Availability and affordability of novel biological therapy i | 50307
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Availability and affordability of novel biological therapy in Serbia for patients with metastatic colorectal cancer


Aleksandra Kovacevic

Patients with metastatic colorectal cancer (mCRC) have typically overall survival (OS) of approximately 30 months, if multi disciplinary team approach was applied. The first-line treatment comprises cytotoxic agents, a fluoropyrimidines in various protocols, combined with irinotecan or oxaliplatin. Additional benefit, in the terms of clinical outcome for such patients, is shown by adding the monoclonal antibodies (bevacizumab, as anti-VEGF and cetuximab and panitumumab as anti-EGFR). Second-line treatment comprehends adding the anti-angiogenic fusion protein aflibercept or anti-VEGFR2 antibody ramucirumab to the first line protocols. The third line treatment is multi-targeted kinase inhibitor regorafenib. In Serbia, all cytotoxic drugs and monoclonal antibodies bevacizumab and cetuximab, are reimbursed for mCRC patients. Aflibercept, ramucirumab and regorafenib are not on the National Health Insurance Fund (NHIF) reimbursement list. Therefore, we conducted a retrospective randomized case series study, in the large tertiary health care hospital in Serbia. It was concluded that patients with added reimbursed monoclonal antibodies, had 6-month longer OS in five-year period, associated with significantly higher direct medical costs and ICER that was three-fold higher than informal willingness to pay threshold of Serbia. Costs could be significantly decreased only when bevacizumab biosimilars would be available on the Serbian market, but not prior than in 2022, when European Avastin patent expires. European patent on Erbitux expired in 2014; there aren’t any biosimilar competitors in Europe approaching the horizon. Aflibercept is the only third-line treatment option that is registered but not reimbursed in Serbia, and ramucirumab and regorafenib are not registered. As a conclusion, it could be said that novel third-line biological treatment is neither available nor reimbursed for the Serbian patients with mCRC. New patent expiration of the monoclonal antibodies is expecting to allow biosimilar market entry and generate significant savings to the NHIF, which is expected to increase the affordability for mCRC treatment.






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