Reason for request

New indication

Key points

Favourable opinion for reimbursement in induction of remission in moderate steroid-dependent Crohn's disease in adult patients refractory or intolerant to thiopurines, in combination with corticosteroids and for maintenance of remission, as monotherapy, in patients who have responded to methotrexate.

What therapeutic improvement?

No clinical added value in the management of Crohn's disease.

Role in the care pathway?

In Crohn’s disease, NORDIMET 25 mg/mL solution for injection in a pre-filled pen is a second-line treatment in corticosteroid-dependent adult patients refractory or intolerant to thiopurines; in moderate forms, the prescription of a TNF inhibitor may also be envisaged.


Clinical Benefit

Moderate

The Committee deems that the clinical benefit of NORDIMET (methotrexate) is moderate in induction of remission in moderate steroid-dependent Crohn's disease in adult patients refractory or intolerant to thiopurines, in combination with corticosteroids and for maintenance of remission, as monotherapy, in patients who have responded to methotrexate.

Insufficient

Clinical Added Value

no clinical added value

The Transparency Committee considers that NORDIMET 25 mg/mL solution for injection in a pre-filled pen (methotrexate) provides no clinical added value (CAV V) in the care pathway in adult patients with Crohn’s disease compared to the other proprietary medicinal products containing methotrexate.


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