Should Personalised Medicine Be Funded in Countries with Limited Resources?

Abstract

Personalised medicine implies that treatment is based on molecular analysis of an individual tumour specimen. A biomarker may define groups of patients who can benefit from a specific treatment, such as the Estrogen Receptor and HER2 in breast cancer, B-RAF mutation in melanoma and EGFR and ALK mutation in lung cancer. Large clinical trials support treatments based on these tests but whether they should be used in countries of limited resources depends on their cost-effectiveness compared to other potential use of limited resources for health-care. ER and tamoxifen and HER2 and trastuzumab as adjuvant therapy for breast cancer should be available in all European countries. The other strategies for palliation of cancer may not represent cost-effective use of limited resources in some countries Personalised medicine is more often used to describe complex molecular analysis followed by selection of a molecular targeted agent active against pathways with activating mutations to provide individualised treatment. This strategy is experimental and there is no high level evidence to indicate that selected therapies lead to better outcome than standard treatment for a given type of cancer. The concept is attractive but substantial problems may limit benefit, even when agents targeting different molecular pathways are available and affordable. There is heterogeneity not only between tumours but within them, so that a biopsy will not be representative of the whole tumour. Cancer cells are expert at developing resistance to all drugs, and if one pathway is inhibited another will usually promote cell survival and avoid cell death. Using several targeted agents might prevent this but is usually impossible because combinations are toxic. Personalised medicine should be investigated in a small number of well-designed studies. My bias is that these programs will lead to only modest benefits for patients, and such programs should be coordinated to avoid duplication. There is no basis for using individualised anticancer therapy based on genetic analysis outside of a well-designed clinical research protocol. Funding of personalised medicine is not appropriate in countries with limited resources.Disclosure: The author has declared no conflicts of interest.