- Katelijne van de Vooren, researcher,
- Alessandro Curto, researcher,
- Livio Garattini, director
- 1Centre for Health Economics, Mario Negri Institute for Pharmacological Research, 24020 Ranica (BG), Italy
- Correspondence to: L Garattini
- Accepted 7 December 2012
Although the total number of new drugs (new chemical entities) approved has gradually decreased over the past decade, the proportion that are expensive biological agents has grown dramatically. In particular, the number of new biological agents registered for treating cancer—so called targeted therapies or personalised medicine1—is increasing, and the costs of these treatments are rising too, with high prices justified by the combination of high research and development costs and small target populations.
Furthermore, although the national authorities that regulate pharmaceutical pricing and reimbursement may exert some control over drug costs in the community setting, their influence on hospital expenditure (where most biological agents are used) is more limited. The emotive nature of cancer also makes it difficult for agencies to resist calls for reimbursement of these high costs drugs, even if their efficacy is marginal. It has therefore proved hard for health authorities either to lower the prices of biological agents or to deny reimbursement, which gives the pharmaceutical industry an incentive to continue developing them.2 The situation is potentially unsustainable.3 Here we argue that because these drugs have only marginal efficacy it is reasonable to ask patients to contribute to their excess costs through optional copayments.
Example of bevacizumab and cetuximab
Bevacizumab and cetuximab, the first two biological agents approved for metastatic colorectal cancer, are interesting examples.4 Their approval has added further options to the existing chemotherapy regimens,5 based on combinations of four off-patent drugs (5-fluorouracil, folinic acid, irinotecan, and oxaliplatin) at various doses.
Most western European countries …