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IMBRUVICA (ibrutinib)
Reason for request
Unfavourable opinion for reimbursement in the treatment of adult patients with Waldenström's macroglobulinaemia (WM) in combination with rituximab.
The strategy for the first-line treatment of Waldenström's macroglobulinaemia (WM) is based on a combination of rituximab with an alkylator or proteasome inhibitor.
The second-line treatment strategy for WM (relapsed patients) depends on the time to relapse and is based either on rituximab-based chemo-immunotherapy or single-agent therapy with IMBRUVICA (ibrutinib).
Role of the medicinal product in the care pathway
IMBRUVICA (ibrutinib) in combination with rituximab has no role in the treatment of adult patients with Waldenström's macroglobulinaemia.
Clinical Benefit
| Insufficient |
The Committee deems that, on the basis of currently available data, the clinical benefit of IMBRUVICA (ibrutinib) in combination with rituximab is insufficient to justify its funding by the French national health insurance system in the treatment of adult patients with Waldenström's macroglobulinaemia. |
