Abstract
Aim: To evaluate the costs and survival estimates of metastatic colorectal carcinoma patients treated with conventional cytostatic protocols and adjuvant monoclonal antibodies (mAbs). Methods: Retrospective randomized case series and cost-of-illness analysis was used. Metastatic colorectal carcinoma cases (62) were randomly selected from the archive of the largest university military hospital in Southeastern Europe. Results: A 6-month longer survival was attributed to mAbs (p = 0.581). Conventional protocols incurred €5137 (95% CI: €3758–€6517) versus €22,113 (95% CI: €16,201–€28,025) total direct medical costs in mAb-based group. ICER of €32,108 per life year gained attributable to mAbs three-fold exceeded informal willingness to pay threshold of Serbia. Conclusion: mAbs adjuvant protocols had modest positive impact on 5-year survival rates. Costs were driven by targeted biologicals, but significantly higher costs of care were recorded in mAb-treated group in other domains, as well. More selective prescription and reimbursement criteria should be applied to increase cost–effectiveness of targeted oncology agents.
Financial & competing interests disclosure
The Ministry of Education Science and Technological Development of the Republic of Serbia has funded the underlying study behind reported results through Grant OI 175014 and 175093. Publication of results was not contingent to Ministry’s censorship or approval. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Prescription and administration of targeted biologicals, such as monoclonal antibodies, is growing in Southeastern Europe. This is clearly visible, for example, at the largest Western Balkan market of Serbia.
Metastatic colorectal carcinoma patients treated with adjuvant mAbs-based protocols tend to survive up to 6 months longer in a 5-year time horizon, although this finding was not statistically significant.
Direct medical costs of specialty care for patients suffering from metastatic colorectal cancer in Balkan university hospitals are mostly driven by drug acquisition costs of expensive pharmaceuticals. Associated costs of laboratory, physician consultations, surgery, radiation therapy and imaging diagnostics are significantly higher in mAbs-treated patients compared with the ones treated by conventional cytostatic protocols.
Keeping in mind rather modest clinical benefits of mAbs administration at very high incremental cost–effectiveness ratio, authorities need to reconsider current reimbursement policies. Targeted biologicals prescription should be reserved for patients most likely to experience clinical improvement and acceptable adverse events. Such limitations should particularly be present in Eastern European national health sectors due to their financial sustainability threatened by global recession.