CESAV, Center for Health Economics, 'Mario Negri' Institute for Pharmacological Research, Via Camozzi 3, 24020 Ranica, Italy. Electronic address: email@example.com.
The number of biological agents (BAs) registered with an indication related to cancer treatment is flourishing and the cost of these treatments is rising dramatically, making the situation potentially unsustainable for healthcare systems. Here we focus on the examples of bevacizumab (BV) and cetuximab (CX), two BAs approved for metastatic colorectal cancer (mCRC). The first clinical trials show an increase in median overall survival of a few months, though these results could not always be repeated in subsequent studies. We reviewed full economic evaluations (FEEs) on BV or CX and despite frequently arguable estimates based on indirect efficacy, only one estimated the addition of CX was cost-effective in a virtual subgroup of patients, albeit with flawed methods. Most Western European countries reimburse BV and CX for mCRC, though clinical evidence seems weak and economic evidence even absent. The underlying question is whether national health authorities are prepared to spend an increasing share of healthcare budgets on very expensive end-of-life treatments, their impact on life expectancy (a few additional months at best) and QoL (enhanced mainly by patients' hopes) being doubtful and their cost-effectiveness hardly ever proved. Further research is needed to explore how ethics could be included and thus assessed under these circumstances.