Annals of Oncology Advance Access originally published online on November 29, 2005
Annals of Oncology 2006 17(5):876-877; doi:10.1093/annonc/mdj086
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© 2005 European Society for Medical Oncology
letter to the editor |
Cost–opportunity analysis in clinical oncology: from the ‘wild far-west’ to a correct integration of the disciplines, avoiding the ‘war of the worlds’
We read with great interest the recent editorial of Colleoni [1
] and the article of Bocci [2]. Both of them focus on the controversial problem of the increasing costs of medical treatments in clinical oncology, which concerns the daily work of all oncology departments. These papers give us the opportunity to deal with some aspects of pharmacoeconomic discipline that risk being underestimated, despite their relevance for clinical research and daily clinical practice.
In the last few years oncology costs have increased dramatically, and the problem of controlling such an increase is becoming more and more urgent, as it could heavily influence the decision-making of oncology departments [3–4]. Pharmacoeconomics should be strictly related to clinical research, and all clinical researchers should know the basic rules of this discipline and make every effort to avoid the risk that the economic aspects of clinical research and clinical practice escape their domain and are managed outside the rules of scientific evidence. All economic considerations need to balance the benefits to be obtained with the costs to obtain the benefits. It follows that the dimension of the costs, which is considered by all clinicians as a burden on their work, needs to be linked to the dimension of the outcomes of a clinical approach. With regard to the outcomes of oncological treatments, clinicians should clearly define a hierarchical order based on scientific evidence, and such an order should be well known by non-clinical researchers before engaging in any economic approach to clinical oncology, to avoid detrimental consequences for either the clinicians' work or the health of the patients.
Two aspects merit underlining: the outcomes worthy of evaluation from an economic point of view must be ‘evidence based’, and the scientific societies must play a key role in their definition.
Cost–opportunity analysis, that is, the dimension of the choice among different options, should become customary to clinicians, who should play a key role in the decision-making process whenever it takes place.
A few years ago, the American Society of Clinical Oncology classified the outcomes for oncologic clinical research and clinical practice in ‘patient outcome’ (mainly survival and quality of life) and ‘cancer outcome’ (mainly response rate), giving priority to the former [5]. Such a distinction has a relevant speculative and practical significance, and the priority of patient outcomes means priority of the efficacy data, that is, priority of the data from phase III clinical trials. Furthermore, the data, which appear obvious from a methodological point of view, need to be reviewed from a pharmacoeconomic point of view. Conversely, although survival or quality of life are the two main patient outcomes for clinical research and clinical practice, in the last few years the registration of new molecules for clinical practice has frequently been based on either phase II trials or trials using surrogate end-points of efficacy, whose clinical significance is often questionable [6].
Many considerations could be made about such an attitude for the registration of novel molecules, but the most important matter is that this kind of approach can be detrimental when it is used in a cost–opportunity analysis. The model of phase II clinical trials gives the opportunity to select active molecules or schedules for the treatment of particular classes of patient, avoiding treatment of too many patients with inactive approaches. However, it never allows any comparative analysis between different approaches, and definitive comparative trials are just phase III trials. It follows that neither efficacy, nor economic comparisons can be made on the basis of the data from phase II trials. As correctly stated by Colleoni, metronomic chemotherapy is an interesting option in the treatment of metastatic breast cancer, and it can also be interesting from a pharmacoeconomic point of view, but further phase III trials should be carried out to make possible any comparison with the other schedules for metastatic breast cancer.
A further crucial matter is represented by the problem of a cost–opportunity analysis, that can appear quite different according to the different points of view of the national health-care system, the pharmaceutical industry, the scientific community or the patients' associations [7]. Indeed, it is not surprising that the national health-care system tries to cut spending on new molecules or new strategies against cancer, whereas the pharmaceutical industry tries to recover the increasing costs sustained to register new molecules for daily clinical practice [8]. In such a contest of different points of view, the role of physicians and scientific societies is fundamental. The new expensive molecules should not be demonized owing to their high cost, but it is also mandatory to keep in mind that not all the new molecules have the same, unquestionable efficacy of imatinib in chronic myeloid leukaemia, trastuzumab in HER2-positive breast cancer or rituximab in CD20-positive non-Hodgkin lymphoma. Therefore, an adequate cost–opportunity analysis should not be limited to a mere analysis of the pharmaceutical costs, but it should also be extended to analysis of all dimensions of the costs for the treatment of cancer patients, reviewing the clinical approaches on the basis of an outcome analysis [9]. There is no doubt that our departments and our daily clinical practice will be heavily conditioned by pharmaco-economic considerations in the near future. With such a prospect, it is mandatory to avoid ‘wild far-west’ scenarios (as nicely painted by Colleoni), in order to assure high-quality assistance to our patients, as well as to avoid a ‘war of the worlds’, in order to maintain a patient-oriented approach in clinical decision-making. Correct integration among physicians, economists, industry researchers and public administrators of the national health-care system is urgently needed to clarify all dimensions of cost–benefit analysis of the new molecules, and all physicians and scientific societies have to maintain a patient-oriented balance in the decision-making process supporting the cost utility analysis in clinical oncology.
1 Department of Oncology, City Hospital, Rimini, Italy; 2 Department of Internal Medicine, Arcispedale S. Anna, Ferrara, Italy
* (E-mail: dtassinari{at}rimini.com)
References
1. Colleoni M, Gelber S, Goldhirsch A. Treatment of advanced breast cancer: the good, the bad and the ugly. Ann Oncol 2005; 16: 1219–1221.
2. Bocci G, Tuccori M, Emmenegger U et al. Cyclophosphamide–methotrexate ‘metronomic’ chemotherapy for the palliative treatment of metastatic cancer. A comparative pharmacoeconomic evaluation. Ann Oncol 2005; 16: 1243–1252.
3. Bosanquet N, Sikora K. The economics of cancer care in the UK. Lancet Oncol 2004; 5: 568–574.[CrossRef][ISI][Medline]
4. Chirikos TN. Cancer economics: on variations in the costs of treating cancer. Cancer Control 2002; 9: 59–66.[Medline]
5. ASCO Special Article. Outcomes of cancer treatment for technology assessment and cancer treatment guidelines. J Clin Oncol 1996; 14: 671–679.
6. Williams G, Pazdur R. Endpoints for Cancer Drug Approval: Regulatory Considerations. American Society of Clinical Oncology Educational Book. Alexandra, VA: American Society of Clinical Oncology, 2005; 482–486.
7. Meropol NJ, Desmond-Hellmann S, Tunis S et al. Can Society Afford State-of-the-art Cancer Treatment? American Society of Clinical Oncology Educational Book. Alexandra, VA: American Society of Clinical Oncology, 2005; 473–480.
8. DiMasi JA, Hansen RW, Grabowski HG. The price of innovation: new estimates of drug development costs. J Health Econ 2003; 22: 151–185.[CrossRef][ISI][Medline]
9. NCI-ASCO Special Article. Integrating economic analysis into cancer clinical trials: the National Cancer Institute–American Society of Clinical Oncology economic workbook. J Natl Cancer Inst Monogr 1998; 24: 1–28.
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