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Ed Forum 2016 SGL

Health Canada Approves Ibrutinib for WM Patients

Apr 12, 2016

Health Canada has approved the use of ibrutinib for all symptomatic WM patients regardless of prior treatment status.

The IWMF and the WM Foundation of Canada have confirmed that, as of March 31, 2016, Health Canada has updated their “Notice of Compliance with Conditions (NOC/c) for Imbruvica (ibrutinib)” to include treatment for WM patients. This means that it is now available for use in Canada for WM patients.

However, while this is exciting news for WM patients in Canada, it does not yet mean that ibrutinib treatment will be provided on a reimbursed basis to patients by public health care providers in Canada. The drug approval process in Canada is complex. The next step, addressing this burden of payment issue, calls for the regulatory bodies to review the data, including: scientific studies, patient organizations’ submissions (such as via Lymphoma Canada surveys), and the pharma-economics. Two distinct bodies then make recommendations as to whether or not the drug in question should be reimbursed: the pan-Canadian Oncology Drug Review (pCODR) for all provinces with the exception of Quebec, and INESSS in Quebec.

In fact, in Canada all new cancer drugs must be reviewed by pCODR before funding recommendations are issued to the provinces. Patient advocacy group input is collected by pCODR and becomes an important input to a drug review. The information is put into the pCODR Clinical Guidance Reports for review by an Expert Review Committee, which then decides whether or not to recommend funding the drug under review.

The IWMF, its Canadian international affiliate, WMF Canada, and the entire WM patient community look forward to a smooth and swift approval process for patients in Canada.

Do your part to help speed the process along for Canadians, and help Lymphoma Canada (LC) gather data from WM patients (regardless of treatment status) and caregivers around the world. The data LC collects will be used throughout the process mentioned above. To help, take their surveys by April 27 – now available at: Lymphoma Canada WM/LPL Survey website.

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