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j.jval.2017.08.2722

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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 versus pdFVIII-prof. Su elevado costo resulta en un ICER sobre el umbral sugerido. Sin
embargo, el beneficio incremental de la profilaxis versus pdFVIII-CL es muy importante traduciéndose en un menor ICER.
PSY30
Cost-Utility Analysis of Tapentadol Prolonged Release Versus
Oxycodone Controlled Release In The First-Line Treatment of
Moderate To Severe Chronic Pain Under The Perspective of The
Colombian Subsidized Public Healthcare System
Lemmer T1, Piedade A1, Engel T1, Sales L1, Martinez C2, Marcondes L2, Fernandez D3,
Rojas S3, Mojica C3, Velasquez C3, Bustos J3, Arteaga A2
1Evidências - Kantar Health, São Paulo, Brazil, 2Grünenthal, Ciudad de México, Mexico,
3Grünenthal, Bogotá, Colombia
Objectives: To evaluate the cost-utility of tapentadol prolonged release (PR) compared with oxycodone controlled release (CR) in the treatment of moderate to severe
chronic pain under the perspective of the subsidized public healthcare system in
Colombia. Methods: Two systematic reviews were performed, one including
randomized controlled trials (RCTs) and another including meta-analyses. Both
compared efficacy and safety of tapentadol PR with placebo or active comparators
in moderate to severe chronic pain. Efficacy and safety data were selected and
oxycodone CR was included as comparator. For second-line treatment, buprenorphine transdermal (TD), fentanyl TD and hydromorphone were considered. Based
on published cost-utility analyses, a Markov model was developed consisting of nine
health states simulating treatment lines, adverse events (AE) and discontinuations
due to AE or lack of treatment effect. Time horizon was 52 weeks with weekly cycles.
Transition probabilities were extracted from meta-analyses and published economic
analyses. Adverse events rates were retrieved from clinical trials and meta-analyses.
Mean dosage for tapentadol was obtained from an observational study, equianalgesic rates were used to obtain other drugs dosages. A 3-weeks titration was considered. Benefits were measured in quality-adjusted life-years (QALYs). A Delphi panel
estimated resource use and switch rates. Direct costs were obtained from public
sources; no discount rate was applied. Values were expressed in 2016 COP. One-way
and probabilistic sensitivity analyses were performed. Results: Incremental QALYs
of tapentadol PR versus oxycodone CR were 0.023 QALYs, resulting in incremental
cost-effectiveness ratio (ICER) of COP$ 54,646,972.80. For willingness-to-pay thresholds of 1 GDP per capita (COP$24,940,164) and 3 GDP (COP$74,820,493.94), respectively 52.7% and 78.3% of tapentadol PR results were cost-effective. Most sensitive
parameter was tapentadol PR 100 mg drug costs and tolerable adverse events utilities. Conclusions: Tapentadol PR may be a cost-effective option for moderate to
severe chronic pain treatment in Colombian subsidized public healthcare system.
PSY31
Estudio De Costo Efectividad Del Factor De Coagulación
Recombinante IX Unido A Proteina Fc Para El Tratamiento De La
Hemofilia B En Chile
Balmaceda C1, Vargas C1, Rodriguez F2, Rojas R1, Espinoza MA3
Universidad Catolica de Chile, Santiago, Chile, 2Universidad San Sebastián, Santiago,
Chile, 3e Investigador Visitante Honorario, Centro para la Economía de Salud, Universidad de York,
York, UK
A895
October 2016. Randomized, controlled trials of various antioxidant supplements that
used for the treatment of DN with enough data were included for MA. Two reviewers
independently extracted data and assessed the study quality. All statistical analyses were performed using RevMan v.5.3. Results: Eleven studies were identified
that evaluated the protective efficacy of antioxidant against DN were identified.
Antioxidant showed significant improvement in kidney function in DN. The pooled
odds ratio from various cross-sectional studies was 1.62 (95% confidence interval,
1.64-2.23; p = 0.003), indicating a significant inverse association between serum antioxidant status and risk for DN. The strength of evidence was insufficient for comparisons of the need for renal replacement, and mortality. The significant variability
in findings on antioxidant efficacy against DN may reflect a lack of uniformity in
the study methodologies and the limited number of clinical trials. Conclusions:
The findings of the reviewed studies show promise in preventing DN with the use
of antioxidant. Nonetheless, based on the currently available evidence, no recommendations for clinical practice can be made at this time. Additional high-quality
studies are needed to establish appropriate recommendations.
PUK2
Efficacy Of Antioxidant Supplements On Prevention And
Amelioration Of Cisplatin-Induced Nephrotoxicity: A Systematic
Review And Meta-Analysis Of Randomized Controlled Trials
Kandhare AD, Mukherjee A
Poona College of Pharmacy, Bharati Vidyapeeth Deemed University, Pune, Maharashtra, India
Background: Various antioxidant has been studied clinically for reducing
CIN. Objectives: To assess the efficacy of antioxidant supplements in the prevention of CIN (CIN). Methods: MEDLINE, EMBASE, Cochrane Library, Clinical-Trials.
gov, and Scopus databases through November 2016. Randomized, controlled trials of
various antioxidant supplements that used for the treatment of CIN with enough data
for meta-analysis. The risk of bias and overall strength of evidence of studies were
assessed. Two reviewers independently extracted data and assessed study quality. All
statistical analyses were performed using RevMan v.5.3. Results: A total of 13 studies
(including 8 randomized, controlled trials) met the selection criteria for evaluating the
protective efficacy of antioxidant against CIN. There was a significantly improvement
in kidney function among the antioxidant recipients, compared with control subjects
(mean difference in calculated creatinine clearance, 2.95 mL/min; 95% confidence
interval [CI], 1.15–4.77mL/min), as well as a reduced risk of acute renal failure (risk
difference, 0.5%; 95% CI, 0.15–0.98). The strength of evidence was generally insufficient
for comparisons of the need for renal replacement, and mortality. The significant variability in findings on antioxidant efficacy against CIN may reflect a lack of uniformity
in the study methodologies and the limited number of clinical trials. Limitation:
Too few studies were done in patients receiving antioxidant treatment for CIN.
Thus, a number of randomized clinical trials are needed on antioxidant efficacy
against CIN. Conclusions: The findings of the reviewed studies show promise in
preventing CIN with the use of antioxidant. Nonetheless, based on the currently
available evidence, no recommendations for clinical practice can be made at this time.
1Pontificia
Objectives: Estimar la costo-efectividad del uso profilactico FIX recombinante unido
a proteína Fc (rFIXFc), FIX recombinante (rFIX), FIX plasmático (pdFIX-prof) versus
FIX plasmático con esquema a demanda en mayores de 15 años (caso basal chileno)
(pdFIX-CL) en pacientes diagnosticados con Hemofilia B desde la perspectiva del
sistema de salud público Chileno. Methods: Se construyó un modelo de Markov
de dos estados: vivo o muerto. Mientras un paciente viva puede presentar eventos
de sangrados determinados por la tasa de sangrado anual determinadas desde una
comparación indirecta de los tratamientos evaluados. La probabilidad de muerte está
determinada por la tasa de mortalidad de la población chilena. Los costos y beneficios
esperados fueron medidos en pesos chilenos (1USD= CLP$676,83) y años de vida
ajustados por calidad (QALYs), respectivamente. Se modelo una cohorte hipotética
de pacientes de 6 años en un tiempo horizonte de 73 años. La tasa de descuento
no diferenciada fue de 3%. Se realizó un análisis de sensibilidad probabilístico para
capturar la incertidumbre de segundo orden. Results: El pdFIX-CL fue dominado
por pdFIX-prof, mientras que el rFIX fue dominado extendidamente por rFIXFc. El
beneficio incremental rFIXFc versus pdFIX-prof fue de 0,28 QALYs y el costo incremental estimado de USD$8.897.537.071. El ICER estimado fue de CLP$31.868.630.443/
QALY, donde la probabilidad de ser costo efectivo al umbral definido de 3xPIB per
cápita fue de 0%. Por otro lado, el pdFIX-prof fue costo efectivo por sobre el pdFIX-CL,
acumulando 5,14 QALYs más que pdFIX-CL y estimando un menor costo incremental. Conclusions: rFIXFc fue la alternativa que más beneficios acumulo, aunque
marginales en comparación a pdFVIII-prof. rFIXFc no fue costo-efectivo al umbral
sugerido dado su elevado costo. Sin embargo, el beneficio incremental de la profilaxis
versus pdFIX-CL es muy importante traduciéndose en un menor ICER.
Urinary/Kidney Disorders – Clinical Outcomes Studies
PUK1
Efficacy Of Antioxidant Supplements On Prevention And
Amelioration Of Diabetes-Induced Nephropathy: A Systematic
Review And Meta-Analysis Of Randomized Controlled Trials
Mukherjee A, Kandhare AD, Bodhankar SL
Poona College of Pharmacy, Bharati Vidyapeeth Deemed University, Pune, Maharashtra, India
Background: Nephropathy is one of the major complications of diabetes often
leading to chronic kidney disease (CKD). An array of antioxidant has been effectively
used in patients with CKD. Objectives: The objectives of this systematic review
and meta-analysis (MA) was to assess the efficacy of antioxidant supplements in the
prevention of DN. Methods: A systematic literature search of MEDLINE, EMBASE,
Cochrane Library, Clinical-Trials.gov, and Scopus databases was conducted through
URINARY/KIDNEY DISORDERS – Cost Studies
PUK3
Cost Analysis of Pre-Dialysis: A Model in the Brazilian context
Moraes Jr CS, Colugnati F, Bastos MG
Federal University of Juiz de Fora, Juiz de Fora, Brazil
Objectives: To present the results of an analysis of cost per patient per year considering the direct costs of an organisational system that provides monitoring services
and prevention of pre-dialysis. Methods: The study population was defined as
being the ambulatory clinical centre (ACC) patients with CKD, which was divided
into four subgroups categorised according to additional morbidities, namely arterial
hypertension (AH) and/or diabetes mellitus (DM). For costs, there are initiatives from
the Ministry of Health (MH) in Brazil. In its manual for the National Program of Cost
Management (ref. 2006), the ministry highlighted the importance of establishing
methodological criteria for funding to obtain data on health expenditures. The cost
estimation was conducted by employing the reciprocal allocation method, valuing
the economic classification of costs criteria. To estimate the variability of costs,
given the possible fluctuations of both the demand and the expenses, a Monte Carlo
simulation was performed with 100,000 iterations, using the licensed software @
RISK v.7.5.1. These data were used for the calculation. Therefore, all previous values
to December 2014 were adjusted for December 2016. Results: The simulated total
costs per patient per year for the ACC averaged between US$ 316.11 (SD= US$169.45)
for CKD and US$1,349.99 (SD= US$520.76) for CKD+AH+DM. The study shows that the
subgroup with greater cost to the ACC (CKD+AH+DM) was between US$434.74 and
US$2,464.86 per patient per year. Conclusions: the ACC provides micro-regional
health coverage for prevention and monitoring of chronic non-communicable diseases and, in the context of the presented results, it is possible to expand the study
model to obtain cost variations from operations in different Brazilian regions. This
would deliver more accurate and relevant information for budget distribution, and
help solve the dilemmas of public spending efficiency problems in health care in a
very large country with distinct regional characteristics.
PUK4
Estudio De Costo- Consecuencia De Darbepoetina Alfa Para EL
Tratamiento De Anemia Sintomática Derivada De La Enfermedad
Renal Crónica En Colombia
Vargas-Valencia J1, Garcia Perlaza J2, Perez M2
Consulting, Mexico, Mexico, 2AMGEN, Bogotá, Colombia
1Econopharma
Objectives: Evaluar el uso de darbepoetina alfa (DA) vs. epoetina beta (EB) para
el tratamiento de anemia sintomática derivada de la enfermedad renal crónica en
pacientes con Hemodiálisis (HD) o Diálisis Peritoneal (DP), desde la perspectiva del
sistema de salud Colombiano. Methods: Con un árbol de decisión se estimó el
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