Health Policy 109 (2013) 97–103 Contents lists available at SciVerse ScienceDirect Health Policy j ourna l ho me pag e: ww w.elsevier.com/locate/healthpol Ethics for end-of-life treatments: Metastatic colorectal cancer is one example Livio Garattini a,* , Katelijne van de Vooren a , Alberto Zaniboni b a CESAV, Center for Health Economics, ‘Mario Negri’ Institute for Pharmacological Research, Via Camozzi 3, 24020 Ranica, Italy b Department of Medical Oncology, Fondazione Poliambulanza, Brescia, Italy a r t i c l e i n f o Article history: Received 1 March 2012 Received in revised form 21 August 2012 Accepted 24 August 2012 Keywords: Colorectal cancer Economic evaluation Health technology assessment Ethics Biological agents a b s t r a c t The number of biological agents (BAs) registered with an indication related to cancer treat- ment 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 can- cer (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 evi- dence 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. © 2012 Elsevier Ireland Ltd. All rights reserved. 1. Introduction In the last decade the total number of new molecu- lar entities approved to market has gradually decreased, while the share of new biological agents (BA) has grown [1]. In particular, the number of new BAs registered with an indication related to cancer treatment is flourishing [2]. The cost of these treatments is rising dramatically too in many developed countries, with very high prices justified according to industry by the combination of high R&D costs and small target populations. The situation is potentially unsustainable for healthcare systems, and could lead to an unavoidable need for priority setting in the long run [3]. * Corresponding author. Tel.: +39 035 4535360; fax: +39 035 4535372. E-mail addresses: lgarattini@marionegri.it, livio.garattini@marionegri.it (L. Garattini). As an interesting example to draw lessons, we focus here on bevacizumab (BV) and cetuximab (CX), the first two BAs approved for metastatic colorectal cancer (mCRC), for which we reviewed the full economic evaluations (FEEs) focused on chemotherapies some years ago (before BAs were launched) [4]. In this paper we outline the mCRC clini- cal background and briefly review the FEEs published so far on BV and CX, finally – as appropriate – reflecting more in general on the ethical implications raised by ‘end stage-of life’ treatments. 2. Clinical background CRC is the third most commonly diagnosed cancer in males and the second in females, with over 1.2 million new cancer cases and 608,700 deaths estimated to have occurred worldwide in 2008. Median age at diagnosis is >70 0168-8510/$ – see front matter © 2012 Elsevier Ireland Ltd. All rights reserved. http://dx.doi.org/10.1016/j.healthpol.2012.08.017