COST-MINIMIZATION ANALYSIS AND TOTAL COST ANALYSIS FOR A WEIGHT RANGE IN CROHN’S DISEASE TREATMENT WITH ANTI-TNF BIOLOGICS UNDER BRAZILIAN PRIVATE HEALTH CARE SYSTEM PERSPECTIVE Authors: Fabiana Gatti de Menezes1, Pharm, Msc, PhD, Vivian Chibana1, Business Administration. Affiliations: 1 HEOR, AbbVie Brazil, São Paulo, Brazil. Presented at ISPOR 18th Annual European Congress, 7-11 November, 2015, MiCo – Milano Congressi in Milan, Italy. ABSTRACT OBJECTIVE: The aim of this study was to describe the total treatment costs related to Crohn’s Disease treatment with biologics and to evaluate these costs based on the most prevalent weight range. METHODS: A cost-minimization analysis was performed among adalimumab-subcutaneous (ADA) and infliximab-intravenous (IFX) to compare the total treatment costs in Crohn's disease according to the Brazilian Private HealthCare System perspective. Total treatment cost was calculated based on the dose per application, number of vial/syringe, cost of application and median and range of weight. These inputs were based on scientific literature. Yearly treatment cost was calculated for patients with a median of 68kg, according to doses defined in product labels. A cost analysis for a weight range was performed. Drug prices were based on Factory Prices plus 18% taxes (CMED source). An univariate analysis was performed to determine the impact on results. RESULTS: The median patient weight used in this analysis was 68±4,08kg (Weight range: 64 to 72kg normal distribution). For IFX the Medication Cost was R$92.478,12, Application Cost was R$2.360,33 and the Total Treatment Cost was R$94.838,45. For ADA the Medication Cost was R$85.807,15, Application Cost was R$3.788,98 and the Total Treatment Cost was R$89.596,13. Comparing the scenario with IFX and ADA, the treatment with ADA presented a savings of R$5.242,32 per patient/year. The weight interval cost analysis presented a savings for ADA of R$5.242,32 per patient/year in a range of 64 to 72kg. In sensitivity analysis ADA presented economic savings in most scenarios, the variation of IFX vial and ADA syringe costs are important factors that could modify the sensitivity analysis. Conclusions: The treatment of Crohn’s disease with ADA compared to IFX presented an economic savings for nearly 68% of patients with Crohn’s Disease in the Brazilian Private HealthCare System. INTRODUCTION Even though the high cost of medication in Chron Disease (CD), monoclonal antibodies represent a major advance in therapy with significant decrease hospitalizations, surgery and laboratory tests numbers. Also, they have a higher effectiveness compared to conventional therapy 1, 2. The last publication related to cost minimization analysis of adalimumab (ADA) and infliximab (IFX) – 2009 - was based on weight range and only medication costs3. METHODS RESULTS The median patient weight used in this analysis was 68±4,08kg (Weight range: 64 to 72kg - normal distribution) with a disease length of 72 months9. Study limitations: we assume the same model of reimbursement between HMOs for all the market; the population growth rate that was used had base just in the population that use the Private Health Care System; variation in costs of infusion and application. In deterministic sensitivity analysis cost per vial of IFX, cost per syringe of ADA and market-share of patients were the most important variables that impacted results. A majority of DSA scenarios indicated that treatment with ADA provides cost savings. 1.853 METHODS A cost-minimization analysis was performed among Adalimumab - subcutaneous (ADA) and Infliximabintravenous (IFX) to compare the total treatment costs in Crohn's disease according to the Brazilian Private HealthCare System perspective. Drug prices were based on Factory Prices plus 18% taxes (CMED source) – Table 1. Total treatment cost was calculated based on the dose per application, number of vial/syringe, cost of application and median and range of weight (Table 2). Yearly treatment cost was calculated for patients with a median of 68kg, according to doses defined in product labels. A cost analysis for a weight range was performed. A univariate analysis was performed to determine the impact on results. 2.004 1.927 2.084 2.167 Table 1: Medication cost description. Drug name and formulation Factory price + taxes 18% (R$) INFLIXIMAB - Vial ADALIMUMAB - 2 Syringes (PEN) 3302,79 ADALIMUMAB - 1 Syringe (PEN) 3300,27 Year 1 Year 2 Year 3 Year 4 Year 5 Figure 2: Costs according the lenght of disease (R$). 68% of patients 6600,55 http://portal.anvisa.gov.br/wps/wcm/connect/cc2b47004a09f81d b4a3bcbb505253ad/LISTA+CONFORMIDADE_2015-0928.pdf?MOD=AJPERES Table 2: Medication costs calculation description. Dose per infusion and subcutaneous injection respectively (mg/Kg or mg)4 mg per vial and syringe Number of vials and syringes/injection Number of infusions and Number of subcutaneous injections/Year4 Number of vials /year Number of syringes/year R$/ vial and ampule (Factory Price)5 Medication cost/year Patient Mediam Weight (kg)6 Cost/infusion and subcutaneous injection7,8 Total cost/injection Final treatment cost Fixed Total dose (mg) IFX ADA 5 40 100 4 40 1 7 26 Figure 3: Sensitivity Analysis Vial Cost IFX 28 26 R$ 3.302,79 R$ 3.300,28 R$ 92.478,12 68 R$ 85.807,15 - R$ 337,19 R$ 145,73 R$ 2.360,33 R$ 94.838,45 R$ 3.788,98 R$ 89.596,13 340 40 OBJECTIVE This study aim study was to describe the total treatment costs related to Crohn’s Disease treatment with biologics and to evaluate these costs based on the most prevalent weight range. 5 year time period. Figure 1: Eligible Patients RESULTS The median patient weight used in this analysis was 68±4,08kg (Weight range: 64 to 72kg - normal distribution). For IFX the Medication Cost was R$92.478,12, Application Cost was R$2.360,33 and the Total Treatment Cost was R$94.838,45. For ADA the Medication Cost was R$85.807,15, Application Cost was R$3.788,98 and the Total Treatment Cost was R$89.596,13 – Table 2. Figure 2 present the treatment costs related to the length of disease, with ADA the costs were stable and with IFX they progressively grow. Comparing the scenario with IFX and ADA, the treatment with ADA presented savings of R$5.242,32 per patient/year – Figure 1. The weight interval cost analysis presented savings of R$5.242,32per patient/year for ADA in a range of 64 to 72kg. In sensitivity analysis ADA presented economic savings in most scenarios, the variation of IFX vial cost and ADA syringe costs are important factors that could modify the model results. Pen Cost ADA SC Application Cost ADA Infusion Cost IFX Minimum case Vial Cost IFX Pen Cost ADA Injection Cost ADA Infusional Cost IFX R$ 618,41 R$ 9.532,68 R$ 5.810,67 R$ 4.888,27 Maximum case -R$ 4.005,49 R$ 13.823,04 R$ 4.673,97 R$ 5.596,37 CONCLUSION The treatment of CD with ADA compared to IFX presented economic savings for nearly 68% of patients with CD in the Brazilian Private HealthCare System. REFERENCES 1.Hanauer SB, Feagan BG, Lichtenstein GR, Mayer LF, Schreiber S, Colombel JF, et al. Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial. Lancet 2002;359:1541-1549.2.Colombel JF, Sandborn WJ, Rutgeerts P, Enns R, Hanauer SB, Panaccione R, et al. Adalimumab for maintenance of clinical response and remission in patients with Crohn's disease: the CHARM trial. Gastroenterology 2007;132(10):52-65.3.Kotze Paulo Gustavo, Albuquerque Idblan Carvalho de, Moraes Antônio Carlos, Vieira Andrea, Souza Fernando de. Análise de custo-minimização entre o Infliximabe (IFX) e o Adalimumabe (ADA) no tratamento da doença de Crohn (DC). Rev bras. colo-proctol. [Internet]. 2009 June [cited 2015 Oct 19] ; 29( 2 ): 158-168. 4. Label. 5. CMED (2014). 6. Andreassen H, Hylander E, Rix M. Gender, age, and body weight are the major predictive factors for bone mineral density in Crohn's disease: a case-control cross-sectional study of 113 patients. Am J Gastroenterol. 1999 Mar;94(3):824-8. 7. Vitale V, Pinto Neto JV, Asano E. Total Treatment Costs Analysis Between Subcutaneous And Intravenous Bortezomib Under Brazilian Private Health Care System Perspective. Poster Presented At ISPOR 19th Annual International Meeting, May 31 - June 4; Montreal, Canada. 8. Vitale V, Asano E, Pereira ML. Budget impact analysis of abiraterone acetate in metastatic castration resistant prostate cancer patients previously treated with docetaxel under Brazilian Private Health Care System Perspective. Value in Health, 11/2013, 16(7): A665. 9.Andreassen H, Hylander E, Rix M. Gender, age, and body weight are the major predictive factors for bone mineral density in Crohn's disease: a case-control cross-sectional study of 113 patients. Am J Gastroenterol. 1999 Mar;94(3):824-8. e Colocar Gráfico da Curva Normal. ACKNOWLEDGEMENTS AbbVie Inc. funded the study. AbbVie was responsible for the study design, research, analysis, data collection, interpretation of data, and writing, reviewing, and approving of the publication. The authors would like to thank Vinicius Vitale from AbbVie for modelling support. DISCLOSURES The design, study conduct, and financial support for the study were provided by AbbVie. AbbVie participated in the interpretation of data, review, and approval of the publication. Fabiana Gatti Menezes and Vivian Chibana are employees of AbbVie and own AbbVie stock.
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