Reason for request

Re-assessment of the IAB following joint referral from the Ministry of Health, the Social Security Directorate and the Directorate General for Health Services on 10 October 2013, in accordance with article R 163-19 of the French Social Security Code.

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Clinical Benefit

Substantial

Despite the lack of specific data on the subpopulation of patients with colorectal cancer in whom fluoropyrimidines are either not tolerated or are contraindicated, but considering the absence of a treatment alternative, the Committee estimates that the actual benefit of TOMUDEX is substantial only in patients with metastatic colorectal cancer in whom fluoropyrimidines are either not tolerated or are contraindicated.


Clinical Added Value

no clinical added value

In the absence of specific data for patients with metastatic colorectal cancer in whom fluoropyrimidines are either not tolerated or are contraindicated, TOMUDEX does not provide an improvement in actual benefit (IAB V, non-existent) in the management of metastatic colorectal cancer.