BUDGET IMPACT ANALYSIS OF PERTUZUMAB + TRASTUZUMAB FOR METASTATIC BREAST CANCER IN THE PERSPECTIVE OF BRAZILIAN PUBLIC HEALTH SYSTEM Luiza Grazziotin¹; Osvaldo Ulises Garay²; Paulo Dornelles Picon¹; Andrés Pichon-Riviere² 1. Federal University of Rio Grande do Sul, Porto Alegre, Brazil; 2. IECS - Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina. INTRODUCTION The novel monoclonal antibody pertuzumab has demonstrated relevant clinical improvement in HER-2 positive metastatic breast cancer (HER2+ MBC) patients when added to trastuzumab + docetaxel.[1] Decision- makers of the Brazilian public health system (SUS) have not yet decided about their incorporation in the metastatic setting. Considering the potential costs that might incur, a budget-impact analysis is remarkably essential. Therefore, we aim to estimate the economic impact of incorporating pertuzumab + trastuzumab in the SUS, as an addition to currently available treatment options for HER2+ MBC. CONCLUSION METHODS A budget-impact model was designed using Microsoft Excel and a freely available web software to include uncertainty in analysis. The target population was estimated using data from the literature and local sources (e.g. DATASUS). Direct costs included drugs, assessments, procedures of oncology reimbursement packages and adverse reactions. Data were expressed in U.S. dollars (USD), 2013. The incorporation of pertuzumab + trastuzumab into the SUS for the treatment of HER2+ MBC is likely to have a high impact upon overall health expenditure, since the net result is a 900% increase of total costs. Therefore, it is necessary to conduct a cost-effectiveness study in order to associate costs in line with clinical benefits. REFERENCES [1] Swain SM, Kim SB, Cortés J, Ro J, Semiglazov V, Campone M, Ciruelos E, Ferrero JM, Schneeweiss A, Knott A, Clark E, Ross G, Benyunes MC, Baselga J. Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA study): overall survival results from a randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncology. 2013 May;14(6):461-71. RESULTS The target population was estimated in 2.142 patients (IC 95% 1.722 – 2.562). Current clinical protocol covered by SUS costs USD 21.097.423 (IC 95% 13.097.748 – 27.172.931). The incremental cost of adding pertuzumab + trastuzumab was estimated to be USD 89.571,36 (IC 95% 55.650,36 – 115.410,6) per patient per year. This would represent an annual budgetary impact of USD 212.959.333 (IC 95% 132.326.470 – 274.382.606) assuming diffusion rate of 100%. The unitary cost of trastuzumab and pertuzumab were the most influential factors in this analysis. Figure 2. Proportion of factor`s influence over the total budgetary impact. Figure 1. Budget impact of trastuzumab + pertuzumab in a 3-years horizon (diffusion rates: 50%, 75% and 100%).

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BUDGET IMPACT ANALYSIS OF PERTUZUMAB + TRASTUZUMAB FOR METASTATIC BREAST CANCER IN THE PERSPECTIVE OF BRAZILIAN PUBLIC HEALTH SYSTEM

Luiza Grazziotin¹; Osvaldo Ulises Garay²; Paulo Dornelles Picon¹; Andrés Pichon-Riviere² 1. Federal University of Rio Grande do Sul, Porto Alegre, Brazil; 2. IECS - Institute for Clinical Effectiveness and

Health Policy, Buenos Aires, Argentina.

INTRODUCTION

The novel monoclonal antibody pertuzumab has demonstrated relevant clinical improvement in HER-2 positive metastatic breast cancer (HER2+ MBC) patients when added to trastuzumab + docetaxel.[1] Decision-makers of the Brazilian public health system (SUS) have not yet decided about their incorporation in the metastatic setting. Considering the potential costs that might incur, a budget-impact analysis is remarkably essential. Therefore, we aim to estimate the economic impact of incorporating pertuzumab + trastuzumab in the SUS, as an addition to currently available treatment options for HER2+ MBC.

CONCLUSION

METHODS

A budget-impact model was designed using Microsoft Excel and a freely available web software to include uncertainty in analysis. The target population was estimated using data from the literature and local sources (e.g. DATASUS). Direct costs included drugs, assessments, procedures of oncology reimbursement packages and adverse reactions. Data were expressed in U.S. dollars (USD), 2013.

The incorporation of pertuzumab + trastuzumab into the SUS for the treatment of HER2+ MBC is likely to have a high impact upon overall health expenditure, since the net result is a 900% increase of total costs. Therefore, it is necessary to conduct a cost-effectiveness study in order to associate costs in line with clinical benefits.

REFERENCES

[1] Swain SM, Kim SB, Cortés J, Ro J, Semiglazov V, Campone M, Ciruelos E, Ferrero JM, Schneeweiss A, Knott A, Clark E, Ross G, Benyunes MC, Baselga J. Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA study): overall survival results from a randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncology. 2013 May;14(6):461-71.

RESULTS The target population was estimated in 2.142 patients (IC 95% 1.722 – 2.562). Current clinical protocol covered by SUS costs USD 21.097.423 (IC 95% 13.097.748 – 27.172.931). The incremental cost of adding pertuzumab + trastuzumab was estimated to be USD 89.571,36 (IC 95% 55.650,36 – 115.410,6) per patient per year. This would represent an annual budgetary impact of USD 212.959.333 (IC 95% 132.326.470 – 274.382.606) assuming diffusion rate of 100%. The unitary cost of trastuzumab and pertuzumab were the most influential factors in this analysis.

Figure 2. Proportion of factor`s influence over the total budgetary impact.

Figure 1. Budget impact of trastuzumab + pertuzumab in a 3-years horizon (diffusion rates: 50%, 75% and 100%).