Reason for request

Inclusion on the list of medicines reimbursed by National Health Insurance and approved for hospital use in the extension of indication for adults aged 18 years and older: “Prevention of depressive episodes in patients with bipolar I disorder who experience predominantly depressive episodes. Lamictal is not indicated for the acute treatment of manic or depressive episodes."


Clinical Benefit


The actual benefit of these products is substantial.

Clinical Added Value

no clinical added value

The efficacy of LAMICTAL and LAMICSTART has only been demonstrated with respect to the time to relapse or recurrence of a depressive episode in bipolar I disorder. As a result, when used as a second-line treatment, these products do not provide an improvement in actual benefit (IAB V) in the prevention of depressive episodes in bipolar I disorder adult patients with predominantly depressive episodes. The Committee considers these products to be an additional therapeutic tool.

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Évaluation des médicaments

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