- Email: [email protected]
Economic Evaluation Of Cobicistat-Boosted Darunavir In Hiv-Infected Patients In Mexico
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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
PIN32 A Sistematic Review Of The Cost-Effectiveness Of Vaccinating Elderly With The 23-Valent Pneumococcal Polysaccharide Vaccine (Ppv23) Nishikawa AM1, Mainardi GM1, Novaes HM2, Sartori AM3, De Soarez PC4 1University of São Paulo, São Paulo, Brazil, 2University of Sao Paulo, Sao Paulo, Brazil, 3Sao Paulo University, São Paulo, Brazil, 4Universidade de São Paulo, São Paulo, Brazil
Objectives: To systematically review the available literature on cost-effectiveness of PPV23 in adults aged > 60 years. Methods: We searched the MEDLINE, LILACS, Bireme, Cochrane, EMBASE, NHSEDD and Centre for Reviews and Dissemination (CRD) databases for full economic evaluations of PPV23 published up to March 2016. Two independent reviewers screened the articles for relevance and extracted the data. Main study characteristics and methods (clinical and epidemiological data, cost and incremental cost-effectiveness ratios (ICERs) were extracted and compared. Costs were updated to US$2016. Results: Twenty-seven studies were reviewed. The studies were published from 1980 to 2016. Most were conducted in Europe and US (81.5%); three studies were conducted in Latin America (Brazil, 2; Colombia, 1). All studies compared VPP23 to not-vaccinating and three studies also compared VPP23 to pneumococcal conjugate 13-valent vaccine (PCV13). All studies used static models. Most use a lifetime (44.4%) or 5 to 6 year’s time horizon (33.3%). Just 3 studies considered herd protection from children immunization with PCV13 in the model. Most studies considered PCV23 cost-effective (less than US$50,000 per LYG or QALY) and sometimes cost-saving (results ranging from cost-saving to 101,670/QALY). Conclusions: This systematic review revealed that the costeffectiveness results have conflicting results, from cost-saving to not cost-effective at all. Assumptions regarding vaccine effectiveness, particularly for non-invasive pneumonia, and waning immunity varies greatly among different studies and impact the results. PIN33 Systematic Review Of Economic Evaluation Studies For Dengue Vaccine: How Valid Are The Results? De Soarez PC1, Silva AB1, Randi BA1, Novaes HM2, Sartori AM1 Paulo University, São Paulo, Brazil, 2University of Sao Paulo, Sao Paulo, Brazil
PIN35 An Economic Evaluation Of Single Tablet Regimens Of Antiretroviral Therapy For Treatment-Naitve Hiv-Infected Patients Chou C1, Terris-Prestholt F2, Miners A3 1Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan, 2London School of Hygiene and Tropical Medicine, London, UK, 3London School of Hygiene & Tropical Medicine, London, UK
Objectives: Antiretroviral therapy (ART) has considerably changed the life expectancy and life quality of HIV-infected patients. However, uprising epidemic of HIV infection and the new recommendation of early ART initiation cause a heavy financial burden. Cost-effectiveness of ART should consequently be considered. Single-tablet regimen (STR), one pill that contains a combination of multiple antiretroviral agents, is a recent advance in HIV treatment and widely used now. The objective of this study is to perform a cost-utility analysis of STR using a decision model to assess the cost-effectiveness of tenofovir disoproxil fumarate/ emtricitabine/rilpivirine (TDF/FTC/RPV) compared to tenofovir disoproxil fumarate/ emtricitabine/efavirenz (TDF/FTC/EFV) for asymptomatic, treatment-naïve HIVinfected patients. Methods: A Markov model with a hypothetical cohort of 1000 HIV-infected patients having initial viral load ≤ 100,000 copies/ml was designed. Quality-adjusted life year (QALY) was used as the health outcome and incremental cost-effectiveness ratio (ICER) comparing the two STRs was calculated. The willingness-to-pay (WTP) threshold of 70000USD was adopted. Most of the parameters in the model were considered stochastic, and the uncertainty was taken into account by deterministic sensitivity analysis (DSA) and probabilistic sensitivity analysis (PSA). Results: The calculated ICER per QALY was 13521.6USD. In terms of uncertainty, the ICER was sensitive to all parameters in the model. DSA showed that the most significant parameter of transition probability was the treatment efficacy of the two STRs. The utility in the first cycle and the costs of two STRs were also found influential. PSA demonstrated that the probability of cost-effectiveness was 61% at the WTP of 70000USD. Conclusions: The ICER per QALY (13521.6USD) of TDF/FTC/RPV to TDF/FTC/EFV comprised a relatively small fraction of the adopted WTP (70000USD), but there was significant uncertainty coming from the treatment efficacy and costs. TDF/FTC/RPV may be more cost-effective compared to TDF/FTC/ EFV for treatment-naïve HIV-infected patients.
1Sao
Objectives: To review the literature on economic evaluation of dengue vaccination to produce evidence to support a local cost-effectiveness study and to subsidize the decision to introduce a dengue vaccine in the Brazilian National Immunization Program (NIP). Methods: We systematically searched multiple databases (MEDLINE (via PubMed), EMBASE, SCOPUS, NHS Economic Evaluation Database (NHS EED), HTA Database (via Centre for Reviews and Dissemination CRD) and LILACS), selecting full HEEs of dengue vaccine. Two independent reviewers screened articles for relevance and extracted the data. The methodology for the quality reporting was assessed using CHEERS checklist. We performed a qualitative narrative synthesis. Results: Eight studies were reviewed. They were conducted in Asian and Latin America countries. All studies were favorable to the incorporation of the vaccine. However, the values and assumptions assumed for vaccine efficacy, safety and duration of protection, as well as the choice of the study population and the type of model used in the analyses, associated to an insufficient reporting of the methodological steps, affect the validity of the studies results. The quality reporting appraisal showed that the majority of the studies reported less than 50% of the CHEERS checklists’ items. Conclusions: This systematic review shows that the economic evaluation of dengue vaccination are not adherent to key recommended general methods for economic evaluation. The presented cost-effectiveness results should not be transferred to other countries. It is recommended to conduct studies with local epidemiological and cost data, as well as assumptions about vaccination that reflect the results observed in clinical trials. PIN34 Health Economic Analysis Of Pneumococcal Conjugated Vaccines For Mexico, Under A Technical Parity Scenario Gomez J1, Carreno Manjarrez R2, Cortes-Alcala R2, Olbrecht J3, DeAntonio R4 1GSK, Victoria, Argentina, 2GSK, Mexico, Mexico, 3GSK, Wavre, Belgium, 4GSK, Panama
City,
Panama
Objectives: To update the cost-effectiveness analysis of 2 Pneumococcal Conjugated Vaccines (PCV) (PCV-13 and PHiD-CV) previously published for Mexico, with a scenario of no superiority between them (“technical parity”) based on the recent systematic review about impact and effectiveness of these PCVs in children from 5 countries in Latin America (de Oliveira et al.,PLoS ONE, 2016, 11 (12): e0166736). Methods: Our previous cost-effectiveness & cost-utility analysis of implementing a PCV program in the Mexican pediatric population was completed with this new scenario of no superiority between PCVs on Invasive Pneumococcal Disease (IPD) and pneumonia in children less than 5 years of age. On this scenario, all original inputs remained the same, even the price parity between vaccines, but the vaccine effectiveness against IPD and pneumonia were considered equal between PCVs. The robustness of the conclusions was assessed through a sensitivity analysis that included all of the parameters considered by the model. Results: In this scenario, PHiD-CV was dominant over PCV-13 in the “cost-utility analysis”; generating more quality-adjusted life years at a lower cost and a lower incremental cost-utility ratio, based on a better profile against acute otitis media. On the “costeffectiveness analysis”, both vaccines generated equal number of life years gained, but PCV-13 at a higher cost. Although both vaccines produced equivalent health outcomes, in this scenario of technical parity against IPD and pneumonia between vaccines, the analysis predicted that PHiD-CV would save 367 / 422 million “2013 Mexican pesos” (discounted / undiscounted), per vaccinated cohort as compared with PCV-13. Conclusions: Even though PCV-13 and PHiD-CV were both costeffective when used to implement a pediatric vaccination campaign for Mexico, PHiD-CV had a better cost-utility / effectiveness profile based on the demonstrated differential effect against acute otitis media.
PIN36 Programa Stewardship: Otimizando A Terapia Antimicrobiana Com Eficiência Em Um Hospital De Ensino De Referência Em Fortaleza, Ceará Reis HP1, Castro K1, Andrade CC1, Neto JA1, Barros A1, Rodrigues JL2, Girao ES3, Pontes LB3, Pitta A2, Fonteles MM4, Ponciano AM1 1UFC, Fortaleza, Brazil, 2Universidade Federal do Ceará, Fortaleza, Brazil, 3HUWC, Fortaleza, Brazil, 4Federal University of Ceará, Fortaleza, Brazil
Objectives: determinar o custo evitado com antimicrobianos (ATM) através das estratégias de racionalização do Programa Stewardship (STWDSP) em um Hospital de ensino de referência no Ceará, Brasil. Methods: estudo prospectivo (follow-up) com dados de mundo real, realizado em um Hospital de referência de ensino em Fortaleza/CE, através do Programa Stewardship (STWDSP) de Gestão Clínica de ATM, entre novembro/2016 a janeiro/2017. Aplicou-se os pressupostos do Protocolo Stewardship da Sociedade Americana de Doenças Infecciosas (IDSA, 2016). Utilizou-se como fontes os prontuários e sistema informatizado da instituição (microbiológico e o logístico). As sugestões foram realizadas nas discussões interdisciplinares do time com o médico assistente. O custo-evitado teve como base o custo do total do esquema proposto inicial e o custo real após validada a estratégia STWDSP discutida. Foi utilizado o preço de cadastro do ATM institucional. Os dados eram registrados em um instrumento de monitorização de ATM contemplando parâmetros clínicos, da farmacoterapia antimicrobiana e microbiológicos. Aprovado pelo Comitê de Ética da Universidade Federal do Ceará Results: As estratégias selecionadas foram: Auditoria interdisciplinar e feedbacks; Protocolo de restrição para dispensação de ATM de reserva; Gestão do tempo de tratamento; Descalonamento; Switch therapy (terapia sequencial oral e Step down para Ertapenem) e Educação permanente. No período foram acompanhados 12 pacientes que usaram ATM reserva/estratégico (clínica médica, cardiologia e transplante renal). Média de idade 55 ± 17 anos, 67% do sexo masculino. A principal indicação foi para pneumonia hospitalar (52,63%). As estratégias mais efetivadas foram redução do tempo tratamento e terapia seqüencial oral. Houve um custo médio evitado de R$ 2.136,86/ paciente (29,58%). Conclusions: Neste trabalho o STWSDP mostrou ser uma eficiente ferramenta de Gestão Clínica, otimizando o uso de ATM, promovendo a interdisciplinaridade e reduzindo o custo dessa farmacoterapia. Sugere-se uma maior sensibilização de todos os envolvidos, especialmente o prescritor, para ampliação das estratégias de racionalização propostas. PIN37 Economic Evaluation Of Cobicistat-Boosted Darunavir In Hiv-Infected Patients In Mexico Guirant Corpi L, Olivares N, Fritz K, Aguirre A Janssen Mexico, Mexico City, Mexico
Objectives: Cobicistat (cobi) is a new booster alternative whose physicochemical properties allow the co-formulation with darunavir to obtain the fixed dose combination of darunavir/cobicistat 800/150 mg (DRV/cobi) in a single tablet per day. This analysis aims to present the economic evaluation of darunavir in a daily dose of 800 mg boosted with 150 mg of cobi or with 100 mg of ritonavir (rtv) in the Mexican context. Methods: A complete economic evaluation was carried out through a cost minimization analysis since DRV/cobi and darunavir boosted with rtv (DRV+rtv) have shown bioequivalence in published studies. The efficacy of DRV/cobi is directed only by darunavir as it is the component with antiviral activity; cobi works as an enhancer to achieve optimal concentrations of darunavir in blood. Therefore, the efficiency shown by DRV+rtv is extrapolated to DRV/cobi. The costs of the drugs to calculate the annual cost of treatment were obtained from published sources
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(1USD = $ 19MXN). A deterministic sensitivity analysis was performed to test the robustness of the model. Results: DRV/cobi showed annual savings per patient of 9.5%. This savings are equivalent to the annual cost of treatment with ritonavir. The annual cost of treatment with DRV/cobi is $2,096 versus the annual cost of DRV+ rtv which is $2,316. The robustness of the analysis was confirmed by a sensitivity analysis on the DRV/cobi acquisition price. Conclusions: The fixed dose combination in one tablet per day of DRV/cobi is a cost-saving and convenient alternative in terms of supply and storage for the institutions in the public health sector in Mexico that use DRV+rtv. Additionally, DRV/cobi favors adherence in patients and decreases the probability of virological failure. PIN38 Descalonamento Da Terapia Antimicrobiana: Uma Estratégia De Racionalização E Custo-Minimização Em Cenário Privado De Saúde No Ceará Reis HP1, Rodrigues JL2, Girao ES1, Pontes L3, Ponte G3 1UFC, Fortaleza, Brazil, 2Universidade Federal do Ceará, Fortaleza, Brazil, 3UNIMED Fortaleza, Fortaleza, Brazil
Objectives: Avaliar impacto farmacoeconômico do descalonamento de antimicrobianos (ATM) nos custos com estes medicamentos, durante a implementação de um programa de Gestão Clínica de ATM no cenário privado de saúde. Methods: Trata-se de um estudo transversal realizado em seis hospitais privados de Fortaleza/CE, através do time interdisciplinar de Auditoria de ATM do Programa Stewardship (STWDSP), entre janeiro/2015 a dezembro/2015. O descalonamento foi considerado quando infecção diagnosticada e início da terapia empírica de amplo espectro com posterior reorientação para um ATM de menor espectro direcionados pela cultura e Teste de Sensibilidade, bem como suspensão da terapia por não ser encontrada evidência infecciosa. As sugestões eram durante as visitas interdisciplinares do time de Auditoria com o médico assistente. O custo-minimizado teve como base o custo do tratamento do(s) ATM escolhido(s) inicialmente no tempo programado e valor real do custo/tratamento após a reorientação do ATM com o descalonamento. Foi utilizado o preço Brasíndice®. Aprovado pelo Comitê de Ética da Universidade de Fortaleza (N°252/2009). Results: foram realizadas 421 visitas para Auditoria de Antimicrobianos, sendo avaliados 989 planos terapêuticos anti-infecciosos com 1712 ATM envolvidos. Destes esquemas, 64% (632/989) eram monoterapia e 357 (36%) foram utilizados mais de um ATM, para cobertura antibacteriana mista. O time STWDSP identificou 121 oportunidades para descalonar, nas quais 65,3% oportunidades (79/121) foi sugerido retirar um dos ATM por não ter sido identificada infecção mista (Gram+ e Gram-). A adesão global para esta estratégia de otimização terapêutica foi de 84% (102/121). O custo-minimizado direto foi de R$168.047,82 (dos R$207.459,09 programados), com redirecionamento terapêutico e suspensão de ATM desnecessário. Conclusions: A adesão ao descalonamento neste estudo, utilizando o Stewardship como ferramenta de Gestão Clínica, promoveu uma reorientação específica da terapia antimicrobiana, diminuindo o espectro de ação da terapia empírica inicial, assim como evitou uso desnecessário destes medicamentos e, consequentemente, minimizou consideravelmente os custos com o tratamento. PIN39 Costo-Utilidad De La Vacunación Contra Varicela En Perú Bolaños-Díaz R1, Tejada RA1, Sanabria C2, Candela JL3 Nacional de Salud, Lima, Peru, 2Universidad Nacional Mayor de San Marcos, Lima, Peru, 3Instituto Nacional de Salud del Niño, Lima, Peru
1Instituto
Objectives: comparar la relación costo-utilidad de la vacunación contra varicela de niños de un año de edad frente a la no vacunación, para su inclusión en el programa nacional de inmunizaciones. Methods: desarrollamos un modelo de Markov desde la perspectiva del Ministerio de Salud del Perú. Consideramos un horizonte temporal de 40 años con ciclos de un año, una tasa de descuento del 3% y años de vida ajustados a la calidad (AVAC) como medida de utilidad. Los costos fueron calculados al 2017 en Soles (S/.). Calculamos la relación costo-efectividad incremental (ICER). Para evaluar la incertidumbre del modelo, realizamos análisis de sensibilidad bivariado y probabilístico mediante simulaciones de Monte Carlo. Consideramos un umbral de pago (UP) igual al 0,5 del producto bruto interno peruano per cápita (PIB pc) anual (S/. 10 000). Finalmente, calculamos la CU considerando un rango de UP entre 0,5 y 1,0 PIB pc. Utilizamos TreeAge 2015 para el análisis. Results: La no vacunación fue más costo-efectiva que la vacunación con un costo por AVAC de S/. 1,42 frente a S/. 2,51, respectivamente. El ICER para la vacunación fue S/. 73 016 por AVAC, con el 71% de las simulaciones en el cuadrante I por encima del límite de UP. El costo por año de vida salvado se estimó en S/. 31 602. La tasa de mortalidad por varicela, el costo de la vacunación, la tasa de descuento y la probabilidad de complicaciones son las variables más sensibles del modelo. Una reducción del 50% en el precio de la vacuna rendiría un ICER en el rango de 0,5-1,0 PBI pc. Conclusions: La vacunación contra varicela no es costo-efectiva en Perú como parte del esquema nacional de inmunizaciones. El costo de la vacuna y la probabilidad de muerte por varicela son las dos variables más influyentes en el modelo.
INFECTION – Patient-Reported Outcomes & Patient Preference Studies PIN40 Assessment of Hiv-Antiretroviral Adherence Using Refill Data From a National Administrative Database in Brazil dos Santos FM1, da Costa MR2 1IESC-UFRJ, Rio de Janeiro, Brazil, 2Faculty of Pharmacy, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil
Objectives: Adherence to highly active antiretroviral therapy (HAART) is crucial to HIV treatment effectiveness. The use of pharmacy refill data has become an increasingly important approach to measure adherence. Thus, administrative databases that contain such data could be especially useful. This is the case of SICLOM, the national
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system for logistic control of medicines of the Brazilian National STD/Aids Program. Despite its administrative nature, this system contains specific information about antiretroviral dispensation providing a unique data source for adherence assessment. This study aimed to assess HAART adherence among patients followed up in a public outpatient facility located in Rio de Janeiro city, Brazil, using pharmacy refill data obtained from SICLOM. Methods: All patients that initiated HAART in 2011 were included and followed up until December 2013. Data about dispensed medicines, including amounts and dates, and demographic data was obtained from SICLOM. Therapy adherence was estimated using the medication possession ratio (MPR) calculated as the ratio between the number of days covered by a refill and treatment duration in days. The number of days without medication (gaps) was also calculated. Results: The analysis included 82 patients. The average age was 36.2 ±10.1 years old and 85.4% were male. Most of the patients (65.9%) were followed up at public facilities. The medians of the gaps and MPR were 66.5 days (28.75-130) and 94.6% (87.997.4) respectively. MPR was lower than 95% for 54.9% of the patients. Conclusions: According to the World Health Organization, HIV patients should take more than 95% of antiretroviral prescribed doses. However, the fact that 54.9% of the patients presented a MPR lower than 95% suggests a high prevalence of HAART non-adherence. SICLOM showed to be a powerful data source for adherence studies that could provide useful information in order to improve HAART effectiveness. PIN41 Randomized Controlled Trial Evaluating the Effectiveness of Pictogram Intervention in Identification and Reporting Adverse Drug Reactions in Naïve Hiv Patients in Ethiopia Bhagavathula AS1, Gebreyohannes EA2, Abegaz TM3, Abebe TB2, Tegegn HG2, Belachew SA2 of Gondar- College of Medicine and Health Sciences, Gondar, Ethiopia, 2University of Gondar, Gondar, Ethiopia, 3University of Gondar-College of Medicine and Health Sciences, Gondar, Ethiopia
1University
Objectives: In this study, we sought to assess whether the pictorial intervention would help to identify and improve ADR reporting in an ART clinic serving HIV patients in Northwest Ethiopia. Methods: A randomized controlled study on ART-naïve HIV-positive patients was conducted from July 15, 2015 to January 15, 2016. The patients were randomly categorized into intervention and control groups based on their identification number. Interventional group were then subjected to receive pictorial medication information and pictograms-enhanced tool to identify and report ADRs. However, control group did not receive any pictogramenhanced intervention to identify the medications and to report ADRs. Results: Bivariate analysis showed that sociodemographic characteristics, age, sex, education, employment, and marital status were predictors of identifying and reporting ADRs. Males were twice more likely to identify ADRs than females. Univariate analysis revealed, intervention group showed a statistically significant association with the ability to identify ART medications using pictograms. Intervention group patients were more likely to identify 3TC [OR (95% CI)= 7.536 (4.042-14.021), p= 0.000], TDF [(OR (95% CI)= 6.250 (2.855-13.682), p= 0.000], NVP [(OR (95% CI)= 5.320 (1.954-14.484), p= 0.001], EFV [(OR (95% CI) = 3.929 (1.876-8.228), p= 0.000], and AZT [(OR (95% CI) = 3.570 (1.602-7.960), p= 0.002] using pictograms. Compared to control group, interventional group showed 4.3 times more likely to identify diarrhea as an ADR using pictogram. Conclusions: We found that the use of pictogram-based intervention for ART medications resulted in increased identification of ADRs and improved ADR reporting among naïve HIV-positive patients with limited literacy in Northwest Ethiopia. This intervention provided promising innovation with the potential implications to improve ADR reporting and promote patients safety, particularly for HIV-positive patients with limited educational levels.
INFECTION – Health Care Use & Policy Studies PIN42 Antibiotic Stewardship Policy in Biella General Hospital (Italy): A Five-Year Surveillance Ussai S1, D’Aloia F2, Lanzone L2, Frassati C2, Bonelli G2 University, Milan, Italy, 2Biella General Hospital, Biella, Italy
1Bocconi
Objectives: A retrospective study was designed to investigate i) prescription trends and antibiotic economic burden ii) microorganisms sensitivity at the Biella General Hospital from the year 2011 to 2016. Methods: Data were collected from official registry for prescriptions and economic burden. Sensitivity was obtained from the Microbiology Department of the Central Laboratory of the same hospital. Information regarding every single culture was collected, classified afterward according to bacteria strains and antibiotics sensitivity; results were used to build sensitivity charts along the studied period. Results: Amoxicillin-Clavulanic Acic (ACA) was the most consistently prescribed antibiotic, not only at the 1stplace of the chart from 2011 to 2016 but also keeping a growthing number of prescriptions (from 51.000 to 55.000 prescriptions/year) during the studied period. Along this time, ACA prescriptions associated costs decreased thanks to the management of public tenders (29.000€ in 2011 - 14.000€ in 2014). Other antibiotics on the top 5 ranking were fluoroquinolones, ceftriaxone and piperacillin-tazobactam. Due to its relatively low cost and broad spectrum, ACA is used to treat all kind of infections, from the airway to the urinary tract, including skin infections. It has shown a stable sensitivity pattern for Escherichia coli, Haemophilus parainfluenzae, Proteus Mirabilis, and even Streptococcus pneumoniae (p< 0.05). It’s worthy of note that the organism Klebsiella pneumonie moved from a 72% of sensitivity in 2012 to 97% in 2016, statistically significative (p value 0.03); this is probably due to a specific clinical policy, ie a better isolation of the patients exposed. According to the recent literature warnings, we observed an increasing tendency on resistance of Escherichia coli and Klebsiella species with extended-spectrum beta-lactamases (sensitivity less than 40%) and Staphylococcus aureus (below 60%). Conclusions: Antibiotic stewardship represents an important strategy to control inadequate antibiotic prescriptions and their consequences.
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PIN32 A Sistematic Review Of The Cost-Effectiveness Of Vaccinating Elderly With The 23-Valent Pneumococcal Polysaccharide Vaccine (Ppv23) Nishikawa AM1, Mainardi GM1, Novaes HM2, Sartori AM3, De Soarez PC4 1University of São Paulo, São Paulo, Brazil, 2University of Sao Paulo, Sao Paulo, Brazil, 3Sao Paulo University, São Paulo, Brazil, 4Universidade de São Paulo, São Paulo, Brazil
Objectives: To systematically review the available literature on cost-effectiveness of PPV23 in adults aged > 60 years. Methods: We searched the MEDLINE, LILACS, Bireme, Cochrane, EMBASE, NHSEDD and Centre for Reviews and Dissemination (CRD) databases for full economic evaluations of PPV23 published up to March 2016. Two independent reviewers screened the articles for relevance and extracted the data. Main study characteristics and methods (clinical and epidemiological data, cost and incremental cost-effectiveness ratios (ICERs) were extracted and compared. Costs were updated to US$2016. Results: Twenty-seven studies were reviewed. The studies were published from 1980 to 2016. Most were conducted in Europe and US (81.5%); three studies were conducted in Latin America (Brazil, 2; Colombia, 1). All studies compared VPP23 to not-vaccinating and three studies also compared VPP23 to pneumococcal conjugate 13-valent vaccine (PCV13). All studies used static models. Most use a lifetime (44.4%) or 5 to 6 year’s time horizon (33.3%). Just 3 studies considered herd protection from children immunization with PCV13 in the model. Most studies considered PCV23 cost-effective (less than US$50,000 per LYG or QALY) and sometimes cost-saving (results ranging from cost-saving to 101,670/QALY). Conclusions: This systematic review revealed that the costeffectiveness results have conflicting results, from cost-saving to not cost-effective at all. Assumptions regarding vaccine effectiveness, particularly for non-invasive pneumonia, and waning immunity varies greatly among different studies and impact the results. PIN33 Systematic Review Of Economic Evaluation Studies For Dengue Vaccine: How Valid Are The Results? De Soarez PC1, Silva AB1, Randi BA1, Novaes HM2, Sartori AM1 Paulo University, São Paulo, Brazil, 2University of Sao Paulo, Sao Paulo, Brazil
PIN35 An Economic Evaluation Of Single Tablet Regimens Of Antiretroviral Therapy For Treatment-Naitve Hiv-Infected Patients Chou C1, Terris-Prestholt F2, Miners A3 1Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan, 2London School of Hygiene and Tropical Medicine, London, UK, 3London School of Hygiene & Tropical Medicine, London, UK
Objectives: Antiretroviral therapy (ART) has considerably changed the life expectancy and life quality of HIV-infected patients. However, uprising epidemic of HIV infection and the new recommendation of early ART initiation cause a heavy financial burden. Cost-effectiveness of ART should consequently be considered. Single-tablet regimen (STR), one pill that contains a combination of multiple antiretroviral agents, is a recent advance in HIV treatment and widely used now. The objective of this study is to perform a cost-utility analysis of STR using a decision model to assess the cost-effectiveness of tenofovir disoproxil fumarate/ emtricitabine/rilpivirine (TDF/FTC/RPV) compared to tenofovir disoproxil fumarate/ emtricitabine/efavirenz (TDF/FTC/EFV) for asymptomatic, treatment-naïve HIVinfected patients. Methods: A Markov model with a hypothetical cohort of 1000 HIV-infected patients having initial viral load ≤ 100,000 copies/ml was designed. Quality-adjusted life year (QALY) was used as the health outcome and incremental cost-effectiveness ratio (ICER) comparing the two STRs was calculated. The willingness-to-pay (WTP) threshold of 70000USD was adopted. Most of the parameters in the model were considered stochastic, and the uncertainty was taken into account by deterministic sensitivity analysis (DSA) and probabilistic sensitivity analysis (PSA). Results: The calculated ICER per QALY was 13521.6USD. In terms of uncertainty, the ICER was sensitive to all parameters in the model. DSA showed that the most significant parameter of transition probability was the treatment efficacy of the two STRs. The utility in the first cycle and the costs of two STRs were also found influential. PSA demonstrated that the probability of cost-effectiveness was 61% at the WTP of 70000USD. Conclusions: The ICER per QALY (13521.6USD) of TDF/FTC/RPV to TDF/FTC/EFV comprised a relatively small fraction of the adopted WTP (70000USD), but there was significant uncertainty coming from the treatment efficacy and costs. TDF/FTC/RPV may be more cost-effective compared to TDF/FTC/ EFV for treatment-naïve HIV-infected patients.
1Sao
Objectives: To review the literature on economic evaluation of dengue vaccination to produce evidence to support a local cost-effectiveness study and to subsidize the decision to introduce a dengue vaccine in the Brazilian National Immunization Program (NIP). Methods: We systematically searched multiple databases (MEDLINE (via PubMed), EMBASE, SCOPUS, NHS Economic Evaluation Database (NHS EED), HTA Database (via Centre for Reviews and Dissemination CRD) and LILACS), selecting full HEEs of dengue vaccine. Two independent reviewers screened articles for relevance and extracted the data. The methodology for the quality reporting was assessed using CHEERS checklist. We performed a qualitative narrative synthesis. Results: Eight studies were reviewed. They were conducted in Asian and Latin America countries. All studies were favorable to the incorporation of the vaccine. However, the values and assumptions assumed for vaccine efficacy, safety and duration of protection, as well as the choice of the study population and the type of model used in the analyses, associated to an insufficient reporting of the methodological steps, affect the validity of the studies results. The quality reporting appraisal showed that the majority of the studies reported less than 50% of the CHEERS checklists’ items. Conclusions: This systematic review shows that the economic evaluation of dengue vaccination are not adherent to key recommended general methods for economic evaluation. The presented cost-effectiveness results should not be transferred to other countries. It is recommended to conduct studies with local epidemiological and cost data, as well as assumptions about vaccination that reflect the results observed in clinical trials. PIN34 Health Economic Analysis Of Pneumococcal Conjugated Vaccines For Mexico, Under A Technical Parity Scenario Gomez J1, Carreno Manjarrez R2, Cortes-Alcala R2, Olbrecht J3, DeAntonio R4 1GSK, Victoria, Argentina, 2GSK, Mexico, Mexico, 3GSK, Wavre, Belgium, 4GSK, Panama
City,
Panama
Objectives: To update the cost-effectiveness analysis of 2 Pneumococcal Conjugated Vaccines (PCV) (PCV-13 and PHiD-CV) previously published for Mexico, with a scenario of no superiority between them (“technical parity”) based on the recent systematic review about impact and effectiveness of these PCVs in children from 5 countries in Latin America (de Oliveira et al.,PLoS ONE, 2016, 11 (12): e0166736). Methods: Our previous cost-effectiveness & cost-utility analysis of implementing a PCV program in the Mexican pediatric population was completed with this new scenario of no superiority between PCVs on Invasive Pneumococcal Disease (IPD) and pneumonia in children less than 5 years of age. On this scenario, all original inputs remained the same, even the price parity between vaccines, but the vaccine effectiveness against IPD and pneumonia were considered equal between PCVs. The robustness of the conclusions was assessed through a sensitivity analysis that included all of the parameters considered by the model. Results: In this scenario, PHiD-CV was dominant over PCV-13 in the “cost-utility analysis”; generating more quality-adjusted life years at a lower cost and a lower incremental cost-utility ratio, based on a better profile against acute otitis media. On the “costeffectiveness analysis”, both vaccines generated equal number of life years gained, but PCV-13 at a higher cost. Although both vaccines produced equivalent health outcomes, in this scenario of technical parity against IPD and pneumonia between vaccines, the analysis predicted that PHiD-CV would save 367 / 422 million “2013 Mexican pesos” (discounted / undiscounted), per vaccinated cohort as compared with PCV-13. Conclusions: Even though PCV-13 and PHiD-CV were both costeffective when used to implement a pediatric vaccination campaign for Mexico, PHiD-CV had a better cost-utility / effectiveness profile based on the demonstrated differential effect against acute otitis media.
PIN36 Programa Stewardship: Otimizando A Terapia Antimicrobiana Com Eficiência Em Um Hospital De Ensino De Referência Em Fortaleza, Ceará Reis HP1, Castro K1, Andrade CC1, Neto JA1, Barros A1, Rodrigues JL2, Girao ES3, Pontes LB3, Pitta A2, Fonteles MM4, Ponciano AM1 1UFC, Fortaleza, Brazil, 2Universidade Federal do Ceará, Fortaleza, Brazil, 3HUWC, Fortaleza, Brazil, 4Federal University of Ceará, Fortaleza, Brazil
Objectives: determinar o custo evitado com antimicrobianos (ATM) através das estratégias de racionalização do Programa Stewardship (STWDSP) em um Hospital de ensino de referência no Ceará, Brasil. Methods: estudo prospectivo (follow-up) com dados de mundo real, realizado em um Hospital de referência de ensino em Fortaleza/CE, através do Programa Stewardship (STWDSP) de Gestão Clínica de ATM, entre novembro/2016 a janeiro/2017. Aplicou-se os pressupostos do Protocolo Stewardship da Sociedade Americana de Doenças Infecciosas (IDSA, 2016). Utilizou-se como fontes os prontuários e sistema informatizado da instituição (microbiológico e o logístico). As sugestões foram realizadas nas discussões interdisciplinares do time com o médico assistente. O custo-evitado teve como base o custo do total do esquema proposto inicial e o custo real após validada a estratégia STWDSP discutida. Foi utilizado o preço de cadastro do ATM institucional. Os dados eram registrados em um instrumento de monitorização de ATM contemplando parâmetros clínicos, da farmacoterapia antimicrobiana e microbiológicos. Aprovado pelo Comitê de Ética da Universidade Federal do Ceará Results: As estratégias selecionadas foram: Auditoria interdisciplinar e feedbacks; Protocolo de restrição para dispensação de ATM de reserva; Gestão do tempo de tratamento; Descalonamento; Switch therapy (terapia sequencial oral e Step down para Ertapenem) e Educação permanente. No período foram acompanhados 12 pacientes que usaram ATM reserva/estratégico (clínica médica, cardiologia e transplante renal). Média de idade 55 ± 17 anos, 67% do sexo masculino. A principal indicação foi para pneumonia hospitalar (52,63%). As estratégias mais efetivadas foram redução do tempo tratamento e terapia seqüencial oral. Houve um custo médio evitado de R$ 2.136,86/ paciente (29,58%). Conclusions: Neste trabalho o STWSDP mostrou ser uma eficiente ferramenta de Gestão Clínica, otimizando o uso de ATM, promovendo a interdisciplinaridade e reduzindo o custo dessa farmacoterapia. Sugere-se uma maior sensibilização de todos os envolvidos, especialmente o prescritor, para ampliação das estratégias de racionalização propostas. PIN37 Economic Evaluation Of Cobicistat-Boosted Darunavir In Hiv-Infected Patients In Mexico Guirant Corpi L, Olivares N, Fritz K, Aguirre A Janssen Mexico, Mexico City, Mexico
Objectives: Cobicistat (cobi) is a new booster alternative whose physicochemical properties allow the co-formulation with darunavir to obtain the fixed dose combination of darunavir/cobicistat 800/150 mg (DRV/cobi) in a single tablet per day. This analysis aims to present the economic evaluation of darunavir in a daily dose of 800 mg boosted with 150 mg of cobi or with 100 mg of ritonavir (rtv) in the Mexican context. Methods: A complete economic evaluation was carried out through a cost minimization analysis since DRV/cobi and darunavir boosted with rtv (DRV+rtv) have shown bioequivalence in published studies. The efficacy of DRV/cobi is directed only by darunavir as it is the component with antiviral activity; cobi works as an enhancer to achieve optimal concentrations of darunavir in blood. Therefore, the efficiency shown by DRV+rtv is extrapolated to DRV/cobi. The costs of the drugs to calculate the annual cost of treatment were obtained from published sources
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
(1USD = $ 19MXN). A deterministic sensitivity analysis was performed to test the robustness of the model. Results: DRV/cobi showed annual savings per patient of 9.5%. This savings are equivalent to the annual cost of treatment with ritonavir. The annual cost of treatment with DRV/cobi is $2,096 versus the annual cost of DRV+ rtv which is $2,316. The robustness of the analysis was confirmed by a sensitivity analysis on the DRV/cobi acquisition price. Conclusions: The fixed dose combination in one tablet per day of DRV/cobi is a cost-saving and convenient alternative in terms of supply and storage for the institutions in the public health sector in Mexico that use DRV+rtv. Additionally, DRV/cobi favors adherence in patients and decreases the probability of virological failure. PIN38 Descalonamento Da Terapia Antimicrobiana: Uma Estratégia De Racionalização E Custo-Minimização Em Cenário Privado De Saúde No Ceará Reis HP1, Rodrigues JL2, Girao ES1, Pontes L3, Ponte G3 1UFC, Fortaleza, Brazil, 2Universidade Federal do Ceará, Fortaleza, Brazil, 3UNIMED Fortaleza, Fortaleza, Brazil
Objectives: Avaliar impacto farmacoeconômico do descalonamento de antimicrobianos (ATM) nos custos com estes medicamentos, durante a implementação de um programa de Gestão Clínica de ATM no cenário privado de saúde. Methods: Trata-se de um estudo transversal realizado em seis hospitais privados de Fortaleza/CE, através do time interdisciplinar de Auditoria de ATM do Programa Stewardship (STWDSP), entre janeiro/2015 a dezembro/2015. O descalonamento foi considerado quando infecção diagnosticada e início da terapia empírica de amplo espectro com posterior reorientação para um ATM de menor espectro direcionados pela cultura e Teste de Sensibilidade, bem como suspensão da terapia por não ser encontrada evidência infecciosa. As sugestões eram durante as visitas interdisciplinares do time de Auditoria com o médico assistente. O custo-minimizado teve como base o custo do tratamento do(s) ATM escolhido(s) inicialmente no tempo programado e valor real do custo/tratamento após a reorientação do ATM com o descalonamento. Foi utilizado o preço Brasíndice®. Aprovado pelo Comitê de Ética da Universidade de Fortaleza (N°252/2009). Results: foram realizadas 421 visitas para Auditoria de Antimicrobianos, sendo avaliados 989 planos terapêuticos anti-infecciosos com 1712 ATM envolvidos. Destes esquemas, 64% (632/989) eram monoterapia e 357 (36%) foram utilizados mais de um ATM, para cobertura antibacteriana mista. O time STWDSP identificou 121 oportunidades para descalonar, nas quais 65,3% oportunidades (79/121) foi sugerido retirar um dos ATM por não ter sido identificada infecção mista (Gram+ e Gram-). A adesão global para esta estratégia de otimização terapêutica foi de 84% (102/121). O custo-minimizado direto foi de R$168.047,82 (dos R$207.459,09 programados), com redirecionamento terapêutico e suspensão de ATM desnecessário. Conclusions: A adesão ao descalonamento neste estudo, utilizando o Stewardship como ferramenta de Gestão Clínica, promoveu uma reorientação específica da terapia antimicrobiana, diminuindo o espectro de ação da terapia empírica inicial, assim como evitou uso desnecessário destes medicamentos e, consequentemente, minimizou consideravelmente os custos com o tratamento. PIN39 Costo-Utilidad De La Vacunación Contra Varicela En Perú Bolaños-Díaz R1, Tejada RA1, Sanabria C2, Candela JL3 Nacional de Salud, Lima, Peru, 2Universidad Nacional Mayor de San Marcos, Lima, Peru, 3Instituto Nacional de Salud del Niño, Lima, Peru
1Instituto
Objectives: comparar la relación costo-utilidad de la vacunación contra varicela de niños de un año de edad frente a la no vacunación, para su inclusión en el programa nacional de inmunizaciones. Methods: desarrollamos un modelo de Markov desde la perspectiva del Ministerio de Salud del Perú. Consideramos un horizonte temporal de 40 años con ciclos de un año, una tasa de descuento del 3% y años de vida ajustados a la calidad (AVAC) como medida de utilidad. Los costos fueron calculados al 2017 en Soles (S/.). Calculamos la relación costo-efectividad incremental (ICER). Para evaluar la incertidumbre del modelo, realizamos análisis de sensibilidad bivariado y probabilístico mediante simulaciones de Monte Carlo. Consideramos un umbral de pago (UP) igual al 0,5 del producto bruto interno peruano per cápita (PIB pc) anual (S/. 10 000). Finalmente, calculamos la CU considerando un rango de UP entre 0,5 y 1,0 PIB pc. Utilizamos TreeAge 2015 para el análisis. Results: La no vacunación fue más costo-efectiva que la vacunación con un costo por AVAC de S/. 1,42 frente a S/. 2,51, respectivamente. El ICER para la vacunación fue S/. 73 016 por AVAC, con el 71% de las simulaciones en el cuadrante I por encima del límite de UP. El costo por año de vida salvado se estimó en S/. 31 602. La tasa de mortalidad por varicela, el costo de la vacunación, la tasa de descuento y la probabilidad de complicaciones son las variables más sensibles del modelo. Una reducción del 50% en el precio de la vacuna rendiría un ICER en el rango de 0,5-1,0 PBI pc. Conclusions: La vacunación contra varicela no es costo-efectiva en Perú como parte del esquema nacional de inmunizaciones. El costo de la vacuna y la probabilidad de muerte por varicela son las dos variables más influyentes en el modelo.
INFECTION – Patient-Reported Outcomes & Patient Preference Studies PIN40 Assessment of Hiv-Antiretroviral Adherence Using Refill Data From a National Administrative Database in Brazil dos Santos FM1, da Costa MR2 1IESC-UFRJ, Rio de Janeiro, Brazil, 2Faculty of Pharmacy, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil
Objectives: Adherence to highly active antiretroviral therapy (HAART) is crucial to HIV treatment effectiveness. The use of pharmacy refill data has become an increasingly important approach to measure adherence. Thus, administrative databases that contain such data could be especially useful. This is the case of SICLOM, the national
A933
system for logistic control of medicines of the Brazilian National STD/Aids Program. Despite its administrative nature, this system contains specific information about antiretroviral dispensation providing a unique data source for adherence assessment. This study aimed to assess HAART adherence among patients followed up in a public outpatient facility located in Rio de Janeiro city, Brazil, using pharmacy refill data obtained from SICLOM. Methods: All patients that initiated HAART in 2011 were included and followed up until December 2013. Data about dispensed medicines, including amounts and dates, and demographic data was obtained from SICLOM. Therapy adherence was estimated using the medication possession ratio (MPR) calculated as the ratio between the number of days covered by a refill and treatment duration in days. The number of days without medication (gaps) was also calculated. Results: The analysis included 82 patients. The average age was 36.2 ±10.1 years old and 85.4% were male. Most of the patients (65.9%) were followed up at public facilities. The medians of the gaps and MPR were 66.5 days (28.75-130) and 94.6% (87.997.4) respectively. MPR was lower than 95% for 54.9% of the patients. Conclusions: According to the World Health Organization, HIV patients should take more than 95% of antiretroviral prescribed doses. However, the fact that 54.9% of the patients presented a MPR lower than 95% suggests a high prevalence of HAART non-adherence. SICLOM showed to be a powerful data source for adherence studies that could provide useful information in order to improve HAART effectiveness. PIN41 Randomized Controlled Trial Evaluating the Effectiveness of Pictogram Intervention in Identification and Reporting Adverse Drug Reactions in Naïve Hiv Patients in Ethiopia Bhagavathula AS1, Gebreyohannes EA2, Abegaz TM3, Abebe TB2, Tegegn HG2, Belachew SA2 of Gondar- College of Medicine and Health Sciences, Gondar, Ethiopia, 2University of Gondar, Gondar, Ethiopia, 3University of Gondar-College of Medicine and Health Sciences, Gondar, Ethiopia
1University
Objectives: In this study, we sought to assess whether the pictorial intervention would help to identify and improve ADR reporting in an ART clinic serving HIV patients in Northwest Ethiopia. Methods: A randomized controlled study on ART-naïve HIV-positive patients was conducted from July 15, 2015 to January 15, 2016. The patients were randomly categorized into intervention and control groups based on their identification number. Interventional group were then subjected to receive pictorial medication information and pictograms-enhanced tool to identify and report ADRs. However, control group did not receive any pictogramenhanced intervention to identify the medications and to report ADRs. Results: Bivariate analysis showed that sociodemographic characteristics, age, sex, education, employment, and marital status were predictors of identifying and reporting ADRs. Males were twice more likely to identify ADRs than females. Univariate analysis revealed, intervention group showed a statistically significant association with the ability to identify ART medications using pictograms. Intervention group patients were more likely to identify 3TC [OR (95% CI)= 7.536 (4.042-14.021), p= 0.000], TDF [(OR (95% CI)= 6.250 (2.855-13.682), p= 0.000], NVP [(OR (95% CI)= 5.320 (1.954-14.484), p= 0.001], EFV [(OR (95% CI) = 3.929 (1.876-8.228), p= 0.000], and AZT [(OR (95% CI) = 3.570 (1.602-7.960), p= 0.002] using pictograms. Compared to control group, interventional group showed 4.3 times more likely to identify diarrhea as an ADR using pictogram. Conclusions: We found that the use of pictogram-based intervention for ART medications resulted in increased identification of ADRs and improved ADR reporting among naïve HIV-positive patients with limited literacy in Northwest Ethiopia. This intervention provided promising innovation with the potential implications to improve ADR reporting and promote patients safety, particularly for HIV-positive patients with limited educational levels.
INFECTION – Health Care Use & Policy Studies PIN42 Antibiotic Stewardship Policy in Biella General Hospital (Italy): A Five-Year Surveillance Ussai S1, D’Aloia F2, Lanzone L2, Frassati C2, Bonelli G2 University, Milan, Italy, 2Biella General Hospital, Biella, Italy
1Bocconi
Objectives: A retrospective study was designed to investigate i) prescription trends and antibiotic economic burden ii) microorganisms sensitivity at the Biella General Hospital from the year 2011 to 2016. Methods: Data were collected from official registry for prescriptions and economic burden. Sensitivity was obtained from the Microbiology Department of the Central Laboratory of the same hospital. Information regarding every single culture was collected, classified afterward according to bacteria strains and antibiotics sensitivity; results were used to build sensitivity charts along the studied period. Results: Amoxicillin-Clavulanic Acic (ACA) was the most consistently prescribed antibiotic, not only at the 1stplace of the chart from 2011 to 2016 but also keeping a growthing number of prescriptions (from 51.000 to 55.000 prescriptions/year) during the studied period. Along this time, ACA prescriptions associated costs decreased thanks to the management of public tenders (29.000€ in 2011 - 14.000€ in 2014). Other antibiotics on the top 5 ranking were fluoroquinolones, ceftriaxone and piperacillin-tazobactam. Due to its relatively low cost and broad spectrum, ACA is used to treat all kind of infections, from the airway to the urinary tract, including skin infections. It has shown a stable sensitivity pattern for Escherichia coli, Haemophilus parainfluenzae, Proteus Mirabilis, and even Streptococcus pneumoniae (p< 0.05). It’s worthy of note that the organism Klebsiella pneumonie moved from a 72% of sensitivity in 2012 to 97% in 2016, statistically significative (p value 0.03); this is probably due to a specific clinical policy, ie a better isolation of the patients exposed. According to the recent literature warnings, we observed an increasing tendency on resistance of Escherichia coli and Klebsiella species with extended-spectrum beta-lactamases (sensitivity less than 40%) and Staphylococcus aureus (below 60%). Conclusions: Antibiotic stewardship represents an important strategy to control inadequate antibiotic prescriptions and their consequences.