Plaque Psoriasis In Bulgaria: Comparative Analysis and Health Technology Assessment

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Objectives: To perform a cost-effectiveness analysis of pirfenidone (PFN) versus nintedanib (NDB) on the treatment of idiopathic pulmonary fibrosis (IPF) under the Brazilian private healthcare system perspective.  Methods: Model results were expressed in a lifetime time horizon. Outcomes were quality-adjusted life years (QALY), progression free survival (PFS) and life years (LY) gained. Treatment’s ex-factory prices were obtained from official published lists, by the Brazilian Ministry of Health, considering the incidence of taxes (ICMS 18%). Costs related to disease management, lung transplantation and end-of-life were calculated thru microcosting (resource use was set after a review of the published literature and costs were attributed from official sources). Efficacy data (time to treatment discontinuation, overall and progression free survival) for PFN were extracted from pooled CAPACITY 1 + 2 and ASCEND trials and projected to a lifetime time horizon thru a parametric distribution (Weibull). NDB’s data were, then, extrapolated from PFN thru an indirect treatment comparison (ITC), whose calculated treatment effects were used to estimate NDB efficacy outcomes. A probabilistic sensitivity analysis (PSA) was performed to validate model results.  Results: PFN and NDB unitary costs were BRL 9,144 (BRL 33.87 per 267 mg tablet) and BRL 14,916 (BRL 248.60 per 150 mg tablet), respectively, according to their list prices. PFN and NDB showed a total cost of BRL 311,158 and BRL 508,203 (PFN-NDB =  -BRL 197,045), respectively, on a lifetime time horizon. PFN outperformed NDB on all outcomes, showing incremental results of 0.47 QALY, 0.81 LY and 0.40 PFS gained when compared to NDB. Overall, PFN was dominant on all outcomes when compared to NDB. The majority of the simulations (77%) on the PSA were located on the 4th quadrant corroborating base case results.  Conclusions: PFN is dominant and can potentially reduce treatment costs associated with the treatment of IPF when compared to NDB. PSY25 Costo-Efectividad De La Cirugía Bariátrica En Colombia Gil-Rojas Y1, Lasalvia P1, Hernández F2, Garzón A3, Andrade PC4, Rosselli D3 Universidad Javeriana, Bogota, Colombia, 2NeuroEconomix, Bogota, Colombia, 3Pontificia Universidad Javeriana, Bogotá, Colombia, 4Johnson & Johnson Medical, Bogotá, Colombia 1Pontificia

Objectives: La obesidad tiene una alta carga de la enfermedad, principalmente por múltiples factores de riesgo cardiovascular. Se estima que 16,5% de la población adulta colombiana presenta obesidad (IMC≥ 30). Los tratamientos incluyen intervenciones nutricionales, promoción de actividad física, tratamiento farmacológico y cirugía bariátrica, que ha mostrado ser la mejor alternativa para obesidad mórbida con mejora o resolución de más de 30 condiciones relacionadas con la obesidad. Estimar la costo-efectividad de la cirugía bariátrica comparada con tratamiento médico no quirúrgico en pacientes obesos con riesgo cardiovascular desde la perspectiva del sistema de salud colombiano.  Methods: Se emplearon árboles de decisión, modelos Markov, combinación de árboles de decisión con modelos Markov y simulación por eventos discretos. Se modelaron pacientes con comorbilidades como diabetes mellitus, hipertensión arterial, dislipidemias y apnea del sueño. La cirugía bariátrica fue comparada con tratamiento convencional no quirúrgico en pacientes > 18 años, IMC= 40kg/m2 o 35> IMC> 40kg/m2 con comorbilidades. Fueron considerados los costos directos desde la perspectiva del tercero pagador, horizonte temporal 5 años, tasa de descuento de 5%, con análisis de sensibilidad determinístico y probabilístico. Umbral 3 PIB per cápita, aprox COP 50 millones.  Results: La cirugía bariátrica es dominante en pacientes con apnea (efectividad incremental 0,354 QALY) es más costo-efectiva en pacientes con diabetes (RCEI 6.194.899, efectividad incremental 0,449 QALY) o hipertensión (RCEI 43.689.527), y es dominada en pacientes con dislipidemia. Análisis de sensibilidad no modifican resultados.  Conclusions: De acuerdo al estudio, en pacientes obesos con apnea de sueño o diabetes, la cirugía báriatrica es una alternativa recomendable por ser dominante o costo-efectiva, respectivamente, y en pacientes con hipertensión puede ser una alternativa conveniente para el sistema de salud colombiano. PSY26 The Cost Effectiveness of Oxycodone In Patients Who Do Not Respond To Morphine From The Brazilian Public Health System Perspective Souza DA1, Aguiar EC1, Miguel AK2, Rosim RP2, Ballalai Ferraz AF2 1Mundipharma, São Paulo, Brazil, 2QuintilesIMS, São Paulo, Brazil

Objectives: There are only two strong opioids available in the Brazilian public healthcare system (SUS): morphine and methadone, which may lead to a small range of therapeutic options, therefore poor pain management in oncologic patients. This study aims to calculate the cost-effectiveness of oxycodone versus morphine for patients who had not responded to morphine from the Brazilian public payer perspective.  Methods: For calculating the cost-effectiveness of oxycodone versus morphine, we built a cost-per-responder model, which considered only drug-related costs, since the drugs have no differences in terms of drug administration cost (both drugs are orally administered) and studies did not reported differences in terms of costly adverse events between morphine and methadone. Morphine’s price was obtained through search in the Brazilian official drug prices database (BPS). Mean prices per tablet are BRL (Brazilian Reais) 0.31 and BRL 0.87 for 10 mg and 30 mg presentations, respectively. Oxycodone´s price was assumed to be the one submitted for Brazilian HTA agency (CONITEC): BRL 6.71, BRL 12.03 and BRL 20.47 per tablet for 10 mg, 20 mg and 40 mg presentations, respectively. Posologic regimens were obtained in the labels approved by the Brazilian drug regulator (ANVISA). Efficacy data was obtained through the clinical trial published by Narabayashi and colleagues.  Results: The calculated number needed to treat (NNT) for oxycodone versus morphine was 1.27. The cost-effectiveness model of oxycodone versus morphine resulted in five thousand BRL per responder.  Conclusions: Despite lack of official willingness-to-pay threshold, oxycodone seems to be a cost-effective option, given BRL 5k certainly is a low value considering health benefits derived from pain management in suffering and frequently end-of-life patients.

PSY27 Plaque Psoriasis In Bulgaria: Comparative Analysis and Health Technology Assessment Djambazov S, Vekov T Medical University Pleven, Pleven, Bulgaria

Objectives: The aim of this study is evaluation of incremental costs, incremental health benefits and the incremental ratio (ICER) of biologic drug therapies used for treatment of plaque psoriasis (PP) in Bulgaria by transferring and adapting data from health technology assessments, conducted in other countries.  Methods: We conducted a systematic review of published data from health technology assessments used for treatment of PP. We used the following databases - MEDLINE, EMBASE, Web of science, Cochrane Library. Publications search covered the period January 2006 – December 2015.  Results: The adapted economic results in Bulgaria showed that SEC is cost-effective therapy, compared to all other biologic drug alternatives for treatment of PP - secukinumab is superior to ustekinumab, secukinumab vs. infliximab (ICER 3173 BGN/QALY), secukinumab vs. adalimumab, (ICER 5657 BGN/ QALY), secukinumab vs. etanercept (ICER 17 BGN/QALY), if we consider a costeffectiveness threshold of three times GDP per capita in Bulgaria (WTPth 36 221 BGN, 2015).  Conclusions: The analysis and evaluation of the alternative biologic therapies used for treatment of plaque psoriasis in Bulgaria showed that, based on the HTA analysis secukinumab could be recommended as a first choice in third therapeutic line in adults with moderate to severe PP (PASI ≥  12, IGAmod 2011 – 3/4, BSA ≥  10%) after failure of local therapy, phototherapy and conventional systemic therapy (cyclosporine, methotrexate, acitretin). PSY28 Cost-Minimization of Adalimumab and Infliximab In Patients With Moderate To Severe Ulcerative Colitis Refractory To Conventional Therapy Jones K1, Rivera Hurtado R2, Ruet E2, Chaves L3, Izquierdo C3, Monroy Cruz B1, Gay Molina JG4, Gonzalez Godinez I4 1ti Salud, Mexico City, Mexico, 2Abbvie, Mexico City, Mexico, 3AbbVie Inc., North Chicago, IL, USA, 4T.I. Salud, Mexico D.F., Mexico

Objectives: Given the similar profiles of efficacy and safety between adalimumab and infliximab, this study aim to conduct a cost-minimization analysis comparing them for moderate to severe ulcerative colitis (UC) refractory to conventional therapy from a payer perspective in Mexico.  Methods: A decision tree model was constructed to assess the incremental cost of adalimumab versus infliximab over a 1-year period. Efficacy and safety data were obtained through a systematic literature review of 5 meta-analysis published between 2006-2016. Treatment was divided into induction and maintenance phases. All patients were assumed to complete induction; patients were then treated in the maintenance phase according to initial treatment response:1) Primary treatment failure, resulting in surgery, 2) Controlled UC on initial dose and 3) Controlled UC with medical action following secondary loss of response. Medical action was defined as dose escalation or biologic switch (infliximab/adalimumab). In the base case, all patients had dose escalation when experiencing secondary loss of response to infliximab or adalimumab. Two scenario analyses were conducted for action to secondary loss of response: 1) all patients switched biologic and 2) patients had either dose escalation or biologic switch. Direct costs were estimated based on public prices and no discount rate was applied; drug wastage impact was analyzed. An indifference point analysis was conducted by varying patient weight (base case: 77kg).  Results: Adalimumab showed savings of 7,017 MXN, 7,462 MXN and 21,113 MXN per patient for the base case and scenarios 1 and 2 respectively, and of 1,102 MXN, 1,542 MXN and 16,287 MXN, respectively, when considering no drug wastage. The results were sensitive to patient weight, acquisition costs, and drug wastage. The cost indifferent point was 71 kg.  Conclusions: The model demonstrated that adalimumab is a cost-minimizing option when used as the initiation biologic for patients refractory to conventional therapy. PSY29 Estudio De Costo Efectividad Del Factor De Coagulación Recombinante VIII Unido A Proteina Fc Para El Tratamiento De La Hemofilia A En Chile Vargas C1, Balmaceda 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

1Pontificia

Objectives: Estimar la costo-efectividad del uso profiláctico del FVIII recombinante unido a la proteína Fc (rFVIIIFc), FVIII recombinante (rFVIII), FVIII plasmático (pdFVIIIprof) versus FVIII plasmático con esquema a demanda en mayores de 15 años (caso basal Chileno) (pdFVII-CL) en pacientes diagnosticados con Hemofilia A desde la perspectiva del sistema de salud público chileno.  Methods: Se construyó un modelo de Markov de dos estados: vivo o muerto. La probabilidad de muerte está determinada por la tasa de mortalidad de la población chilena. Un paciente vivo puede presentar episodios de sangrado determinadas por el efecto de tratamiento de las alternativas evaluadas y medido como tasa anual de sangrado. Esta se obtuvo desde una comparación indirecta de los tratamientos. Se modelo una cohorte hipotética de pacientes de 6 años asumiendo un tiempo horizonte de 73 años. Costos y beneficios esperados fueron medidos en pesos chilenos (1USD= CLP$676,83) y en años de vida ajustados por calidad (QALYs) respectivamente. Se asumió una tasa de descuento indiferenciada de un 3%. Se realizó un análisis de sensibilidad probabilístico para capturar la incertidumbre de segundo orden.  Results: El pdFVIII-prof versus pdFVIII-CL fue costo-efectivo, mientras que el rFVIII fue dominado extendidamente por rFVIIIFc y pfFVIII-prof. El beneficio y costo incremental de rFVIIIFc versus pdFVIII-prof fue de 0,79 QALYs y USD$15.297.544 respectivamente. El ICER estimado fue de USD$19.376.274/QALY con un 0% de probabilidad de costo-efectividad al umbral sugerido de 3xPIB per cápita. El pdFVIII-prof acumuló 4,18 QALYs más que pdFVIII-CL, pero su costo incremental fue mayor por lo que no fue costo-efectivo al umbral determinado.  Conclusions: rFVIIIFc es la alternativa que más QALY produce, aunque marginal cuando se compara