The Budget Impact of Monoclonal Antibodies Used to Treat Metastatic Colorectal Cancer in Minas Gerais, Brazil

Abstract

Introduction: Biological medicines have increased the cost of cancer treatment and has raised sustainability concerns. In Brazil, three monoclonal antibodies (MABs): bevacizumab (BEVA), cetuximab (CETUX) and panitumumab (PANIT), are indicated for the treatment of metastatic colorectal cancer (mCRC) but currently not currently funded by the Unified Health System (SUS). However, they have been funded following successful litigation cases. Objective: Evaluate the budget impact of BEVA, CETUX and PANIT MABs if they became part of standard chemotherapy to treat mCRC within the SUS of Minas Gerais (MG), in Brazil. Method: Budget impact analysis incorporating MABs as first-line treatment of mCRC in MG/Brazil was explored. The Brazilian health system -SUS perspective was adopted and a 5-year time horizon was applied. Data from the lawsuits from January 2009 to December 2016 were collected and the model was populated based national databases and published sources. Costs are expressed in USD. Results: 351 court lawsuits were granted for first-line MAB treatment for mCRC. In three alternative scenarios analyzed there was an increase in costs, which ranged from 348 to 395% compared to the reference scenario. PANIT presented a $103,360,980 budget impact compared to the reference scenario over a 5-year time horizon. BEVA and CETUX presented a $111,334,890 and $113,772,870 budget impact, respectively. Considering the restrictions on the use of MABs Anti EGFR (CETUX and PANIT) in patients with about 41% KRAS mutations, the best cost alternative adopted for incorporation should be the combination of the PANIT and BEVA antibodies, which demonstrated a cost of approximately $106 million. Conclusion: These results highlight the appreciable costs for incorporating BEVA, CETUX and PANIT into the SUS. It is likely appreciable discounts will be needed to permit incorporation.

Is the Scope of Costs Considered in Budget Impact Analyses for Anticancer Drugs Rational? A Systematic Review and Comparative Study

“…Most of the included studies originated in the United States (n = 18, 62%) (42-46, 48, 50-59, 64, 66), followed by Italy (n = 2, 7%) (69,70) and one from each of Brazil (60), the Netherlands (62), France (47), Japan (49), Norway (65), Saudi Arabia (61), Spain (63), and Thailand (67), as well as one multi-country study (58). The studies covered 11 types of cancer including non-small-cell lung cancer (n =8, 28%) (43,45,47,54,55,57,62,65), prostate cancer (n =5, 17%) (42,44,48,59,64), colorectal cancer (n = 4, 14%) (60,67,68,70), ovarian cancer (n = 3, 10%) (46,53,63), breast cancer (n = 2, 7%) (56,61), myeloma (n = 2, 7%) (49,58), melanoma (n = 1, 3%) (52), head and neck cancer (n = 1, 3%) (69), cell carcinoma of the urothelium (n = 1, 3%) (50), gastroenteropancreatic neuroendocrine tumor (n = 1, 3%) (66), and epithelial ovarian, fallopian tube or primary peritoneal cancer (n = 1, 3%) (51). Most of the interventions in these studies involved innovative anticancer drugs, including selective poly ADP-ribose polymerase (PARP)-1 and PARP-2 inhibitor (e.g., niraparib) (51,53), epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 tyrosine kinases inhibitor (e.g., afatinib) (55,…”

“…The studies covered 11 types of cancer including non-small-cell lung cancer (n =8, 28%) (43,45,47,54,55,57,62,65), prostate cancer (n =5, 17%) (42,44,48,59,64), colorectal cancer (n = 4, 14%) (60,67,68,70), ovarian cancer (n = 3, 10%) (46,53,63), breast cancer (n = 2, 7%) (56,61), myeloma (n = 2, 7%) (49,58), melanoma (n = 1, 3%) (52), head and neck cancer (n = 1, 3%) (69), cell carcinoma of the urothelium (n = 1, 3%) (50), gastroenteropancreatic neuroendocrine tumor (n = 1, 3%) (66), and epithelial ovarian, fallopian tube or primary peritoneal cancer (n = 1, 3%) (51). Most of the interventions in these studies involved innovative anticancer drugs, including selective poly ADP-ribose polymerase (PARP)-1 and PARP-2 inhibitor (e.g., niraparib) (51,53), epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 tyrosine kinases inhibitor (e.g., afatinib) (55,62), immune checkpoint inhibitors (e.g., nivolumab, pembrolizumab) (47), and vascular endothelial growth factor inhibitor (e.g., bevacizumab) (60).…”

“…Regarding the perspective, three studies (10%) considered the societal perspective (57,67,69), four studies (14%) considered the healthcare system perspective (60,62,63,70), and all other studies (n = 22, 76%) considered the budget-holder perspective (42-56, 58, 59, 61, 64-66, 68). Regarding the budget-holder perspective, one study calculated the budget impact from the hospital perspective (66), five adopted the health-plan perspective (45,46,48,55,64), and 16 adopted the third-party payer perspective including public health insurance, Medicare, and commercial insurance (42-44, 47-54, 56, 58, 59, 61, 65, 68).…”

“…Four studies (14%) did not consider condition-related costs. Monirul et al (47) and Goldstein et al (57) assumed that all costs other than for drugs were equivalent under the two strategies, while Silva et al (60) and Ortendahl et al (66) did not mention costs other than those for drugs in their studies.…”

Table_1.DOCX

“…Most of the included studies originated in the United States (n = 18, 62%) (42-46, 48, 50-59, 64, 66), followed by Italy (n = 2, 7%) (69,70) and one from each of Brazil (60), the Netherlands (62), France (47), Japan (49), Norway (65), Saudi Arabia (61), Spain (63), and Thailand (67), as well as one multi-country study (58). The studies covered 11 types of cancer including non-small-cell lung cancer (n =8, 28%) (43,45,47,54,55,57,62,65), prostate cancer (n =5, 17%) (42,44,48,59,64), colorectal cancer (n = 4, 14%) (60,67,68,70), ovarian cancer (n = 3, 10%) (46,53,63), breast cancer (n = 2, 7%) (56,61), myeloma (n = 2, 7%) (49,58), melanoma (n = 1, 3%) (52), head and neck cancer (n = 1, 3%) (69), cell carcinoma of the urothelium (n = 1, 3%) (50), gastroenteropancreatic neuroendocrine tumor (n = 1, 3%) (66), and epithelial ovarian, fallopian tube or primary peritoneal cancer (n = 1, 3%) (51). Most of the interventions in these studies involved innovative anticancer drugs, including selective poly ADP-ribose polymerase (PARP)-1 and PARP-2 inhibitor (e.g., niraparib) (51,53), epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 tyrosine kinases inhibitor (e.g., afatinib) (55,…”