Obinutuzumab vs. Ibrutinib in the Treatment of Treatment-Naïve Patients with Chronic Lymphocytic Leukemia —A Cost-Comparison Study in Colombia

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82 patients followed by 24 months. The highest cost was found in the patients with MELD 29-32 (US$ 16,5575.74 ± 12,651.51) followed by those with MELD > = 33 (US$ 15,811.85 ± 16,836.09). In the same way, the inpatient and outpatient care were more expensive in the patients with MELD > = 30 (US$ 13,783.65 ± 16,836.09) and MELD 29 - 32 (US$ 6,073.01 ± 4,939.78), respectively. The inpatient costs were responsible for 70,59% of the total expenditure, while medicines accounted for 20,87% and the human resources 17,97%. Procedures directly related to hepatocellular carcinoma were the most expensive resources, reaching 21,28% of the total cost, being TACE (Trans arterial chemo-embolization) 11,8% and RFA (Radio-Frequency Ablation) 9,48% the main cost drivers.  Conclusions: The cost of HCC patient increases as increases the severity of the disease. Inpatient and procedures related to HCC such as TACE and RFA seem to be the main causes of the high cost to this patient and to the healthcare system. PCN25 Obinutuzumab vs. Ibrutinib in the Treatment of Treatment-Naïve Patients with Chronic Lymphocytic Leukemia —A Cost-Comparison Study in Colombia Vecino-Ortiz A1, Díaz-Sotelo OD2, Rodríguez M3, Diaz-Toro YR4, Moreno-Silva NA4 de los Andes, Bogota, Colombia, 2Random Foundation, Bogota, Colombia, 3Fundación Santa Fe de Bogotá, Bogota, Colombia, 4Productos Roche S.A. Colombia, Bogotá, Colombia 1Universidad

Objectives: To carry out a cost-comparison evaluation of treating Colombian unfit patients with chronic lymphocytic leukemia (CLL) with Obinutuzumab vs. Ibrutinib from both a third-party payer and a social perspective, in the first two years of treatment.  Methods: We carried out a deterministic cost-comparison analysis evaluating the treatment of unfit patients with CLL using Obinutuzumab vs. Ibrutinib in the first two years of treatment. We included both direct and indirect costs (lost wage for caregiver and transport) in this analysis by using a micro-costing strategy. Drug costs were obtained from the Ministry of Health Drug Price System Information and procedures costs came from SOAT-2016. Resource utilization was obtained from integrated claims records from the Ministry of Health (RIPS) and expert opinion. The base case is a 60 year old treatment-naïve and unfit patient with CLL. Indirect costs came from Ministry of Labor. Discounting for the second year was assumed at 3%.  Results: The total 2-year average cost per patient for the base case receiving treatment for Obinutuzumab vs. Ibrutinib reaches 32,075 USD vs. 124,926 USD, respectively. The most important factor in the difference in annual costs are drug prices and frequency of utilization. Indirect costs for Ibrutinib are twofold those for Obinutuzumab due to the more frequent need for monitoring and evaluation considering the treatment protocol and dose.  Conclusions: Our results suggest that Obinutuzumab is a cost-saving treatment alternative over Ibrutinib in Colombia for patients with CLL in unfit patients in both direct and indirect costs. Due to the novelty of both molecules, our results are susceptible to assumptions of the model, including economic impact in the caregiver, effectiveness and safety. More research is needed to understand these economic and clinical aspects for both molecules. Future work should consider performing multi-criteria decision analyses to provide evidence to decision makers. PCN26 Cetuximab in the First-Line Treatment of Ras Wild-Type Metastatic Colorectal Cancer with Liver-Limited Disease Souza PV1, Zanini FE1, Biglia LV1, Kim HS2, Fahham L2 1Merck, São Paulo, Brazil, 2SENSE Company, São Paulo, Brazil

Objectives: To evaluate the efficacy, safety and cost-effectiveness of cetuximab for first-line treatment of patients with wild-type RAS metastatic colorectal cancer (mCRC) with liver-limited disease.  Methods: A Markov model was developed for RASwt mCRC patients and EGFR expression with liver-limited disease who started treatment with cetuximab + chemotherapy or chemotherapy alone. The transition probabilities were populated according to the OS and PFS curves of a phase II head-to-head randomized controlled trial. The present study was conducted from a Brazilian public health system perspective and direct medical costs were obtained through micro-costing and expert opinion. Incremental cost-effectiveness ratio (ICER) was reported as R$ (BRL) per life year (LY) and budget impact analysis were conducted to assists the decision. One-way sensitivity analysis was also conducted. A 20-year time horizon was used. Future costs and health benefits were discounted at 5%.  Results: The comparison results showed that the association of cetuximab + chemotherapy presented higher cost and greater effectiveness. ICER resulted in R$56,750 per life year gained (LYG). The budget impact analysis projects additional costs around R$ 41 million in the first year after the incorporation and R$ 326 million accumulated in 5 years. Results were sensitive to changes in percentage of patients undergoing curative resection, mean body surface area, outcomes discount rates, tested patients rates and market share.  Conclusions: The addition of cetuximab to the standard chemotherapeutic treatment of RASwt mCRC patients with liver-limited disease resulted in improved response rate and may increase the resectability rate of liver metastasis in this population. It’s worth mentioning that this treatment is cost-effective as the ICER (R$56,750/LYG) of the association of cetuximab and chemotherapy compared to chemotherapy alone results in acceptable levels that justify the higher costs due to significant clinical gains. PCN27 Cost Per Response Analysis of Nivolumab Versus Everolimus in the Treatment of Patients Previously Treated with Advanced Renal Cell Carcinoma – Brazil Private Health Care System Perspective Brust L1, Bernardino G2, Aratangy G2, Tanaka S2, Paladini L3, Borges L3, Clark OA4 1Centro Universitário Univates, Rio Grande do Sul, Brazil, 2Bristol-Myers Squibb, São Paulo, Brazil, 3Evidencias - Kantar Health, Campinas, Brazil, 4Evidencias - Kantar Health, Campinas, NJ, Brazil

Objectives: Nivolumab demonstrated a significant survival benefit when compared with everolimus (median OS 25.0 vs 19.6 months; hazard ratio: 0.73, P= 0.002) in a randomized Phase III trial conducted in patients with advanced renal cell carcinoma (aRCC) who had received previous anti-angiogenic treatment. Similarly, a

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substantially higher objective response rates favouring patients receiving nivolumab (25.1% vs 5.4%; odds ratio: 5.98, P< 0.001) was observed in this trial. The aim of this analysis was to compare the monthly cost per responder with nivolumab versus everolimus in the Brazilian private healthcare system perspective.  Methods: This analysis was based on investigator-based patient-level data from a randomized phase III trial. ORR was defined as the proportion of patients who achieved a partial or complete response. Costs were calculated based on drug, administration, and managing of grade 1-4 treatment related adverse events (TRAEs) reported on Checkmate 025. Drug costs for nivolumab and everolimus were obtained from the official Brazilian price list (Feb/2017) by CMED. The management of  TRAEs was obtained through a Delphi panel, followed by microcosting of resources obtained from public sources (Kairos and Simpro Magazine n105/2016 for drugs and materials, CBHPM 2016 for medical appointments and procedures, and UNIDAS National Research 2015 for hospitalizations). Monthly cost per objective response was calculated by dividing the average monthly cost per patient by ORR.  Results: Median duration of treatment was 5.5 months for nivolumab and 3.7 months for everolimus. Monthly cost per patient was R$ 37.764 for nivolumab and R$12.886 for everolimus. Monthly cost per responder was R$ 90.419 lower for nivolumab versus everolimus (R$ 150.322 vs R$ 240.741).  Conclusions: The present analysis suggests that in the face of nivolumab’s substantial clinical benefits on OS and ORR treatment with this agent can result in significant reductions in health care costs to achieve one responder compared to everolimus. PCN28 Number Needed to Treat (NNT) and Cost of Preventing an Event (COPE) Comparison Between the Association of Cobimetinib and Vemurafenib Among Other Treatment Options for Metastatic Melanoma With BRAF V600 Mutation Ho R, Rufino C, Simões J, Alves M Roche Brazil, São Paulo, Brazil

Objectives: To estimate and compare the association of cobimetinib + vemurafenib (COBI-VEM) versus other therapeutic options for the first line treatment of metastatic melanoma with BRAF V600 mutation in number needed to treat (NNT) and cost of preventing an event (COPE).  Methods: NNT was calculated as the inverse of the absolute risk from an intervention in a definite time point (12 months). COPE consisted of the product of total cost of treatment multiplied by the NNT. The studied perspective was the Brazilian Supplementary Health System. The comparators were vemurafenib monotherapy, dabrafenib, nivolumab and ipilimumab. Clinical outcomes were obtained from the main clinical studies considering progression free survival (PFS) curves (CoBRIM, BRIM-3, BREAK-3 and Checkmate67). Treatment cost was based on drug acquisition and adverse events cost. Drug acquisition cost was calculated including drug prices obtained from the official price list published by the Brazilian Ministry of Health and drug dosage from each respective label. Adverse events cost was based on micro-costing, which resource use was defined by specialists and costs were attributed accordingly. The incidence of adverse events were obtained from the pivotal studies. The time horizon considered was 12 months.  Results: The results in 12 months demonstrated the following NNT values: COBI-VEM =  1.92; vemurafenib =  3.33; dabrafenibe =  4.67; nivolumabe =  4.39; ipilimumab =  7.84. In terms of COPE, the COBI-VEM association showed the lowest COPE values when compared to the other therapies (COBI-VEM =  BRL 1’136’308; vemurafenib =  BRL 1’295’974; dabrafenib =  BRL 1’678’091; nivolumab =  BRL 1’650’868 and ipilimumab =  BRL 2’076’855).  Conclusions: COBI-VEM demonstrated lower NNT and COPE results, showing that cobimetinib associated to vemurafenib can promote resource savings in terms of COPE when compared to other therapeutic options in the first line treatment of metastatic melanoma with BRAF V600 mutation. PCN29 Cost Consequence Analysis of Immune-Enhancing Nutritional Formula in Patients with Digestive Cancer Surgery Danel A1, Viana SD2, Dias A2, Lopez SN2, Tauil DA2, Meale MM2 Health Science, Vevey, Switzerland, 2Nestle Health Science, Sao Paulo, Brazil

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Objectives: Postsurgical infectious complications related to surgical stress can result in additional health care resource utilization costs. Immune-enhancing nutritional formula containing arginine, omega-3 fatty acids and nucleotides has been demonstrated to decrease complications and length of stay in cancer surgery patients. This study aims to determine the impact of an immune-enhancing nutritional formula on hospital costs in Brazil in cancer patients undergoing elective gastrointestinal surgeries.  Methods: An economic model was developed to compare the cost consequence of an immune-enhancing nutritional formula with the standard of care, both used prior to surgery, from a Brazilian health care system perspective, for the period of hospital stay. The clinical estimates associated with the use of the immune-enhancing nutritional formula containing arginine, omega-3 fatty acids and nucleotides were based on previous published meta-analysis of clinical trials in gastrointestinal cancer patients. The average costs of hospitalization with or without infectious complications were calculated using the rate of surgical infections and the mean time of patient hospitalization based on the analysis of the Datasus database (Departamento de Informática do Sistema Unico de Saúde). Costs were expressed in Brazilian Real (BRL). Preoperative use of an immune-enhancing formula was for 5 days before surgery (3 times/ day).  Results: The infectious complications increased the cost of hospital stay by 50%, to a total of BRL 10007 per stay. Use of immune-enhancing nutritional formula resulted in savings per patient of BRL 272 when considering costs based on reduction in infectious complications and BRL 1223 with costs based on reduction in hospital length of stay.  Conclusions: An immune-enhancing nutritional formula containing arginine, omega-3 fatty acids and nucleotides used before surgery is a cost saving intervention for cancer patients with elective gastrointestinal surgeries in Brazil. The acquisition cost of the formula is off set by the decrease of complications and length of stay.