Broad funding for oxaliplatin in Ontario (finally!)

Since the presentation of trials such as the Intergroup N9741 study (National Cancer Institute of Canada CO.15) and the MOSAIC (Multicenter International Study of Oxaliplatin/5-FU–LV in the Adjuvant Treatment of Colon Cancer) trial at the 2003 American Society of Clinical Oncology meeting, oncologists have broadly accepted that oxaliplatin is part of the standard management of colorectal cancer, both in the metastatic and adjuvant settings 1–4. The Gastrointestinal Cancer Disease Site Group within Cancer Care Ontario's Program in Evidence-Based Care (PEBC) immediately began the thorough process of systematic review, development of evidence based recommendations, review by the Report Approval Panel (a methodologic oversight group), practitioner feedback, and eventual finalization and publication of guidelines. For oxaliplatin in colorectal cancer, that process was required for three settings: • Metastatic colorectal cancer • Resected colon cancer • Resected rectal cancer The guideline for the metastatic colorectal cancer setting was published in Current Oncology in 2006 5. The guideline for stages II and III colon cancer was updated to incorporate the most recent data for oxaliplatin (Cancer Care Ontario, Program in Evidence-Based Care. Evidence-based series 2-29: Adjuvant systemic chemotherapy for stage II and III colon cancer following complete resection. In development). Final approval and publication of the stages II and III colon and rectal cancer guidelines are pending (Cancer Care Ontario, Program in Evidence-Based Care. Evidence-based series 2-3, Ver. 2.2007. Postoperative adjuvant radiotherapy and/or chemo-therapy for resected stage II or III rectal cancer. In development). Once a guideline is made available by the PEBC, it undergoes a joint review process in Ontario that evaluates all cancer-related drugs for consideration under the New Drug Funding Program or the Ontario Drug Benefit program, or both. The Committee to Evaluate Drugs (CED), an expert advisory committee to the Ministry of Health and Long-Term Care, conducts the joint review and makes a recommendation regarding the funding of the drug in the province of Ontario 6. Given the intrinsic delays in the rigorous PEBC guideline development cycle, the CED has always accepted late drafts of the recommendations to assist in making timely decisions for emerging therapies. The guidelines on colorectal cancer were therefore made available to the CED in 2006. Complicating the story for oxaliplatin was the absence of a Health Canada Notice of Compliance (NOC). In the context of the incomplete intellectual property protection pertaining in Canada before Oc-tober 2006, Sanofi-Aventis could not submit its confidential data 7 from …