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EXECUTIVE SUMMARY Scope Datamonitor insight into the colorectal cancer market The drug combination of 5-FU (fluorouracil) and leucovorin remains the gold-standard treatment for advanced colorectal cancer in the major pharmaceutical markets. Patents for these drugs have already expired and thus cheaper generics are available. Despite this, there are considerable regional variations in prices and these discrepancies may affect newer drugs gaining reimbursement status in the respective markets. New drugs, such as irinotecan, which are proven to be efficacious can command high premiums. However, recent Medicare cuts on reimbursement rates, and toxicity problems for the drug are likely to exert negative pressure on irinotecan’s sales. Despite this, reimbursement authorities need to consider irinotecan-based regimens as the gold-standard in order for novel drugs to be able to gain reimbursement status in their respective markets. Roche’s Xeloda (capecitabine) is one of only seven oral anti-cancer prodrugs covered by Medicare. The convenience and flexibility of oral formulation means that Xeloda may replace injectable 5-FU as a more cost-effective treatment for advanced colorectal cancer. Datamonitor believes that, Roche, collaborating with Sanofi-Synthelabo, can further challenge the growing force of irinotecan-based regimens in the US. Despite recent problems with the FDA, Erbitux has generated sufficient interest among the medical communities and it is expected to gain significant clinical uptake when launched and command a high premium. Key metrics COLORECTAL CANCER OVERVIEW The colon and rectum Causes of colorectal cancer Risk factors of colorectal cancer Screening Diagnosis Epidemiology Histology Staging Treatment options Surgery Radiotherapy Pharmacological therapies Current clinical practices Treatment option overview by stage Gold-standard drug regimens Follow-up Prognosis PHARMACOECONOMIC, PRICING AND REIMBURSEMENT SYSTEMS Pharmacoeconomics Types of pharmacoeconomic studies The value of pharmacoeconomics Pharmacoeconomic practice in different markets The UK The US Price control or free market? COST COMPARISONS OF COMMON TREATMENT REGIMENS The cost of anti-cancer therapies: an overview Common treatment regimens: comparing cost per mg Regimen 1: 5-FU + leucovorin Regimen 2: Irinotecan + 5-FU + leucovorin Regimen 3: Oxaliplatin monotherapy or in combination with 5-FU and leucovorin Cost comparison of oxaliplatin monotherapy and in combination with 5-FU/folinic acid Cost comparison of treatment regimens CASE SCENARIOS Case one: irinotecan versus oxaliplatin Irinotecan Oxaliplatin Which will prevail? Case two: Xeloda (capecitabine) Case three: Erbitux (IMC-C225) The Erbitux saga The consequences The likely impact on pricing in Europe PRICING LIST APPENDIX Pharmacoeconomic practice in different markets Australia Canada Contrasting Australian and Canadian use of pharmacoeconomics Germany Italy Spain France Japan References