best P2, Pillsbury M4, Weiss TJ4, Pavelyev A4, Wolfson LJ4 1Cayetano Heredia Peruvian University, Lima, Peru, 2Merck Sharp & Dohme Peru S.R.L, Lima, Peru, 3Merck Sharp & Dohme (IA) LLC, Carolina, PR, USA, 4Merck & Co., Inc., Kenilworth, NJ, USA
Objectives: Corneal crosslinking consists of minimally invasive therapeutic procedure aimed at avoiding the progression of keratoconus by strengthening the molecular bonds of the corneal stroma, preventing or delaying corneal transplant. The aim of the study is to assess the effectiveness of corneal crosslinking in keratoconus stabilization and the prevention of progressive worsening of visual acuity. Methods: The PICO tool was used: patients with keratoconus (P) submitted to corneal crosslinking (I) compared to standard procedure (C), with the outcomes being corneal topography measurements, visual acuity, corneal transplantation, complications and adverse events (O). The databases used were Pubmed, Embase, Bireme Evidence Portal, Lilacs and Cochrane Library, and health technologies assessment sites. The costs of crosslinking were obtained by direct costing system, including fixed cost and variable components directly related to the execution of the procedure. Results: 152 studies were identified and, after selection, two systematic reviews with meta-analysis, one systematic review, four randomized controlled trials, one nonrandomized controlled trial and five health technology assessments were included. Literature analysis demonstrated that corneal crosslinking is an effective procedure in the stabilization of keratoconus by avoiding the progression of corneal curvature measurements (moderate level of evidence to the GRADE, and outcome classified as important). Visual acuity was a critical outcome, which showed moderate level of evidence. No study identified the occurrence of serious complications. The crosslinking costs are low (US$ 95.36) and, based on the incidence of keratoconus in our population, the annual cost to provide this technology in Brazil would be US$ 232,078.33. Conclusions: The corneal crosslinking is a minimally invasive procedure, with low cost and low risk of complications. There is moderate level of evidence for its effectiveness in stabilizing keratoconus measures of the corneal curvature and visual acuity.
Objectives: Sentinel surveillance in Peru reports 29,132 outpatient (average 200914) and 9,124 hospitalized (2016) varicella cases, likely an underestimate of true burden. The objective of this study was to quantify the burden of varicella in Peru, and estimate potential impact and cost-effectiveness of universal varicella vaccination (UVV). Methods: A dynamic transmission model of varicella infection was calibrated to reported age-specific varicella incidence data, adjusted for underreporting and care-seeking patterns. Results from a recent chart review study provided data on unit costs and health-care resource utilization. Vaccination strategies based on the current Peruvian vaccination calendar and coverage were considered (A: 1st dose 12m/90% coverage; B: 1st dose 18m/60%; C: 1st dose 12m/90% + 2nd dose 18m/60%; D: 1st dose 12m/90% + 2nddose 4y/50%). Scenario analyses focused on varicella vaccine qualities (effectiveness, duration) and costs. Results: More than 500,000 varicella cases per year at a cost of over S/50M (Peruvian S/1= 0.31USD) were estimated, and all vaccination strategies were cost-saving (payer perspective). The most cost-effective strategy for a vaccine with long duration of protection was D, followed by C, A, and B, but for vaccines with shorter duration of protection C was preferred to D. Notably, two-dose strategies based on high-quality vaccines, even at higher prices, were more effective and cost-effective than strategies (one or two dose) using low-quality vaccines at lower prices. The least expensive strategy is A with a high-quality vaccine; this is estimated to prevent 3.4M cases and 557 deaths over ten years. Conclusions: Both one and two dose UVV are cost-effective/cost saving. Due to low coverage of other vaccines administered at potential time points for 2nddose (18m or 4y), the incremental value of this dose is dependent on ability to raise coverage at that visit. UVV in Peru has the potential to bring immediate and sustainable health gains.
PSS3 Visual Outcome of Cataract Surgery At Gondar University Hospital Tertiary Eye Care and Training Center, North West Ethiopia
SENSORY SYSTEMS DISORDERS – Health Care Use & Policy Studies
Seid MA University of Gondar, Gondar, Ethiopia
Objectives: To evaluate the postoperative level of visual acuity to provide a baseline information regarding visual outcome and design a standardized protocol to maximize it. Methods: A hospital-based cross-sectional study was conducted at the Gondar University Hospital Tertiary Eye Care and Training Center on 223 patients who underwent cataract surgery, selected using simple random technique from April to June 2015. Results: This study consisted of 218 patients or eyes that underwent cataract surgery. The median age of the participants was 65 years with an interquartile range of 20 years. Of 218 cataract-operated visually impaired eyes (< 6/60), 26.6% of them achieved good visual acuity (≥ 6/18), 28.9% of them had borderline acuity (< 6/18–6/60), and the remaining of 44.5% were remained as poor visual acuity (< 6/60). It has been observed that the postoperative visual acuity had an association with postoperative follow up time duration (P= 0.035). Conclusions: In this study, the visual outcome of cataract surgery was significantly low as com-
PSS7 Cataract Prevalence Estimation and Financial Requirements for Surgery Unmet Needs in Mexico: A Secondary Sources Analysis De leon M1, Sashka D2, Castañón I1, Ortiz A1, Gryzbowski E3, Kramis J3 1ALCON, CDMX, Mexico, 2ALCON a Novartis company, Distrito Federal, Mexico, 3Springer Health Care, México DF, Mexico
Objectives: There is a lack in information in Mexico regarding to cataract prevalence estimation, unmeet surgery needs and resource allocation to meet this need. The aim of this study is to present the expected financial requirements to treat cataract in Mexico from the analysis of public secondary sources. Methods: Through a literature review and a critical analysis cataract prevalence (CP) was extracted from three different sources and were standardized to 2015 Intercensal National Survey, using assumptions we assessed the cataract patient affiliation, number of surgeries (NS) and access to health institutions; subsequently, a multi-scenario comparison